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Understanding Treatment

ZYKADIA® (ceritinib)

Important Safety Information and Approved Use

ZYKADIA may cause serious side effects, such as:

  • Stomach and intestinal problems
    ZYKADIA causes stomach and intestinal problems in most people, including diarrhea, nausea, vomiting, and stomach-area pain. These problems can sometimes be severe. Follow your health care provider’s instructions about taking medicines to help these symptoms. Call your health care provider for advice if your symptoms are severe or do not go away
  • 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 experience any of the following symptoms:
    • 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 experience vomiting
    • You have pain on the right side of your stomach area
    • 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 mucous
    • Fever
    • 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, 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
    • Urinating often
    • Increased hunger
    • Blurred vision
    • Headaches
    • Tiredness
    • Trouble thinking or concentrating
    • 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 perform blood tests to check your pancreatic enzyme blood levels before you start ZYKADIA and as needed during your treatment

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 breast milk. Do not breastfeed during treatment with ZYKADIA and for 2 weeks after stopping ZYKADIA

Tell your health care provider about the medicines you take, including:

  • Prescription medicines
  • Vitamins
  • Over-the-counter medicines
  • Herbal supplements

The most common side effects of ZYKADIA include:

  • Diarrhea
  • Stomach-area pain
  • Weight loss
  • Nausea
  • Tiredness (fatigue)
  • Vomiting
  • Decreased appetite

Tell your health care provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of ZYKADIA. For more information, ask your health care provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

How to take ZYKADIA and what to avoid

  • Take ZYKADIA exactly as your health care provider tells you. Do not change your dose or stop taking unless your health care provider tells you to
  • Take ZYKADIA 1 time each day
  • Take ZYKADIA at least 1 hour before or at least 2 hours after meals. If you vomit after taking ZYKADIA, do not take an additional dose, but 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, skip the missed dose. Just take the next dose at your regular time
  • 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

Please see the full Prescribing Information and the Patient Information for ZYKADIA® (ceritinib) capsules.

Approved Use:

ZYKADIA® (ceritinib) capsules 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.

Important Safety Information:

ZYKADIA may cause serious side effects, such as:

  • Stomach and intestinal problems ZYKADIA causes stomach and intestinal problems in most people, including diarrhea, nausea, vomiting, and stomach-area pa

... See More
Approved Use:

ZYKADIA® (ceritinib) capsules 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 ZYKADIA?

ZYKADIA® (ceritinib) is a prescription medicine used to treat non-small cell lung cancer (NSCLC) that is caused by a defect in a gene called ALK, which is short for anaplastic lymphoma kinase.

ZYKADIA is used to treat people who have been diagnosed with ALK-positive (ALK+) NSCLC that has spread to other parts of the body (metastatic) and who have taken the medicine crizotinib, but their NSCLC worsened or they could not tolerate taking crizotinib.

The effectiveness of ZYKADIA in these patients is based on a study that measured 2 types of response to treatment (response rate and duration of response). There is no clinical information available to show if patients treated with ZYKADIA live longer or if their symptoms improve. There are ongoing studies to find out how ZYKADIA works over a longer period of time. It is not known if ZYKADIA is safe and effective in children.

How ZYKADIA works

The ALK gene is thought to play a critical role in the growth of some NSCLCs. ZYKADIA is an ALK inhibitor, which means it may block the action of the ALK gene. It's believed that this helps to shrink or slow cancer growth.

APPROVED USE

ZYKADIA® (ceritinib) capsules 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.

IMPORTANT SAFETY INFORMATION About ZYKADIA® (ceritinib) capsules

ZYKADIA may cause serious side effects, such as:

  • Stomach and intestinal problems
    ZYKADIA causes stomach and intestinal problems in most people, including diarrhea, nausea, vomiting, and stomach-area pain. These problems can sometimes be severe. Follow your health care provider’s instructions about taking medicines to help these symptoms. Call your health care provider for advice if your symptoms are severe or do not go away
  • 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 experience any of the following symptoms:
    • 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 experience vomiting
    • You have pain on the right side of your stomach area
    • 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 mucous
    • Fever
    • 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, 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
    • Urinating often
    • Increased hunger
    • Blurred vision
    • Headaches
    • Tiredness
    • Trouble thinking or concentrating
    • 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 perform blood tests to check your pancreatic enzyme blood levels before you start ZYKADIA and as needed during your treatment

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 breast milk. Do not breastfeed during treatment with ZYKADIA and for 2 weeks after stopping ZYKADIA

Tell your health care provider about the medicines you take, including:

    • Prescription medicines
    • Vitamins
    • Over-the-counter medicines
    • Herbal supplements

The most common side effects of ZYKADIA include:

    • Diarrhea
    • Stomach-area pain
    • Weight loss
    • Nausea
    • Tiredness (fatigue)
    • Vomiting
    • Decreased appetite

Tell your health care provider if you have any side effect that bothers you or does not go away. These are not all of the possible side effects of ZYKADIA. For more information, ask your health care provider or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

How to take ZYKADIA and what to avoid

  • Take ZYKADIA exactly as your health care provider tells you. Do not change your dose or stop taking unless your health care provider tells you to
  • Take ZYKADIA 1 time each day
  • Take ZYKADIA at least 1 hour before or at least 2 hours after meals. If you vomit after taking ZYKADIA, do not take an additional dose, but 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, skip the missed dose. Just take the next dose at your regular time
  • 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

Please see the full Prescribing Information and the Patient Information for ZYKADIA® (ceritinib) capsules.