Blenrep

BLENREP- belantamab mafodotin injection, powder, lyophilized, for solution
GlaxoSmithKline LLC

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:

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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.

Table 1. Dosage Modifications for Corneal Adverse Reactions per the 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.

Table 2. Dosage Modifications for Other Adverse Reactions

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.