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Overview: Pasatru is used to treat certain people with a rare genetic condition that causes extra bones to form where they should not be. It is given as an intravenous (IV) infusion into a vein. Common side effects may include nosebleeds, mouth ulcers, and loss of eyelashes, eyebrows, or both. Serious side effects may include skin infections or nosebleeds that are severe or hard to stop. Contact your health care provider right away if you have a nosebleed that does not stop by pinching your nose or if you think you have a skin infection.

Uses

What is Pasatru used for?

Pasatru (garetosmab-grts) is used to reduce flares and the formation of extra bone in certain people with fibrodysplasia ossificans progressiva (FOP). FOP is a rare genetic condition where bone forms in areas of the body where bone is not normally present. The extra bone is called heterotopic ossification. This often happens in areas where ligaments, tendons and muscles normally are. FOP flare-ups often involve swelling, pain, and a reduced ability to move around. 

Pasatru may also be used for other conditions as determined by your health care provider.

How does Pasatru work (mechanism of action)?

A protein in your body called activin A acts like a switch that tells your body to start making bone. In people with FOP, this switch is turned on when it should not be. This leads to new bone growth in the wrong places. 

Pasatru is a type of medicine called a monoclonal antibody.  It attaches to activin A and holds onto it, so activin A cannot flip the switch on and tell your body to make bone. Pasatru works to slow down and reduce new abnormal bone from forming. Pasatru is not a cure for FOP. It does not remove bone that has already formed.

How is Pasatru supplied (dosage forms)?

Pasatru is available in an injectable form that is given by a health care provider.

How should I store Pasatru?

Pasatru is usually given by a health care provider in a hospital or clinic. You will not store it at home.

Side Effects

What are the most common side effects of Pasatru?

The most common side effects of Pasatru are listed below. Tell your health care provider if you have any of these side effects that bother you.

  • Abscess
  • Acne
  • Increased hair growth
  • Loss of eyelashes, eyebrows, or both
  • Mouth ulcers
  • Nosebleeds (see below)

There may be other side effects of Pasatru that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Pasatru?

While less common, the most serious side effects of Pasatru are described below, along with what to do if they happen.

Severe Allergic Reactions. Pasatru may cause allergic reactions, which can be serious. Stop using Pasatru and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching or skin rash
  • Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Skin Infections. Pasatru can increase your risk of skin infections, including abscesses and cellulitis. Sometimes these infections can be severe, even requiring you to stay in the hospital.  Call your health care provider right away if you have any of the following symptoms of a skin infection.

  • Skin redness, pain, swelling, or tenderness
  • Skin feels warm to the touch
  • Fever
  • Feeling generally unwell

Severe Nosebleeds. Nosebleeds are a common side effect from Pasatru. Sometimes these can be severe. Call your health care provider right away if you have any of the following signs of severe nose bleeding while using Pasatru.

  • Does not stop with first-aid measures, such as pinching your nostrils with firm pressure
  • Severe or heavy
  • Lasts longer than 20 minutes

Warnings & Precautions

Who should not use Pasatru?

Allergies to Ingredients. People who are allergic to any of the following should not use Pasatru.

  • Garetosmab-grts
  • Pasatru
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Pasatru.

Pregnancy. Do not use Pasatru if you are pregnant. If you become pregnant, contact your health care provider right away. See the Pregnancy section for more details.

What should I know about Pasatru before using it?

Pasatru is usually given by a health care provider in a hospital or clinic. It is given as an intravenous (IV) infusion into a vein.

Pasatru may make it hard for you to get your partner pregnant. Talk to your health care provider if you have concerns.

What should I tell my health care provider before using Pasatru?

Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Pasatru is right for you.

In particular, make sure that you discuss any of the following.

Pregnancy. Pasatru can cause harm to a fetus. You should not use Pasatru while you are pregnant. If you can get pregnant, your health care provider will likely do a test to make sure you are not pregnant before you can receive Pasatru. You should also use effective birth control while you are receiving Pasatru and for 6 months after your last dose. If you find out you are pregnant while using Pasatru, stop using it right away and contact your health care provider.

Breastfeeding. It is not known if Pasatru passes into breast milk. You should not breastfeed while you are using Pasatru or for 6 months after your last dose. Tell your health care provider if you are breastfeeding or plan to breastfeed.

How can I get more information about Pasatru?

For more information about Pasatru, you can visit the drugmaker’s website at www.pasatru.com or call them at 844-734-6643.

Interactions

Does Pasatru interact with foods or drinks?

There are no known interactions between Pasatru and foods or drinks.

It is unknown if drinking alcohol will affect Pasatru, but alcohol can increase your risk of bleeding, and nosebleeds are a common side effect of Pasatru. It is likely best to limit the amount of alcohol you drink.

Does Pasatru interact with other medicines (drug interactions)?

It is not known if Pasatru interacts with other medicines. Always tell your health care provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Pasatru?

If you or someone else has used too much Pasatru, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Pasatru?

Pasatru is usually given by a health care provider in a hospital or clinic. Your health care provider will make sure you are receiving Pasatru as scheduled.

If you miss an appointment to get your Pasatru dose, call to make another appointment as soon as possible.