Ensartinib

WHY is this medicine prescribed?

Ensartinib is used is used in adults to treat certain types of non-small cell lung cancer (NSCLC) that has spread to nearby tissues or to other parts of the body. Ensartinib 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.

Are there OTHER USES for this medicine?

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

HOW should this medicine be used?

Ensartinib comes as a capsule to take by mouth. It is usually taken with or without food once a day. Take ensartinib 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 ensartinib exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the capsules whole; do not chew or crush them. Do not open or dissolve the content of the capsule.

Your doctor may temporarily or permanently stop your treatment or decrease the dose if you experience serious side effects of ensartinib.

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

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

What SPECIAL PRECAUTIONS should I follow?

Before taking ensartinib,

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

• some medications should not be taken with ensartinib. Make sure you have discussed any medications you are currently taking or plan to take before starting ensartinib with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking ensartinib, please get the advice of your doctor or pharmacist.

• tell your doctor if you have had an allergic reaction to FD&C Yellow No. 5 (tartrazine) or aspirin. Your doctor may tell you not to take ensartnib.

• tell your doctor if you have or have ever had diabetes, glucose intolerance, lung problems other than lung cancer, a slow heartbeat, vision problems, or liver disease.

• tell your doctor if you are pregnant or plan to become pregnant. You will need to have a pregnancy test before you start treatment with ensartinib. If able to become pregnant, you should use birth control during your treatment and for 1 week after your final dose. If your partner is able to become pregnant, your partner should use birth control during your treatment and for 1 week after your final dose. Talk to your doctor about which method of birth control you should use. If you become pregnant while taking ensartinib, call your doctor immediately. Ensartinib may harm the fetus.

• tell your doctor if you are breastfeeding. Do not breastfeed during your treatment and for 1 week after your final dose.

• you should know that ensartinib may cause vision problems, dizziness, and excessive tiredness. Do not drive a car or operate machinery until you know how this medication affects you.

• plan to avoid unnecessary or prolonged exposure to sunlight and to wear protective clothing, sunglasses, and sunscreen (with a Sun Protection Factor [SPF] of 30 or greater). Ensartinib may make your skin sensitive to sunlight.

• you should know that ensartinib may cause vision problems. Call your doctor right away if you have any of the following symptoms: changes in vision, loss of vision, double or blurred vision, sensitivity to light, seeing sudden flashes of light, seeing new or increased floaters (spots in your vision), or any other problems with your vision.

What SPECIAL DIETARY instructions should I follow?

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

What should I do IF I FORGET to take a dose?

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

What SIDE EFFECTS can this medicine cause?

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

• muscle or joint pain
• constipation
• tiredness
• swelling of the hands, feet, or legs

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

• shortness of breath, chest pain, cough, fever
• excessive tiredness, decreased appetite, nausea, vomiting, pain in the right upper part of the stomach, dark urine, or itching
• rash, itching, or swelling of the skin
• slow or irregular heartbeat, dizziness, or fainting
• feeling hungry or thirsty, increased urination, nausea, tiredness, or confusion
• unexplained muscle pain, tenderness, or weakness
• red, hot, tender, or swollen joints, especially your big toe; nausea or vomiting; pain in your abdomen or sides; pink or brown urine

Ensartinib 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).

What should I know about STORAGE and DISPOSAL of this medication?

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 the desiccant (drying agent) pouch in the bottle of medication to keep the tablets dry. Do not open or eat the desiccant pouch.

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.

What should I do in case of OVERDOSE?

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.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to ensartinib. Your doctor will also check your heart rate regularly during your treatment.

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.