Ensartinib

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.

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.

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

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.

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

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.

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).

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.

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. https://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 (https://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 certain lab tests to check your body's response to ensartinib. Your doctor will also check your heart rate regularly during your treatment.

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.

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