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Gavreto is the brand name for pralsetinib oral capsules.

Gavreto is available as a 100 mg oral capsule.

Gavreto is an RET kinase inhibitor that is used to treat:
Metastatic NSCLC with RET gene fusion in adults
Advanced or metastatic thyroid cancers with RET mutations, in adults and children 12 years of age or older

Gavreto interrupts tumor growth by blocking these abnormal RET proteins from sending the growth signal.

The typical dose is 400 mg by mouth daily on an empty stomach.

Gavreto is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Gavreto:

• Lower electrolyte levels (calcium, sodium, magnesium, phosphate)
• Labs suggesting liver or kidney problems
• Muscle, bone, or joint pain
• Constipation
• High blood pressure
• Feeling very tired
• Diarrhea

Serious side effects are rare with Gavreto. Contact your healthcare provider immediately if you experience any of the following.

• Lung inflammation: cough, shortness of breath, fever
• Liver injury: pain in the right side of the stomach, yellowing of the eyes or skin, dark or brown urine
• High blood pressure: headache, dizziness, confusion, chest pain
• Severe bleeding: sudden or painful headache, changes in vision, severe stomach pain, coughing or spitting up blood
• Tumor lysis syndrome: muscle cramps, dark or brown urine, fluttering or pounding heart beat

The following medications may interact with Gavreto:

• Strong or moderate CYP3A inhibitors and/or P-gp inhibitors: Avoid coadministration. If coadministration cannot be avoided, reduce the dose of Gavreto
• Strong or moderate CYP3A inducers: Avoid coadministration. If coadministration cannot be avoided, increase the dose of Gavreto

Genentech, Inc.

Gavreto can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider will do a pregnancy test before you start treatment with Gavreto.
You should use an effective form of non-hormonal birth control (contraception) during treatment 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: You should use effective birth control (contraception) during treatment and for 1 week after your last dose of Gavreto.

• Pralsetinib