What is ZYKADIA (Ceritinib)?
ZYKADIA is a prescription medicine that is used to treat people with non-small cell lung cancer (NSCLC) that:
- Is caused by a defect in a gene called anaplastic lymphoma kinase (ALK), and
- Has spread to other parts of the body
It is not known if ZYKADIA is safe and effective in children.
What is the most important information I should know about ZYKADIA?
ZYKADIA can cause serious side effects. These serious side effects include:
- Stomach and intestinal (gastrointestinal) problems. ZYKADIA may cause stomach and intestinal problems, including diarrhea, nausea, vomiting, and stomach-area pain.
- Liver problems. ZYKADIA may cause liver injury.
- Lung problems (pneumonitis)
- Heart problems
- High blood sugar (hyperglycemia). People who have diabetes or glucose intolerance or who take a corticosteroid medicine have an increased risk of high blood sugar with ZYKADIA.
- Inflammation of the pancreas (pancreatitis). ZYKADIA can cause pancreatitis that has led to death. You may develop increased pancreatic enzyme blood levels, which may be a sign of pancreatitis. Signs and symptoms of pancreatitis include upper abdominal pain that may spread to the back and get worse with eating. Your healthcare provider should do blood tests to check your pancreatic enzyme blood levels before you start ZYKADIA and as needed during your treatment.
- The most common side effects of ZYKADIA include:
- Tiredness,
- Decreased appetite
- Weight loss
How should I take ZYKADIA ?
- Take ZYKADIA exactly as your healthcare provider tells you. Do not change your dose or stop taking ZYKADIA unless your healthcare provider tells you to.
- Take ZYKADIA one time a day.
- Take ZYKADIA with food.
- If you vomit after taking ZYKADIA, do not take an additional dose. Continue with the next scheduled dose.
- If you miss a dose of ZYKADIA, take it as soon as you remember. If your next dose is due within 12 hours, then skip the missed dose. Just take the next dose at your regular time.
Important Safety Information
- Before you take ZYKADIA, tell your healthcare provider about all of your medical conditions.
- You should not drink grapefruit juice or eat grapefruit during treatment with ZYKADIA. It may make the amount of ZYKADIA in your blood increase to a harmful level.
- If you vomit after taking ZYKADIA, do not take an additional dose. Continue with the next scheduled dose.
- If you miss a dose of ZYKADIA, take it as soon as you remember. If your next dose is due within 12 hours, then skip the missed dose. Just take the next dose at your regular time
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking ZYKADIA?
Before you take ZYKADIA, tell your healthcare provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements also about all of your medical conditions, including if you:
- Have liver problems
- Have diabetes or high blood sugar
- Have heart problems, including a condition called long QT syndrome
- Have or have had pancreatitis
- Are pregnant or plan to become pregnant. ZYKADIA can harm your unborn baby. Females who are able to become pregnant should use an effective method of birth control during treatment with ZYKADIA and for 6 months after stopping ZYKADIA. Talk to your healthcare provider about birth control methods that may be right for you.
- Males with female partners who are able to become pregnant should use condoms during treatment with ZYKADIA and for 3 months after stopping ZYKADIA
- Are breastfeeding or plan to breastfeed. It is not known if ZYKADIA passes into your breast milk. Do not breastfeed during treatment with ZYKADIA and for 2 weeks after stopping ZYKADIA
- Your healthcare provider should do blood tests at least every month to check your liver during treatment with ZYKADIA. Tell your healthcare provider right away if you get any of the following:
- You feel tired
- Your skin or the whites of your eyes turn yellow
- You have a decreased appetite
- Your urine turns dark or brown (tea color)
- You have itchy skin
- You have nausea or vomiting
- You have pain on the right side of your stomach-area
- You bleed or bruise more easily than normal
- Trouble breathing or shortness of breath
- Cough with or without mucus
- Chest pain
General information about ZYKADIA
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use ZYKADIA for a condition for which it was not prescribed. Do not give it to other people, even if they have the same symptoms you have. It may harm them.
What are the ingredients in ZYKADIA?
Active ingredient: Ceritinib
Inactive ingredients capsules: Colloidal silicon dioxide, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate.
Inactive ingredients tablets: Tablet core: colloidal silicon dioxide, croscarmellose sodium, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and povidone.