Blenrep
BLENREP- belantamab mafodotin injection, powder, lyophilized, for solution
GlaxoSmithKline LLC
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 [see Warnings and Precautions (5.1)].
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 [see Dosage and Administration (2.3), Warnings and Precautions (5.1)].
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 [see Warnings and Precautions (5.2)].
1 INDICATIONS AND USAGE
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 [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).
2 DOSAGE AND ADMINISTRATION
2.1 Important Safety Information
Perform an ophthalmic exam prior to initiation of BLENREP and during treatment [see Warnings and Precautions (5.1)].
Advise patients to use preservative-free lubricant eye drops and avoid contact lenses unless directed by an ophthalmologist [see Warnings and Precautions (5.1)].
2.2 Recommended Dosage
The recommended dosage of BLENREP is 2.5 mg/kg of actual body weight given as an intravenous infusion over approximately 30 minutes once every 3 weeks until disease progression or unacceptable toxicity.
2.3 Dosage Modifications for Adverse Reactions
The recommended dose reduction for adverse reactions is:
- •
- BLENREP 1.9 mg/kg intravenously once every 3 weeks.
Discontinue BLENREP in patients who are unable to tolerate a dose of 1.9 mg/kg (see Tables 1 and 2).
Corneal Adverse Reactions
The recommended dosage modifications for corneal adverse reactions, based on both corneal examination findings and changes in best-corrected visual acuity (BCVA), are provided in Table 1[see Warnings and Precautions (5.1)]. Determine the recommended dosage modification of BLENREP based on the worst finding in the worst affected eye. Worst finding should be based on either a corneal examination finding or a change in visual acuity per the Keratopathy and Visual Acuity (KVA) scale.
KVA = Keratopathy and Visual Acuity, BCVA = best corrected visual acuity. 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. | ||
Corneal Adverse Reaction | Recommended Dosage Modifications | |
Grade 1 | Corneal examination finding(s): Mild superficial keratopathya Change in BCVA b : 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 BCVA b : 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 BCVA b : 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 BCVA b : 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. |
Other Adverse Reactions
The recommended dosage modifications for other adverse reactions are provided in Table 2.
Adverse Reaction | Severity | Recommended Dosage Modifications |
Thrombocytopenia [see Warnings and Precautions (5.3)] | 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 [see Warnings and Precautions (5.4)] | 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 [see Adverse Reactions (6.1)] | 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. |
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