Pralsetinib (pral-SE-ti-nib)

Treats non-small cell lung cancer and thyroid cancer.

Brand Name(s):

Gavreto

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the capsule whole. Do not crush, open, or chew it.
• It is best to take this medicine on an empty stomach. Do not eat for at least 2 hours before and 1 hour after taking this medicine.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. If you vomit after taking a dose of this medicine, do not take an extra dose. Take your next dose at your regular time the next day.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how pralsetinib works. Tell your doctor if you are using cyclosporine, efavirenz, fluconazole, itraconazole, rifampin, verapamil, or voriconazole.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you are female and able to get pregnant, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment and for at least 2 weeks after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 1 week after the last dose.
• Do not breastfeed while you are using this medicine and for at least 1 week after your last dose.
• Tell your doctor if you have kidney disease, liver disease, lung or breathing problems, high blood pressure, or bleeding problems. Tell your doctor if you had a recent surgery.
• This medicine may cause the following problems:
  • Lung or breathing problems, including interstitial lung disease (ILD), pneumonitis
  • High blood pressure
  • Liver problems
  • Bleeding problems
  • Tumor lysis syndrome (electrolyte and metabolic problems that can be life-threatening)
• This medicine may affect the way your body heals from cuts and wounds. Make sure any doctor who treats you knows that you are using this medicine.
• This medicine could cause infertility. Talk with your doctor before using this medicine if you plan to have children.
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Change in how much or how often you urinate, lower back or side pain
• Chest pain, cough, fever, trouble breathing
• Confusion, dizziness, headache, slow or fast heartbeat
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Rapid weight gain, swelling in your hands, ankles, or feet
• Unusual bleeding, bruising, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation, diarrhea, dry mouth
• Joint or muscle pain
• Tiredness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088