Blenrep belantamab mafodotin 50 mg/mL Injection, Powder, For Solution, 1 vial
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Other monoclonal antibodies and antibody drug conjugates class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Belantamab mafodotin-blmf injection is used to treat multiple myeloma (a type of cancer of the bone marrow). Belantamab mafodotin-blmf is in a class of medications called antibody-drug conjugates. It works by killing cancer cells.
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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UNII 2968PHW8QP
A weak organic acid derived from citrus fruits or made through fermentation. It works as a buffer to control pH, a preservative to extend shelf life, and a flavoring agent in medications.
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UNII 7FLD91C86K
Edetate disodium is a chemical compound that binds and removes certain metal ions. In medicines, it acts as a preservative and stabilizer by preventing metals like calcium from interfering with the product's shelf life and consistency.
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UNII 6OZP39ZG8H
Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
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UNII 1Q73Q2JULR
Sodium citrate is a salt derived from citric acid. It works as a buffer to maintain the medicine's pH level and may also help improve taste or act as a preservative in the formulation.
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UNII B8WCK70T7I
Trehalose is a natural sugar made from two glucose molecules linked together. It's used in medicines as a filler to add bulk, a sweetener for taste, and a stabilizer to help keep active ingredients effective during storage.
5 inactive ingredients listed in the exact product block matched to this NDC.
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ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per mL | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · quarterly | No Part D plan price is available for this NDC in our data. | |
| Medicare Part B allowsASP · J9053 | $36.250 / J9053 unit | — |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Blenrep 50 mg/mLthis 00173-0913-01 | GlaxoSmithKline | 1 vial | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
Why the date isn’t exact: Biosimilar timing can change because patents may be challenged, settled, licensed, added or removed, and litigation can move the real date earlier or later.
🛈 What do these terms mean?
- Biologic patent
- A patent the reference product’s maker has publicly listed. A biosimilar generally can’t launch until these expire — unless they’re invalidated or resolved in a settlement.
- Reference-product exclusivity
- A flat 12 years of FDA market protection from the biologic’s first licensure (the BPCIA). No biosimilar can be licensed before it ends, regardless of patents.
- Interchangeable exclusivity
- The first interchangeable biosimilar can earn a period as the only interchangeable version (pharmacists can substitute it without the prescriber).
- Earliest biosimilar (LOE)
- The latest of all the dates above — the soonest a biosimilar can realistically reach the market. Litigation and settlements can move it earlier.
Biologics have no small-molecule “generics” — competition comes from FDA-licensed biosimilars, tracked in the FDA Purple Book.
| Code | What it grants | Expires |
|---|---|---|
| RefProduct | Reference-product exclusivity (12-year, BPCIA) — no biosimilar can be licensed before this date | Oct 23, 2037 |
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🔬 Reported adverse events (FAERS)
Top reported reactions
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00173-0913-01 You're viewing this | 1 VIAL in 1 CARTON (0173-0913-01) / 1.4 mL in 1 VIAL | 2025-10-23 | Active |
🧭 About this NDC listing & data coverage
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| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: 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. 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. ( 2.3 , 5.1 ) • BLENREP is available only through a restricted program, called the BLENREP Risk Evaluation and Mitigation Strategy (REMS). ( 5.2 )
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE BLENREP 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.
( 1 )
⏱️ Dosage and Administration ▾
2 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. ( 2.2 ) • See Full Prescribing Information for instructions on preparation and administration. ( 2.4 )
2.1Important Safety Information Ophthalmic exams, including slit lamp exam and assessment of best‑corrected visual acuity (BCVA), should be conducted by an eye care professional, such as an ophthalmologist or optometrist. Conduct ophthalmic exams at baseline, before each dose of BLENREP, promptly for new or worsening symptoms, and as clinically indicated [see Warnings and Precautions ( 5.1 )]. Counsel patients to promptly inform their healthcare provider of any ocular symptoms.
Advise patients to use preservative‑free artificial tears at least 4 times a day starting with the first infusion and continuing until end of treatment, and to avoid wearing contact lenses for the duration of therapy. Bandage contact lenses may be used under the direction of an eye care professional [see Warnings and Precautions ( 5.1 )].
2.2Recommended Dosage The recommended dosage for BLENREP is 2.5 mg/kg of actual body weight once every 3 weeks in combination with bortezomib and dexamethasone (BVd) for the first 8 cycles, followed by BLENREP 2.5 mg/kg of actual body weight once every 3 weeks as a single agent until disease progression or unacceptable toxicity. For dosing instructions of agents administered in combination with BLENREP, see Clinical Studies ( 14 ) and respective Prescribing Information, as appropriate. BLENREP is administered as an intravenous infusion over approximately 30 minutes.
2.3Dosage Modifications for Adverse Reactions In the BVd arm of the clinical study, 98% of patients required a dosage modification for any component of treatment for an adverse reaction, including 87% who required a dosage modification of BLENREP [see Clinical Studies ( 14 )] . Eighty-three percent of patients required a dosage modification of BLENREP for ocular toxicity based on ophthalmic exam findings or other ocular adverse reactions as defined by the Common Terminology Criteria for Adverse Events (CTCAE) [see Adverse Reactions ( 6.1 )] .
There were high rates of dosage modifications in early treatment cycles. By Cycle 3, 53% of patients had a dosage interruption or reduction, 7% had discontinued treatment, and only 40% received the planned dose of BLENREP. The recommended dosage modifications for ocular toxicity based on ophthalmic exam findings are provided in Tables 1 and 2.
Ophthalmic exam findings include both corneal exam findings and change in BCVA as assessed by an eye care professional. The overall grade of ophthalmic exam findings is based on the worst finding in the worst affected eye, based on either corneal exam finding or a change in BCVA. Corneal exam findings may or may not be accompanied by changes in BCVA or ocular symptoms. • Do not re‑escalate the dose of BLENREP after a dosage reduction is made for ocular toxicity based on ophthalmic exam findings. • In the clinical study, 67% of patients required a dosage interruption of BLENREP for ocular toxicity that lasted longer than 3 weeks (time between doses, median: 5.7 weeks [range: 3 to 31 weeks]).
The recommended dosage modifications for other adverse reactions, including dosage modifications for ocular adverse reactions based on the CTCAE, are provided in Table 3 . Table 1. Recommended Dosage Reductions of BLENREP for Adverse Reactions a Reduced Dosage Level 2 is specific to dosage reductions due to ocular toxicity based on ophthalmic exam findings.
BLENREP Reduced Dosage Level 1 1.9 mg/kg every 3 weeks Reduced Dosage Level 2 a 1.9 mg/kg every 8 weeks Table 2. Recommended Dosage Modifications for Ocular Toxicity Based on Ophthalmic Exam Findings a BCVA = best‑corrected visual acuity. a Mild superficial keratopathy (docu…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS For injection: 70 mg of belantamab mafodotin-blmf as a white to yellow lyophilized powder in a single-dose vial for reconstitution and further dilution. For injection: 70 mg as a lyophilized powder in a single‑dose vial for reconstitution and further dilution. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS None. None. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS • Thrombocytopenia: Monitor complete blood counts at baseline and periodically during treatment. Withhold or reduce the dosage based on severity. ( 2.3 , 5.3 ) • Embryo‑fetal Toxicity: Can cause fetal harm. Advise patients of the potential risk to fetus and to use effective contraception. ( 5.4 , 8.1 , 8.3 )
5.1Ocular Toxicity BLENREP causes ocular toxicity, defined as changes in the corneal epithelium and changes in BCVA based on ophthalmic exam (including slit lamp exam), or other ocular adverse reactions as defined by the CTCAE [see Adverse Reactions ( 6.1 )] . In DREAMM-7, ocular toxicity occurred in 92% of patients, including Grade 3 or 4 in 77% of patients. The most common ocular toxicities (>25%) were reduction in BCVA (89%) and corneal exam findings (86%) based on ophthalmic exam findings, blurred vision (66%), dry eye (51%), photophobia (47%), foreign body sensation in eyes (44%), eye irritation (43%), and eye pain (33%) [see Adverse Reactions ( 6.1 )] .
Ocular toxicity based on ophthalmic exam findings was reported as Grade 2 in 9% of patients, Grade 3 in 56% of patients, and Grade 4 in 21% of patients. The median time to onset of the first Grade 2 to 4 ophthalmic exam findings was 43 days (range: 15 to 611 days). The median duration of all Grade 2 to 4 ophthalmic exam findings was 85 days (range: 5 to 813 days).
Patients experienced a median of 3 episodes (range: 1 to 11 episodes) of ocular toxicity based on ophthalmic exam findings. Of the patients with Grade 2 to 4 ophthalmic exam findings, 42% had improvement of the last event to Grade 1 or better; 22% had resolution of the last event based on return to baseline or normal ophthalmic exam findings. The most commonly reported corneal exam findings included superficial punctate keratopathy, microcyst-like deposits, epithelial changes, and haze.
Cases of corneal ulcer, including cases with infection, have been reported and should be managed promptly by an eye care professional [see Adverse Reactions ( 6.1 )] . A reduction in BCVA to 20/50 or worse in at least one eye occurred in 69% of patients, including 29% who experienced a change in BCVA to 20/100 or worse, and 12% who experienced a change in BCVA to 20/200 or worse. Of the patients with reduced BCVA to 20/50 or worse in at least one eye, 61% had resolution of the last event to baseline or better.
Of the patients with reduced BCVA to 20/100 or worse, 57% had resolution of the last event. Of the patients with reduced BCVA to 20/200 or worse, 48% had resolution of the last event. Ophthalmic exams (including slit lamp exam and BCVA assessment) should be conducted by an eye care professional, such as an ophthalmologist or optometrist, at baseline, before each dose of BLENREP, promptly for new or worsening symptoms, and as clinically indicated.
Perform baseline exam within 4 weeks prior to the first dose. Perform each follow-up exam within 10 days prior to the next planned dose. All effort should be made to schedule the exam as close to BLENREP dosing as possible.
Withhold BLENREP until improvement in both corneal exam findings and change in BCVA to Grade 1 or less and resume at same or reduced dose or permanently discontinue based on severity [see Dosage and Administration ( 2.1 , 2.3 )]. Counsel patients to promptly inform their healthcare provider of any ocular symptoms. Counsel patients to use preservative‑free artificial tears at least 4 times a day starting with the first infusion and continuing until the end of treatment, and to avoid wearing contact lenses for the duration of therapy.
Bandage contact lenses may be used under the direction of an eye care professional [see Dosage and Administration ( 2.1 )]. Changes in visual acuity may be associated with difficulty for driving and reading. Counsel patients to use caution when driving or operating machinery.
BLENREP is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) [see Warnings and…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: • Ocular Toxicity [see Warnings and Precautions ( 5.1 )] • Thrombocytopenia [see Warnings and Precautions ( 5.3 )] 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 COVID-19.
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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Relapsed or Refractory Multiple Myeloma in Combination with Bortezomib and Dexamethasone The safety of BLENREP with bortezomib and dexamethasone (n = 242) compared with daratumumab with bortezomib and dexamethasone (n = 246) was evaluated in DREAMM‑7 in patients with relapsed or refractory multiple myeloma who received at least one prior line of therapy [see Clinical Studies ( 14 )] .
Patients received BLENREP 2.5 mg/kg of actual body weight once every 3 weeks in combination with bortezomib and dexamethasone (BVd) for the first 8 cycles, followed by BLENREP as a single agent or daratumumab in combination with bortezomib and dexamethasone (DVd) for the first 8 cycles, followed by daratumumab as a single agent. Among patients who received BLENREP, 69% were exposed for 6 months or longer and 55% were exposed for greater than one year. The safety of BLENREP in combination with bortezomib and dexamethasone in patients who received only one prior line of therapy (n = 125) has not been established.
Serious adverse reactions occurred in 50% of patients who received BVd. Serious adverse reactions in ≥2% of patients included pneumonia (18%), pyrexia (5%), thrombocytopenia (5%), COVID-19 (5%), upper respiratory tract infection (4%), sepsis (4%), second primary malignancy (3%), and anemia (2%). Fatal adverse reactions occurred in 10% of patients who received BVd.
Fatal adverse reactions which occurred in >1 patient included pneumonia (4%), sepsis (2%), COVID-19 (1%), respiratory failure (<1%), and intracranial hemorrhage (<1%). Permanent discontinuation of BLENREP due to an adverse reaction occurred in 17% of patients. Adverse reactions which resulted in permanent discontinuation of BLENREP in ≥3% of patients included ocular toxicity (9%) and pneumonia (4%).
Dosage interruptions of BLENREP due to an adverse reaction occurred in 78% of patients. Adverse reactions which required dosage interruption of BLENREP in ≥3% of patients included ocular toxicity based on ophthalmic exam findings (74%), blurred vision (32%), upper respiratory tract infection (20%), dry eye (14%), photophobia (14%), pneumonia (14%), eye irritation (13%), COVID-19 (12%), foreign body sensation in eyes (12%), eye pain (10%), thrombocytopenia (9%), visual impairment (7%), cataract (5%), diarrhea (4%), and neutropenia (4%).
Dosage reductions of BLENREP due to an adverse reaction occurred in 36% of patients. Adverse reactions which required dosage reductions for BLENREP in ≥3% of patients included ocular toxicity based on ophthalmic exam findings (30%), thrombocytopenia (14%), and blurred vision (10%). The most common adverse reactions (≥20%) were reduction in BCVA, corneal exam findings, blurred vision, dry eye, photophobia…
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS Lactation: Advise not to breastfeed. ( 8.2 )
8.1Pregnancy Risk Summary Based on its mechanism of action, BLENREP can cause fetal harm when administered to a pregnant woman, because it contains a genotoxic compound (the microtubule inhibitor, MMAF) and it targets actively dividing cells [see Clinical Pharmacology ( 12.1 ), Nonclinical Toxicology ( 13.1 )] . Human immunoglobulin G (IgG) is known to cross the placenta; therefore, belantamab mafodotin-blmf has the potential to be transmitted from the mother to the developing fetus. There are no available data on the use of BLENREP in pregnant women to evaluate for drug-associated risk.
No animal reproduction studies were conducted with BLENREP. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data: Animal reproductive or developmental toxicity studies were not conducted with belantamab mafodotin‑blmf. The cytotoxic component of BLENREP, mcMMAF, disrupts microtubule function, is genotoxic, and can be toxic to rapidly dividing cells, suggesting it has the potential to cause embryo‑fetal toxicity.
8.2Lactation Risk Summary There are no data on the presence of belantamab mafodotin-blmf in human milk or the effects on the breastfed child or milk production. Because of the potential for serious adverse reactions in the breastfed child, advise women not to breastfeed during treatment with BLENREP and for 3 months after the last dose.
8.3Females and Males of Reproductive Potential BLENREP can cause fetal harm when administered to pregnant women [see Use in Specific Populations ( 8.1 )]. Pregnancy Testing Verify the pregnancy status of females of reproductive potential prior to initiating BLENREP. Contraception Females: Advise females of reproductive potential to use effective contraception during BLENREP treatment and for 4 months after the last dose.
Males: Because of the potential for genotoxicity, advise males with female partners of reproductive potential to use effective contraception during treatment with BLENREP and for 6 months after the last dose [see Nonclinical Toxicology ( 13.1 )]. Infertility Based on findings in animal studies, BLENREP may impair fertility in females and males. The effects were not reversible in male rats but were reversible in female rats [see Nonclinical Toxicology ( 13.1 )] .
8.4Pediatric Use The safety and effectiveness of BLENREP in pediatric patients have not been established.
8.5Geriatric Use Of 242 patients who received BLENREP in DREAMM-7, 121 patients (50%) were aged 65 years or older and 37 patients (15%) were 75 years or older. No overall differences in the safety of BLENREP were observed between patients 65 years of age and older and younger adult patients. Of the 108 patients who received BLENREP and were evaluated for efficacy in the DREAMM-7 study, there was an insufficient number of older adult patients to determine if the effectiveness in patients 65 years of age and older is different than in younger adult patients.
8.6Hepatic Impairment No dose adjustment is recommended for patients with mild hepatic impairment (total bilirubin > upper limit of normal [ULN] to ≤1.5 × ULN and any aspartate aminotransferase [AST] or total bilirubin ≤ULN with AST >ULN). The recommended dose of BLENREP has not been established in patients with moderate or severe hepatic impairment [see Clinical Pharmacology ( 12.3 )].
🤰 Pregnancy ▾
8.1Pregnancy Risk Summary Based on its mechanism of action, BLENREP can cause fetal harm when administered to a pregnant woman, because it contains a genotoxic compound (the microtubule inhibitor, MMAF) and it targets actively dividing cells [see Clinical Pharmacology ( 12.1 ), Nonclinical Toxicology ( 13.1 )] . Human immunoglobulin G (IgG) is known to cross the placenta; therefore, belantamab mafodotin-blmf has the potential to be transmitted from the mother to the developing fetus. There are no available data on the use of BLENREP in pregnant women to evaluate for drug-associated risk.
No animal reproduction studies were conducted with BLENREP. Advise pregnant women of the potential risk to a fetus. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Data Animal Data: Animal reproductive or developmental toxicity studies were not conducted with belantamab mafodotin‑blmf. The cytotoxic component of BLENREP, mcMMAF, disrupts microtubule function, is genotoxic, and can be toxic to rapidly dividing cells, suggesting it has the potential to cause embryo‑fetal toxicity.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of BLENREP in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Of 242 patients who received BLENREP in DREAMM-7, 121 patients (50%) were aged 65 years or older and 37 patients (15%) were 75 years or older. No overall differences in the safety of BLENREP were observed between patients 65 years of age and older and younger adult patients. Of the 108 patients who received BLENREP and were evaluated for efficacy in the DREAMM-7 study, there was an insufficient number of older adult patients to determine if the effectiveness in patients 65 years of age and older is different than in younger adult patients.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Belantamab mafodotin‑blmf is an antibody‑drug conjugate (ADC). The antibody component is an afucosylated IgG1 directed against BCMA, a protein expressed on normal B lymphocytes and multiple myeloma cells. The small molecule component is mcMMAF, a microtubule inhibitor.
Upon binding to BCMA, belantamab mafodotin‑blmf is internalized followed by release of the cytotoxic agent (cys‑mcMMAF) via proteolytic cleavage. The released cys‑mcMMAF intracellularly disrupts the microtubule network, leading to cell cycle arrest and apoptosis. Belantamab mafodotin‑blmf had antitumor activity in multiple myeloma cells and mediated killing of tumor cells through cys‑mcMMAF‑induced apoptosis, as well as by tumor cell lysis through antibody‑dependent cellular cytotoxicity and antibody‑dependent cellular phagocytosis.
12.2Pharmacodynamics Exposure‑Response Relationships When BLENREP was used in combination with Vd, higher belantamab mafodotin‑blmf Cycle 1 exposure was associated with a higher incidence of some safety adverse reactions (e.g., Grade ≥2 corneal exam findings). Cardiac Electrophysiology Belantamab mafodotin‑blmf had no meaningful QT c prolongation (>10 ms) at the recommended dosage.
12.3Pharmacokinetics Belantamab mafodotin‑blmf exhibited dose‑proportional pharmacokinetics, with a gradual decrease in clearance over time. After a planned infusion duration of 30 minutes, maximum belantamab mafodotin‑blmf plasma concentrations occurred at or shortly after the end of the infusion. Accumulation of belantamab mafodotin‑blmf was minimal to moderate for the ADC (Cycle 3 to Cycle 1 ratio was 1.13 for C max and 1.58 for AUC) as observed with a dosing regimen of every 3 weeks.
Table 7 describes the pharmacokinetics of belantamab mafodotin‑blmf for the 2.5 mg/kg dose on Cycle 1 at the end of the first 3‑week intervals. Table 7. Summary of Pharmacokinetic Parametersa AUC b C max C tau ADC = antibody drug conjugate; AUC = area under the curve; C max = maximum plasma concentration; C tau = concentration at the end of a dosing interval. a Data presented as geometric mean (CV%). b AUC for ADC is AUC (0‑21days) and for cys-mcMMAF is AUC (0‑7days) .
ADC (%) 3,950 mcg•h/mL (30.6) 43.7 mcg/mL (22.1) 2.03 mcg/mL (62.5) cys‑mcMMAF (%) 94.2 ng•h/mL (42.3) 0.976 ng/mL (45.3) – Distribution In vitro, cys‑mcMMAF exhibited low protein binding (70% unbound at a concentration of 5 ng/mL) in human plasma. The geometric mean (CV%) steady‑state volume of distribution of belantamab mafodotin‑blmf was
10.8L (22.2%). Elimination The geometric mean (CV%) belantamab mafodotin‑blmf (ADC) initial systemic clearance (CL) was 0.901 L/day (40%), and the elimination half‑life was 13 days (26%). Following treatment, steady‑state CL was 0.605 L/day (43%) or approximately 33% lower than initial systemic CL with an elimination half‑life of 17 days (31%).
The fraction of intact cys‑mcMMAF excreted in urine was approximately 18% of the dose in Cycle 1, with no evidence of other mcMMAF‑related metabolites. Metabolism: The monoclonal antibody portion of belantamab mafodotin‑blmf is expected to undergo proteolysis to small peptides and individual amino acids by ubiquitous proteolytic enzymes. Cys‑mcMMAF had limited metabolic clearance in human hepatic S9 fraction incubation studies.
Specific Populations No clinically significant differences in the pharmacokinetics of belantamab mafodotin‑blmf were observed based on age (32 to 89 years), sex, race (White vs. Black vs. Asian), body weight (37 to 170 kg), mild to severe renal impairment and kidney failure (eGFR <30 mL/min), or mild hepatic impairment (total bilirubin >ULN to ≤1.5 × ULN and any AST or total bilirubin ≤ULN with AST >ULN).
The effects of moderate (total bilirubin >1.5 × ULN to ≤3 × ULN and any AST) or severe hepatic impairment (total bilirubin >3 × ULN and any AST) on the pharmacokinetics of belantamab mafodotin‑blmf are unknown. In Vitro Studies: Cytochrome P450 (CYP) Enzy…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Belantamab mafodotin‑blmf is an antibody‑drug conjugate (ADC). The antibody component is an afucosylated IgG1 directed against BCMA, a protein expressed on normal B lymphocytes and multiple myeloma cells. The small molecule component is mcMMAF, a microtubule inhibitor.
Upon binding to BCMA, belantamab mafodotin‑blmf is internalized followed by release of the cytotoxic agent (cys‑mcMMAF) via proteolytic cleavage. The released cys‑mcMMAF intracellularly disrupts the microtubule network, leading to cell cycle arrest and apoptosis. Belantamab mafodotin‑blmf had antitumor activity in multiple myeloma cells and mediated killing of tumor cells through cys‑mcMMAF‑induced apoptosis, as well as by tumor cell lysis through antibody‑dependent cellular cytotoxicity and antibody‑dependent cellular phagocytosis.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING BLENREP (belantamab mafodotin‑blmf) for injection is a sterile, preservative‑free, white to yellow lyophilized powder for reconstitution and further dilution prior to intravenous use. BLENREP is supplied in a carton containing one 70 mg single‑dose vial with a rubber stopper (not made with natural rubber latex) and aluminum overseal with removable cap (NDC 0173‑0913‑01). Store vials refrigerated at 36ºF to 46ºF (2ºC to 8ºC).
BLENREP is a hazardous drug. Follow applicable special handling and disposal procedures. 1
📋 Description ▾
11 DESCRIPTION Belantamab mafodotin‑blmf is a B‑cell maturation antigen (BCMA)‑directed antibody and microtubule inhibitor conjugate. Belantamab mafodotin‑blmf is an antibody conjugate composed of 3 components: 1) afucosylated, humanized immunoglobulin G1 monoclonal antibody covalently linked to 2) the microtubule inhibitor mcMMAF via 3) a protease‑resistant maleimidocaproyl linker. The antibody is produced in a mammalian cell line (Chinese Hamster Ovary) using recombinant DNA technology and the microtubule inhibitor and linker are produced by chemical synthesis.
Approximately 4 molecules of mafodotin are attached to each antibody molecule. The molecular weight of belantamab mafodotin‑blmf is approximately 152 kDa. Belantamab mafodotin‑blmf has the following structure: BLENREP (belantamab mafodotin‑blmf) for injection is a sterile, preservative‑free, white to yellow, lyophilized powder in a single‑dose vial for reconstitution and further dilution prior to intravenous use.
BLENREP is supplied as 70 mg per vial and requires reconstitution with 1.4 mL of Sterile Water for Injection, USP, to obtain a concentration of 50 mg/mL. Each mL of reconstituted solution contains belantamab mafodotin‑blmf (50 mg) and the inactive ingredients, citric acid monohydrate (0.46 mg), edetate disodium (0.017 mg), polysorbate 80 (0.2 mg), sodium citrate (5.88 mg), and trehalose (68.4 mg). The pH of the reconstituted solution is 6.2.
Belantamab mafodotin-blmf chemical structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA‑approved patient labeling (Medication Guide). Ocular Toxicity • Advise patients that ocular toxicity may occur during treatment with BLENREP [see Warnings and Precautions ( 5.1 )] . • Advise patients to promptly tell their healthcare provider if they notice any new or worsening eye symptoms [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.1 )] . • Advise patients that they will be sent to an eye care professional to obtain ophthalmic exams before starting BLENREP, before each dose, promptly for any new or worsening eye symptoms, and as clinically indicated [see Dosage and Administration ( 2.1 ), Warnings and Precautions ( 5.1 )] . • Advise patients to administer preservative‑free artificial tears at least 4 times per day starting with the first infusion and continuing until the end of treatment and to avoid wearing contact lenses for the duration of therapy.
Bandage contact lenses may be used under the direction of an eye care professional [see Dosage and Administration ( 2.1 , 2.3 ), Warnings and Precautions ( 5.1 )] . • Advise patients to use caution when driving or operating machinery as BLENREP may adversely affect their vision [see Warnings and Precautions ( 5.1 )] . BLENREP REMS • Advise patients that because of the risk of ocular toxicity, BLENREP is available only through a restricted program called the BLENREP REMS [see Warnings and Precautions ( 5.2 )] . • Patients must receive counseling about the risk of ocular toxicity, enroll in the REMS, and adhere to ongoing monitoring via ophthalmic exams.
Patients will be given the BLENREP REMS Patient Guide. This guide describes the risk of ocular toxicity with BLENREP [see Warnings and Precautions ( 5.2 )] . Thrombocytopenia • Advise patients to inform their healthcare provider if they develop signs or symptoms of bleeding [see Warnings and Precautions ( 5.3 )] .
Embryo‑fetal Toxicity • Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions ( 5.4 ), Use in Specific Populations ( 8.1 , 8.3 )] . • Advise females of reproductive potential to use effective contraception during treatment with BLENREP and for 4 months after the last dose [see Warnings and Precautions ( 5.4 ), Use in Specific Populations ( 8.3 )] . • Advise males with female partners of reproductive potential to use effective contraception during treatment with BLENREP and for 6 months after the last dose [see Use in Specific Populations ( 8.3 ), Nonclinical Toxicology ( 13.1 )] .
Lactation • Advise women not to breastfeed during treatment with BLENREP and for 3 months after the last dose [see Use in Specific Populations ( 8.2 )] . Infertility • Advise males and females of reproductive potential that BLENREP may impair fertility [see Use in Specific Populations ( 8.3 )] . Pneumonitis • Advise patients to immediately report any new or worsening respiratory symptoms to their healthcare provider [see Adverse Reactions ( 6.1 )] .
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💬 Medication Guide ▾
MEDICATION GUIDE BLENREP (BLEN-REP) (belantamab mafodotin-blmf) for injection, for intravenous use 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. To receive BLENREP, you must enroll in the REMS program and receive eye exams during treatment. See “What are the possible side effects of BLENREP?” for more information about side effects.
What is BLENREP? BLENREP is a prescription medicine used in combination with the medicines bortezomib and dexamethasone to treat adults with multiple myeloma who: • have received at least 2 prior treatments, including a proteasome inhibitor and an immunomodulatory agent, and • their cancer has come back or did not respond to prior treatment. It is not known if BLENREP is safe and effective in children.
Before receiving BLENREP, tell your healthcare provider about all of your medical conditions, including if you: • have or had vision or eye problems. • have or had bleeding problems. • are pregnant or plan to become pregnant. BLENREP can harm your unborn baby. Females who are able to become pregnant: o Your healthcare provider will do a pregnancy test before you start treatment with BLENREP. o Use effective birth control during treatment with BLENREP and for 4 months after the last dose.
Talk to your healthcare provider about birth control methods you can use during this time. o Tell your healthcare provider if you become pregnant or think you may be pregnant during treatment with BLENREP. Males with female partners who are able to become pregnant: o Use effective birth control during treatment with BLENREP and for 6 months after the last dose. • are breastfeeding or plan to breastfeed. It is not known if BLENREP passes into your breast milk.
Do not breastfeed during treatment with BLENREP and for 3 months after the last dose. Tell your healthcare provider about all the medicines you take , including prescription and over‑the‑counter medicines, vitamins, and herbal supplements. How will I receive BLENREP? • Your healthcare provider will give you BLENREP as an infusion into your vein over about 30 minutes. • BLENREP is usually given every 3 weeks. • Your healthcare provider will decide how many treatments you will need. • If you miss any appointments, call your healthcare provider as soon as pos…