Pralsetinib

Pralsetinib is used to treat a certain type of non small-cell lung cancer (NSCLC) in adults that has spread to other parts of the body. It is also used to treat a certain type of thyroid cancer in adults and children 12 years of age and older that is getting worse or that has spread to other parts of the body. Pralsetinib is used to treat a certain type of thyroid cancer in adults and children 12 years of age and older that is getting worse or that has spread to other parts of the body and cannot be treated with radioactive iodine. Pralsetinib is in a class of medications called kinase inhibitors. It works by blocking the action of a certain naturally occurring substance that may be needed to help cancer cells multiply.

Pralsetinib comes as a capsule to take by mouth. It is usually taken once daily on an empty stomach, at least 2 hours before and at least 1 hour after a meal. Take pralsetinib at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take pralsetinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

If you vomit after taking pralsetinib, do not take another dose. Continue your regular dosing schedule.

Your doctor may decrease your dose or temporarily or permanently stop your treatment if you experience certain side effects. Be sure to tell your doctor how you are feeling during your treatment with pralsetinib.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking pralsetinib,

• tell your doctor and pharmacist if you are allergic to pralsetinib, any other medications, or any of the ingredients in pralsetinib capsules. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antifungal medications including itraconazole (Onmel, Sporanox) and ketoconazole; clarithromycin (in Biaxin); certain HIV medications such as efavirenz (Sustiva, in Atripla, Symfi), indinavir (Crixivan), nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra, Viekira Pak), and saquinavir (Invirase); oxcarbazepine (Oxtellar XR, Trileptal); phenobarbital; phenytoin (Dilantin, Phenytek); pioglitazone (Actos, in Oseni, Duetact); rifabutin (Mycobutin); and rifampin (Rifadin, Rimactane, in Rifater). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• tell your doctor what herbal products you are taking, especially St. John's wort.

• tell your doctor if you have or have ever had lung or breathing problems other than lung cancer, bleeding problems, high blood pressure, or liver disease.

• tell your doctor if you are pregnant, plan to become pregnant, or if you plan to father a child. Pralsetinib may interfere with the action of hormonal contraceptives (birth control pills, patches, rings, implants, or injections), so you should not use these as your only method of birth control during your treatment. You must use a non-hormonal birth control such as a barrier method (device that blocks sperm from entering the uterus such as a condom or a diaphragm). Ask your doctor to help you choose a method of birth control that will work for you. If you are female, you will need to have a pregnancy test before you start treatment, and you should use non-hormonal birth control to prevent pregnancy during your treatment and for 2 weeks after your final dose. If you are a male and your partner can become pregnant, you should use effective birth control to prevent pregnancy during your treatment and for 1 week after your final dose. You should know that this medication may decrease fertility in men and women; however, you should not assume that you cannot get pregnant or that you cannot get someone else pregnant. If you or your partner becomes pregnant while taking pralsetinib, call your doctor. Pralsetinib may harm the fetus.

• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while taking pralsetinib and for 1 week after your final dose.

• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking pralsetinib.

• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking pralsetinib. Your doctor may tell you not to take pralsetinib 5 days before your surgery and will tell you when to start taking the medication again.

• you should know that your blood pressure may increase during your treatment with pralsetinib. Your doctor will monitor your blood pressure carefully, and may prescribe medication to treat high blood pressure if it develops.

• you should know that you may experience tumor lysis syndrome (TLS; a condition caused by the fast breakdown of cancer cells that can cause kidney failure and other complications) during your treatment with pralsetinib. To help reduce your risk of experiencing TLS, your doctor may ask you to drink water before and during your treatment, and each time your dose is increased. In addition, your doctor will give you a medication to take before starting and during your treatment to help prevent this side effect. If you experience any of the following symptoms of TLS, call your doctor immediately: fever, chills, nausea, vomiting, confusion, shortness of breath, seizures, irregular heartbeat, dark or cloudy urine, unusual tiredness, or muscle or joint pain.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose on the same day as soon as you remember it. Then, continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

• Pralsetinib may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

  • constipation

  • diarrhea

  • dry mouth

  • muscle or bone pain

  • swelling of hands, ankles, or feet

• Some side effects can be serious. If you experience any of these symptoms or those listed in SPECIAL PRECAUTIONS, call your doctor immediately or get emergency medical treatment:

  • confusion, headache, shortness of breath, dizziness, or chest pain

  • fever, shortness of breath, or cough

  • pale skin, fatigue, or shortness of breath

  • yellowing of skin or eyes, dark-colored urine, bleeding or bruising more easily than normal, loss of appetite, decreased energy, or pain on right side of stomach area

  • black and tarry stools

  • red blood in stools

  • bloody vomit

  • vomiting material that looks like coffee grounds

  • coughing up blood

  • unusual bleeding or bruising

  • unusual vaginal bleeding

  • frequent nose bleeds

  • drowsiness, confusion, headache, or difficulty speaking

• Pralsetinib may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

• If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Keep all appointments with your doctor and the laboratory. Your doctor will order a lab test before your treatment to find out if your cancer can be treated with pralsetinib. Your doctor will also order certain lab tests before, during, and after your treatment to check your body's response to pralsetinib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.