What is the recommended dosage of Pralsetinib?

Pralsetinib, also known as GAVRETO, is a targeted therapy medication administered orally once daily. It is indicated for the treatment of certain cancers caused by abnormal RET gene alterations.

What is the recommended dosage of Pralsetinib?

1. Pralsetinib is a RET inhibitor to be taken once daily only.

2. Recommended starting dose: 400 mg (four 100 mg capsules) once daily.

3. Patients should take GAVRETO on an empty stomach (no food consumption for at least 2 hours before dosing and at least 1 hour after dosing).

4. Continue treatment until disease progression or unacceptable toxicity occurs.

5. If a dose of GAVRETO is missed, it can be taken as soon as possible on the same day. Resume the regular once-daily dosing schedule of GAVRETO the next day.

6. Inform patients that if vomiting occurs after taking a dose, no additional dose should be taken; instead, the next scheduled dose should be administered as planned.

7. Patients eligible for GAVRETO treatment should be selected based on the presence of RET gene fusion.

8. Currently, there is no FDA-approved testing method for the detection of RET gene fusion in thyroid cancer.

Possible Side Effects of Pralsetinib

There are various measures to manage the side effects of Pralsetinib. Discuss these recommendations with your healthcare team, who can help determine the most suitable options for you. Below are some of the most common or clinically significant side effects:

Hepatotoxicity

This medication may cause hepatotoxicity. Your oncology care team may monitor this through blood tests called liver function tests. If you notice yellowing of the skin or eyes, dark or brown urine, or abdominal pain, inform your healthcare provider promptly, as these may be signs of hepatotoxicity.

Decreased Red Blood Cell Count (Anemia)

Red blood cells are responsible for delivering oxygen to body tissues. When red blood cell count is low, you may experience fatigue or weakness. Notify your oncology care team immediately if you develop any shortness of breath, difficulty breathing, or chest pain. If the count becomes too low, blood transfusion may be required.

Decreased White Blood Cell Count (Leukopenia or Neutropenia)

White blood cells are critical for fighting infections. During treatment, your white blood cell count may decrease, increasing susceptibility to infections. Contact your doctor or nurse immediately if you develop fever (temperature above 100.4°F or 38°C), sore throat or cold symptoms, shortness of breath, cough, painful urination, or non-healing wounds.

How Should Pralsetinib Be Used?

1. Pralsetinib is available as capsules for oral administration. The medication should generally be taken on an empty stomach, once daily, at least 2 hours before or 1 hour after a meal. Take Pralsetinib at approximately the same time each day.

2. Follow the instructions on the prescription label strictly. Consult your doctor or pharmacist if you have any questions. It is crucial to take the medication exactly as prescribed—do not adjust the dosage or frequency without medical approval.

3. If vomiting occurs after taking Pralsetinib, do not take an extra dose; continue with the regular dosing schedule.

4. If specific adverse reactions occur during treatment, your doctor may adjust the dosage, temporarily interrupt treatment, or discontinue it permanently. Be sure to inform your doctor of any physical discomfort experienced during the course of treatment.