Ocular Management Support

The eye care professional is an integral part of the BLENREP journey

The oncologist and eye care professional partner to create one cohesive treatment plan.

  • Eye exams are required with BLENREP1

  • Find an eye care professional near you

 

 

 

BLENREP Eye Drop Supportive Care Program

  • Patients can receive complimentary shipments of eye drops throughout therapy

  • 60 vials of preservative-free lubricant eye drops mailed every 60 days

SOUND FX: 2 heartbeats
ANIMATION: GSK Oncology On Demand for US HCPs


VO: INDICATION
BLENREP (belantamab mafodotin-blmf) is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.


This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.


IMPORTANT SAFETY INFORMATION

WARNING: OCULAR TOXICITY

BLENREP caused changes in the corneal epithelium resulting in changes in vision, including severe vision loss and corneal ulcer, and symptoms such as blurred vision and dry eyes.


Conduct ophthalmic exams at baseline, prior to each dose, and promptly for worsening symptoms. Withhold BLENREP until improvement and resume, or permanently discontinue, based on severity.


Because of the risk of ocular toxicity, BLENREP is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BLENREP REMS.


Please see IMPORTANT SAFETY INFORMATION and full Prescribing Information, including BOXED WARNING.
TEXT ON SCREEN: BLENREP
belantamab
mafodotin-blmf
for injection 100 mg


INDICATION

BLENREP is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.


This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).


IMPORTANT SAFETY INFORMATION

  1. WARNING: OCULAR TOXICITY
  2. BLENREP caused changes in the corneal epithelium resulting in changes in vision, including severe vision loss and corneal ulcer, and symptoms such as blurred vision and dry eyes.
  3. Conduct ophthalmic exams at baseline, prior to each dose, and promptly for worsening symptoms. Withhold BLENREP until improvement and resume, or permanently discontinue, based on severity.
  4. Because of the risk of ocular toxicity, BLENREP is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BLENREP REMS.

Please see IMPORTANT SAFETY INFORMATION and full Prescribing Information, including BOXED WARNING.


VO: Have you told your patients about BLENREP’s Eye Drop Supportive Care Program?
TEXT ON SCREEN: EYE DROP SUPPORTIVE CARE PROGRAM
Please see Important Safety Information and full Prescribing Information, including BOXED WARNING.


VO: It’s a program that provides free eye drops to patients throughout therapy.
TEXT ON SCREEN: EYE DROPS
60 vials of eye drops every 60 days
VO: Patients will need an ophthalmic exam at baseline, prior to each dose, and promptly for worsening symptoms.


TEXT ON SCREEN: EYE DROPS
Patients will need an ophthalmic exam at baseline, prior to each dose, and promptly for worsening symptoms.


VO: During treatment with BLENREP
TEXT ON SCREEN: Please see Important Safety Information and full Prescribing Information, including BOXED WARNING.


VO: it’s important for patients to apply preservative-free lubricant eye drops at least four times a day
TEXT ON SCREEN: FOUR TIMES PER DAY
Starting with the 1st infusion and continuing until the end of treatment


VO: starting with the 1st infusion and continuing until the end of treatment.
TEXT ON SCREEN: Starting with the 1st infusion and continuing until the end of treatment


VO: The Eye Drop Supportive Care Program can help them do just that.
TEXT ON SCREEN: EYE DROP SUPPORTIVE CARE PROGRAM


VO: Help patients enroll in 3 easy steps:
TEXT ON SCREEN: HELP PATIENTS ENROLL IN 3 EASY STEPS


VO: Print the Eye Drop Supportive Care Program enrollment form
TEXT ON SCREEN: STEP 1
PRINT
View Enrollment Form


VO: from BLENREPHCP.com.
TEXT ON SCREEN: Image of the front of the BLENREP Eye Drop Supportive Care Program form is displayed. The following text matches the text on the front of this form. BLENREP Eye Drop Supportive Care Program


BLENREP
belantamab
mafodotin-blmf
for injection 100 mg


This form must be completed, signed, and submitted before you can receive preservative-free lubricant eye drops. Print and submit the completed form by fax at 1-888-635-1044.


Patient Information
Fields marked * are REQUIRED
First Name*:
Middle Initial:
Last Name*:
Date of Birth (MM/DD/YYYY)*:
Phone Number*:
Email Address:
Address*:
City*:
State*:
ZIP Code:
Shipping address is same as mailing address (above).
Preferred shipping address entered below.
Preferred Shipping Address:
City:
State:
ZIP Code:


Patient Authorization to Use Health Information

By signing this form, I agree to allow my doctors, doctors’ offices, hospitals, infusion
sites, specialty distributor(s), and authorized staff supporting these entities (collectively
“Healthcare Providers”), to use and disclose my health information to GSK and its agents,
authorized representatives, and contractors (collectively “GSK”) so that GSK can use and
disclose my health information for purposes of providing me with preservative-free lubricant
eye drops. The following activities are included:

  1. Utilizing my REMS information such as REMS ID, REMS Enrollment Status, REMS Enrollment Form, Patient Status Forms, Eye Care Professional Consult Forms, and the REMS Checklist completed by my Healthcare Providers.
  2. Communicating with my Healthcare Providers about my BLENREP prescription and medical condition.
  3. Disclosing my information to third parties if required by law.

Access to this form at www.blenrephcp.com
Continued on reverse.


Please see Important Safety Information and full Prescribing Information, including BOXED WARNING.


VO: Complete the form with your patient.
TEXT ON SCREEN: STEP 2
*Remember to give your patient a copy of the form for their records!


Animation showing the front of the BLENREP Eye Drop Supportive Care Program form being completed is shown.


TEXT ON SCREEN: STEP 2
*Remember to give your patient a copy of the form for their records!


Image of the back of the BLENREP Eye Drop Supportive Care Program form is displayed. The following text matches the text on the front of this form. Animation showing the back of the BLENREP Eye Drop Supportive Care Program form being completed is shown.


Patient Authorization to Use Health Information (cont’d)


By signing this authorization, I acknowledge my understanding that:

  • My Healthcare Providers will not and may not condition my treatment, payment for treatment, or eligibility for or enrollment in benefits on whether I sign this patient authorization.
  • Once information about me is released to GSK based on this authorization, federal privacy laws may no longer protect my information and may not prevent GSK from further disclosing my information. However, I understand that GSK has agreed to use or disclose information received only for the purposes described in this authorization or as required by law.
  • This authorization will remain in effect for two (2) years after I sign it (unless a shorter period is required by state law) or for as long as I participate in the eye drop program, whichever is longer.
  • I have the right to revoke this authorization at any time by mailing a signed, written statement of my revocation to United BioSource LLC, BLENREP Eye Drop Supportive Care Program, 200 Pinecrest Plaza Morgantown, WV 26505 US, but such a revocation would end my eligibility to participate in the eye drop program. (The revocation process may also be initiated by calling the Coordinating Center at 1-855-209-9188). Revoking this authorization will prohibit further disclosures by my Healthcare Providers based on this authorization after the date a written revocation is received but will not apply to the extent that they have already taken action in reliance on this authorization. After this authorization is revoked, I understand that information provided to GSK prior to the revocation may be disclosed within GSK to maintain records of my participation.

The patient, or the patient’s legal guardian, MUST sign this form in order for the patient to receive preservative-free lubricant eye drops. If a legal guardian signs for the patient, please indicate relationship to the patient.


Patient Signature and Acknowledgment
By signing this form, I agree that GSK can utilize the health information described above,
including my REMS information, to provide me free preservative-free lubricant eye drops.
Patient / Legal Guardian Signature
PRINT NAME
Date
MONTH/DAY/YEAR


Trademarks are owned by or licensed to the GSK group of companies.
©2020 GSK or licensor.
BLMLTR200018 October 2020
Produced in USA. 0002-0009-50


BLENREP
belantamab
mafodotin-blmf
for injection 100 mg


VO: Fax the form
TEXT ON SCREEN: STEP 3


VO: to 1-888-635-1044.
TEXT ON SCREEN: FAX TO:
1-888-635-1044


VO: Once the patient is enrolled, the patient is expected to receive the shipment within 4 business days.
TEXT ON SCREEN: MON 1
TUE 2
WED 3
THU 4
EYE DROPS


VO: After that, your patient will continue to receive an eye drop shipment in the mail
TEXT ON SCREEN: EYE DROPS
These eye drops are intended to serve as a sample. If your patient runs out during treatment, then your patient will need to purchase additional preservative-free eye drops. There are instructions about purchasing the correct over-the-counter drops in the BLENREP REMS Patient Guide.


VO: every 60 days throughout therapy.
TEXT ON SCREEN:
EVERY 60 DAYS These eye drops are intended to serve as a sample. If your patient runs out during treatment, then your patient will need to purchase additional preservative-free eye drops. There are instructions about purchasing the correct over-the-counter drops in the BLENREP REMS Patient Guide.


VO: Tell your patients about an additional supportive resource during treatment with BLENREP.
TEXT ON SCREEN: Enroll your patients at


VO: Download the enrollment form and get your patient started today at
www.BLENREPHCP.com
TEXT ON SCREEN: Enroll your patients at
BLENREPHCP.com


VO: WARNINGS AND PRECAUTIONS.
Ocular Toxicity: Ocular adverse reactions occurred in 77% of the 218 patients in the pooled safety population. Ocular adverse reactions included keratopathy (76%), changes in visual acuity (55%), blurred vision (27%), and dry eye (19%). Among patients with keratopathy (n = 165), 49% had ocular symptoms, 65% had clinically relevant visual acuity changes (decline of 2 or more lines on Snellen Visual Acuity in any eye), and 34% had both ocular symptoms and visual acuity changes.


Keratopathy: Keratopathy was reported as Grade 1 in 7% of patients, Grade 2 in 22%, Grade 3 in 45%, and Grade 4 in 0.5% per the KVA scale. Cases of corneal ulcer (ulcerative and infective keratitis) have been reported. Most keratopathy events developed within the first 2 treatment cycles (cumulative incidence of 65% by Cycle 2). Of the patients with Grade 2 to 4 keratopathy (n = 149), 39% recovered to Grade 1 or lower after median follow-up of 6.2 months. Of the 61% who had ongoing keratopathy, 28% were still on treatment, 9% were in follow-up, and in 24% the follow-up ended due to death, study withdrawal, or lost to follow-up. For patients in whom events resolved, the median time to resolution was 2 months (range: 11 days to 8.3 months).


Visual Acuity Changes: A clinically significant decrease in visual acuity of worse than 20/40 in the better-seeing eye was observed in 19% of the 218 patients and of 20/200 or worse in the better-seeing eye in 1.4%. Of the patients with decreased visual acuity of worse than 20/40, 88% resolved and the median time to resolution was 22 days (range: 7 days to 4.2 months). Of the patients with decreased visual acuity of 20/200 or worse, all resolved and the median duration was 22 days (range: 15 to 22 days).


Monitoring and Patient Instruction: Conduct ophthalmic examinations (visual acuity and slit lamp) at baseline, prior to each dose, and promptly for worsening symptoms. Perform baseline examinations within 3 weeks prior to the first dose. Perform each follow-up examination at least 1 week after the previous dose and within 2 weeks prior to the next dose. Withhold BLENREP until improvement and resume at same or reduced dose, or consider permanently discontinuing based on severity. Advise patients to use preservative-free lubricant eye drops at least 4 times a day starting with the first infusion and continuing until end of treatment. Avoid use of contact lenses unless directed by an ophthalmologist. Changes in visual acuity may be associated with difficulty for driving and reading. Advise patients to use caution when driving or operating machinery. BLENREP is only available through a restricted program under a REMS.


Thrombocytopenia: Thrombocytopenia occurred in 69% of 218 patients in the pooled safety population, including Grade 2 in 13%, Grade 3 in 10%, and Grade 4 in 17%. The median time to onset of the first thrombocytopenic event was 26.5 days. Thrombocytopenia resulted in dose reduction, dose interruption, or discontinuation in 9%, 2.8%, and 0.5% of patients, respectively. Grade 3 to 4 bleeding events occurred in 6% of patients, including Grade 4 in 1 patient. Fatal adverse reactions included cerebral hemorrhage in 2 patients. Perform complete blood cell counts at baseline and during treatment as clinically indicated. Consider withholding and/or reducing the dose based on severity.


Infusion-Related Reactions: Infusion-related reactions occurred in 18% of 218 patients in the pooled safety population, including Grade 3 in 1.8%. Monitor patients for infusion-related reactions. For Grade 2 or 3 reactions, interrupt the infusion and provide supportive treatment. Once symptoms resolve, resume at a lower infusion rate. Administer premedication for all subsequent infusions. Discontinue BLENREP for life-threatening infusion-related reactions and provide appropriate emergency care.


Embryo-Fetal Toxicity: Based on its mechanism of action, BLENREP can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with BLENREP and for 4 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with BLENREP and for 6 months after the last dose. Pregnancy testing is recommended for females of reproductive potential prior to initiating BLENREP.


ADVERSE REACTIONS

The pooled safety population described in Warnings and Precautions reflects exposure to BLENREP at a dosage of 2.5 mg/kg or 3.4 mg/kg (1.4 times the recommended dose) administered intravenously once every 3 weeks in 218 patients in DREAMM-2. Of these patients, 194 received a liquid formulation (not the approved dosage form) rather than the lyophilized powder.


Patients received BLENREP at the recommended dosage of 2.5 mg/kg administered intravenously once every 3 weeks (n = 95). Permanent discontinuation due to an adverse reaction occurred in 8% of patients who received BLENREP; keratopathy (2.1%) was the most frequent adverse reaction resulting in permanent discontinuation. Dosage interruptions due to an adverse reaction occurred in 54% of patients who received BLENREP. Adverse reactions which required a dosage interruption in >3% of patients included keratopathy (47%), blurred vision (5%), dry eye (3.2%), and pneumonia (3.2%). Dose reductions due to an adverse reaction occurred in 29% of patients. Adverse reactions which required a dose reduction in >3% of patients included keratopathy (23%) and thrombocytopenia (5%).


The most common adverse reactions (≥20%) were keratopathy (71%), decreased visual acuity (53%), nausea (24%), blurred vision (22%), pyrexia (22%), infusion-related reactions (21%), and fatigue (20%). The most common Grade 3 or 4 (≥5%) laboratory abnormalities were lymphocytes decreased (22%), platelets decreased (21%), hemoglobin decreased (18%), neutrophils decreased (9%), creatinine increased (5%), and gamma-glutamyl transferase increased (5%).


Serious adverse reactions occurred in 40% of patients who received BLENREP. Serious adverse reactions in >3% of patients included pneumonia (7%), pyrexia (6%), renal impairment (4.2%), sepsis (4.2%), hypercalcemia (4.2%), and infusion-related reactions (3.2%). Fatal adverse reactions occurred in 3.2% of patients, including sepsis (1%), cardiac arrest (1%), and lung infection (1%).


Clinically relevant adverse reactions from expanded access programs include: pneumonitis including fatal cases.


USE IN SPECIFIC POPULATIONS

Lactation: Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with BLENREP and for 3 months after the last dose.


Females and Males of Reproductive Potential: Based on findings in animal studies, BLENREP may impair fertility in females and males.


Geriatric Use: Of the 218 patients who received BLENREP in DREAMM-2, 43% were aged 65 to less than 75 years and 17% were aged 75 years and older. Keratopathy occurred in 80% of patients aged less than 65 years and 73% of patients aged 65 years and older. Among the 95 patients who received BLENREP at the 2.5-mg/kg dose, keratopathy occurred in 67% of patients aged less than 65 years and 73% of patients aged 65 years and older.


Renal or Hepatic Impairment: The recommended dosage has not been established in patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2) or end-stage renal disease (ESRD) with eGFR <15 mL/min/1.73 m2 not on dialysis or requiring dialysis. The recommended dosage has not been established in patients with moderate or severe hepatic impairment (total bilirubin >1.5 × ULN and any AST).


Please see full Prescribing Information, including BOXED WARNING.


TEXT ON SCREEN (Scrolling ISI):

IMPORTANT SAFETY INFORMATION (CONT’D)

WARNINGS AND PRECAUTIONS

Ocular Toxicity: Ocular adverse reactions occurred in 77% of the 218 patients in the pooled safety population. Ocular adverse reactions included keratopathy (76%), changes in visual acuity (55%), blurred vision (27%), and dry eye (19%). Among patients with keratopathy (n = 165), 49% had ocular symptoms, 65% had clinically relevant visual acuity changes (decline of 2 or more lines on Snellen Visual Acuity in any eye), and 34% had both ocular symptoms and visual acuity changes.


Keratopathy: Keratopathy was reported as Grade 1 in 7% of patients, Grade 2 in 22%, Grade 3 in 45%, and Grade 4 in 0.5% per the KVA scale. Cases of corneal ulcer (ulcerative and infective keratitis) have been reported. Most keratopathy events developed within the first 2 treatment cycles (cumulative incidence of 65% by Cycle 2). Of the patients with Grade 2 to 4 keratopathy (n = 149), 39% recovered to Grade 1 or lower after median follow-up of 6.2 months. Of the 61% who had ongoing keratopathy, 28% were still on treatment, 9% were in follow-up, and in 24% the follow-up ended due to death, study withdrawal, or lost to follow-up. For patients in whom events resolved, the median time to resolution was 2 months (range: 11 days to 8.3 months).


Visual Acuity Changes: A clinically significant decrease in visual acuity of worse than 20/40 in the better-seeing eye was observed in 19% of the 218 patients and of 20/200 or worse in the better-seeing eye in 1.4%. Of the patients with decreased visual acuity of worse than 20/40, 88% resolved and the median time to resolution was 22 days (range: 7 days to 4.2 months). Of the patients with decreased visual acuity of 20/200 or worse, all resolved and the median duration was 22 days (range: 15 to 22 days).


Monitoring and Patient Instruction: Conduct ophthalmic examinations (visual acuity and slit lamp) at baseline, prior to each dose, and promptly for worsening symptoms. Perform baseline examinations within 3 weeks prior to the first dose. Perform each follow-up examination at least 1 week after the previous dose and within 2 weeks prior to the next dose. Withhold BLENREP until improvement and resume at same or reduced dose, or consider permanently discontinuing based on severity. Advise patients to use preservative-free lubricant eye drops at least 4 times a day starting with the first infusion and continuing until end of treatment. Avoid use of contact lenses unless directed by an ophthalmologist. Changes in visual acuity may be associated with difficulty for driving and reading. Advise patients to use caution when driving or operating machinery. BLENREP is only available through a restricted program under a REMS.


Thrombocytopenia: Thrombocytopenia occurred in 69% of 218 patients in the pooled safety population, including Grade 2 in 13%, Grade 3 in 10%, and Grade 4 in 17%. The median time to onset of the first thrombocytopenic event was 26.5 days. Thrombocytopenia resulted in dose reduction, dose interruption, or discontinuation in 9%, 2.8%, and 0.5% of patients, respectively. Grade 3 to 4 bleeding events occurred in 6% of patients, including Grade 4 in 1 patient. Fatal adverse reactions included cerebral hemorrhage in 2 patients. Perform complete blood cell counts at baseline and during treatment as clinically indicated. Consider withholding and/or reducing the dose based on severity.


Infusion-Related Reactions: Infusion-related reactions occurred in 18% of 218 patients in the pooled safety population, including Grade 3 in 1.8%. Monitor patients for infusion-related reactions. For Grade 2 or 3 reactions, interrupt the infusion and provide supportive treatment. Once symptoms resolve, resume at a lower infusion rate. Administer premedication for all subsequent infusions. Discontinue BLENREP for life-threatening infusion-related reactions and provide appropriate emergency care.


Embryo-Fetal Toxicity: Based on its mechanism of action, BLENREP can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with BLENREP and for 4 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with BLENREP and for 6 months after the last dose. Pregnancy testing is recommended for females of reproductive potential prior to initiating BLENREP.


ADVERSE REACTIONS

The pooled safety population described in Warnings and Precautions reflects exposure to BLENREP at a dosage of 2.5 mg/kg or 3.4 mg/kg (1.4 times the recommended dose) administered intravenously once every 3 weeks in 218 patients in DREAMM-2. Of these patients, 194 received a liquid formulation (not the approved dosage form) rather than the lyophilized powder.

Patients received BLENREP at the recommended dosage of 2.5 mg/kg administered intravenously once every 3 weeks (n = 95). Permanent discontinuation due to an adverse reaction occurred in 8% of patients who received BLENREP; keratopathy (2.1%) was the most frequent adverse reaction resulting in permanent discontinuation. Dosage interruptions due to an adverse reaction occurred in 54% of patients who received BLENREP. Adverse reactions which required a dosage interruption in >3% of patients included keratopathy (47%), blurred vision (5%), dry eye (3.2%), and pneumonia (3.2%). Dose reductions due to an adverse reaction occurred in 29% of patients. Adverse reactions which required a dose reduction in >3% of patients included keratopathy (23%) and thrombocytopenia (5%).

The most common adverse reactions (≥20%) were keratopathy (71%), decreased visual acuity (53%), nausea (24%), blurred vision (22%), pyrexia (22%), infusion-related reactions (21%), and fatigue (20%). The most common Grade 3 or 4 (≥5%) laboratory abnormalities were lymphocytes decreased (22%), platelets decreased (21%), hemoglobin decreased (18%), neutrophils decreased (9%), creatinine increased (5%), and gamma-glutamyl transferase increased (5%).

Serious adverse reactions occurred in 40% of patients who received BLENREP. Serious adverse reactions in >3% of patients included pneumonia (7%), pyrexia (6%), renal impairment (4.2%), sepsis (4.2%), hypercalcemia (4.2%), and infusion-related reactions (3.2%). Fatal adverse reactions occurred in 3.2% of patients, including sepsis (1%), cardiac arrest (1%), and lung infection (1%).


Clinically relevant adverse reactions from expanded access programs include: pneumonitis including fatal cases.


USE IN SPECIFIC POPULATIONS

Lactation: Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with BLENREP and for 3 months after the last dose.


Females and Males of Reproductive Potential: Based on findings in animal studies, BLENREP may impair fertility in females and males.


Geriatric Use: Of the 218 patients who received BLENREP in DREAMM-2, 43% were aged 65 to less than 75 years and 17% were aged 75 years and older. Keratopathy occurred in 80% of patients aged less than 65 years and 73% of patients aged 65 years and older. Among the 95 patients who received BLENREP at the 2.5-mg/kg dose, keratopathy occurred in 67% of patients aged less than 65 years and 73% of patients aged 65 years and older.


Renal or Hepatic Impairment: The recommended dosage has not been established in patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2) or end-stage renal disease (ESRD) with eGFR <15 mL/min/1.73 m2 not on dialysis or requiring dialysis. The recommended dosage has not been established in patients with moderate or severe hepatic impairment (total bilirubin >1.5 × ULN and any AST).


Please see full Prescribing Information, including BOXED WARNING.

 


VO: If you have questions, please call us at 1-855-209-9188.
TEXT ON SCREEN: Enroll your patients at
BLENREPHCP.com
Call us at 1-855-209-9188


TEXT ON SCREEN: BLENREP
belantamab mafodotin-blmf
for injection 100 mg


Please see full Prescribing Information, including BOXED WARNING.
Trademarks are owned by or licensed to the GSK group of companies.
©2022 GSK or licensor.
BLMVID220006 July 2022
Produced in USA.


 

Eye drop administration

  • Watch this instructional video with best practices for patients using eye drops.

TEXT ON SCREEN: GSK ONCOLOGY ON DEMAND


VO: Welcome to our video, “The Proper Use of Eye Drops.” To demonstrate the proper way to use eye drops we will show you how to use preservative-free lubricant eye drops.
TEXT ON SCREEN: THE PROPER USE OF EYE DROPS


VO: Preservative-free lubricant eye drops provide moisture to the eye which can help to soothe feelings of dryness.


VO: Step 1: Before Putting In Eye Drops
TEXT ON SCREEN: STEP 1: BEFORE PUTTING IN EYE DROPS


VO: Before opening the vial and putting eye drops in your eyes, remember to wash your hands with soap and water for 20-30 seconds.
TEXT ON SCREEN: WASH HANDS WITH SOAP / 20-30 SECONDS


VO: Next, read the label to confirm that you have the correct eye drop.
TEXT ON SCREEN: READ LABEL

VO: Because labels can vary among different types of eye drops, remember the following: check the expiration date, check the recommended time to discard, and follow the instructions of your healthcare professional as they may vary from the general directions on the package.
TEXT ON SCREEN: CHECK THE EXPIRATION DATE AND RECOMMENDED TIME TO DISCARD


VO: Step 2: How to Put In Eye Drops
TEXT ON SCREEN: STEP 2: HOW TO PUT IN EYE DROPS


VO: To begin, open the vial. Be careful to not touch the tip of the vial to your eye or other objects.
TEXT ON SCREEN: OPEN THE VIAL


VO: Then, while sitting in a chair, lean your head back and tilt your chin up towards the ceiling.
TEXT ON SCREEN: LEAN YOUR HEAD BACK AND TILT YOUR CHIN UP TOWARDS THE CEILING


VO: Next, open both eyes. With your free hand, gently pull down your lower eyelid to create a “pouch” or “pocket,” which helps to catch the eye drop.
TEXT ON SCREEN: GENTLY PULL DOWN YOUR LOWER EYELID TO CREATE A “POUCH” OR “POCKET”


VO: Then, hold the vial as close to your eye as possible. Again, remember to not touch your eye with the tip. If your hand is shaking, rest your hand with the vial either on your face or on your other hand.
TEXT ON SCREEN: HOLD THE VIAL AS CLOSE TO YOUR EYE AS POSSIBLE WITHOUT TOUCHING IT
DO NOT TOUCH YOUR EYE WITH THE TIP


VO: Next, squeeze the belly of the vial until 1 drop falls into your eye. If you do not feel a drop in your eye, add another drop.
TEXT ON SCREEN: SQUEEZE THE BELLY OF THE VIAL UNTIL 1 DROP FALLS INTO YOUR EYE


VO: Slowly let go of your lower eyelid, then gently close both eyes for 30 seconds to 1 minute. Using your finger, apply light pressure to the inner corner of your eyelid, next to your nose, to close the tear ducts. This helps the eye drop to be fully absorbed into the eye.
TEXT ON SCREEN: GENTLY CLOSE BOTH EYES FOR 30 SECONDS TO 1 MINUTE


VO: Carefully blot away excess liquid that may be on your skin.


VO: Next, open both eyes and repeat the above steps with your other eye. Note that your vision may be slightly blurry for a few minutes from the drops.
TEXT ON SCREEN: REPEAT THE SAME PROCEDURE WITH THE OTHER EYE


VO: As an alternative method, you may also lie down on a flat surface like your bed or sofa. With your eyes closed and without touching the bottle to your eyelid, put an eye drop in the corner of your eye near your nose. Then, blink to let the drop enter the eye.


VO: Step 3: After Putting In Eye Drops
TEXT ON SCREEN: STEP 3: AFTER PUTTING IN EYE DROPS


VO: Now that you have put in your eye drops, wash your hands again with soap and water for 20-30 seconds. To properly care for your eye drops, store the box of vials according to the manufacturer’s instructions.
TEXT ON SCREEN: WASH HANDS WITH SOAP / 20-30 SECONDS


VO: As an additional tip, a family member or caregiver can help if you have difficulty putting in your eye drops. Make sure that they wash their hands before providing you with assistance. There are also eye drop assistance devices which come in several forms. These devices can help with squeezing the vial, keeping the eye open, and aiming the eye drop. You can ask your healthcare professional about the right device for you.


VO: Finally, remember to follow the instructions of your healthcare professional when putting in your eye drops.
TEXT ON SCREEN: FOLLOW THE INSTRUCTIONS OF YOUR HEALTHCARE PROFESSIONAL WHEN PUTTING IN YOUR EYE DROPS


TEXT ON SCREEN: THANK YOU FOR WATCHING
Trademarks are property of their respective owners.
©2021 GSK or licensor.
BLMVID210016 August 2021
Produced in USA.

Learn more about management considerations for ocular reactions before and during treatment.

Build a strong care team for your BLENREP patients

  • Create the optimal care team using the key tips outlined in this video by three experienced professionals.

  • Paid consultants to GSK at the time of filming.

SUPER:

BLENREP

belantamab

mafodotin-blmf

for injection 100 mg


STRENGTHENING THE CARE CONTINUUM

For appropriate patients with relapsed or refractory multiple myeloma.

SUPER:


INDICATION

BLENREP is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.


This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).


IMPORTANT SAFETY INFORMATION

WARNING: OCULAR TOXICITY

BLENREP caused changes in the corneal epithelium resulting in changes in vision, including severe vision loss and corneal ulcer, and symptoms, such as blurred vision and dry eyes.


Conduct ophthalmic exams at baseline, prior to each dose, and promptly for worsening symptoms. Withhold BLENREP until improvement and resume, or permanently discontinue, based on severity.


Because of the risk of ocular toxicity, BLENREP is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BLENREP REMS.


Please see IMPORTANT SAFETY INFORMATION continued in this video and full Prescribing Information, including BOXED WARNING.



VO:

INDICATION

BLENREP (belantamab mafodotin-blmf) is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.


This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.



IMPORTANT SAFETY INFORMATION

WARNING: OCULAR TOXICITY

BLENREP caused changes in the corneal epithelium resulting in changes in vision, including severe vision loss and corneal ulcer, and symptoms, such as blurred vision and dry eyes.


Conduct ophthalmic exams at baseline, prior to each dose, and promptly for worsening symptoms. Withhold BLENREP until improvement and resume, or permanently discontinue, based on severity.


Because of the risk of ocular toxicity, BLENREP is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BLENREP REMS.


Please see IMPORTANT SAFETY INFORMATION continued in this video and full Prescribing Information, including BOXED WARNING.



VO (Gasparetto):


Hi, my name is Cristina Gasparetto and I am a hematologist oncologist.


SUPER:

Cristina Gasparetto, MD

Hematologist-Oncologist


VO:

I’ve been in practice for over 20 years, and currently, I serve as the leading physician of the multiple myeloma program within the Duke Cancer Institute. Our center uses advanced practice providers to help manage treatment, plus triage nurses like Bethany Clements to manage logistical care coordination. To date, I have treated over 30 patients for their relapsed or refractory multiple myeloma with BLENREP.


Alongside my care partners, I have some best practices, strategies, and tips to share with any office prescribing BLENREP. Our care team for BLENREP includes Dr. Newman, a local optometrist in my area, and Mrs. Clements, an oncology nurse in my practice.



VO (Newman):

Hello, I’m Mark Newman and I’ve been in practice as an eye care professional for over 20 years.


SUPER:

Mark Newman, MD

Optometrist


VO:

I joined this care team for BLENREP to help support patients with relapsed or refractory multiple myeloma, also known as RRMM, who require ocular health monitoring and management throughout their treatment.


VO:

Hi, I’m Bethany Clements and I work with Dr. Gasparetto as an oncology nurse on her care staff.


SUPER:

Bethany Clements, RN


VO (Clements): I help with care team logistics by onboarding patients and coordinating between each office. Working together, the three of us have discovered three best practices that we feel can help optimize the coordination of care between offices using BLENREP.



SUPER:


Tip 1: Set treatment expectations through patient education from the outset



VO (Gasparetto):

Like any oncologist, I’m fairly close to my patients and have invested a lot of time building trust with them.


SUPER:

Review efficacy, safety, dosing and admin, and the need for regular exams, labs, and infusions, and supportive care.

VO (Gasparetto):

The first visit should always include what to expect in terms of the efficacy and safety profile, the frequency of office visits for labs, eye exams, and infusions, and the requirements of supportive care during treatment.

As the prescribing physician, it’s very important that I discuss the potential for ocular side effects or adverse events with BLENREP before sending patients to any eye care specialist.

SUPER:

Discuss ocular AEs prior to connecting patients to an eye care specialist.

VO (Gasparetto):

When introducing another care professional into the mix, I rely on my personal relationships with my patients to instill confidence into whichever eye care specialist we select.


My staff and I set expectations for patients by covering not only the potential for response, but also the potential for dose modification, including dose hold, dose reduction, and discontinuation in some cases due to side effects.

If you are prescribing BLENREP for the first time, educate yourself and your staff on what a typical treatment journey looks like. That way, you can share the safety profile, supportive eye care, including incidence and management information with patients and caregivers.


VO (Newman):

And I can attest that the up-front time explaining those treatment details is truly appreciated. It goes a long way for patients to know that their care team is monitoring the potential for side effects closely.


As a partnering eye care professional, my goal is to safeguard the eye health of my patients, so it’s important that my patients receiving BLENREP feel a deep level of trust and comfort with me and my role in their care.

VO (Gasparetto):

Agreed. My team works very hard to ensure that patients see us all as one collective care team, rather than separate health professionals.


The oncology team should firmly define the roles and responsibilities of each care team member, and then the eye care specialist can reinforce them when they meet patients for the first time.


This means that my first visit is usually my longest.

SUPER:

“My first visit is usually the longest.”

VO (Gasparetto):

I walk patients through a typical treatment journey. This is a crucial step to outlining the commitment to the requirements needed for treatment.


Personally, I have found that if I can convey my support of BLENREP and articulate its benefit-to-risk ratio to patients, then that often helps in understanding and decision making.


Our oncology care team nurse then takes over to ensure any paperwork is taken care of. They coordinate scheduling patients for eye exams, aligning with their BLENREP infusion schedule, which is once every 3 weeks.


VO (Newman):

I expect that, by the time the patient is ready for my office, they already understand my role and responsibilities for treatment with BLENREP.


SUPER:

Who is on the patient’s care team, and what is the role of each person?


The initial connection is a great opportunity to get to know each other and learn a bit of the patient’s background.


SUPER:


The oncologist, the physician who prescribed BLENREP

The eye care specialist, the physician who monitors ocular side effects

The oncology nurse, the professional who oversees logistics and office processes


VO (Newman):

The initial connection is a great opportunity to get to know each other and learn a bit of the patient’s background. I look through their medical history to understand if they have a history of vision or eye problems. I spend time reviewing the safety profile again and defining the terms for them. I make sure to highlight that the side effects can be managed with dose modification, including dose hold, dose reduction, and discontinuation in some cases.


The oncology team should have already explained the potential and likelihood of having to modify (ie, discontinue, reduce, or delay) the dose, and how they conduct labs during the dose delays.


SUPER:

Spend time discussing who and when to modify the dose, either:

  • Discontinue
  • Reduce
  • Delay


VO (Gasparetto):

Yes, any oncologist’s office prescribing BLENREP should cover those details in the first patient visit. However, I have learned to rely on my eye doctor partner, Dr. Newman, to answer additional questions patients may have related to cornea or visual issues.


After reviewing detailed eye health information in the first visit with a patient, new offices should turn to preparing themselves for smooth care team coordination. Working out a care team process is vital to setting up your office for BLENREP. The most vital person to this process is Mrs. Clements, our oncology nurse. She will share our next tip.



SUPER:

Tip 2: Establish logistics with nursing team and collaborating ECP prior to initiating BLENREP


VO (Clements):

As a nurse in the practice, I ensure patient scheduling is on track and that communication of exam results between both offices happens in a timely manner. You can think of my role as a delegate or primary point of contact. I act on behalf of the oncologist’s office.


Both new and experienced BLENREP offices should consider appointing a primary point of contact for BLENREP–it has been instrumental in our care team’s success to have one point of contact at both the oncologist’s and eye care professional’s office.


SUPER:

Be sure to:

  • Appoint delegates at both offices
  • Enroll patient in BLENREP REMS
  • Enroll patient in Eye Drop program
  • Connect patient to an eye care professional

Honestly, most of the best practices for the nursing staff can be started from the moment an oncologist decides to prescribe BLENREP.


SUPER:

“Most of the best practices for the nursing staff can be started from the moment an oncologist decides to prescribe BLENREP.”


VO (Clements):

Typically, when Dr. Gasparetto confirms she’s prescribing BLENREP, I will begin the process of collecting the patient’s information and enrolling them in the BLENREP REMS and Eye Drop Supportive Care Program simultaneously. I will also mail the patient materials that were reviewed with them during that visit so that they have them at home. If REMS enrollment doesn’t occur during the BLENREP’s treatment initiation decision, then I will have it completed prior to their infusion, since it’s mandatory for treatment with BLENREP.


Depending on whether the patient is in the office or not, you can begin to collect all necessary forms and educational resources for them. If they are in the office, it is recommended to enroll the patient in the BLENREP REMS and Eye Drop Supportive Care Program simultaneously.


SUPER:

“It is recommended to enroll the patient in the BLENREP REMS and the Eye Drop Supportive Care Program simultaneously.”


VO (Clements):

This is the time to counsel patients on the eye exam’s requirements and the risk of ocular side effects. If they are not in the office, you can mail the forms and resources with return postage and packaging to begin the process of a quick enrollment.


Once patients are enrolled in the BLENREP REMS and the BLENREP Eye Drop Supportive Care Program, you can either connect them with an existing BLENREP-educated eye care partner or initiate with a new eye care provider.


VO (Newman):

Before deciding to join a care team for BLENREP, it’s common for eye care professionals to ask for educational materials or time to help familiarize themselves with BLENREP.


If you can find an eye doctor who has BLENREP experience, then that can save your office some onboarding time. But when setting up a new eye care practice to monitor patients, we have found the following best practices work well:


Firstly, take the time to provide any educational materials that your office has to the eye doctor’s office and answer as many questions as you feel comfortable answering. Eye care professionals are very familiar with the eye exams required for BLENREP.


SUPER:

Introduce yourself and BLENREP to the Eye Care Professional


VO (Newman):

Secondly, determine who will act as your primary point of contact or key contact from your office, and who the dedicated staff member is for the oncologist’s office. This is the person who you and your staff address all communications to and who helps ensure smooth coordination.


SUPER:

Determine the office for the eye care professional and define the primary point of contact’s responsibilities and role


VO (Clements):

The oncologist's primary point of contact should schedule and maintain all exam appointments.


SUPER:

“The oncologist's primary point of contact should schedule and maintain all exam appointments.”


VO: Once the eye care specialist finish their exam and assessment, the eye care professional’s primary point of contact collects the findings for the oncologist’s primary point of contact to receive. It’s ideal to have the ophthalmic exam the same day as the infusion, but this requires close scheduling coordination.


VO (Newman):

There are various ways to communicate exam results— by email, phone, or fax. The consult form is not mandatory to use, but I do find it convenient to use. It allows me to provide all critical exam findings and add any extra contextual information. If I don’t choose to use it, I still include all the sections listed on the consult form in my summation when I call, email, or fax the findings. Again, I contact the oncologist’s primary point of contact.


SUPER:

Communicate findings of the eye exam in a timely and regular manner to ensure next BLENREP infusion.


VO (Newman):

Like Dr. Gasparetto said earlier, I can spend time explaining my role or how BLENREP can affect their eye health, but honestly, I recommend consistently communicating exam results back to your collaborating oncologist – it makes the process so much more seamless.


No matter the results, my office has found that ensuring a timely response from my team is crucial. That means that I complete my assessment, fill out the consult form with the exam findings, and provide a summary of how the patient is trending. I make sure the patient has a copy of the form and then also send it to the oncologist's primary point of contact.


SUPER:

Remind patients about the treatment required with BLENREP which includes maintaining eye exams and treatment appointments


VO (Newman):

Maintaining the infusion schedule every 3 weeks is critical and depends on the oncologist’s office receiving the eye exam results. That’s why it’s crucial that I complete the exam and provide the necessary information back to the oncologist’s office in a timely manner. If you know your office needs a day to complete the exam and return the results, communicate this to the oncologist’s primary point of contact to work into the infusion schedule.


Only the required exam information is needed for the oncologist to determine if a patient can continue with their scheduled infusion. I’ve found it helpful to also include a summary of my findings, explaining how the patient’s eye health is trending, which is why the consult form is so helpful because it includes an open box field. Again, I send the results to the oncologist’s primary point of contact.


SUPER:

Tip 3: Consider continuing ophthalmic exams and supportive care during a dose hold


VO (Gasparetto):

Like I said earlier, we have treated 30-40 patients with BLENREP as a care team. We have experience dealing with dose modification. Each case is different, but the following things have helped us so much with setting expectation and preparing for a hopeful restart of BLENREP after a delay. In some cases, patients may need to discontinue.


It is common for patients to experience dose delays, so explaining that to your staff and patients is helpful to maintain treatment until the side effect resolves.


Another critical factor of compliance is to maintain the cadence of patients’ eye exams throughout a dose delay.


We have found that this serves multiple purposes:


  • It allows us to monitor the ocular side effects for any improvement or a sign to restart treatment.
  • Maintains the patient’s relationship with their eye doctor throughout a dose modification.
  • Keeps patients on the every-three-weeks dosing schedule, so that when the next infusion is permitted, the appointment is not delayed.


SUPER:


During a dose hold, encourage patients to keep a regular eye exam schedule with their eye care specialist in order to:

  • Monitor existing side effects
  • Maintain the eyecare doctor relationship
  • Prepare for reinitiating treatment with BLENREP if appropriate

VO (Gasparetto):

Additionally, the oncologist’s primary point of contact should maintain contact with the eye doctor’s primary point of contact.


SUPER:

Encourage your staff to maintain regular communication with the eyec care office for a timely decision to reinitiate treatment with BLENREP


VO (Newman):

Making sure that I include all context from the exam is extremely important; for example, how the exam findings are trending: either positive or negative. This is helpful to both the oncologist and patient because it sets expectations for continued delays or the potential to restart treatment.


SUPER:

“Making sure that I include all context from the exam is extremely important.”


VO (Gasparetto):

As Mrs. Clements mentioned earlier, scheduling a patient’s lab testing on the same day as the eye exam is a helpful and preferred practice.


SUPER:

Scheduling a patient’s lab testing on the same day as the eye exam is a helpful practice.


VO (Gasparetto):

With the eye exam results available, the oncologist has a comprehensive view of the patient. That way, they can assess if their eye exam results are trending toward an infusion, or trending toward a dose modification.


Since the eye results and grading are mandatory per the REMS requirements, the oncologist's office must have the results prior to infusion. That way, there are no hiccups on the day of treatment.


VO (Gasparetto):

Additionally, caregivers and patients can coordinate transportation and hear their labs firsthand.


SUPER:

  • Oncologist can assess what’s next, a dose hold, dose delay, or dose discontinuation
  • Caregivers and patients can coordinate transportation for one day
  • Patients and oncologist can discuss their labs firsthand

VO (Clements):

The unique requirements for BLENREP treatment demand specific roles from each member of the care team.


Part of why we work so well together is that we can trust each other to fulfill our roles.


The eye exams and findings initiate each infusion cycle, so it’s important for the eye care specialist to be responsive and clear with the exam results. The oncologists can assess and schedule infusions based on the findings. The eye exam trends can also help inform the whole care team of what’s next. Throughout the whole process, the oncologist’s primary point of contact is working behind the scenes to make sure everything is running smoothly and keep the patient on track.


VO (Gasparetto):

As I’m sure everyone has already said, the insights from our care team should serve as best practices for any new office looking to treat patients with BLENREP.


SUPER:

Use these 3 helpful tips to set up your office when prescribing BLENREP.


VO (Newman):

Yes, agreed, we are sharing what we have seen help our offices and staff optimize care for both our patients and practices after prescribing BLENREP.


SUPER:

Tip 1: Set treatment expectations through patient education from the outset

Tip 2: Establish logistics with the nursing team and collaborating eye care professional prior to initiating BLENREP

Tip 3: Consider continuing ophthalmic exams and supportive care during a dose hold.


VO (Clements):

We experienced a lot of success with our approach, and we wish each office the best as they begin prescribing BLENREP for appropriate patients.

 

SUPER:

INDICATION

BLENREP is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.


This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

IMPORTANT SAFETY INFORMATION


  1. WARNING: OCULAR TOXICITY

  2. BLENREP caused changes in the corneal epithelium resulting in changes in vision, including severe vision loss and corneal ulcer, and symptoms such as blurred vision and dry eyes.

  3. Conduct ophthalmic exams at baseline, prior to each dose, and promptly for worsening symptoms. Withhold BLENREP until improvement and resume, or permanently discontinue, based on severity.

  4. Because of the risk of ocular toxicity, BLENREP is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BLENREP REMS.

WARNINGS AND PRECAUTIONS

Ocular Toxicity: Ocular adverse reactions occurred in 77% of the 218 patients in the pooled safety population. Ocular adverse reactions included keratopathy (76%), changes in visual acuity (55%), blurred vision (27%), and dry eye (19%). Among patients with keratopathy (n = 165), 49% had ocular symptoms, 65% had clinically relevant visual acuity changes (decline of 2 or more lines on Snellen Visual Acuity in any eye), and 34% had both ocular symptoms and visual acuity changes.


Keratopathy: Keratopathy was reported as Grade 1 in 7% of patients, Grade 2 in 22%, Grade 3 in 45%, and Grade 4 in 0.5% per the KVA scale. Cases of corneal ulcer (ulcerative and infective keratitis) have been reported. Most keratopathy events developed within the first 2 treatment cycles (cumulative incidence of 65% by Cycle 2). Of the patients with Grade 2 to 4 keratopathy (n = 149), 39% recovered to Grade 1 or lower after median follow-up of 6.2 months. Of the 61% who had ongoing keratopathy, 28% were still on treatment, 9% were in follow-up, and in 24% the follow-up ended due to death, study withdrawal, or lost to follow-up. For patients in whom events resolved, the median time to resolution was 2 months (range: 11 days to 8.3 months).


Visual Acuity Changes: A clinically significant decrease in visual acuity of worse than 20/40 in the better-seeing eye was observed in 19% of the 218 patients and of 20/200 or worse in the better-seeing eye in 1.4%. Of the patients with decreased visual acuity of worse than 20/40, 88% resolved and the median time to resolution was 22 days (range: 7 days to 4.2 months). Of the patients with decreased visual acuity of 20/200 or worse, all resolved and the median duration was 22 days (range: 15 to 22 days).


Monitoring and Patient Instruction: Conduct ophthalmic examinations (visual acuity and slit lamp) at baseline, prior to each dose, and promptly for worsening symptoms. Perform baseline examinations within 3 weeks prior to the first dose. Perform each follow-up examination at least 1 week after the previous dose and within 2 weeks prior to the next dose. Withhold BLENREP until improvement and resume at same or reduced dose, or consider permanently discontinuing based on severity. Advise patients to use preservative-free lubricant eye drops at least 4 times a day starting with the first infusion and continuing until end of treatment. Avoid use of contact lenses unless directed by an ophthalmologist. Changes in visual acuity may be associated with difficulty for driving and reading. Advise patients to use caution when driving or operating machinery. BLENREP is only available through a restricted program under a REMS


Thrombocytopenia: Thrombocytopenia occurred in 69% of 218 patients in the pooled safety population, including Grade 2 in 13%, Grade 3 in 10%, and Grade 4 in 17%. The median time to onset of the first thrombocytopenic event was 26.5 days. Thrombocytopenia resulted in dose reduction, dose interruption, or discontinuation in 9%, 2.8%, and 0.5% of patients, respectively. Grade 3 to 4 bleeding events occurred in 6% of patients, including Grade 4 in 1 patient. Fatal adverse reactions included cerebral hemorrhage in 2 patients. Perform complete blood cell counts at baseline and during treatment as clinically indicated. Consider withholding and/or reducing the dose based on severity.


Infusion-Related Reactions: Infusion-related reactions occurred in 18% of 218 patients in the pooled safety population, including Grade 3 in 1.8%. Monitor patients for infusion-related reactions. For Grade 2 or 3 reactions, interrupt the infusion and provide supportive treatment. Once symptoms resolve, resume at a lower infusion rate. Administer premedication for all subsequent infusions. Discontinue BLENREP for life-threatening infusion-related reactions and provide appropriate emergency care.


Embryo-Fetal Toxicity: Based on its mechanism of action, BLENREP can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with BLENREP and for 4 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with BLENREP and for 6 months after the last dose. Pregnancy testing is recommended for females of reproductive potential prior to initiating BLENREP.



ADVERSE REACTIONS

The pooled safety population described in Warnings and Precautions reflects exposure to BLENREP at a dosage of 2.5 mg/kg or 3.4 mg/kg (1.4 times the recommended dose) administered intravenously once every 3 weeks in 218 patients in DREAMM-2. Of these patients, 194 received a liquid formulation (not the approved dosage form) rather than the lyophilized powder.


Patients received BLENREP at the recommended dosage of 2.5 mg/kg administered intravenously once every 3 weeks (n = 95). Permanent discontinuation due to an adverse reaction occurred in 8% of patients who received BLENREP; keratopathy (2.1%) was the most frequent adverse reaction resulting in permanent discontinuation. Dosage interruptions due to an adverse reaction occurred in 54% of patients who received BLENREP. Adverse reactions which required a dosage interruption in >3% of patients included keratopathy (47%), blurred vision (5%), dry eye (3.2%), and pneumonia (3.2%). Dose reductions due to an adverse reaction occurred in 29% of patients. Adverse reactions which required a dose reduction in >3% of patients included keratopathy (23%) and thrombocytopenia (5%).


The most common adverse reactions (≥20%) were keratopathy (71%), decreased visual acuity (53%), nausea (24%), blurred vision (22%), pyrexia (22%), infusion-related reactions (21%), and fatigue (20%). The most common Grade 3 or 4 (≥5%) laboratory abnormalities were lymphocytes decreased (22%), platelets decreased (21%), hemoglobin decreased (18%), neutrophils decreased (9%), creatinine increased (5%), and gamma-glutamyl transferase increased (5%).


Serious adverse reactions occurred in 40% of patients who received BLENREP. Serious adverse reactions in >3% of patients included pneumonia (7%), pyrexia (6%), renal impairment (4.2%), sepsis (4.2%), hypercalcemia (4.2%), and infusion-related reactions (3.2%). Fatal adverse reactions occurred in 3.2% of patients, including sepsis (1%), cardiac arrest (1%), and lung infection (1%).


Clinically relevant adverse reactions from expanded access programs include: pneumonitis including fatal cases.


USE IN SPECIFIC POPULATIONS

Lactation: Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with BLENREP and for 3 months after the last dose.


Females and Males of Reproductive Potential: Based on findings in animal studies, BLENREP may impair fertility in females and males.


Geriatric Use: Of the 218 patients who received BLENREP in DREAMM-2, 43% were aged 65 to less than 75 years and 17% were aged 75 years and older. Keratopathy occurred in 80% of patients aged less than 65 years and 73% of patients aged 65 years and older. Among the 95 patients who received BLENREP at the 2.5-mg/kg dose, keratopathy occurred in 67% of patients aged less than 65 years and 73% of patients aged 65 years and older.


Renal or Hepatic Impairment: The recommended dosage has not been established in patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2) or end-stage renal disease (ESRD) with eGFR <15 mL/min/1.73 m2 not on dialysis or requiring dialysis. The recommended dosage has not been established in patients with moderate or severe hepatic impairment (total bilirubin >1.5 × ULN and any AST).


VO:

INDICATION

BLENREP (belantamab mafodotin-blmf) is indicated for the treatment of adults with relapsed or refractory multiple myeloma who have received at least 4 prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.


This indication is approved under accelerated approval based on response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.



IMPORTANT SAFETY INFORMATION


  1. WARNING: OCULAR TOXICITY

  2. BLENREP caused changes in the corneal epithelium resulting in changes in vision, including severe vision loss and corneal ulcer, and symptoms such as blurred vision and dry eyes.

  3. Conduct ophthalmic exams at baseline, prior to each dose, and promptly for worsening symptoms. Withhold BLENREP until improvement and resume, or permanently discontinue, based on severity.

  4. Because of the risk of ocular toxicity, BLENREP is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BLENREP REMS.

WARNINGS AND PRECAUTIONS

Ocular Toxicity: Ocular adverse reactions occurred in 77% of the 218 patients in the pooled safety population. Ocular adverse reactions included keratopathy (76%), changes in visual acuity (55%), blurred vision (27%), and dry eye (19%). Among patients with keratopathy (n = 165), 49% had ocular symptoms, 65% had clinically relevant visual acuity changes (decline of 2 or more lines on Snellen Visual Acuity in any eye), and 34% had both ocular symptoms and visual acuity changes.


Keratopathy: Keratopathy was reported as Grade 1 in 7% of patients, Grade 2 in 22%, Grade 3 in 45%, and Grade 4 in 0.5% per the KVA scale. Cases of corneal ulcer (ulcerative and infective keratitis) have been reported. Most keratopathy events developed within the first 2 treatment cycles (cumulative incidence of 65% by Cycle 2). Of the patients with Grade 2 to 4 keratopathy (n = 149), 39% recovered to Grade 1 or lower after median follow-up of 6.2 months. Of the 61% who had ongoing keratopathy, 28% were still on treatment, 9% were in follow-up, and in 24% the follow-up ended due to death, study withdrawal, or lost to follow-up. For patients in whom events resolved, the median time to resolution was 2 months (range: 11 days to 8.3 months).


Visual Acuity Changes: A clinically significant decrease in visual acuity of worse than 20/40 in the better-seeing eye was observed in 19% of the 218 patients and of 20/200 or worse in the better-seeing eye in 1.4%. Of the patients with decreased visual acuity of worse than 20/40, 88% resolved and the median time to resolution was 22 days (range: 7 days to 4.2 months). Of the patients with decreased visual acuity of 20/200 or worse, all resolved and the median duration was 22 days (range: 15 to 22 days).


Monitoring and Patient Instruction: Conduct ophthalmic examinations (visual acuity and slit lamp) at baseline, prior to each dose, and promptly for worsening symptoms. Perform baseline examinations within 3 weeks prior to the first dose. Perform each follow-up examination at least 1 week after the previous dose and within 2 weeks prior to the next dose. Withhold BLENREP until improvement and resume at same or reduced dose, or consider permanently discontinuing based on severity. Advise patients to use preservative-free lubricant eye drops at least 4 times a day starting with the first infusion and continuing until end of treatment. Avoid use of contact lenses unless directed by an ophthalmologist. Changes in visual acuity may be associated with difficulty for driving and reading. Advise patients to use caution when driving or operating machinery. BLENREP is only available through a restricted program under a REMS.


Thrombocytopenia: Thrombocytopenia occurred in 69% of 218 patients in the pooled safety population, including Grade 2 in 13%, Grade 3 in 10%, and Grade 4 in 17%. The median time to onset of the first thrombocytopenic event was 26.5 days. Thrombocytopenia resulted in dose reduction, dose interruption, or discontinuation in 9%, 2.8%, and 0.5% of patients, respectively. Grade 3 to 4 bleeding events occurred in 6% of patients, including Grade 4 in 1 patient. Fatal adverse reactions included cerebral hemorrhage in 2 patients. Perform complete blood cell counts at baseline and during treatment as clinically indicated. Consider withholding and/or reducing the dose based on severity.


Infusion-Related Reactions: Infusion-related reactions occurred in 18% of 218 patients in the pooled safety population, including Grade 3 in 1.8%. Monitor patients for infusion-related reactions. For Grade 2 or 3 reactions, interrupt the infusion and provide supportive treatment. Once symptoms resolve, resume at a lower infusion rate. Administer premedication for all subsequent infusions. Discontinue BLENREP for life-threatening infusion-related reactions and provide appropriate emergency care.


Embryo-Fetal Toxicity: Based on its mechanism of action, BLENREP can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with BLENREP and for 4 months after the last dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with BLENREP and for 6 months after the last dose. Pregnancy testing is recommended for females of reproductive potential prior to initiating BLENREP.


ADVERSE REACTIONS

The pooled safety population described in Warnings and Precautions reflects exposure to BLENREP at a dosage of 2.5 mg/kg or 3.4 mg/kg (1.4 times the recommended dose) administered intravenously once every 3 weeks in 218 patients in DREAMM-2. Of these patients, 194 received a liquid formulation (not the approved dosage form) rather than the lyophilized powder.


Patients received BLENREP at the recommended dosage of 2.5 mg/kg administered intravenously once every 3 weeks (n = 95). Permanent discontinuation due to an adverse reaction occurred in 8% of patients who received BLENREP; keratopathy (2.1%) was the most frequent adverse reaction resulting in permanent discontinuation. Dosage interruptions due to an adverse reaction occurred in 54% of patients who received BLENREP. Adverse reactions which required a dosage interruption in >3% of patients included keratopathy (47%), blurred vision (5%), dry eye (3.2%), and pneumonia (3.2%). Dose reductions due to an adverse reaction occurred in 29% of patients. Adverse reactions which required a dose reduction in >3% of patients included keratopathy (23%) and thrombocytopenia (5%).


The most common adverse reactions (≥20%) were keratopathy (71%), decreased visual acuity (53%), nausea (24%), blurred vision (22%), pyrexia (22%), infusion-related reactions (21%), and fatigue (20%). The most common Grade 3 or 4 (≥5%) laboratory abnormalities were lymphocytes decreased (22%), platelets decreased (21%), hemoglobin decreased (18%), neutrophils decreased (9%), creatinine increased (5%), and gamma-glutamyl transferase increased (5%).


Serious adverse reactions occurred in 40% of patients who received BLENREP. Serious adverse reactions in >3% of patients included pneumonia (7%), pyrexia (6%), renal impairment (4.2%), sepsis (4.2%), hypercalcemia (4.2%), and infusion-related reactions (3.2%). Fatal adverse reactions occurred in 3.2% of patients, including sepsis (1%), cardiac arrest (1%), and lung infection (1%).


Clinically relevant adverse reactions from expanded access programs include: pneumonitis including fatal cases.


USE IN SPECIFIC POPULATIONS

Lactation: Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with BLENREP and for 3 months after the last dose.


Females and Males of Reproductive Potential: Based on findings in animal studies, BLENREP may impair fertility in females and males.


Geriatric Use: Of the 218 patients who received BLENREP in DREAMM-2, 43% were aged 65 to less than 75 years and 17% were aged 75 years and older. Keratopathy occurred in 80% of patients aged less than 65 years and 73% of patients aged 65 years and older. Among the 95 patients who received BLENREP at the 2.5-mg/kg dose, keratopathy occurred in 67% of patients aged less than 65 years and 73% of patients aged 65 years and older.


Renal or Hepatic Impairment: The recommended dosage has not been established in patients with severe renal impairment (eGFR 15 to 29 mL/min/1.73 m2) or end-stage renal disease (ESRD) with eGFR <15 mL/min/1.73 m2 not on dialysis or requiring dialysis. The recommended dosage has not been established in patients with moderate or severe hepatic impairment (total bilirubin >1.5 × ULN and any AST).




SUPER:
For US Healthcare Professionals only.
Trademarks owned by or licensed to the GSK group of companies.
©2022 GSK or licensor.
BLMVID210017 May 2022
Produced in USA

Along the BLENREP Path

  • Welcome to our video, “Along the BLENREP Path.” Whether you are the prescribing physician or a member of a BLENREP care team, we at GSK are here to support you along the way. This video will help prepare you for what to expect while treating patients receiving BLENREP.

Scene 1:

 

On screen:

 

GSK ONCOLOGY ON DEMAND [title]

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

[GSK Logo]

 

Scene 2:

 

On screen:

 

[BLENREP logo]

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

Scene 3:

 

On Screen:

 

Along the BLENREP Path [title]

 

[Image of BLENREP package]

 

Trademarks are owned by or licensed to the GSK group of companies.



©2021 GSK or licensor.
BLMVID210005 September 2021
Produced in USA.

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

[BLENREP Logo] [GSK logo]

 

VO:

 

Welcome to our video, "Along the BLENREP Path." Whether you are prescribed or considering treatment with BLENREP, we at GSK are here to support you along the way.

 

Scene 4:

 

On Screen:

 

Testing, Scheduling, Treatment, Modification [Animation of treatment path]

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

This video will help prepare you for what to expect on the path for treatment with BLENREP.

 

Scene 5:

 

On Screen:

 

[Animation of treatment path]

 

BLENREP is a prescription medicine used to treat adults with multiple myeloma who have received at least 4 prior medicines to treat multiple myeloma, and their cancer has come back or did not respond to prior treatment.

 

It is not known if BLENREP is safe and effective in children.

 

BLENREP is approved based on patient response rate. Studies are ongoing to confirm the clinical benefit of BLENREP for this use.

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

BLENREP is a prescription medicine used to treat adults with multiple myeloma who have received at least 4 prior medicines to treat multiple myeloma, and their cancer has come back or did not respond to prior treatment. It is not known if BLENREP is safe and effective in children.

 

BLENREP is approved based on patient response rate. Studies are ongoing to confirm the clinical benefit of BLENREP for this use.

 

Scene 6:

 

On Screen:

 

[Animation of treatment path]

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO: Like many choices for cancer treatment, BLENREP has a unique side effects profile.

 

Scene 7:

 

On Screen:

 

[Animation of treatment path]

 

Risk Evaluation and Mitigation Strategy (REMS)

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

BLENREP has a Risk Evaluation and Mitigation Strategy, also known as REMS, because of the risk of eye problems.

 

The BLENREP REMS educates patients and healthcare providers about the risk of eye problems associated with BLENREP.

 

Scene 8:

 

On Screen:

 

Risk Evaluation and Mitigation Strategy (REMS)

 

Healthcare Provider Certification Patient Counseling Patient Enrollment  Eye Health Requirements

 

IMPORTANT SAFETY INFORMATION

 

What is the most important information I should know about BLENREP?

 

Before you receive BLENREP, you must read and agree to all of the instructions in the BLENREP Risk Evaluation and Mitigation Strategy (REMS). Before prescribing BLENREP, your healthcare provider will explain the BLENREP REMS to you and have you sign the Patient Enrollment Form.

 

If you have questions along your path with BLENREP, you should talk to your healthcare provider.

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

What is the most important information I should know about BLENREP?

 

Before you receive BLENREP, you must read and agree to all of the instructions in the BLENREP Risk Evaluation and Mitigation Strategy (REMS). Before prescribing BLENREP, your healthcare provider will explain the BLENREP REMS to you and have you sign the Patient Enrollment Form.

 

If you have questions along your path with BLENREP, you should talk to your healthcare provider.

 

Scene 9:

 

On Screen:

 

Cornea [Image of eye] [Animation of treatment path]

 

IMPORTANT SAFETY INFORMATION (CONT’D)

 

BLENREP can cause serious side effects, including:

 

Eye problems. Eye problems are common with BLENREP. BLENREP can cause changes to the surface of your eye that can lead to dry eyes, blurred vision, worsening vision, severe vision loss, and corneal ulcer.

 

Tell your healthcare provider if you have any vision changes or eye problems during treatment with BLENREP.

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

BLENREP can cause serious side effects, including:

 

Eye problems. Eye problems are common with BLENREP. BLENREP can cause changes to the surface of your eye that can lead to dry eyes, blurred vision, worsening vision, severe vision loss, and corneal ulcer.

 

Tell your healthcare provider if you have any vision changes or eye problems during treatment with BLENREP.

 

The ocular events that can occur during treatment with BLENREP can be managed with supportive care and dose modification.

 

Scene 10:

 

On Screen:

 

Step 1 [Animation of treatment path] [Image of REMS Patient Guide]

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

First, your healthcare provider will counsel you to ensure you understand the risk of eye problems and the need for an eye specialist to check your eyes.

 

Scene 11:

 

On Screen:

 

Step 2 [Animation of treatment path]

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

Next, your healthcare provider will help you complete and sign the Patient Enrollment Form to enroll you in the BLENREP REMS so that you can be started on treatment.

 

Scene 12:

 

On Screen:

 

Step 3 [Animation of treatment path] EYE EXAM

 

[bullets]

 

Before starting treatment with BLENREP

 

Prior to each dose of BLENREP

 

If you have worsening symptoms of eye problems

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

You will need an eye exam before starting treatment, prior to each dose, and if you have worsening symptoms of eye problems.



Scene 13:

 

On Screen:

 

[Animation of treatment path]

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

Your healthcare provider’s support staff can help you schedule the first visit with an eye care professional for your baseline eye exam.

 

Scene 14:

 

On Screen:

 

[Animation of treatment path] [Image of Together with GSK Oncology (TwGO) enrollment form]

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

If you don’t have an eye care professional that you see regularly, consult with your healthcare provider on how to find an eye care professional. The “Together with GSK Oncology (TwGO)” support program offers ophthalmic support services including ophthalmic insurance verification, help finding an eye care professional, and ophthalmic appointment scheduling and reminders. There is also a tool available on BLENREP.com.

 

Scene 15:

 

On Screen:

 

[Animation of treatment path] Ongoing monitoring of vision

 

Additional eye exam appointments prior to each dose

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

It is important to know that you will need additional eye exam appointments while on treatment. This is something to consider when choosing an eye care professional.



Scene 16:

 

On Screen:

 

[Animation of treatment path]

 

[Flow chart]

 

3 weeks

 

Initial Eye Exam Before 1st Dose

 

Perform initial eye exam within 3 weeks prior to the first dose

 

1ST BLENREP Dose

 

3 weeks

 

Eye Exam Before Subsequent Doses

 

Perform each follow-up eye exam at least 1 week after the previous dose and within 2 weeks prior to the next dose

Subsequent BLENREP doses

 

Your healthcare provider will decide how many treatments you need

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

You will need your first eye exam within 3 weeks prior to your first dose of BLENREP. Each follow-up eye exam needs to occur at least 1 week after the previous dose and within 2 weeks prior to the next dose of BLENREP. It is important for your care team to know these eye exam results prior to you starting on BLENREP and prior to each dose.

 

Scene 17:

 

On Screen:

 

Step 4 [Image of BLENREP package] [Animation of treatment path]

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

After your healthcare provider reviews your eye exam results and confirms you are ready for BLENREP, you will begin your infusion appointments. BLENREP is administered once every 3 weeks.

 

Scene 18:

 

On Screen:

 

[Animation of treatment path]

 

~ 30 min. [Image of treatment clock]

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

The infusion itself is estimated to take 30 minutes, and your appointment may last longer than that for examination and monitoring.

 

Scene 19:

 

On Screen:

 

Step 5 [Animation of treatment path]

 

4x daily [Image of eye drop vial]

 

[Image of How to Put in Eye Drops Instructions]

 

Caution driving

 

Avoid contact lenses

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

Supportive care for eye health is also part of your path with BLENREP. You should use preservative-free lubricant eye drops at least 4 times each day during treatment as instructed by your healthcare provider.

Also, you should use caution when driving or operating machinery as BLENREP may affect your vision and you should avoid wearing contact lenses during treatment with BLENREP unless directed by an eye care professional.

 

Scene 20:

 

On Screen:

 

Step 6 [Animation of treatment path]

 

CONTINUED BLENREP TREATMENT

 

EYE EXAM

 

BLENREP TREATMENT MODIFICATION

 

Dose modifications can include decreasing your dose, temporarily stopping or completely stopping treatment.

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

Eye problems may occur and can be managed with dose modifications. Monitoring for adverse reactions throughout treatment will help your healthcare provider determine whether dose modifications are necessary. Inform your healthcare provider if you have signs or symptoms of worsening eyesight or eye health.

 

Dose modifications may be needed based on results from eye care professional examinations, even if you aren’t experiencing any symptoms of worsening eyesight or eye health.

 

Scene 21:

 

On Screen:

 

[Animation of treatment path]

 

BLENREP TREATMENT MODIFICATION

 

Your healthcare provider may decrease your dose, temporarily stop or completely stop treatment with BLENREP

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

Your healthcare provider may decrease your dose, temporarily stop or completely stop treatment with BLENREP if you have adverse reactions.

 

Although your healthcare provider may modify your dose, you may be able to restart or continue treatment with BLENREP if your healthcare provider thinks it is appropriate.

 

Scene 22:

 

On Screen:

 

[Animation of treatment path]

 

Slit lamp exam [label]

 

Visual acuity [label]

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

The eye exams consist of two important noninvasive tests that are part of a typical eye examination: the slit lamp exam and the visual acuity exam.

 

Scene 23:

 

On Screen:

 

[Animation of treatment path]

 

Slit lamp exam [label]

 

You may have experienced this exam in the past during a comprehensive eye exam.

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

The slit lamp exam consists of the surface of the eye being examined to identify damaged cells or any changes to the surface of the eye. You position your head into the support frame, and the eye care professional uses a slit lamp to examine the surface of your eye to monitor for changes that may not be obvious to you.

 

Scene 24:

 

On Screen:

 

[Animation of treatment path]

 

Visual acuity [label]

 

Snellen chart [label]

 

Phoropter or refractor [label]

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

The visual acuity test consists of being asked to read the letters on a chart placed a distance from you; a visual acuity score of 20/20 is considered normal vision. The chart used is called a Snellen chart, and you may have read a Snellen chart at one point during your routine healthcare exams. As part of the eye monitoring requirements related to BLENREP, a device called a phoropter or refractor may be used.

 

Scene 25:

 

On Screen:

 

[Animation of treatment path] The steps along the path

 

[Image of BLENREP package]

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

The steps along the path with BLENREP are clear:

 

1. Your healthcare provider will counsel you to ensure you understand the risk of eye problems and the need for an eye specialist to check your eyes

 

2. You enroll in the BLENREP REMS program

 

3. You schedule your first eye care professional appointment with the help of your healthcare provider’s support staff. Before you can receive your infusion, you are required to have an eye exam by an eye care professional

 

4. You then begin your BLENREP infusions and will continue your eye exam appointments prior to each dose. Results of eye exam appointments must be provided to your healthcare provider prior to each dose of BLENREP. Eye exams help to determine if you need dose modifications, including decreasing your dose, temporarily stopping or completely stopping treatment, even if you are not experiencing symptoms. In the event that an adverse reaction affects your eyes, your eye care professional may continue to perform eye exams until the adverse reaction is resolved

 

5. You should use preservative-free lubricant eye drops at least 4 times each day during treatment with BLENREP as instructed by your healthcare provider

 

6. Along the way, your multiple myeloma will be monitored to see the effectiveness of BLENREP. Additional monitoring will also be performed to watch for potential adverse reactions. Your healthcare provider will decide how many treatments you need.

 

Scene 26:

 

On Screen:

 

[Animation of treatment path]

 

[Image of BLENREP package]

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

You and your caregiver are encouraged to ask your healthcare provider or eye care professional any questions along the way.

 

Scene 27:

 

On Screen:

 

IMPORTANT SAFETY INFORMATION (CONT’D)

 

Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with BLENREP, prior to each dose of BLENREP, and for worsening symptoms of eye problems.

 

Even if your vision seems fine, it is important that you get your eyes checked during treatment with BLENREP because some changes can happen without symptoms and may only be seen on an eye exam.

 

You should use preservative-free lubricant eye drops at least 4 times per day during treatment with BLENREP as instructed by your healthcare provider.

 

You should use caution when driving or operating machinery as BLENREP may affect your vision.

 

Avoid wearing contact lenses during treatment with BLENREP unless directed by your eye specialist.

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]



VO:

 

IMPORTANT SAFETY INFORMATION, CONTINUED

 

Your healthcare provider will send you to an eye specialist to check your eyes before you start treatment with BLENREP, prior to each dose of BLENREP, and for worsening symptoms of eye problems.

 

Even if your vision seems fine, it is important that you get your eyes checked during treatment with BLENREP because some changes can happen without symptoms and may only be seen on an eye exam.

 

You should use preservative-free lubricant eye drops at least 4 times per day during treatment with BLENREP as instructed by your healthcare provider.

 

You should use caution when driving or operating machinery as BLENREP may affect your vision.

 

Avoid wearing contact lenses during treatment with BLENREP unless directed by your eye specialist.

 

Scene 28:

 

On Screen:

 

Decrease in platelets (thrombocytopenia) is common with BLENREP, and can also be serious. Platelets are a type of blood cell that help your blood to clot. Your healthcare provider will check your blood cell counts before you start treatment with BLENREP and during treatment. Tell your healthcare provider if you have bleeding or bruising during treatment with BLENREP.

 

Infusion-related reactions are common with BLENREP, and can also be serious. Tell your healthcare provider or nurse right away if you get any of the following signs or symptoms of an infusion-related reaction while receiving BLENREP:

  • chills or shaking

  • redness of your face (flushing)

  • itching or rash

  • shortness of breath, cough, or wheezing

  • swelling of your lips, tongue, throat, or face

  • dizziness

  • feel like passing out

  • tiredness

  • fever

  • feel like your heart is racing (palpitations)

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]



VO:

 

Decrease in platelets (thrombocytopenia) is common with BLENREP and can also be serious. Platelets are a type of blood cell that help your blood to clot. Your healthcare provider will check your blood cell counts before you start treatment with BLENREP and during treatment. Tell your healthcare provider if you have bleeding or bruising during treatment with BLENREP.

 

Infusion reactions are common with BLENREP and can also be serious. Tell your healthcare provider or nurse right away if you get any of the following signs or symptoms of an infusion reaction while receiving BLENREP:

  • chills or shaking

  • redness of your face (flushing)

  • itching or rash

  • shortness of breath, cough, or wheezing

  • swelling of your lips, tongue, throat, or face

  • dizziness

  • feel like passing out

  • tiredness

  • fever

  • feel like your heart is racing (palpitations)

Scene 29:

 

On Screen:

 

The most common side effects of BLENREP include vision or eye changes such as findings on eye exam (keratopathy), decreased vision or blurred vision, nausea, low blood cell counts, fever, infusion-related reactions, tiredness, and changes in kidney or liver function blood tests.

 

Tell your healthcare provide right away if you get new or worsening unexplained signs or symptoms of lung problems, including shortness of breath, chest pain, and cough.

 

Before receiving BLENREP, tell your healthcare provider about all of your medical conditions, including if you:

 

have a history of vision or eye problems.

 

have bleeding problems or a history of bleeding problems.

 

are pregnant or plan to become pregnant. BLENREP can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider may do a pregnancy test before you start treatment with BLENREP. You should use effective birth control during treatment with BLENREP and for 4 months after the last dose. Talk to your healthcare provider about birth control methods you can use during this time. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with BLENREP. Males with female partners who are able to become pregnant should use effective birth control during treatment with BLENREP and for 6 months after the last dose.

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

The most common side effects of BLENREP include vision or eye changes such as findings on eye exam (keratopathy), decreased vision or blurred vision, nausea, low blood cell counts, fever, infusion-related reactions, tiredness, and changes in kidney or liver function blood tests.

 

Before receiving BLENREP, tell your healthcare provider about all of your medical conditions, including if you:

 

have a history of vision or eye problems.

 

have bleeding problems or a history of bleeding problems.

 

are pregnant or plan to become pregnant. BLENREP can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider may do a pregnancy test before you start treatment with BLENREP. You should use effective birth control during treatment with BLENREP and for 4 months after the last dose. Talk to your healthcare provider about birth control methods you can use during this time. Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with BLENREP. Males with female partners who are able to become pregnant should use effective birth control during treatment with BLENREP and for 6 months after the last dose.

 

Scene 30:

 

On Screen:

 

are breastfeeding or plan to breastfeed. It is not known if BLENREP passes into your breast milk. Do not breastfeed during treatment with BLENREP and for 3 months after the last dose.

 

BLENREP may affect fertility in males and females. Talk to your healthcare provider if this is a concern for you.

 

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

 

These are not all the possible side effects of BLENREP.

 

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

are breastfeeding or plan to breastfeed. It is not known if BLENREP passes into your breast milk. Do not breastfeed during treatment with BLENREP and for 3 months after the last dose.

 

BLENREP may affect fertility in males and females. Talk to your healthcare provider if this is a concern for you.

 

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

 

These are not all the possible side effects of BLENREP.

 

Please see full Prescribing Information, including BOXED WARNING and Medication Guide.

 

Scene 31:

 

On Screen:

 

[Image of computer] Visit BLENREP.com for helpful resources to help you along your path with BLENREP

 

[Please see IMPORTANT SAFETY INFORMATION covered in this video and full Prescribing Information, including BOXED WARNING and Medication Guide.]

 

VO:

 

To further support you, GSK has resources available to help you along your path with BLENREP. These resources are available at BLENREP.com.

 

 

Eye Drop Administration Instructions

RESOURCES*

HCP Ocular GuideHCP Ocular Guide

Eye Care Professional Ocular Guide

For the eye care professional and their office staff, this overview of the ocular adverse events associated with BLENREP is helpful to monitor and manage patients.

Eye Care Professional Ocular GuideEye Care Professional Ocular Guide

HCP Ocular Guide

For the prescribing oncologist and their office staff, this overview of the ocular adverse events is useful to understand the safety profile of BLENREP.

Eye Care Professional Quick Reference CardEye Care Professional Quick Reference Card

Eye Care Professional Quick Reference Flashcard

Learn about the eye care professional’s role in the BLENREP treatment journey.

Eye Care Professional Resources FlashcardEye Care Professional Resources Flashcard

Eye Care Professional Resources Flashcard

Information for eye care professionals to support the management of patients on BLENREP treatment.

*See accompanying full Prescribing Information.