Zidesamtinib

Zidesamtinib is used to treat certain types of non-small cell lung cancer (NSCLC; a type of lung cancer). Zidesamtinib is in a class of medications called kinase inhibitors. It works by blocking the action of an abnormal protein that signals cancer cells to multiply. This helps slow or stop the spread of cancer cells.

Zidesamtinib comes as a tablet to take by mouth. Take with or without food once a day. Take zidesamtinib at around the same time every day. How long you take zidesamtinib will depend on how your body responds to the medicine. Your doctor will determine how long you will receive it.

Take zidesamtinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

If you vomit after taking zidesamtinib, do not take an additional dose. Take your next dose at the regularly scheduled time.

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

Before taking zidesamtinib,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• you should know that some medications should not be taken with zidesamtinib. Other medications may cause dosing changes or extra monitoring when taken with zidesamtinib. Make sure you have discussed any medications you are currently taking or plan to take before starting zidesamtinib with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking zidesamtinib, please get the advice of your doctor or pharmacist.
• you should know the following nonprescription or herbal products may interact with zidesamtinib: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking zidesamtinib. Do not start any of these medications while taking zidesamtinib without discussing with your healthcare provider.
• tell your doctor if you have or have ever had QT interval prolongation (an irregular heart rhythm that can lead to fainting, loss of consciousness, seizures, or sudden death), heart failure, a heart attack or any other heart problems; lung disease or breathing problems; osteoporosis, bone metasteses or any other bone condition; or pancreatitis (inflammation of the pancrease) or any other disease of the pancreas.
• tell your doctor if you or your partner are pregnant or plan to become pregnant. You or your partner should not become pregnant while you are taking zidesamtinib. You may have to take a pregnancy test before starting treatment. You should use effective birth control to prevent pregnancy during your treatment and for 6 months after your final dose. You and your partner should use effective birth control to prevent pregnancy during treatment for 3 months after your final dose. Talk to your doctor about what birth control would work best for you and your partner. If you or your partner become pregnant while taking zidesamtinib, call your doctor immediately. Zidesamtinib may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed during treatment with zidesamtinib and for 1 week after treatment.
• you should know that this medication may decrease fertility in men and women. Talk to your doctor about the risks of taking zidesamtinib.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking zidesamtinib.
• you should know that zidesamtinib may make you dizzy or confused. Do not drive a car or operate machinery until you know how this medication affects you.
• ask your doctor about the safe use of alcoholic beverages while you are taking zidesamtinib. Alcohol can make the side effects from zidesamtinib worse.
• you should know that zidesamtinib has caused central nervous system (CNS) toxicity including psychiatric effects. Before starting treatment, tell your doctor if you have depression, anxiety, or any other psychiatric condition or have had thoughts of harming yourself. Call your doctor right away if you have any of the following symptoms: dizziness, clumsiness, unsteadiness, changes in gait (the way you walk), balance difficulties, memory difficulties, cognitive impairment, hallucinations, confusion, attention difficulties, changes in speech pattern, anxiety, depression or mood changes, agitation, irritability, changes in behavior or personality, or thoughts of harming oneself.

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medication.

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

Take the missed dose as soon as you remember it if it is within 12 hours of the scheduled dose. However, if it is more than 12 hours from the missed dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

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

• swelling
• tiredness
• numbness, tingling or pain in fingers or toes
• changes in taste
• headache
• constipation, diarrhea
• difficulty breathing, cough
• muscle or joint aches or pains
• rash
• blurry or double vision

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

• new or worsening shortness of breath, cough, or fever
• muscle aches or pains, dark urine, weakness, tiredness

Zidesamtinib may increase your risk of bone fractures. Talk to your doctor about the risks of taking this medication.

Zidesamtinib 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 (https://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).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

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 certain lab tests to check your body's response to zidesamtinib.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking zidesamtinib.

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

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Jideytro^®