Pralsetinib Oral Capsules

What is this medication?

PRALSETINIB (pral SE ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat certain kinds of lung and thyroid cancer.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): GAVRETO

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• bleeding disorders
• having surgery or recent surgery
• high blood pressure
• liver disease
• lung or breathing disease, like asthma
• scarring or thickening of the lungs
• an unusual or allergic reaction to pralsetinib, other medicines, foods, dyes or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take this medicine on an empty stomach, at least 1 hour before or 2 hours after food. Do not take with food. Do not take with grapefruit juice. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor's advice.

Talk to your pediatrician about the use of this medicine in children. While this drug may be prescribed for children as young as 12 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• certain antivirals for HIV or hepatitis
• certain medicines for fungal infections like ketoconazole, itraconazole, or posaconazole
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• grapefruit juice

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your health care professional for regular checks on your progress. Tell your health care professional if your symptoms do not start to get better or if they get worse.

Do not become pregnant while taking this medicine or for 2 weeks after stopping it. Women should use a non-hormonal form of birth control. Women should inform their health care professional if they wish to become pregnant or think they might be pregnant. Men should not father a child while taking this medicine and for 1 week after stopping it. There is potential for serious side effects to an unborn child. Talk to your health care professional for more information. Do not breast-feed an infant while taking this medicine or for 1 week after stopping it.

This medicine may make it more difficult to get pregnant or to father a child. Talk to your health care professional if you are concerned about your fertility.

Before having surgery, talk to your health care provider to make sure it is ok. This drug can increase the risk of poor healing of your surgical site or wound. You will need to stop this drug for 5 days before surgery. After surgery, wait at least 2 weeks before restarting this drug. Make sure the surgical site or wound is healed enough before restarting this drug. Talk to your health care provider if questions.

Your mouth may get dry. Chewing sugarless gum or sucking hard candy and drinking plenty of water may help. Contact your health care professional if the problem does not go away or is severe.

Call your health care professional for advice if you get a fever, chills, or sore throat, or other symptoms of a cold or flu. Do not treat yourself. This medicine decreases your body's ability to fight infections. Try to avoid being around people who are sick.

Avoid taking medicines that contain aspirin, acetaminophen, ibuprofen, naproxen, or ketoprofen unless instructed by your health care professional. These medicines may hide a fever.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• chest pain
• confusion
• cough
• dizziness
• fever
• headache
• increase in blood pressure
• signs and symptoms of bleeding such as bloody or black, tarry stools; red or dark brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eyes, gums, or nose
• signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin
• signs and symptoms of tumor lysis syndrome like vomiting, shortness of breath, seizures, muscle pain, and/or muscle weakness

Side effects that usually do not require medical attention (report these to your doctor or health care professional if they continue or are bothersome):

• constipation
• diarrhea
• dry mouth
• joint pain
• tiredness

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Throw away any unused medicine after the expiration date.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.