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.
Before you take ZYKADIA, tell your health care provider 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. Women 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 health care provider about birth control methods that may be right for you. Tell your health care provider right away if you become pregnant or think that you may be pregnant
- Men 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
Tell your health care provider about all the medicines you take, including prescription medicines, over-the-counter medicines, vitamins, and herbal supplements.
- Take ZYKADIA exactly as your health care provider tells you. Do not change your dose or stop taking ZYKADIA unless your health care 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
If you are currently taking ZYKADIA on an empty stomach, contact your health care provider to discuss the best dose for you
You can eat either a snack or a full meal. The important thing is to eat some food when taking ZYKADIA at the recommended 450-mg once-daily dose.
- 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
ZYKADIA may cause serious side effects, including:
Stomach and intestinal (gastrointestinal) problems. ZYKADIA may cause stomach and intestinal problems, including diarrhea, nausea, vomiting, and stomach-area pain. Follow your health care provider's instructions about taking medicines to help with these symptoms. Call your health care provider for advice if your symptoms are severe or cannot be tolerated.
Liver problems. ZYKADIA may cause liver injury. Your health care provider should do blood tests at least every month to check your liver during treatment with ZYKADIA. Tell your health care provider right away if you get any of the following:
- you feel tired
- you have itchy skin
- your skin or the whites of your eyes turn yellow
- you have nausea or vomiting
- you have a decreased appetite
- you have pain on the right side of your stomach area
- your urine turns dark or brown (tea color)
- you bleed or bruise more easily than normal
Lung problems (pneumonitis). ZYKADIA may cause severe or life-threatening swelling (inflammation) of the lungs during treatment that can lead to death. Symptoms may be similar to those symptoms from lung cancer. Tell your health care provider right away if you have any new or worsening symptoms, including:
- trouble breathing or shortness of breath
- cough with or without mucus
- chest pain
Heart problems. ZYKADIA may cause very slow, very fast, or abnormal heartbeats. Your health care provider may check your heart during treatment with ZYKADIA. Tell your health care provider right away if you feel new chest pain or discomfort, dizziness or lightheadedness, if you faint, or have abnormal heartbeats. Tell your health care provider if you start to take or have any changes in heart or blood pressure medicines.
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. Your health care provider will check your blood sugar level before starting ZYKADIA and as needed during treatment with ZYKADIA. Call your health care provider right away if you have any symptoms of high blood sugar, including:
- increased thirst
- increased hunger
- trouble thinking or concentrating
- urinating often
- blurred vision
- your breath smells like fruit
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 health care 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:
- stomach and intestinal (gastrointestinal) problems, including: diarrhea, nausea, vomiting, and stomach-area pain
- tiredness, decreased appetite, and weight loss
These are not all of the possible side effects of ZYKADIA. For more information, ask your health care provider or pharmacist. Call your health care provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
- Store ZYKADIA at room temperature between 68°F to 77°F (20°C to 25°C)
Keep ZYKADIA and all medicines out of the reach of children.
Active ingredient: ceritinib
Inactive ingredients capsules: colloidal silicon dioxide, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. Capsule shell contains FD&C Blue # 2, gelatin, and titanium dioxide.
Inactive ingredients tablets: Tablet core: colloidal silicon dioxide, croscarmellose sodium, low-substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose and povidone. Tablet coating: FD&C Blue # 2 aluminum lake, hypromellose, polyethylene glycol, talc, and titanium dioxide.