Generic name: pralsetinib [ pral-SE-ti-nib ]
Drug class: Multikinase inhibitors

Medically reviewed by Judith Stewart, BPharm. Last updated on May 2, 2022.

What is Gavreto?

Gavreto is tyrosine kinase inhibitor and is used as an antineoplastic agent.

Gavreto is a prescription medicine used to treat adults with non-small cell lung cancer that has spread to other parts of the body (metastatic).

Gavreto is used to treat adults and children 12 years of age and older with advanced medullary thyroid cancer (MTC) or MTC that has spread who require a medicine by mouth or injection (systemic therapy).

Gavreto is also used to treat adults and children 12 years of age and older with advanced thyroid cancer or thyroid cancer that has spread who require a medicine by mouth or injection (systemic therapy) and who have received radioactive iodine and it did not work or is no longer working.

Gavreto 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.

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

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. Gavreto may affect the way other medicines work, and other medicines may affect how Gavreto works.

Before taking this medicine

To make sure Gavreto is safe for you, 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 this medicine.

• If you are a woman, do not use Gavreto 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 Gavreto.

Gavreto can make hormonal birth control less effective, including birth control pills, injections, implants, skin patches, and vaginal rings. To prevent pregnancy while using Gavreto, 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.

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

How should I take Gavreto?

Take Gavreto exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

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

If you vomit shortly after taking Gavreto, 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.

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) or RET gene mutation (MTC).
-However, FDA-approved gene fusion tests for RET gene fusion (thyroid cancer) and RET gene mutations are currently not available.

Uses:
-For the treatment of advanced or metastatic RET mutant medullary thyroid cancer (MTC) who require systemic therapy.
-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).

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) or RET gene mutation (MTC).
-However, FDA-approved gene fusion tests for RET gene fusion (thyroid cancer) and RET gene mutations are currently not available.

Uses:
-For the treatment of advanced or metastatic RET mutant medullary thyroid cancer (MTC) who require systemic therapy.
-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 to avoid

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

Gavreto side effects

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

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 Gavreto side effects 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.

What other drugs will affect Gavreto?

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 interact with 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 interact with 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 Gavreto 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

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