Entrectinib

What is entrectinib used for?

• Entrectinib is used to treat cancer.

Before taking entrectinib, tell your doctor:

• If you are allergic to entrectinib; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you take any other drugs (prescription or OTC, natural products, vitamins). There are many drugs that interact with entrectinib, like certain drugs that are used for HIV, infections, or seizures.
• If you are breast-feeding. Do not breast-feed while you take entrectinib and for 1 week after your last dose.

This is not a list of all drugs or health problems that interact with entrectinib.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take entrectinib with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take entrectinib?

• Tell all of your health care providers that you take entrectinib. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how entrectinib affects you.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You will need to have your heart checked before starting entrectinib and while taking it. This includes an ECG. Talk with your doctor.
• Avoid grapefruit and grapefruit juice.
• High uric acid levels have happened with entrectinib. Call your doctor right away if you have joint pain, swelling, or stiffness.
• This medicine may cause or make heart failure worse. Talk with the doctor.
• A type of abnormal heartbeat (prolonged QT interval) can happen with entrectinib. Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.
• This medicine may raise the chance of a broken bone. Talk with the doctor.
• Use with care in children. Talk with the doctor.
• This medicine may cause harm to an unborn baby. A pregnancy test will be done before you start entrectinib to show that you are NOT pregnant.
• Women must use birth control while taking entrectinib and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.
• Men with a partner who may get pregnant must use birth control while taking entrectinib and for some time after the last dose. Ask your doctor how long to use birth control. If your partner gets pregnant, call the doctor right away.

How is entrectinib best taken?

Use entrectinib as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with or without food.
• Swallow whole. Do not chew, break, open, or dissolve.
• Keep taking entrectinib as you have been told by your doctor or other health care provider, even if you feel well.
• If you throw up right after taking entrectinib, take 1 more dose as soon as you can on the same day. Then go back to your normal time the next day.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is less than 12 hours until the next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of entrectinib that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of nervous system problems like a burning, numbness, or tingling feeling; change in balance; confusion; dizziness; hallucinations (seeing or hearing things that are not there); memory problems or loss; new or worse behavior or mood changes like anxiety, depression, or thoughts of killing yourself; trouble focusing; trouble sleeping; or trouble thinking or speaking.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Bone pain.
• Change in eyesight.
• If bright lights bother your eyes.
• Swelling.
• Very bad dizziness or passing out.
• Feeling very tired or weak.
• Fever, chills, or sore throat.

What are some other side effects of entrectinib?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling dizzy, tired, or weak.
• Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry.
• Change in taste.
• Muscle pain or weakness.
• Back pain.
• Pain in arms or legs.
• Weight gain.
• Cough.
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out entrectinib?

• Store at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer information use and disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about entrectinib, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take entrectinib or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to entrectinib. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.