How should I take pralsetinib (Gavreto)?

Pralsetinib comes as a capsule to take by mouth. It is usually taken once daily on an empty stomach, at least 2 hours before and at least 1 hour after a meal. Take pralsetinib at around the same time every day. Take pralsetinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you vomit after taking pralsetinib, do not take another dose. Continue your regular dosing schedule. Be sure to tell your doctor how you are feeling during your treatment with pralsetinib.

Do not stop taking treatment without talking to your doctor. You can help them by tracking your side effects in Ankr.

What are the side effects of pralsetinib (Gavreto)?

Pralsetinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication. If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online or by phone (1-800-332-1088).

Use the free Ankr platform or Ankr app to track your symptoms.

What special precautions should I follow?

Before taking pralsetinib (Gavreto)

• tell your doctor about your allregies
• tell your doctor about other intakes
• tell your doctor if you have or have ever had any disease, symptom, or treatment
• tell your doctor if you are pregnant, plan to become pregnant, or if you plan to father a child. Ask your doctor to help you choose a method of birth control that will work for you

While you are on pralsetinib (Gaverto)

• if you or your partner becomes pregnant while taking pralsetinib, call your doctor. Pralsetinib may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while taking pralsetinib and for 1 week after your final dose.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking pralsetinib.
• you should know that you may experience tumor lysis syndrome (TLS; a condition caused by the fast breakdown of cancer cells that can cause kidney failure and other complications) during your treatment with pralsetinib.

I forgot a dose. What should I do?

Take the missed dose on the same day as soon as you remember it. Then, continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

In case of an emergency/overdose

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can’t be awakened, immediately call emergency services at 911.

How should I safely store and dispose of pralsetinib (Gavreto)

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

You should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA’s Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

Brand names

• Gavreto^®

Last Revised – 06/22/2023, FDA-updated- 02/15/2021, SG