Belantamab Mafodotin

Belantamab Mafodotin is a prescription medication used for the treatment of relapsed or refractory multiple myeloma in adults (on November 22, 2022, the drug company is following the request of the FDA and has initiated the withdrawal process of the US marketing authorization for belantamab Mafodotin)

• Belantamab Mafodotin is available under the following different brand names: Blenrep, belantamab Mafodotin-blmf

Common side effects of Belantamab Mafodotin include:

• keratopathy (corneal epithelium changes on eye exam)
• decreased visual acuity
• nausea
• blurred vision
• fever
• fatigue
• infusion-related reactions
• decreased platelets
• decreased lymphocytes
• decreased hemoglobin
• decreased neutrophils
• increased creatinine
• increased gamma-glutamyl transferase
• dry eyes, constipation
• diarrhea
• joint pain
• back pain
• decreased appetite
• upper respiratory tract infection

Serious side effects of Belantamab Mafodotin include:

• decrease in platelets (thrombocytopenia)
• infusion reactions are chills or shaking, redness of your face (flushing), itching or rash, shortness of breath, cough, or wheezing, swelling of your lips, tongue, throat, or face, dizziness, feeling like passing out, tiredness fever, feel like your heart is racing (palpitations)

Rare side effects of Belantamab Mafodotin include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, coordination loss, unsteady, very stiff muscles, high fever, profuse sweating, or tremors
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, light-headedness, or passing out

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Injection, lyophilized powder for reconstitution

• 100 mg/single-dose vial

Multiple myeloma

Adult dosage

• 2.5 mg/kg of actual body weight given as an IV infusion over approximately 30 minutes once every 3 weeks until disease progression or unacceptable toxicity
• On November 22, 2022, the drug company followed the request of the FDA and initiated the withdrawal process of the US marketing authorization for belantamab Mafodotin
• Request was based on the previously announced outcome of the DREAMM-3 phase III trial, which did not meet the requirements of the FDA accelerated approval regulations.
• Approved for monotherapy treatment for adult patients 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.
• Patients already enrolled in the Blenrep Risk Evaluation and Mitigation Strategy (REMS) program will have the option to enroll in a compassionate use program to continue to access treatment
• Further information on how to enroll patients into the compassionate use program will be provided directly to REMS-enrolled prescribers
• Patients currently being treated should consult their healthcare provider

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Belantamab Mafodotin has no noted severe interactions with any other drugs.
• Belantamab Mafodotin has no noted serious interactions with any other drugs.
• Belantamab Mafodotin has no noted moderate interactions with any other drugs.
• Belantamab Mafodotin has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Belantamab Mafodotin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Belantamab Mafodotin?”

Cautions

• Severe ocular adverse reactions occurred in clinical trials; changes in visual acuity may be associated with difficulty driving and reading; advise patients to use caution when driving or operating machinery; only available through restricted REMS program
• Thrombocytopenia reported; perform CBC counts at baseline and during treatment as clinically indicated
• Infusion-related reactions reported; monitor for infusion-related reactions; if reactions occur, administer premedications for all subsequent infusions
• May cause fetal harm when administered to pregnant women

Pregnancy and Lactation

• Based on its mechanism of action, fetal harm may occur when administered to pregnant women; contains a genotoxic compound (the microtubule inhibitor, monomethyl auristatin phenylalanine) that targets actively dividing cells
• Human IgG is known to cross the placenta; therefore, belantamab Mafodotin has the potential to be transmitted from the mother to the developing fetus
• No data available on use in pregnant women to evaluate for drug-associated risks
• No animal reproduction studies were conducted
• Advise pregnant women of potential risks
• Recommend pregnancy testing for women of reproductive potential before initiating treatment
• Contraception
  • Women of reproductive potential: Use effective contraception during treatment and for 4 months after the last dose
  • Men with female partners of reproductive potential: Use effective contraception during treatment and for 6 months after the last dose
• Infertility
  • Based on findings in animal studies, may impair fertility in women and men
  • Effects were not reversible in male rats but were reversible in female rats
• Lactation
  • There are no data on the presence of human milk or its effects on breastfed children or milk production
  • Advise women not to breastfeed during treatment and for 3 months after the last dose