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Uses

What is Gavreto used for?

Gavreto (pralsetinib) is commonly used to treat certain types of non-small-cell lung cancer (NSCLC) and thyroid cancer.

Gavreto may also be used for other conditions as determined by your healthcare provider.

How does Gavreto work (mechanism of action)?

Gavreto is a type of medicine called a kinase inhibitor. It targets a protein called RET. In certain cancers, RET can cause cells to grow too quickly. By blocking RET fusions, Gavreto helps slow or stop cancer cells from growing.

How is Gavreto supplied (dosage forms)?

Brands and other names

  • Gavreto

Dosage forms and strengths

  • 100 mg oral capsules

How should I store Gavreto?

Gavreto should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place.

Side Effects

What are the most common side effects of Gavreto?

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

There may be other side effects of Gavreto that are not listed here. Contact your healthcare 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. 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 Gavreto?

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

Severe Allergic Reactions. Gavreto may cause allergic reactions, which can be serious. Stop taking Gavreto 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, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Lung Inflammation. Gavreto can cause inflammation in your lungs, also called interstitial lung disease or pneumonitis. This can be serious or even life-threatening. Get emergency help if you have trouble breathing. You may also have a cough, fever, or chest pain. 

High Blood Pressure (Hypertension). Gavreto may increase your blood pressure or make it worse if you have a history of high blood pressure. Call your healthcare provider if your blood pressure increases while taking this medicine.

If you measure your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, get medical attention right away. Increases in blood pressure may not be noticeable, but look out for and tell your healthcare provider right away if you have any of the following symptoms of severely high blood pressure.

  • Sudden severe headache
  • Chest pain
  • Dizziness or confusion
  • Trouble breathing
  • Nausea or vomiting
  • Blurry or other changes to vision
  • Anxiety
  • Buzzing in the ears
  • Nosebleed
  • Feeling of skipped heartbeats

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Gavreto. Keep all appointments to have your blood work checked so your liver health can be monitored. Call your healthcare provider right away if you have any of the following symptoms of liver damage.

  • Nausea or vomiting
  • Stomach or belly pain
  • Fever
  • Weakness or unusual tiredness
  • Itching
  • Loss of appetite
  • Light-colored poop
  • Dark-colored urine (pee)
  • Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Severe Bleeding. Gavreto can increase your risk of severe bleeding that can lead to death. Some people with serious bleeding may need a blood transfusion or surgery. Call your healthcare provider right away if you have any of the following signs of severe bleeding while taking Gavreto.

  • Pink, red, or brown urine (pee)
  • Vomit with blood that looks like coffee grounds
  • Red or black stools (looks like tar)
  • Coughing up blood or blood clots
  • Unusual bleeding or bruising, including vaginal bleeding or nosebleeds
  • Difficulty staying awake or being woken up
  • Confusion
  • Headache
  • Problems or changes with speaking

Tumor Lysis Syndrome. Gavreto can cause a fast breakdown of cancer cells. This can lead to a condition called tumor lysis syndrome, which can be serious. It is important to drink plenty of water while taking Gavreto and to keep all of your appointments for blood work so your healthcare provider can see how your body is responding to the medicine. Tell your healthcare provider right away if you have any of the following signs of tumor lysis syndrome while taking Gavreto.

  • Nausea and vomiting
  • Weakness
  • Swelling or fluid retention
  • Shortness of breath
  • Muscle cramps
  • Seizures

Warnings & Precautions

Who should not use Gavreto?

Allergies to Ingredients. People who are allergic to any of the following should not take Gavreto.

  • Gavreto
  • Pralsetinib
  • Any of the ingredients in the specific product dispensed

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

What should I know about Gavreto before using it?

Do not take Gavreto unless it has been prescribed to you by a healthcare provider. Take it as prescribed.

Do not share Gavreto with other people, even if they have the same condition as you. It may harm them.

Keep Gavreto out of the reach of children.

Gavreto should be taken on an empty stomach at least one hour after or two hours before eating. 

What should I tell my healthcare provider before using Gavreto?

Tell your healthcare 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 determine if Gavreto is right for you.

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

Current and Past Health Conditions. Tell your healthcare provider if you have any of the following.

  • Lung or breathing problems
  • High blood pressure
  • Bleeding problems
  • Liver problems

Other Medicines and Supplements. Gavreto may interact with other medicines and supplements. Before taking Gavreto, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Wound Healing Issues. Gavreto can make it difficult for your body to heal wounds. Tell your healthcare provider if you have any planned or emergency surgeries or if you have any injuries that occur while taking Gavreto.

Planned Surgery. If you have a planned surgery, talk with your healthcare provider. Gavreto can increase your risk for serious bleeding and will need to be stopped at least five days before certain surgeries. Talk with your healthcare provider before you stop taking Gavreto. 

Pregnancy. Gavreto may cause harm to an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. You must not be pregnant before starting Gavreto. If you can become pregnant, use effective nonhormonal birth control, such as condoms, while using Gavreto and for at least two weeks after your last dose. If you are assigned male at birth and have a partner who can get pregnant, use effective birth control while using Gavreto and for at least one week after your last dose. 

Infertility. Gavreto may cause fertility problems. Talk with your healthcare provider if this is a concern for you. 

Breastfeeding. It is not known if Gavreto passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. You should not breastfeed while using Gavreto and for at least one week after your last dose.

How can I get more information about Gavreto?

For more information about Gavreto, you can visit the manufacturer’s website at www.gavreto.com or call them at 833-744-3562.

Interactions

Does Gavreto interact with foods or drinks?

Gavreto should be taken on an empty stomach. Avoid taking Gavreto within two hours before food or within one hour after food.

Grapefruit interacts with Gavreto. It is important to avoid eating grapefruit or drinking grapefruit juice while taking Gavreto. This is because grapefruit can interfere with your body’s ability to break down Gavreto, which can lead to high levels of the medicine and an increased risk of side effects. 

It is unknown if drinking alcohol will affect Gavreto, but both Gavreto and alcohol can increase your risk of bleeding. It is best to limit the amount of alcohol you drink.

Does Gavreto interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Gavreto.

  • Itraconazole (Sporanox, Tolsura), fluconazole, or voriconazole (Vfend), which is a medicine used to treat fungal infections or yeast infections
  • Verapamil (Verelan, Verelan PM), which is a medicine used for high blood pressure or chest pain
  • A birth control pill, patch, vaginal ring, implant, injection, or intrauterine device (IUD)

Many other medicines may alter the blood levels of Gavreto. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Gavreto. Always check with your healthcare provider.

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 Gavreto?

If you or someone else has used too much Gavreto, 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 Gavreto?

If you miss a dose, take it as soon as you remember the same day. If you do not remember in the same day, skip the missed dose and only take the next dose. Do not take double or extra doses.

If you vomit after taking a dose, do not take an extra dose. Instead, take your next dose at the regular time.