How do I take GAVRETO?

Take GAVRETO at home or wherever you go

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*Assumes a recommended starting dose of 400 mg, once daily. Dosing can vary from person to person.

Dosing can vary from person to person

  • Remember to take GAVRETO capsules exactly as directed by your healthcare provider.
  • Do not change your dose or stop taking GAVRETO unless your healthcare provider tells you to.
  • Reporting side effects can help your healthcare provider decide if a lower dose may be better for you.
  • Before taking GAVRETO: Tell your healthcare provider about all of your medical conditions and all of the medicines you take.
  • While taking GAVRETO: Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with GAVRETO if you develop side effects.
  • If you miss a dose: Take the missed dose as soon as possible on the same day. Then take your next dose of GAVRETO at your regular time the next day.
  • If you vomit after taking a dose: Do not take an extra dose. Take your next dose of GAVRETO at your regular time the next day.

Tips for taking GAVRETO

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Make GAVRETO part of your daily routine

Take GAVRETO at the same time every day on an empty stomach. For example, take it right when you wake up and then wait to eat breakfast for at least 1 hour. Or, eat dinner 2 hours before your regular bedtime and then take it before going to bed.

Nightstand tips
Keep GAVRETO where you can see it

Place your medicine in a spot you’ll be sure to notice, like on your nightstand or next to your cell phone charger. That way, you’re less likely to forget a dose.

Reminder tips
Set a daily reminder

Create an alarm on your cell phone or a calendar reminder to alert you to take your medicine at the same time every day.

Temperature lung

How do I store GAVRETO?

  • At room temperature between 68°F to 77°F (20°C to 25°C)
  • Away from moisture
  • Out of the reach of children

GAVRETO can be briefly exposed to temperatures between 59°F to 86°F (15°C to 30°C). But if you think your medicine has been exposed to extreme temperatures, please contact your pharmacy.

Side Effects
Everyone responds to treatment differently

It is helpful to know what side effects you might experience.

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Indications & Important Safety Information

WHAT IS GAVRETO?

GAVRETO is a prescription medicine used to treat certain cancers caused by abnormal rearranged during transfection (RET) genes in:

  • adults with non-small cell lung cancer (NSCLC) that has spread
  • 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*

Your healthcare provider will perform a test to make sure that GAVRETO is right for you.

It is not known if GAVRETO is safe and effective when used to treat cancers caused by abnormal RET genes in children for the treatment of NSCLC or in children younger than 12 years of age for the treatment of thyroid cancer.

*GAVRETO was approved based on the percentage of patients whose tumor size shrank or disappeared after treatment and how long that response lasted. There are ongoing studies to confirm the benefit of GAVRETO.

IMPORTANT SAFETY INFORMATION

GAVRETO may cause serious side effects, including:

Lung problems: GAVRETO may cause severe or life-threatening inflammation of the lungs during treatment, that can lead to death. Tell your healthcare provider right away if you have any new or worsening symptoms, including shortness of breath, cough, or fever.

High blood pressure (hypertension): High blood pressure is common with GAVRETO and may sometimes be severe. You should check your blood pressure regularly during treatment with GAVRETO. Tell your healthcare provider if you have increased blood pressure readings or get any symptoms of high blood pressure, including confusion, dizziness, headaches, chest pain or shortness of breath.

Liver problems: Liver problems (increased liver function blood test results) can happen during treatment with GAVRETO and may sometimes be serious. Your healthcare provider will do blood tests before and during treatment with GAVRETO to check you for liver problems. Tell your healthcare provider right away if you get any signs or symptoms of liver problem during treatment, including yellowing of your skin or the white part of your eyes (jaundice), loss of appetite, nausea or vomiting, dark “tea-colored” urine, pain on the upper right side of your stomach area, sleepiness, bleeding or bruising.

Bleeding problems: GAVRETO can cause bleeding which can be serious and cause death. Tell your healthcare provider if you have any signs or symptoms of bleeding during treatment, including vomiting blood or if your vomit looks like coffee grounds, unusual vaginal bleeding, nose bleeds that happen often, pink or brown urine, drowsiness or difficulty being awakened, red or black (looks like tar) stools, confusion, coughing up blood or blood clots, headache, unusual bleeding or bruising of your skin, change in speech, or menstrual bleeding that is heavier than normal.

Tumor lysis syndrome (TLS): TLS is caused by a fast breakdown of cancer cells. TLS can cause you to have kidney failure and the need for dialysis treatment, an abnormal heartbeat, and may sometimes lead to hospitalization. Your healthcare provider may do blood tests to check you for TLS. You should stay well hydrated during treatment with GAVRETO. Call your healthcare provider or get emergency medical help right away if you develop any of these symptoms during treatment with GAVRETO: nausea, shortness of breath, vomiting, muscle cramps, weakness, seizures or swelling.

Risk of wound healing problems: Wounds may not heal properly during treatment with GAVRETO. Tell your healthcare provider if you plan to have any surgery before or during treatment with GAVRETO. You should not take GAVRETO for at least 5 days before surgery. Your healthcare provider should tell you when you may start taking GAVRETO again after surgery.

Before taking GAVRETO, tell your healthcare provider about all of your medical conditions, including if you:

  • have lung or breathing problems other than lung cancer
  • have high blood pressure
  • have bleeding problems
  • have liver problems
  • plan to have surgery
  • are pregnant or plan to become pregnant. GAVRETO can harm your unborn baby.

    Females who are able to become pregnant:

    • Your healthcare provider will do a pregnancy test before you start GAVRETO.
    • Should use an effective form of non-hormonal birth control (contraception) during treatment with GAVRETO and for 2 weeks after your last dose of GAVRETO.
    • Birth control methods that contain hormones (such as birth control pills, injections or transdermal system patches) may not work as well during treatment with GAVRETO.
    • Talk to your healthcare provider about birth control methods that may be right for you during this time.
    • Tell your healthcare provider right away if you become pregnant or think you might be pregnant during treatment with GAVRETO.

    Males with female partners who are able to become pregnant should use effective birth control (contraception) during treatment and for 1 week after your last dose of GAVRETO.

  • are breastfeeding or plan to breastfeed. It is not known if GAVRETO passes into your breast milk. Do not breastfeed during treatment and for 1 week after your last dose of GAVRETO.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking GAVRETO with other medicines may affect how GAVRETO works.

The most common side effects of GAVRETO include: muscle and joint pain, constipation, diarrhea, tiredness, swelling of your face, arms, legs, hands, and feet (edema), fever, and cough.

The most common severe abnormal blood test results with GAVRETO include: decreased white blood cell, red blood cell, and platelet counts, decreased levels of phosphate, body salt (sodium), calcium and potassium, abnormal liver function, increased levels of enzyme called alkaline phosphatase, and increased levels of potassium.

GAVRETO may affect fertility in males and females, which may affect your ability to have children. Talk to your healthcare provider if this is a concern for you.

These are not all of the possible side effects of GAVRETO. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Click here for full Prescribing Information, including Patient Information.