Leukemias, lymphomas, and other hematologic cancers:
Indications for: BLENREP
In 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.
Adult Dosage:
Give by IV infusion over ~30mins. 2.5mg/kg (of actual body wt.) once every 3 weeks until disease progression or unacceptable toxicity. Dose modifications for adverse reactions: see full labeling.
Children Dosage:
Not established.
Boxed Warning:
Ocular toxicity.
BLENREP Warnings/Precautions:
Risk of ocular toxicity. Conduct ophthalmic exams at baseline (within 3 weeks prior to first dose), prior to each subsequent dose, and for worsening symptoms (perform each follow-up exam at least 1 week after the previous dose and within 2 weeks prior to the next dose). Withhold therapy until improvement; resume or permanently discontinue based on severity. Thrombocytopenia: obtain CBCs at baseline and during treatment as clinically indicated; withhold and/or reduce dose based on severity. Monitor for infusion-related reactions; interrupt therapy for Grade 2 or 3 reactions; discontinue if life-threatening reactions occur. Advise use of preservative-free lubricant eye drops at least 4 times daily. Avoid contact lenses (unless directed by an ophthalmologist). Severe renal impairment (eGFR 15–29mL/min/1.73m2) or ESRD (eGFR <15mL/min/1.73m2) not on dialysis or requiring dialysis. Moderate or severe hepatic impairment (total bilirubin >1.5×ULN and any AST). Embryo-fetal toxicity. Advise to use effective contraception during and for 4 months (females of reproductive potential) or 6 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 3 months after the last dose).
BLENREP Classification:
BCMA-directed antibody + microtubule inhibitor conjugate.
Adverse Reactions:
Keratopathy, decreased visual acuity, nausea, blurred vision, pyrexia, infusion-related reactions, fatigue; Grade 3 or 4 lab abnormalities (decreased platelets, decreased lymphocytes, decreased hemoglobin, decreased neutrophils, increased creatinine, increased gamma-glutamyl transferase).
Note:
Only available through the Blenrep REMS Program. For more information visit www.BlenrepREMS.com or call (855) 209-9188.
REMS:
Generic Drug Availability:
NO
How Supplied:
Single-dose vial—1
