pralsetinib

What is the most important information I should know about pralsetinib?

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

What is pralsetinib?

Pralsetinib is used to treat non-small cell lung cancer that has spread to other parts of the body (metastatic).

Pralsetinib is used only if your cancer has a specific genetic marker (an abnormal "RET" gene fusion). Your doctor will test you for this gene fusion.

Pralsetinib was approved by the US Food and Drug Administration (FDA) on an "accelerated" basis. In clinical studies, some people responded to this medicine, but further studies are needed.

Pralsetinib may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking pralsetinib?

Tell your doctor if you have ever had:

• lung or breathing problems other than lung cancer;
• bleeding problems; or
• high blood pressure.

• If you are a woman, do not use pralsetinib if you are pregnant. You may need to have a negative pregnancy test before starting this treatment. Use effective non-hormonal birth control to prevent pregnancy while you are using this medicine and for at least 2 weeks after your last dose.
• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 1 week after your last dose.
• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using pralsetinib.

How should I take pralsetinib?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

If you vomit shortly after taking pralsetinib, do not take another dose. Wait until your next scheduled dose time to take the medicine again.

Your blood pressure will need to be checked often and you will need frequent blood tests.

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

Do not change your dose or stop using a medicine without your doctor's advice.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

What should I avoid while taking pralsetinib?

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

What are the possible side effects of pralsetinib?

• fever, chills;
• new or worsening cough, shortness of breath, or chest pain;
• severe headache, dizziness, confusion, trouble speaking;
• any wound that will not heal;
• unusual bleeding --bruising, nosebleeds, bleeding gums, abnormal vaginal bleeding, any bleeding that will not stop;
• signs of bleeding inside your body --weakness, drowsiness, pink or brown urine, bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• low blood cell counts --fever, tiredness, sore throat, mouth sores, skin sores, pale skin, cold hands and feet, feeling light-headed or short of breath; or
• liver problems --nausea, vomiting, loss of appetite, stomach pain (upper right side), tiredness, dark urine, jaundice (yellowing of the skin or eyes).

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• high blood pressure;
• low blood cell counts or other abnormal laboratory tests;
• muscle or joint pain;
• feeling tired; or
• constipation.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect pralsetinib?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Tell your doctor about all your current medicines. Many drugs can affect pralsetinib, especially:

• an antibiotic or antifungal medicine;
• antiviral medicine to treat HIV or hepatitis C;
• cancer medicine;
• certain cholesterol medicines; or
• seizure medicine.

This list is not complete and many other drugs may affect pralsetinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about pralsetinib.