Garetosmab

Garetosmab is used in adults with fibrodysplasia ossificans progressiva (FOP). FOP causes abnormal bone growth outside the skeleton. Garetosmab helps reduce new abnormal bone growth outside the skeleton and flare-ups, which can cause painful swelling and worsening of symptoms.

Garetosmab may also be used for reasons not mentioned in this medication guide.

Garetosmab is given as an infusion into a vein. A healthcare provider will give you this infusion over 60 minutes, once every 4 weeks.

May harm an unborn baby, including serious birth defects. Do not receive garetosmab if you are pregnant. Use effective birth control during treatment and for 6 months after your last dose.

Garetosmab can cause serious skin infections. Call your doctor right away if you have signs of a skin infection.

Garetosmab can cause serious nosebleeds. Call your doctor right away if a nosebleed is severe, does not stop with basic first aid, or lasts more than 20 minutes.

Garetosmab can harm an unborn baby. You should not receive garetosmab if you are pregnant.

• You will need a pregnancy test before starting treatment.
• Use effective birth control while receiving garetosmab and for 6 months after your last dose.
• If you become pregnant or think you may be pregnant, call your doctor right away. Do not receive any more garetosmab.

Do not breastfeed while receiving garetosmab and for 6 months after your last dose.

It may be harder for you to get a woman pregnant while you are using this medicine.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

Garetosmab may cause serious side effects. Call your doctor right away if you have:

• signs of a skin infection—redness, warmth, swelling, pain or tenderness, fever, or feeling generally unwell; or
• a nosebleed that is severe or heavy, does not stop with basic first aid, or lasts more than 20 minutes.

Common side effects of garetosmab may include:

• infected lumps (abscesses), such as under the skin or around a tooth;
• acne, increased hair growth, hair loss of eyebrows or lashes;
• mouth sores (oral ulcers);
• nosebleed.

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.

Call your doctor for instructions if you miss an appointment for your garetosmab infusion.

In a medical setting, an overdose would be treated promptly.

Follow your doctor's instructions regarding any limits on food, drinks, or activities.

Other drugs may affect garetosmab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.