Ensartinib

Ensartinib is used to treat non-small cell lung cancer in adults who have not taken a type of cancer medicine called ALK-inhibitors.

Ensartinib is used when the cancer has spread to other parts of the body (metastatic).

Your doctor will confirm that you have the correct tumor type to be treated with ensartinib.

Ensartinib may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Do not change your dose or stop taking this medicine without your doctor's advice.

Ensartinib is usually taken once per day with or without food, at the same time each day.

Swallow the capsule whole and do not crush, chew, break, or open it.

If you vomit shortly after taking ensartinib, do not take another dose. Take your next dose as scheduled.

You may need frequent medical tests including tests to check your liver function, heart rate, and blood sugar. Your cancer treatments may change, be delayed, or discontinued based on the results.

Keep the capsules in their original container, along with the packet or canister of moisture-absorbing preservative.

Store at room temperature away from moisture and heat.

Use only as directed. Inform your doctor if you are taking other medicines or have any other medical conditions or allergies.

You should not use ensartinib if you are allergic to it, or to food dye yellow number 5 (tartrazine).

Tell your doctor if you have or have ever had:

• lung or breathing problems other than lung cancer;
• heart problems, irregular heart rhythm such as slow heartbeats;
• type 2 diabetes mellitus or higher than normal blood glucose (sugar) levels;
• vision problems;
• an allergy to aspirin; or
• liver disease.

Ensartinib can harm an unborn baby if the mother or the father is using ensartinib.

• If you are a woman, you may need a pregnancy test to make sure you are not pregnant. Use birth control while using this medicine and for at least 1 week after your last dose. Tell your doctor right away if you become pregnant.
• If you are a man, use birth control if your sex partner is able to get pregnant. Keep using birth control for at least 1 week after your last dose.
• Tell your doctor right away if a pregnancy occurs.

Do not breastfeed while using this medicine, and for at least 1 week after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Ensartinib may cause serious side effects. Call your doctor right away if you have:

• muscle pain, tenderness, or weakness;
• slow heart rate, dizziness, a light-headed feeling, like you might faint;
• lung problems--trouble breathing, shortness of breath, cough with or without mucus, chest pain, fever;
• liver problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• skin problems--skin rash, itching, skin swelling;
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;
• vision changes--blurred or double vision, seeing flashes of light or "floaters" in your vision, eyes being more sensitive to light; or
• high levels of uric acid in blood--joint problems, stomach pain, little or no urination, nausea, vomiting, pink or brown urine.

Common side effects of ensartinib may include:

• cough;
• skin rash, itching, skin swelling;
• bone or muscle pain;
• tiredness, fever;
• constipation, nausea or vomiting;
• abnormal liver function tests;
• low white blood cell counts;
• low red blood cells (anemia); or
• other abnormal blood tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Usual Adult Dose for Non-Small Cell Lung Cancer:

225 mg orally once a day Duration of therapy: Until disease progression or unacceptable toxicityComments:-Select patients for the treatment based on the presence of anaplastic lymphoma kinase (ALK) rearrangement(s) in tumor specimens; a US FDA-approved test to detect ALK rearrangements is not currently available.-May administer with or without foodUse: For the treatment of ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) in patients who have not previously received an ALK-inhibitor

Take the medicine as soon as you can, but if your next dose is due in less than 12 hours, skip the missed dose and return to your regular schedule. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Ensartinib could make you more sensitive to sunlight. Avoid sunlight or tanning beds for at least 1 week after your last dose. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors while using ensartinib.

Sometimes it is not safe to use certain medicines together. Some drugs can change how much of other drugs is in your blood, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially:

• heart or blood pressure medication.

Other drugs may affect ensartinib, including prescription and over-the-counter medicines, vitamins, and herbal products. Make sure to inform your doctor about all other medicines you are using.