Pralsetinib

Generic name: pralsetinib [ pral-SE-ti-nib ]
Brand name: Gavreto
Dosage form: oral capsule (100 mg)
Drug class: Multikinase inhibitors

Medically reviewed by Drugs.com on Oct 9, 2023. Written by Cerner Multum.

What is pralsetinib?

Pralsetinib is used to treat non-small cell lung cancer that has spread to other parts of the body (metastatic).

Pralsetinib is used only if your cancer has a specific genetic marker (an abnormal "RET" gene fusion). Your doctor will test you for this gene fusion.

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

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

Pralsetinib side effects

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

Pralsetinib may cause serious side effects. Call your doctor at once if you have:

• fever, chills;

• new or worsening cough, shortness of breath, or chest pain;

• severe headache, dizziness, confusion, trouble speaking;

• any wound that will not heal;

• unusual bleeding--bruising, nosebleeds, bleeding gums, abnormal vaginal bleeding, any bleeding that will not stop;

• signs of bleeding inside your body--weakness, drowsiness, pink or brown urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• low blood cell counts--fever, tiredness, sore throat, mouth sores, skin sores, pale skin, cold hands and feet, feeling light-headed or short of breath; or

• liver problems--nausea, vomiting, loss of appetite, stomach pain (upper right side), tiredness, dark urine, jaundice (yellowing of the skin or eyes).

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

Common side effects of pralsetinib may include:

• high blood pressure;

• low blood cell counts or other abnormal laboratory tests;

• muscle or joint pain;

• feeling tired; or

• constipation.

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.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

Tell your doctor if you have ever had:

• lung or breathing problems other than lung cancer;

• bleeding problems; or

• high blood pressure.

Pralsetinib can harm an unborn baby if the mother or the father is using pralsetinib.

• If you are a woman, do not use pralsetinib if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective non-hormonal birth control to prevent pregnancy while you are using this medicine and for at least 2 weeks 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 1 week after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using pralsetinib.

Pralsetinib can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using pralsetinib, use a barrier form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Pralsetinib is not approved for use by anyone younger than 18 years old.

How should I take pralsetinib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Take pralsetinib on an empty stomach, at least 1 hour before or 2 hours after a meal.

If you vomit shortly after taking pralsetinib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Your blood pressure will need to be checked often and you will need frequent blood tests.

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

Do not change your dose or stop using a medicine without your doctor's advice.

Store at room temperature away from moisture and heat.

Pralsetinib dosing information

Usual Adult Dose for Non-Small Cell Lung Cancer:

400 mg orally once a day

Duration of therapy: Continue until disease progression or unacceptable toxicity.

Comments:
-Select patients based on the presence of a RET (rearranged during transfection) gene fusion.
-Information on FDA-approved tests for RET gene fusion is available at http://www.fda.gov/CompanionDiagnostics.

Use: For the treatment of metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA-approved test

Usual Adult Dose for Thyroid Cancer:

400 mg orally once a day

Duration of therapy: Continue until disease progression or unacceptable toxicity.

Comments:
-Select patients based on the presence of a RET (rearranged during transfection) gene fusion (thyroid cancer).
-However, FDA-approved gene fusion tests for RET gene fusion (thyroid cancer) and are currently not available.

Use:
-For the treatment of advanced or metastatic RET fusion-positive thyroid cancer patients who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)

Usual Pediatric Dose for Thyroid Cancer:

12 years or older: 400 mg orally once a day

Duration of therapy: Continue until disease progression or unacceptable toxicity.

Comments:
-Select patients based on the presence of a RET (rearranged during transfection) gene fusion (thyroid cancer).
-However, FDA-approved gene fusion tests for RET gene fusion (thyroid cancer) are currently not available.

Use:
-For the treatment of advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate)

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking pralsetinib?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What other drugs will affect pralsetinib?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can affect pralsetinib, especially:

• an antibiotic or antifungal medicine;

• antiviral medicine to treat HIV or hepatitis C;

• cancer medicine;

• certain cholesterol medicines; or

• seizure medicine.

This list is not complete and many other drugs may affect pralsetinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Medical Disclaimer

Copyright 1996-2024 Cerner Multum, Inc. Version: 1.01.