Ensartinib (By mouth)

Ensartinib (en-SAR-ti-nib)

Treats non-small cell lung cancer.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Swallow the capsule whole. Do not crush or chew it. Do not open or dissolve the contents of the capsule.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: If you miss a dose, take it as soon as you remember. If you miss a dose and it is within 12 hours until your next regular dose, skip the missed dose and take your next dose at the regular time. If you vomit after taking a dose, skip that dose and go back to your regular dosing schedule. Do not take 2 doses on the same day.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the medicine in its original bottle. Do not throw the desiccant (drying agent) packet.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some medicines can affect how ensartinib works. Tell your doctor if you are using any other medicine.

Warnings While Using This Medicine:

• This medicine may cause birth defects if either partner is using it during conception or pregnancy. Tell your doctor right away if you or your partner becomes pregnant. If you can get pregnant, your doctor may do tests to make sure you are not pregnant before starting this medicine. Use an effective form of birth control during treatment with this medicine and for at least 1 week after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 1 week after the last dose.
• Do not breastfeed during treatment and for 1 week after the last dose.
• Tell your doctor if you have liver disease, lung or breathing problems, eye or vision problems, heart rhythm problems, or diabetes.
• This medicine may cause the following problems:
  • Lung or breathing problems, including interstitial lung disease (ILD), pneumonitis
  • Liver problems
  • Serious skin reactions, including drug reaction with eosinophilia and systemic symptoms (DRESS)
  • Heart rhythm problems, including bradycardia
  • High blood sugar
  • Eye or vision problems
  • Muscle problems, including myalgia
  • Hyperuricemia (high uric acid in the blood)
• This medicine may make your skin more sensitive to sunlight. Use a sunscreen and protective clothing when you are outdoors. Avoid sunlamps and tanning beds during treatment and for at least 1 week after the last dose.
• This medicine contains a yellow dye called tartrazine, which may cause serious allergic reactions (including bronchial asthma). Tell your doctor if you have any allergies (including an aspirin allergy).
• Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash
• Blurred vision, double vision, seeing flashes of light
• Bone pain
• Chest pain, cough, fever, trouble breathing
• Confusion, sweating, increased hunger, thirst, or urination
• Dark urine or pale stools, loss of appetite, nausea, vomiting, stomach pain, yellow skin or eyes
• Joint pain, stiffness, or swelling
• Rapid weight gain, swelling in your hands, ankles, or feet
• Slow or uneven heartbeat
• Unexplained muscle pain, tenderness, or weakness

If you notice these less serious side effects, talk with your doctor:

• Constipation

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Last Updated: 3/4/2025