Ceritinib (se-RI-ti-nib)

Treats non-small cell lung cancer.

Brand Name(s):

Zykadia

When This Medicine Should Not Be Used:

How to Use This Medicine:

Capsule, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• It is best to take this medicine with food or milk.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose:
  • Less than 12 hours until next regular dose: Skip the missed dose and take your next dose at the regular time.
  • More than 12 hours until next regular dose: Take the missed dose as soon as possible, and then go back to your regular schedule.
  • If you vomit after taking a dose, skip that dose and go back to your regular dosing schedule. Do not double doses.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

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 foods and medicines can affect how ceritinib works. Tell your doctor if you are using any of the following:
  • Clonidine, digoxin, ketoconazole, midazolam, rifampin
  • Blood pressure medicine or heart medicine
  • Blood thinner (including warfarin)
• Do not eat grapefruit or drink grapefruit juice while you are using this 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 are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant before starting treatment. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for at least 6 months after the last dose. Male patients with female partners should also use an effective form of birth control during treatment with this medicine and for at least 3 months after the last dose.
• Do not breastfeed while you are using this medicine and for at least 2 weeks after the last dose.
• Tell your doctor if you have liver disease, lung or breathing problems, diabetes, heart failure, or heart rhythm problems (including congenital long QT syndrome).
• This medicine may cause the following problems:
  • Stomach and bowel problems
  • Liver problems
  • Lung or breathing problems, including interstitial lung disease (ILD), pneumonitis (which may be life-threatening)
  • Heart rhythm problems, including QT prolongation or slow heartbeat
  • High blood sugar
  • Pancreatitis (swelling of the pancreas)
• 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.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Cancer medicine can cause nausea or vomiting, sometimes even after you receive medicine to prevent these effects. Ask your doctor or nurse about other ways to control any nausea or vomiting that might happen.
• 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
• Confusion, sweating, increased hunger, thirst, or urination
• Dark urine or pale stools, loss of appetite, yellow skin or eyes
• Fast, slow, pounding, or uneven heartbeat
• Lightheadedness, dizziness, fainting
• Severe diarrhea, nausea, vomiting, stomach pain
• Trouble breathing, chest pain, fever, chills, cough

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

• Constipation
• Heartburn, trouble swallowing
• Redness or other discoloration of the skin, severe sunburn, skin rash
• Tiredness

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