For patients in need of treatment in either academic or community settings,* BLENREP is a single agent administered as an approximately 30-minute in-office infusion1

Dosage and administration

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OPHTHALMIC exam

is required prior to initiation
and during treatment1

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IN-OFFICE
ADMINISTRATION

as a single-agent
monotherapy at 2.5 mg/kg1

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Approximately 30-MINUTE
intravenous infusion Q3W
until disease progression or unacceptable toxicity1

In the DREAMM-2 trial, dose was reduced or withheld in some cases due to adverse reactions.

  • Advise patients to use preservative-free lubricant eye drops and avoid contact lenses unless directed by an ophthalmologist.1,2

  • Modify dosage as needed for adverse reactions.1,2

  • Reconstitute and dilute prior to administration. Please see full Prescribing Information for instructions.1,2

  • Systemic steroids are not required in combination with BLENREP for the treatment of relapsed/refractory multiple myeloma. Additionally, premedication with a steroid is not required prior to initial infusion with BLENREP. Patients should be monitored for infusion-related reactions.1,2

    • For Grade 2 or 3 reactions, interrupt the infusion and provide supportive treatment.

    • Once symptoms resolve, resume at a lower infusion rate.

    • Administer premedication, such as a corticosteroid, for all subsequent infusions

    • Discontinue BLENREP for life-threatening infusion-related reactions and provide appropriate emergency care.

  • In the DREAMM-2 study, neither inpatient hospital stays nor leukapheresis or lymphodepletion therapy were required for BLENREP treatment initiation.3

Recommended dose modifications

The recommended dose reduction for adverse reactions is 1.9 mg/kg intravenously once every 3 weeks.1

Discontinue BLENREP in patients who are unable to tolerate a dose of 1.9 mg/kg.1

Dosage Modifications for Corneal Adverse Reactions1:

Recommended dosage modifications for corneal adverse reactions are based on both corneal examination findings and changes in best-corrected visual acuity (BCVA). Determine the recommended dosage modification of BLENREP based on the worst finding in the worst affected eye. The worst finding should be based on a corneal examination finding or a change in visual acuity per the Keratopathy and Visual Acuity (KVA) scale.

Corneal adverse reactions: Grading and recommended dosage modifications1

Determined by eye care professional

Determined by oncologist

Corneal examination finding(s)

Change in BCVA due to treatment-related corneal findings4

Recommended dosage modifications1

Grade 1

Mild superficial keratopathy
(documented worsening from baseline), with or without symptoms.

Decline from baseline by 1 line on Snellen Visual Acuity

Continue treatment at current dose.

Grade 2

Moderate superficial keratopathy with or without patchy microcyst-like deposits, sub-epithelial haze (peripheral), or a new peripheral stromal opacity

Decline from baseline by 2 or 3 lines on Snellen Visual Acuity and not worse than 20/200

Withhold BLENREP until improvement in both corneal examination findings and change in BCVA to Grade 1 or better and resume at same dose.

Grade 3

Severe superficial keratopathy
with or without diffuse microcyst-like deposits, sub-epithelial haze (central), or a new central stromal opacity

Decline from baseline by more than 3 lines on Snellen Visual Acuity and not worse than 20/200

Withhold BLENREP until improvement in both corneal examination findings and change in BCVA to Grade 1 or better and resume at reduced dose.

Grade 4

Corneal epithelial defect
such as corneal ulcers

Snellen Visual Acuity worse than 20/200

Consider permanent discontinuation of BLENREP. If continuing treatment, withhold BLENREP until improvement in both corneal examination findings and change in BCVA to Grade 1 or better and resume at reduced dose.

The worst grade for the keratopathy or the change in BCVA should be used to determine the grade of the corneal adverse event.4

Dosage Modifications for Other Adverse Reactions1

Adverse reaction

Severity

Recommended dosage modifications

Thrombocytopenia

Platelet count 25,000 to less than 50,000/mcL

Consider withholding BLENREP and/or reducing the dose of BLENREP.

Platelet count less than 25,000/mcL

Withhold BLENREP until platelet count improves to Grade 3 or better. Consider resuming at a reduced dose.

Infusion-related reactions

Grade 2 (moderate) or Grade 3 (severe)

Interrupt infusion and provide supportive care. Once symptoms resolve, resume at lower infusion rate; reduce the infusion rate by at least 50%.

Grade 4
(life-threatening)

Permanently discontinue BLENREP and provide emergency care.

Other adverse reactions

Grade 3

Withhold BLENREP until improvement to Grade 1 or better. Consider resuming at a reduced dose.

Grade 4

Consider permanent discontinuation of BLENREP. If continuing treatment, withhold BLENREP until improvement to Grade 1 or better and resume at reduced dose.

Initiate and maintain a regular dosing and eye exam schedule1

Visual showing a dosing and eye exam schedule
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If a patient experiences a dose hold, continue following the monitoring guidance outlined above. If a patient will restart treatment, ensure there is an ophthalmic exam within 2 weeks of next dose.

Dosing schedule and ocular management considerations1

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Ophthalmic exams

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.

Icon: Eye drops
Eye drops

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.

For eligible patients, eye care support is available. The BLENREP Eye Drop Supportive Care Program provides patients with eye drops throughout their therapy.

Learn how you can help patients administer eye drops with this educational video.

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Avoid contact lenses

Advise patients to avoid using contact lenses unless directed by an ophthalmologist.

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Caution when driving

Advise patients to use caution when driving or operating machinery, as BLENREP may adversely affect their vision.

During treatment while on a dose hold, continue to follow the supportive care guidance provided above.

BLENREP is available only through a restricted program under a REMS called the BLENREP REMS, because of the risks of ocular toxicity.1

Notable requirements of the BLENREP REMS include the following:

  • Prescribers must be certified with the program by enrolling and completing training in the BLENREP REMS.

  • Prescribers must counsel patients receiving BLENREP about the risk of ocular toxicity and the need for ophthalmic examinations prior to each dose.

  • Patients must be enrolled in the BLENREP REMS and comply with monitoring.

  • Healthcare facilities must be certified with the program and verify that patients are authorized to receive BLENREP.

  • Wholesalers and distributors must only distribute BLENREP to certified healthcare facilities.

In a post hoc analysis at the 13-month follow-up

The majority of responders who experienced a prolonged dose delay* continued to exhibit a clinical response1,5

Results presented are descriptive and should be interpreted with caution.

  • 54% of patients (51/95) experienced a dose interruption due to adverse reaction, observed at both 6 months and at the 13-month follow-up.

    These data represent dose delay information for patients who went on to restart treatment after a documented dose delay, and patients who were unable to restart treatment following a dose delay due to other reasons (such as investigator discretion).

  • 41% of patients (39/95) experienced at least 1 dose delay of any duration.

    • 15% (14/95) experienced 1 dose delay

    • 13% (12/95) experienced 2 dose delays

    • 14% (13/95) experienced 3 or more dose delays

    These data represent dose delay information for patients who went on to restart treatment after a documented dose delay.

In a post hoc analysis:

  • Half of responders (16/31) had a prolonged dose delay.

  • Of the responders with a prolonged dose delay, 75% (12/16) maintained or improved their clinical response.

Clinical outcomes with first prolonged dose delay (>63 days)

BLENREP
2.5 mg/kg (n = 16)

Improved clinical responsea

6 (38%)

Maintained same response categoryb

6 (38%)

Did not meet progression criteriac

2 (13%)

Developed progressive diseased

2 (13%)