Class: Biological Therapy

Generic Name: pralsetinib

Trade Name: Gavreto™

For which conditions is this drug approved? Gavreto is approved for the treatment of patients with cancers caused by abnormal rearranged during transfection (RET) genes including:

· metastatic non-small cell lung cancer (NSCLC)

· advanced medullary thyroid cancer (MTC)

· advanced thyroid cancer.

Gavreto is approved under accelerated approval and ongoing clinical trials are further evaluating efficacy.

What is the mechanism of action? Gavreto is a precision cancer medicine designed to target cancers with genomic alterations in the RET kinase, which include fusions and activating point mutations which lead to overactive RET signaling and uncontrolled cell growth. Gavreto targets oncogenic RET alterations, including those that are resistant to multikinase inhibitors.

How is Gavreto typically given (administered)? Gavreto is given orally (capsule) once daily.

How are patients typically monitored? Gavreto can cause complications involving the lungs, blood pressure, liver, bleeding, kidneys, and wound healing. Respiratory symptoms, blood pressure, blood tests to evaluate liver and kidney function are checked regularly.

What are the common (occur in 25% or more of patients) side effects of treatment with Gavreto?

  • Constipation
  • High blood pressure
  • Fatigue
  • Muscle and joint pain
  • Diarrhea
  • Decreased white blood cell, red blood cell and platelet counts
  • Decreased phosphate levels
  • Decreased calcium levels
  • Decreased sodium levels
  • Abnormal liver function blood tests

What are the less common side effects of treatment with Gavreto?

  • Lung problems
  • Bleeding problems
  • Tumor Lysis syndrome
  • Wound healing problems

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This is not a complete list of side effects. Some patients may experience other side effects that are not listed here. Patients may wish to discuss with their physician the other less common side effects of this drug, some of which may be serious.

Some side effects may require medical attention. Other side effects do not require medical attention and may go away during treatment. Patients should check with their physician about any side effects that continue or are bothersome.

What can patients do to help alleviate or prevent discomfort and side effects?

  • Tell your doctor about all of your medical conditions and about all the medicines you take, including prescription and over­-the-counter medicines, vitamins, and herbal supplements.
  • Take Gavreto exactly as your healthcare provider tells you. Do not change your dose or stop taking it unless your healthcare provider tells you to.
  • Take Gavreto one time each day on an empty stomach; do not eat for at least 2 hours prior to taking Gavreto and at least 1 hour after taking Gavreto.
  • If you miss a dose of Gavreto, take it as soon as possible on the same day. Take your next dose at your regular time the next day. If you vomit after taking Gavreto, do not take an extra dose.

Are there any special precautions patients should be aware of before starting treatment?

  • Tell your healthcare provider if you have any of the following: Lung or breathing problems High blood pressure Plan to have surgery
  • Tell your doctor if you are pregnant or plan to become pregnant. Gavreto may harm your unborn baby. Women who are able to become pregnant should use an effective method of birth control during treatment with Gavreto and for at least two weeks after stopping Gavreto. Talk to your healthcare provider about birth control methods that may be right for you. Men should also use effective birth control while on treatment with Gavreto and for at least one week after completing treatment.
  • Tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with Gavreto and for one weeks after you complete treatment.
  • Gavreto may affect fertility.

When should patients notify their physician? Tell your doctor if you have signs of lung problems including shortness of breath, any cough or fever. Also tell your doctor if you have any signs of high blood pressure such as headaches, shortness of breath, confusion, dizziness or chest pain. Any signs of liver problems should also be reported to you doctor right away including yellowing or your ski or eyes, changes in urine color, sleepiness, bleeding or bruising, loss of appetite, nausea or vomiting or pain on the upper right side of your stomach area. In addition, let your doctor know right away if you experience any signs of bleeding problems including any abnormal bleeding, drowsiness, confusion, headache or change in speech. Call your healthcare provider or go to emergency medical help right away if you develop any of the following signs of tumor lysis syndromes: nausea, vomiting, weakness, welling, shortness of breath, muscle cramps or seizures. Due to potential wound healing problems, talk to your doctor if you plan on undergoing surgery and avoid Gavreto at least 5 days prior to surgery.

What is a package insert?

A package insert is required by the FDA and contains a summary of the essential scientific information needed for the safe and effective use of the drug for healthcare providers and consumers. A package insert typically includes information regarding specific indications, administration schedules, dosing, side effects, contraindications, results from some clinical trials, chemical structure, pharmacokinetics and metabolism of the specific drug. By carefully reviewing the package insert, you will get the most complete and current information about how to safely use this drug. If you do not have the package insert for the drug you are using, your pharmacist or physician may be able to provide you with a copy.

Last updated on 12/20.

Important Limitations of Use

The information provided above on the drug you have selected is provided for your information only and is not a substitute for consultation with an appropriate medical doctor. We are providing this information solely as a courtesy and, as such, it is in no way a recommendation as to the safety, efficacy or appropriateness of any particular drug, regimen, dosing schedule for any particular cancer, condition or patient nor is it in any way to be considered medical advice. Patients should discuss the appropriateness of a particular drug or chemotherapy regimen with their physician.

As with any printed reference, the use of particular drugs, regimens and drug dosages may become out-of-date over time, since new information may have been published and become generally accepted after the latest update to this printed information. Please keep in mind that health care professionals are fully responsible for practicing within current standards, avoiding use of outdated regimens, employing good clinical judgment kin selecting drugs and/or regimens, in calculating doses for individual patients, and verifying all dosage calculations.

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