Words or phrases you may hear when talking with your doctor

    A
    Abnormal RET genes

    These genes drive the uncontrolled growth of cells, leading to cancer.

    Advanced thyroid cancer

    Thyroid cancer that has spread to nearby tissue or distant parts of the body.

    B
    Biomarker

    A molecule or gene measured in tissue, blood, or other bodily fluids that can help determine the type of disease you have, how aggressive it is, and the best treatment.

    Biomarker testing

    A test performed by your healthcare provider to identify the gene(s) that may impact the way a tumor grows, spreads, or reacts to certain treatments.

    C
    Chemotherapy

    Standard chemotherapy aims to stop the growth of cancer cells by blocking all rapidly dividing cells. Chemotherapy may be given by mouth, injection, infusion, or put directly on the skin. This depends on the type and stage of cancer being treated.

    Clinical study

    A type of research, also known as a “clinical trial,” that tests how well a medication works in people and what the side effects may be.

    Complete response

    All tumors have responded to a treatment and completely disappeared. This does not mean the cancer has been cured.

    Comprehensive biomarker testing

    Biomarker testing that is performed by your doctor that includes testing for all of the biomarkers recommended by current guidelines.

    D
    DNA

    The molecules inside cells that carry genetic information and pass it from one generation to the next.

    F
    Fusion

    When a gene breaks off and reattaches to another gene.

    G
    Gene

    A piece of DNA that gives the cells in your body instructions to perform certain functions.

    H
    Hormones

    A substance produced by glands in the body that regulates the activities of different cells and organs.

    M
    Metastasized/Metastatic

    When cancer spreads to other parts of the body.

    Multikinase inhibitor (MKI)

    A type of targeted therapy that targets multiple types of cancer cells.

    P
    Papillary thyroid cancer (PTC)

    A type of cancer that forms in the thyroid and is the most common type of thyroid cancer.

    Partial response

    Tumors have responded to a treatment and shrunk in size by at least 30%.

    Patient Information

    A document for patients and caregivers included in the packaging of a medicine. It has information about the medicine and its use.

    Prescribing Information

    A document for doctors that's included in the packaging of a medicine. It has important scientific information needed for the safe and effective use of that medicine.

    R
    Radioactive iodine (RAI)

    A treatment that shrinks or kills thyroid cells. It is used to treat certain types of thyroid cancer.

    RET

    RET stands for rearranged during transfection and it’s a type of gene that everyone has within their cells. In specific types of cancer cells, the RET gene is abnormal.

    RET+

    RET+ stands for rearranged during transfection positive and the term RET+ is used to describe cancer caused by abnormal RET genes.

    RET+ advanced thyroid cancer

    A type of thyroid cancer driven by abnormal RET genes that has spread to nearby tissue or distant parts of the body.

    S
    Systemic therapy

    A treatment that uses substances that travel through the bloodstream, reaching and affecting cells all over the body.

    T
    Targeted therapy

    A type of cancer treatment that targets specific types of cancer cells.

    Thyroid gland

    A butterfly-shaped organ that makes hormones to help regulate your heart rate, metabolism, blood pressure, and body temperature.

    Tumor lysis syndrome (TLS)

    When a large number of cancer cells die within a short period, releasing their contents into the blood.

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GAV_THR-24017 0924

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.