BLENREP is administered as an outpatient, in-office infusion over approximately 30 minutes

Dosage and administration

BLENREP is approved as a single-agent monotherapy1

BLENREP Dosing and Administration
BLENREP Dosing and Administration: Infusion Timing
BLENREP Dosing and Administration: Administration Schedule
  • Perform an ophthalmic exam prior to initiation of BLENREP and during treatment.
  • Advise patients to use preservative-free lubricant eye drops and avoid contact lenses unless directed by an ophthalmologist.
  • Modify dosage as needed for adverse reactions.
  • Reconstitute and dilute prior to administration. Please see full Prescribing Information for instructions.
  • 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.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.

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 Recommended dosage modifications
Grade 1

Corneal examination finding(s):

Mild superficial keratopathya

Change in BCVAb:

Decline from baseline of 1 line on Snellen Visual Acuity

Continue treatment at current dose.
Grade 2

Corneal examination finding(s):

Moderate superficial keratopathyc

Change in BCVAb:

Decline from baseline of 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

Corneal examination finding(s):

Severe superficial keratopathyd

Change in BCVAb:

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 examination finding(s):

Corneal epithelial defecte

Change in BCVAb:

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.
a
Mild superficial keratopathy (documented worsening from baseline), with or without symptoms.
b Changes in visual acuity due to treatment-related corneal findings.
c Moderate superficial keratopathy with or without patchy microcyst-like deposits, sub-epithelial haze (peripheral), or a new peripheral stromal opacity.
d Severe superficial keratopathy with or without diffuse microcyst-like deposits, sub-epithelial haze (central), or a new central stromal opacity.
e Corneal epithelial defect such as corneal ulcers.

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.

Management considerations for ocular reactions before and during treatment

Manage with dose modification or discontinuation, per the REMS requirements (available at BLENREPREMS.com). 

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Conduct ophthalmic examinations (visual acuity and slit lamp) 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.

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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.

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

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

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

 

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.

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