belantamab mafodotin

What is the most important information I should know about belantamab mafodotin?

An eye doctor will need to examine your eyes before each dose of this medicine. Belantamab mafodotin can cause eye problems that may lead to blurred vision, an ulcer on the surface of your eye, or vision loss.

What is belantamab mafodotin?

Belantamab mafodotin is used to treat multiple myeloma in adults. This medicine is given after at least 4 other treatments did not work or have stopped working.

Belantamab mafodotin was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.

Belantamab mafodotin is available only under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Belantamab mafodotin may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before receiving belantamab mafodotin?

Tell your doctor if you have ever had:

• problems with your eyes;
• vision problems; or
• bleeding problems.

You may need to have a negative pregnancy test before starting this treatment.

• If you are a woman, do not use belantamab mafodotin if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 4 months after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 6 months after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using belantamab mafodotin.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because belantamab mafodotin can harm an unborn baby.

How is belantamab mafodotin given?

Belantamab mafodotin is given as an infusion into a vein, usually every 3 weeks. A healthcare provider will give you this injection.

This medicine must be given slowly, and the infusion can take at least 30 minutes to complete.

An eye doctor will need to examine your eyes before each dose of this medicine. Belantamab mafodotin may cause changes to the surface of your eyes, which can lead to vision changes. More serious effects may include an ulcer on the surface of your eye, or vision loss.

Belantamab mafodotin may cause eye problems without causing any vision changes at first. Do not miss any eye examinations while using this medicine.

Belantamab mafodotin can also increase your risk of bleeding. You will need frequent blood tests.

Your doctor will determine how long to treat you with belantamab mafodotin.

What happens if I miss a dose?

What happens if I overdose?

Since this medicine is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid while receiving belantamab mafodotin?

Do not wear contact lenses without your doctor's advice while you are receiving belantamab mafodotin.

What are the possible side effects of belantamab mafodotin?

Some side effects may occur during the injection (infusion reaction). Tell your caregiver if you feel dizzy, tired, nauseated, light-headed, itchy, feverish, chilled, sweaty, short of breath, or have racing heartbeats, trouble breathing, or swelling in your face.

• sudden vision loss;
• easy bruising, unusual bleeding; or
• signs of bleeding in the brain --weakness, dizziness, confusion, numbness or tingling on one side of the body, loss of movement in your face.

Tell your eye doctor if you have any eye problems, changes in your vision, dry eyes, or vision loss.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• vision changes;
• eye changes found during an eye exam;
• infusion reaction;
• abnormal lab tests;
• fever, tiredness; or
• nausea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect belantamab mafodotin?

Other drugs may affect belantamab mafodotin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about belantamab mafodotin.