Belantamab Mafodotin (bel-AN-ta-mab ma-foe-DOE-tin)

Treats multiple myeloma.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through an IV placed in a vein. This medicine must be given slowly, so the needle will need to stay in place for at least 30 minutes.
• You will receive this medicine while you are in a hospital or cancer treatment center. A nurse or other trained health professional will give you this medicine.
• 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.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• 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.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. 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 to keep from getting pregnant during treatment and for at least 4 months after the last dose. Males who are taking this medicine, with female partners who can become pregnant must use effective birth control during treatment and for at least 6 months after the last dose.
• Do not breastfeed during treatment and for at least 3 months after the last dose.
• Tell your doctor if you have kidney disease, liver disease, lung or breathing problems, bleeding problems, or a history of eye or vision problems.
• This medicine may cause the following problems:
  • Eye or vision problems
  • Infusion reaction, which can be life-threatening
• This medicine may cause blurred vision or difficulty in reading, Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• This medicine lowers the number of certain blood cells, so you may bleed or bruise more easily. Be careful to avoid injuries.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor) before or during treatment.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blurred vision, dry eye, eye redness, irritation, or pain
• Chest pain, trouble breathing
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Headache, lightheadedness, dizziness, fainting, or fast, pounding, or uneven heartbeat
• Unusual bleeding, bruising, tiredness, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, nausea, loss of appetite
• Joint, muscle, or back pain
• Pain, itching, burning, swelling, or a lump under your skin where the needle is placed

If you notice other side effects that you think are caused by this medicine, tell your doctor

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