Initial US Approval:
2020
Key Clinical Studies:
DREAMM-7 (NCT04246047)
Drug Class/Description:
B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate
WARNING: OCULAR TOXICITY
See full prescribing information for complete boxed warning.
- BLENREP causes changes in the corneal epithelium resulting in changes in vision, including severe visual impairment, and symptoms such as blurred vision and dry eyes. In the clinical study, corneal ulcers, including cases with infection, also occurred.
- Conduct ophthalmic exams at baseline, before each dose, promptly for new or worsening symptoms, and as clinically indicated. In the clinical study, 83% of patients required a dosage modification due to ocular toxicity. Withhold BLENREP until improvement and resume or permanently discontinue, based on severity.
- BLENREP is available only through a restricted program, called the BLENREP Risk Evaluation and Mitigation Strategy (REMS).
Indications and Usage:
BLENREP, a B-cell maturation antigen (BCMA)-directed antibody and microtubule inhibitor conjugate, is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least two prior lines of therapy, including a proteasome inhibitor and an immunomodulatory agent.
Dosage and Administration:
- The recommended dosage of BLENREP, in combination with bortezomib and dexamethasone, is 2.5 mg/kg as an intravenous infusion over 30 minutes once every 3 weeks for 8 cycles, followed by BLENREP 2.5 mg/kg every 3 weeks as a single agent.
- See Full Prescribing Information for instructions on preparation and administration.
Dosage Forms and Strengths:
For injection: 70 mg as a lyophilized powder in a single-dose vial for reconstitution and further dilution.
Contraindications:
None.
Warnings and Precautions:
- Thrombocytopenia: Monitor complete blood counts at baseline and periodically during treatment. Withhold or reduce the dosage based on severity.
- Embryo-fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to fetus and to use effective contraception.
Adverse Reactions:
The most common adverse reactions (≥20%) with BLENREP in combination with bortezomib and dexamethasone are reduction in best-corrected visual acuity (BCVA), corneal exam findings, blurred vision, dry eye, photophobia, foreign body sensation in eyes, eye irritation, upper respiratory tract infection, hepatotoxicity, eye pain, diarrhea, fatigue, pneumonia, cataract, and COVID19. The most common Grade 3 or 4 (≥10%) laboratory abnormalities are decreased platelets, decreased lymphocytes, decreased neutrophils, increased gamma-glutamyl transferase, decreased white blood cells, and decreased hemoglobin.
Use in Specific Populations:
Lactation: Advise not to breastfeed.
Adapted From:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761440s000lbl.pdf
Every health-care provider should make their own determination regarding specific safe and appropriate patient care practices, including drug dosages and indications. The provider should always consult the most recent prescribing/product information. FDA Focus information is not guaranteed to be accurate, complete, or current. JADPRO and its editors, authors, reviewers, and commentators cannot be held responsible for any liability incurred as a consequence of the application of any of the information listed within.
