Gavreto

What is Gavreto?

Gavreto, a tyrosine-kinase inhibitor, may be used in adults with NSCLC that has spread (metastatic) to other parts. This drug is only prescribed if you have a cancer that has a certain genetic marker (a "RET" gene abnormal fusion). This gene fusion will be tested by your doctor using an FDA-approved test. Gavreto can also be used to treat adults or children over 12 years old with metastatic or advanced thyroid cancer that has RET fusion positivity. These patients require a systemic treatment (oral or intravenous) and are resistant to radioactive iodine (in cases where radioactive iodine would be appropriate). Gavreto received its first approval by the US Food and Drug Administration on an "accelerated" basis on September 4, 2020, for metastatic RET fusion-positive NSCLC. It also received accelerated approval on December 1, 2020, for metastatic RET fusion-positive thyroid cancer. On August 9, 2023, it was fully approved for metastatic RET fusion-positive NSCLC.

Warnings

Please carefully follow all instructions printed on the label or package of your medication. Inform your healthcare provider about your medical conditions, allergies, and medicines. Gavreto can affect the way that other medicines work, and it may also affect other medicines. It is not recommended to co-administer Gavreto with P-gp, strong or medium CYP3A inducers, or strong or moderate CYP3A inhibitors. Gavreto is not contraindicated. Gavreto treatment should be stopped in patients with Grade 1 or 2 interstitial pulmonary disease (ILD/pneumonitis), then resumed with a lower dosage once the condition has resolved. Gavreto must be discontinued permanently if the ILD returns or if OLD Grades 3 and 4 occur. Gavreto is not recommended for patients with uncontrolled hypertension. The blood pressure should be monitored before treatment begins and again after the first month of treatment. If blood pressure rises, the dosage can be reduced, stopped, or discontinued permanently.

Gavreto is toxic to the liver. Before starting Gavreto, your doctor will monitor the liver function (specifically ALT and AST enzymes), then every two weeks for the first three weeks, and then monthly thereafter, or as directed. If liver toxicity is detected, the dosage can be reduced, discontinued, or even stopped permanently. Gavreto can increase the risk of bleeding. The risk of tumor lysis syndrome is also present. Gavreto may impair wound healing. Gavreto should be avoided at least five days prior to elective surgery. It should also be avoided for two weeks after major surgery or until the wound is sufficiently healed. Gavreto is a teratogen that can harm fetuses. Females with reproductive potential are advised to use non-hormonal forms of contraception. Gavreto growth plates should be checked, and medication should be withdrawn or stopped if abnormalities are found.

Similar/related drugs

Opdivo, methotrexate, cisplatin, Keytruda, Paclitaxel, Armour Thyroid, and Avastin

Before you take this drug

Tell your doctor about any of the following to ensure that Gavreto will be safe for you:

• Other lung or breathing disorders other than lung cancer
• Bleeding problems
• High blood pressure.

Gavreto can harm an unborn baby. Before starting Gavreto, females with reproductive potential should undergo a pregnancy test. While taking this medication and for 2 weeks following your last dose, use effective birth control that is not hormonal to prevent pregnancy. Tell your doctor immediately if you become pregnant by mistake. Use effective birth control when your partner is pregnant if you are a male prescribed Gavreto. Continue to use birth control for at least one week after your last dose. If your partner becomes pregnant while taking Gavreto, tell your doctor immediately. Gavreto may reduce the effectiveness of hormonal birth control. This includes birth control pills and injections. It can also affect skin patches, vaginal rings, skin patches, or implants. Use a barrier birth control method to prevent pregnancy when using Gavreto: condoms, diaphragms, cervical caps, or contraceptive swabs. You should not breastfeed for at least a week after taking this medication. Gavreto may impair fertility. Gavreto has only been approved for adults with NSCLC and for children and adults 12 years and older with thyroid cancer that is RET fusion positive.

How to take Gavreto?

Follow the directions on your prescription label and read all medication guides or instructions sheets. Please read the instructions on the prescription label. Do not discontinue taking medication without consulting with your physician first or alter the dose without consulting them first.Gavreto will be prescribed to you after your doctor performs a RET gene fusion. Gavreto, an oral medication, is taken orally. For adults and children over 12 years old, the recommended dose is 400mg taken orally daily. You will need 4 capsules, each of which is 100mg. Gavreto is best taken with an empty stomach at least one hour before or two hours after eating. Do not take another dose of Gavreto if you vomit soon after taking it. Do not take another dose of Gavreto until you have taken your next scheduled dose. You will need to have your blood pressure checked frequently and will also need frequent blood tests. Tell your surgeon if you are considering surgery that you use this medication. Your healthcare provider may suggest discontinuing taking this medicine temporarily. Duration of treatment: Continue therapy until disease progression occurs or unacceptable toxicities occur.

What happens if I miss the dose?

If it is near time for your next dose, skip any missed one as taking two of the same medicine at once could prove fatal.

What happens if I overdose?

Call 1-800-222-1222 immediately if you suspect poison exposure and seek immediate medical care.

What should be avoided?

If your doctor prescribes any restrictions regarding food, beverage, or activity, follow their instructions.

Side effects of Gavreto

If you experience symptoms such as difficulty breathing, swelling of lips, face, tongue or throat or hives requiring emergency medical assistance immediately - contact an ambulance as quickly as possible for medical help.

If you experience:

• Fever, chills;
• Chest pain, new or worsening shortness of breath, or a new cough
• Severe headache, dizziness, confusion, and trouble speaking;
• Any wound that does not heal
• Unusual bleeding: bruises, nosebleeds, and bleeding gums
• Signs of bleeding in your body: weakness, drowsiness, bloody or tarry stool, or bloody vomit or coughing
• Low counts of blood cells: fatigue, fever, sore throat, mouth sores, and skin sores; pale skin; cold feet and hands; feeling lightheaded or short of breath.
• Liver problem: nausea; vomiting; loss of appetite (upper right); fatigue; dark urine; and jaundice.

If you experience certain side effects, your cancer treatment may be delayed or discontinued permanently.

Gavreto can cause a variety of side effects.

• Muscle or joint pain
• Constipation or diarrhea
• High blood pressure
• Low blood cell count or other abnormal lab tests
• Feeling tired
• Edema
• Cough
• Low sodium levels and other electrolyte variations

There may be other side effects. For medical advice on side effects, call your doctor. The FDA can be contacted at 1-800-FDA-1088 to report side effects

Interaction with other drug

It is sometimes not safe to take certain drugs at the same time. The blood level of some drugs may affect the effectiveness or side effects of the medications you are taking.

Inform your doctor of all the medications you are taking, including over-the-counter drugs, prescriptions, and herbal and vitamin products. Gavreto can be affected by many drugs, including:

• Some antibiotics or antifungal medications
• Antiviral drugs used for HIV/hepatitis C treatment
• Some cancer drugs
• Certain cholesterol medications
• Seizure medications.

Gavreto should not be administered with strong or medium CYP3A and/or Pgp inhibitors, such as clarithromycin (erythromycin), diltiazem (itraconazole), ketoconazole (ketoconazole), ritonavir verapamil goldenseal, and grapefruit. If coadministration cannot be avoided, your doctor can reduce Gavreto's dosage. Gavreto should not be administered with CYP3A-inducers such as phenytoin or phenobarbital. If coadministration cannot be avoided, your doctor can increase Gavreto's dosage. The list of drugs that may have an interaction with dasatinib is not exhaustive. Included are prescription, over-the-counter, herbal, and vitamin products. This list does not include all drug interactions.