Pronunciation:

bel-AN-ta-mab ma-foe-DOE-tin

Brand Names:

• Blenrep

Dosage Forms:

• Powder for Solution

Warnings:

Ocular ToxicityBelantamab mafodotin-blmf caused changes in the corneal epithelium resulting in changes in vision, including severe vision loss and corneal ulcer, and symptoms, such as blurred vision and dry eyes.Conduct ophthalmic exams at baseline, prior to each dose, and promptly for worsening symptoms. Withhold belantamab mafodotin-blmf until improvement and resume, or permanently discontinue, based on severity.Because of the risk of ocular toxicity, belantamab mafodotin-blmf is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BLENREP REMS .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Antibody Drug Conjugate

Uses of This Medicine:

Belantamab mafodotin-blmf injection is used to treat multiple myeloma (a type of bone marrow cancer) in patients whose cancer has come back and who have received at least 4 previous treatments (eg, anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent) that did not work well.

This medicine is available only under a restricted distribution program called the Blenrep REMS (Risk Evaluation and Mitigation Strategy) program.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of belantamab mafodotin-blmf injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of belantamab mafodotin-blmf injection in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Eye or vision problems, history of or
• Lung or breathing problems (eg, pneumonitis) or
• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital. It is given through a needle placed into one of your veins. This medicine must be given slowly, so the IV tube will need to stay in place for at least 30 minutes. It is usually given once every 3 weeks.

It is very important that you understand the rules of the Blenrep REMS program. Read the patient Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. You might be asked to sign a form to show that you understand the information.

Use preservative-free lubricant eye drops at least 4 times a day during treatment with this medicine. Do not use contact lenses unless directed by your eye doctor.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose, call your doctor, home health caregiver, or treatment clinic for instructions.

Precautions While Using This Medicine:

It is very important that your doctor check your progress closely while you are receiving this medicine to make sure that it is working properly. Blood tests may be needed to check for unwanted effects. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor) before or during treatment.

Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control while you are receiving this medicine and for at least 4 months after the last dose to keep from getting pregnant. Males who are taking this medicine, with female partners who can become pregnant, must use effective birth control during and for at least 6 months after the last dose of this medicine. If you think you have become pregnant while receiving the medicine, tell your doctor right away.

This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.

Check with your doctor immediately if blurred vision or any other change in vision, difficulty in reading, dry eyes, or eye redness, irritation, or pain occurs during or after treatment. These may be symptoms of a serious eye problem (eg, ocular toxicity). Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine will lower the number of some types of blood cells in your body. Because of this, you may bleed more easily. Stay away from rough sports or other situations where you could be bruised, cut, or injured. Brush and floss your teeth gently. Be careful when using sharp objects, including razors and fingernail clippers.

This medicine may cause infusion-related reactions, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you start to have a fever, chill or shaking, dizziness, headache, trouble breathing, itching or skin rash, lightheadedness, fainting, or fast, pounding, or uneven heartbeat after receiving this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

Black, tarry stools

bleeding gums

blood in urine or stools

blurred vision or any other change in vision

body aches or pain

change in color vision

chest pain or tightness

chills

confusion

constipation

cough

decreased frequency or amount of urine

depression

difficulty seeing at night

difficulty with swallowing

dizziness

dry eye

dry mouth

ear congestion

eye redness, irritation, or pain

fainting

fast heartbeat

fever

headache

incoherent speech

increased sensitivity of the eyes to sunlight

increased thirst

increased urination

lightheadedness or faintness

loss of appetite

loss of voice

low blood pressure or pulse

lower back or side pain

metallic taste

muscle weakness

nausea

pinpoint red spots on the skin

pounding in the ears

rapid, shallow breathing

runny or stuffy nose

skin rash, itching, or hives

sneezing

sore throat

stomach pain

swelling in the face, hands, or lower legs

trouble breathing

unconsciousness

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

weight gain or loss

Incidence not known

General feeling of discomfort or illness

thickening of bronchial secretions

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Constipation

diarrhea

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.