IMPORTANT SAFETY INFORMATION

What is the most important information I should know about PASATRU?

• Harm to your unborn baby including serious birth defects if taken during pregnancy. Females who are pregnant must not take PASATRU.
  • Females who can become pregnant:
    • Your healthcare provider will ask you to take a pregnancy test to verify that you are not pregnant before starting treatment with PASATRU. Your healthcare provider may ask you to take pregnancy tests periodically, as needed, throughout treatment and for at least 6 months after you stop treatment with PASATRU.
    • Use effective birth control (contraception) during treatment with PASATRU and for 6 months after the last dose of PASATRU. Talk to your healthcare provider about birth control methods that may be right for you.
    • If you become pregnant or think you may be pregnant during treatment with PASATRU, stop taking PASATRU immediately and call your healthcare provider right away.
• Infections of the skin and tissue under the skin requiring treatment or hospitalization, such as infected lumps (abscesses) and bacterial skin infections (cellulitis), may happen while you are taking PASATRU. Call your healthcare provider right away if you have signs or symptoms of skin infection, such as:
  • redness
  • skin feels warm to the touch
  • swelling
  • pain or tenderness
  • fever
  • feeling generally unwell
• Nosebleeds (epistaxis) including serious nosebleeds that require medical care, can happen while taking PASATRU. Tell your healthcare provider right away if you have a nosebleed that:
  • is severe or heavy
  • does not stop with basic first-aid measures, such as pinching your nose with continuous firm pressure
  • lasts more than 20 minutes

Do not receive PASATRU if you are pregnant.

Before you receive PASATRU, tell your healthcare provider about all your medical conditions, including if you:

• are breastfeeding. It is not known whether PASATRU passes into your breastmilk. Breastfeeding is not recommended during treatment with PASATRU and for 6 months after the last dose of PASATRU. Talk to your healthcare provider about the best way to feed your baby during this time.
• are concerned about male fertility. PASATRU may affect your ability to father a child. Talk to your healthcare provider if this is a concern for you.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

The most common side effects of PASATRU include:

• infected lumps (abscess)
• acne
• increased hair growth
• hair loss of eyebrows or lashes (madarosis)
• mouth sores (oral ulcers)
• nosebleeds (epistaxis)

These are not all of the possible side effects of PASATRU. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is PASATRU?

PASATRU™ (garetosmab-grts) is a prescription medicine used to reduce the formation of new abnormal bone growth outside of the skeleton (heterotopic ossification) and flare-ups in adults with fibrodysplasia ossificans progressiva (FOP).

It is not known if PASATRU is safe and effective in children.

Please click here for full Prescribing Information, including Medication Guide.