Prescription medicine
Belantamab mafodotin Brand names: Blenrep
Belantamab mafodotin (Blenrep) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the belantamab mafodotin FDA label on DailyMed (effective October 23, 2025); every belantamab mafodotin label on DailyMed.
Highlights of the record
FDA label of October 23, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
OCULAR TOXICITY •.
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 [see Warnings and Precautions ( 5.1 )].
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 [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 called the BLENREP Risk Evaluation and Mitigation Strategy (REMS) [see Warnings and Precautions ( 5.2 )]. 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. ( 5.1 )
Conduct ophthalmic exams at baseline, before each dose, promptly for new or worsening symptoms, and as clinically indicated. […]
Used for
From the label: indications and usageBLENREP 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.
Forms and strengths
- 50 mg/ml
Injection (powder) for solution.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 2,911 through July 30, 2026
What is belantamab mafodotin used for?
From the label: indications and usageBLENREP 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. 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.
Conditions named in the indications of belantamab mafodotin's FDA labels, with every medicine labeled for each:
Source: FDA drug label (Blenrep), GlaxoSmithKline LLC, effective October 23, 2025 (SPL set aef7c34c-fef8-407c-99c0-a68aded53c60), via openFDA; the full label on DailyMed
What does the patient leaflet for belantamab mafodotin say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about BLENREP?BLENREP can cause serious side effects, including: • Eye problems. Eye problems are common with BLENREP and can also be severe. BLENREP can cause changes to the surface of your eye, which can lead to symptoms of eye problems, including: o decreased vision o blurred vision o dry eyes o sensitivity to light o feeling like something is in your eyes o eye irritation o eye pain Ulcers on the surface of the eye (corneal ulcers), including with infection, may also happen during treatment with BLENREP. Tell your healthcare provider right away if you notice any new or worsening eye symptoms or vision changes during treatment with BLENREP. Your healthcare provider will refer you to an eye care specialist (such as an ophthalmologist or optometrist) to check your eyes before you start treatment, before you receive each dose of BLENREP, and as needed for any new or worsening eye problems. It is important that you: o Keep all of your eye care appointments because some changes can happen without symptoms and may only be seen on an eye exam. o Use preservative‑free artificial tears at least 4 times per day starting with your first infusion and continuing until the end of treatment with BLENREP. o Avoid wearing contact lenses during treatment with BLENREP unless directed by your eye care specialist. o Use caution when driving or operating machinery because BLENREP may cause changes to your vision. Because of the risk of eye problems, BLENREP is available only through a restricted program called the BLENREP Risk Evaluation and Mitigation Strategy (REMS). Your healthcare provider will give you the BLENREP REMS Patient Guide, which describes the risk of eye problems, and will explain the REMS program to you. […]
Source: FDA drug label (Blenrep), GlaxoSmithKline LLC, effective October 23, 2025 (SPL set aef7c34c-fef8-407c-99c0-a68aded53c60), via openFDA; the full label on DailyMed
Is there a generic for belantamab mafodotin (Blenrep)?
No generic belantamab mafodotin is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for belantamab mafodotin?
The FDA Adverse Event Reporting System holds 2,911 reports that list belantamab mafodotin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 993 are coded as a death and 742 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2022 (1,149, against a median of 82 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as belantamab mafodotin?
36 other medicines are given the same way (intravenous) and in the same FDA class as belantamab mafodotin or labeled mainly for the same use (leukemia, lymphoma and myeloma), the same class first. Leukemia, lymphoma and myeloma lists all 98 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (intravenous) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Cyclophosphamide | Leukemia, lymphoma and myeloma | 15 labelers | n/a | No current entry |
| Doxorubicin | Leukemia, lymphoma and myeloma | 16 labelers | n/a | No current entry |
| Bortezomib | Leukemia, lymphoma and myeloma | 22 labelers | n/a | No current entry |
| Arsenic trioxide | Leukemia, lymphoma and myeloma | 16 labelers | n/a | A presentation being discontinued |
| Bendamustine | Leukemia, lymphoma and myeloma | 4 labelers | n/a | A presentation being discontinued |
| Nelarabine | Leukemia, lymphoma and myeloma | 12 labelers | n/a | No current entry |
| Idarubicin | Leukemia, lymphoma and myeloma | 2 labelers | n/a | No current entry |
| Clofarabine | Leukemia, lymphoma and myeloma | 9 labelers | n/a | No current entry |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Belantamab mafodotin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other