Belantamab mafodotin
Package labels
Loading package label images…
Looking up MedlinePlus…
From MedlinePlus, U.S. National Library of Medicine
Specialty pharmacy: therapy management checklist, storage and cold chain, dosing calendar, Medicare Part D coverage.
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 )
Handling and access
NIOSH hazardous drug
Table 1NIOSH lists belantamab mafodotin as a hazardous drug. AHFS class: 10:00 antineoplastic agents.
- The package insert includes manufacturer's special handling information (MSHI). Follow it when preparing, administering, and disposing of this drug.
- Biologic (Biologics License Application).
Handle with the precautions your facility uses for hazardous drugs (USP <800>). NIOSH's Managing Hazardous Drug Exposures lists controls by drug form and activity.
REMS
RequiredStated in the label quoted on this page.
- Restricted distribution (ETASU)
- Prescriber certification or enrollment
- Healthcare setting certification
- Patient enrollment
- Medication Guide
Dosing in kidney impairment
This label has no separate kidney-impairment dosing section. Check warnings and clinical pharmacology in the full label.
Dosing in liver impairment
Hepatic 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].
Preparation and administration
Prepare this dose
Your numbers for belantamab mafodotin. Take vial strength, diluent, and limits from the label below.
Enter a dose to see draw volume, final concentration, and rates.
Preparation and Administration BLENREP is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Calculate the dose (mg), total volume (mL) of solution required, and the number of vials of BLENREP needed based on the patient’s actual body weight. More than one vial may be needed for a full dose.
Reconstitution
Remove the vial(s) of BLENREP from the refrigerator and allow to stand for approximately 10 minutes to reach room temperature (68°F to 77°F [20°C to 25°C]).
Reconstitute each 70 mg vial of BLENREP with 1.4 mL of Sterile Water for Injection, USP, to obtain a final concentration of 50 mg/mL. Gently swirl the vial to aid dissolution. Do not shake.
If the reconstituted solution is not used immediately, store in the original container refrigerated at 36ºF to 46ºF (2ºC to 8ºC) or at room temperature (68°F to 77°F [20°C to 25°C]) for up to 4 hours. Discard if not diluted within 4 hours. Do not freeze.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The reconstituted solution should be a clear to opalescent, colorless to yellow to brown liquid. Discard if extraneous particulate matter is observed. Dilution
Withdraw the calculated volume of BLENREP from the appropriate number of vials and dilute in a 250 mL infusion bag of 0.9% Sodium Chloride Injection, USP, to a final concentration of 0.2 mg/mL to 2 mg/mL. The infusion bag must be made of polyvinylchloride (PVC) or polyolefin (PO).
Mix the diluted solution by gentle inversion. Do not shake.
Discard any unused reconstituted solution of BLENREP left in the vial(s).
If the diluted infusion solution is not used immediately, store refrigerated at 36ºF to 46ºF (2ºC to 8ºC) for up to 24 hours. Do not freeze . Once removed from refrigeration, administer the diluted infusion solution of BLENREP within 6 hours (including infusion time).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. The diluted infusion solution should be clear and colorless. Discard if particulate matter is observed. Administration
If refrigerated, allow the diluted infusion solution to equilibrate to room temperature (68ºF to 77ºF [20ºC to 25ºC]) prior to administration. Diluted infusion solution may be kept at room temperature for no more than 6 hours (including infusion time).
Administer by intravenous infusion over approximately 30 minutes using an infusion set made of PVC or PO.
Filtration of the diluted solution is not required; however, if the diluted solution is filtered, use a polyethersulfone (PES)-based filter (0.2 micron). Do not mix or administer BLENREP with other products. The product does not contain a preservative.
| a Adverse reactions were graded according to the Common Terminology Criteria for Adverse Events v5.0. b Consider reverting to previous dose, if appropriate once platelet count recovers to 50,000/mcL or higher. | ||
| Adverse Reaction | Severity | Recommended Dosage Modification |
| Thrombocytopenia[see Warnings and Precautions (5.3)] | Platelet count between 25,000/mcL and 50,000/mcL without bleeding | For patients on 2.5 mg/kg, reduce to Reduced Dosage Level 1 as per Table 1.b For patients on 1.9 mg/kg, continue at same dosage. |
| Platelet count between 25,000/mcL and 50,000/mcL with bleeding | Withhold BLENREP until bleeding resolves. For patients previously on 2.5 mg/kg, resume at Reduced Dosage Level 1 as per Table 1. For patients on 1.9 mg/kg, resume at same dosage. | |
| Platelet count less than 25,000/mcL | Withhold BLENREP until platelet count recovers to 25,000/mcL or higher. For patients previously on 2.5 mg/kg, resume at Reduced Dosage Level 1 as per Table 1. For patients on 1.9 mg/kg, resume at same dosage. | |
| Infusion-related Reactions | Grade 2 | Interrupt infusion and provide supportive care. Once symptoms resolve to Grade 1 or less, resume infusion at 50% of the initial rate prior to the event. Consider premedication for subsequent infusions. |
| Grade 3 | Interrupt infusion and provide supportive care. Once symptoms resolve to Grade 1 or less, resume at 50% of the initial rate prior to the event. Administer premedication for subsequent infusions. | |
| Grade 4 | Permanently discontinue BLENREP.If anaphylactic or life‑threatening infusion reaction, permanently discontinue the infusion and institute appropriate emergency care. | |
| Other Adverse Reactions[see Adverse Reactions (6.1] | Grade 3 | Withhold BLENREP until adverse reaction improves to Grade 1 or less. For patients previously on 2.5 mg/kg, resume at Reduced Dosage Level 1 as per Table 1. For patients on 1.9 mg/kg, resume at same dosage. |
| Grade 4 | Consider permanent discontinuation of BLENREP.If continuing treatment, withhold BLENREP until adverse reaction improves to Grade 1 or less.For patients previously on 2.5 mg/kg, resume at Reduced Dosage Level 1 as per Table 1. For patients on 1.9 mg/kg, resume at same dosage. | |
Drug interactions
Check interactions
Add the patient's other drugs. Matches come from both FDA labels: by name, drug class, and enzyme or transporter pathway.
- Belantamab mafodotin
Contraindications
None. None. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
DLikelihood score D: Possible cause of clinically apparent liver injury most likely due to sinusoidal obstruction syndrome.
Belantamab mafodotin is a humanized monoclonal antibody conjugate that was given accelerated approval for therapy of relapsed or refractory multiple myeloma in 2020 but was withdrawn in 2022 after failing to demonstrate a significant increase in survival compared to conventional therapies. Belantamab mafodotin has been linked to transient serum enzyme elevations during therapy and has been implicated in at least one case of fatal sinusoidal obstruction syndrome.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy 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.
For breastfeeding, also see LactMed (National Library of Medicine), which summarizes milk levels and infant effects.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
Not the price at the counterThese are not what a patient pays at the pharmacy counter. They are what pharmacies, health plans, and government buyers pay, before manufacturer rebates. A patient's cost depends on their insurance (copay, coinsurance, or deductible) or the pharmacy's cash price.