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Home > Drug Category > Cancer Medications > Gavreto and Equivalent

Gavreto Information

Gavreto (pralsetinib) capsules are used for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC), as detected by an FDA-approved test. It is also indicated for the treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer who require systemic therapy and whose tumour is refractory to radioactive iodine (if radioactive iodine is appropriate). Gavreto is a kinase inhibitor that works by targeting and blocking the activity of the rearranged during transfection (RET) receptor tyrosine kinase. In certain cancers, RET fusions or mutations can lead to uncontrolled cell growth and survival. By specifically inhibiting the abnormal RET protein, Gavreto helps to reduce the growth and spread of these cancer cells. This leads to a reduction in tumour size and progression of cancer. Gavreto delivers the active substance pralsetinib, which specifically targets the RET protein, helping to manage RET-driven cancers.

Gavreto Side Effects

The most common side effects of Gavreto may include anemia, musculoskeletal pain, constipation, hypertension (high blood pressure), abdominal pain, diarrhea, fatigue, edema (swelling), pyrexia (fever), and cough. Call your doctor right away if you have any of the serious side effects, such as:
• Bloody diarrhea
• Chest pain
• Hemorrhagic events (bleeding problems): vomiting blood or if your vomit looks like coffee grounds, pink or brown urine, red or black (looks like tar) stools, coughing up blood or blood clots, unusual bleeding or bruising of your skin, menstrual bleeding that is heavier than usual, unusual vaginal bleeding, frequent nosebleeds, drowsiness or difficulty being awakened, confusion, headache, change in speech
• Hepatotoxicity (liver problems): yellowing of your skin or the whites of your eyes, dark urine, unusual tiredness, loss of appetite, nausea or vomiting, pain on the upper right side of your stomach area, bleeding or bruising more easily than normal
• Hypertension (high blood pressure): confusion, headaches, dizziness, chest pain, shortness of breath (do not initiate in patients with uncontrolled hypertension)
• Interstitial Lung Disease (ILD)/Pneumonitis (lung problems): new or worsening shortness of breath, cough, fever
• Irregular heart rhythms
• Pancreatitis: severe abdominal pain, nausea, and vomiting
• Risk of impaired wound healing: wounds that do not heal or take longer than usual to heal
• Signs of an allergic reaction, such as rash, breathing difficulties, itching or swelling of the face, tongue, or throat
• Tumor Lysis Syndrome (TLS): nausea, vomiting, weakness, swelling, shortness of breath, muscle cramps, seizures, decreased or change in the amount of urine, joint pain, stiffness, or swelling, lower back, side or stomach pain, rapid weight gain

Gavreto Precautions

Do not use Gavreto if you are allergic to pralsetinib or other ingredients in this medication. Before you start using this medication, tell your doctor about your medical history, including if you have lung or breathing problems (other than lung cancer), high blood pressure (especially if uncontrolled), bleeding problems, liver problems, pancreatitis, seizures, or plan to have surgery. Tell your doctor about all your medications, including prescription, OTC, herbal supplements, and vitamins. There may be a drug interaction between Gavreto and other medications, such as potent or moderate CYP3A inhibitors (e.g., ketoconazole, clarithromycin, atazanavir), combined P-gp and potent/moderate CYP3A inhibitors (e.g., cyclosporine, verapamil), and strong or moderate CYP3A inducers (e.g., rifampin, carbamazepine, St. John's wort). These interactions can significantly alter the levels of Gavreto in your body. Avoid consuming grapefruit, starfruit, Seville oranges, or their juices while taking this drug, as they can increase the amount of drug in your blood and increase side effects. Inform your doctor if you are pregnant or planning to become pregnant before using Gavreto. Based on findings from animal studies and its mechanism of action, Gavreto can cause fetal harm when administered to a pregnant woman.

Females of reproductive potential should use effective contraception during treatment and for 1 week after the final dose. Males with female partners of reproductive potential should use effective contraception during treatment and for 3 months after the last dose. Inform your doctor if you are breastfeeding or planning to breastfeed before using Gavreto. It is unknown if pralsetinib passes into breast milk. Do not breastfeed during treatment with Gavreto and for 1 week after the last dose due to the potential for severe adverse reactions in breastfed infants. Do not use this medicine in children without talking to your doctor. Gavreto is indicated for children 12 years of age and older with advanced or metastatic RET fusion-positive thyroid cancer; the safety and effectiveness in children for NSCLC or children younger than 12 years of age for thyroid cancer have not been established.

Use your medicine exactly as prescribed by your doctor. Gavreto comes as a capsule. Swallow the capsule whole; do not open or chew it. You must take Gavreto on an empty stomach (no food intake for at least 2 hours before and at least 1 hour after taking Gavreto). The recommended dosage is 400 mg orally once daily. If a dose of Gavreto is missed, it can be taken as soon as possible on the same day. Resume the regular daily dose schedule the next day. Do not take an additional dose if vomiting occurs after Gavreto, but continue with the next dose as scheduled. Take Gavreto at the same time(s) each day to help you remember. Your doctor may order regular blood tests to monitor your blood pressure, liver function (ALT and AST), and other parameters and adjust your dosage as needed based on side effects. Your doctor may also monitor for pulmonary symptoms indicative of ILD/pneumonitis. Your doctor may withhold, reduce the dose, or permanently discontinue Gavreto based on the severity of adverse reactions. Continue treatment until disease progression or unacceptable toxicity. Withhold Gavreto for at least 5 days before elective surgery. Do not administer for at least 2 weeks following major surgery and until adequate wound healing. Store Gavreto at room temperature, away from moisture and heat. Keep all medicines out of reach of children.

Do I need a prescription to order Gavreto?

Yes, a prescription is required from your physician to order Gavreto.