Zykadia

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to ceritinib.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Pregnancy

Based on animal studies and its mechanism of action, therapy can cause fetal harm when administered to a pregnant woman; limited data available on use of in pregnant women are insufficient to inform a risk; administration to rats and rabbits during period of organogenesis at maternal plasma exposures below the recommended human dose caused increases in skeletal anomalies in rats and rabbits; advise pregnant women of potential risk to fetus

 Lactation

There are no data regarding presence of ceritinib or metabolites in human milk; effects of ceritinib on breastfed infant, or effects on milk production; because of potential for serious adverse reactions including gastrointestinal toxicity, hepatotoxicity, pneumonitis, bradycardia and pancreatitis, advise a woman not to breastfeed during treatment and for 2 weeks following completion of therapy

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• slow heartbeats, weak pulse, weak or shallow breathing;
• headache with chest pain and severe dizziness, fainting, fast or pounding heartbeats;
• severe diarrhea;
• severe stomach pain, ongoing nausea or vomiting;
• sudden chest pain or discomfort, fever, dry cough or cough with mucus, feeling short of breath;
• easy bruising or bleeding (nosebleeds, bleeding gums);
• signs of pancreatitis--severe pain in your upper stomach spreading to your back, nausea and vomiting, fast heart rate;
• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or
• high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss.

Common side effects may include:

• stomach pain, loss of appetite;
• nausea, vomiting;
• diarrhea, constipation;
• tired feeling; or
• abnormal liver tests (high liver enzyme levels).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Zykadia is a prescription medication used to treat non-small cell lung cancer (NSCLC).

Zykadia belongs to a group of drugs called anaplastic lymphoma kinase (ALK) inhibitors. These drugs work by blocking proteins that promote the development of cancerous cells.

This medication comes in capsule form and is taken once a day, on an empty stomach.

Common side effects include diarrhea, nausea, vomiting, and abdominal pain.

Zykadia can also cause blurred vision. Do not drive or operate heavy machinery until you know how Zykadia affects you.

Zykadia is a prescription medication 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 (advanced), and
• who have taken the medicine crizotinib, but their NSCLC worsened or they cannot tolerate taking crizotinib

This medication treats tumors that are anaplastic lymphoma kinase (ALK)-positive which is detected by an FDA-approved test. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Zykadia. See the “Zykadia Precautions” section.

Common side effects of Zykadia include the following:

• diarrhea
• nausea
• vomiting
• constipation
• abdominal pain
• fatigue
• decreased appetite
• elevated liver enzymes

This is not a complete list of Zykadia side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Ceritinib can harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine and for several months after your last dose, whether you are a man or a woman. Ceritinib use by either parent may cause birth defects.

Ceritinib can cause liver problems. Call your doctor right away if you have right-sided-stomach pain, nausea, loss of appetite, unusual tiredness, easy bruising or bleeding, dark urine, or yellowing of the skin or eyes.

Ceritinib can also cause lung or heart problems. Call your doctor right away if you have chest pain, dizziness, irregular heartbeats, trouble breathing, cough, fever, or if you feel light-headed.

You should not use ceritinib if you are allergic to it.

To make sure ceritinib is safe for you, tell your doctor if you have ever had:

• heart disease, a heart rhythm disorder, or long QT syndrome;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• a pancreas disorder;

• diabetes or high blood sugar; or

• liver disease.

Ceritinib can harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine, whether you are a man or a woman. Men should use condoms. Ceritinib use by either parent may cause birth defects.

If you are a woman, keep using birth control for at least 6 months after your last dose of ceritinib. If you are a man, keep using condoms for at least 3 months after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using ceritinib.

It is not known whether ceritinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine and for at least 2 weeks after your last dose.

Take the missed dose as soon as you remember. Skip the missed dose if your next dose is less than 12 hours away. Do not take extra medicine to make up the missed dose.

Non-small Cell Lung Cancer (NSCLC)

Treatment of anaplastic lymphoma kinase (ALK)-positive metastatic NSCLC in patients following failure (secondary to resistance or intolerance) of prior crizotinib therapy1 2 3 (designated an orphan drug by FDA for this use).4

Accelerated approval based on tumor response rate and duration of response; improvement in survival or disease-related symptoms not demonstrated.1 Continued approval may be contingent on verification and description of clinical benefit in confirmatory studies.1

About 1–7% of patients with NSCLC have ALK-positive disease;2 6 7 10 12 13 14 19 such patients typically are nonsmokers or light smokers and often have adenocarcinoma.8 13 19 20 21

ALK-positive NSCLC usually is initially sensitive to crizotinib (another ALK inhibitor) but eventually becomes resistant, which limits the drug's long-term therapeutic potential.2 22 23 (See Actions.)

Ceritinib is used to treat metastatic (cancer that has already spread) non-small cell lung cancer in patients who have certain types of abnormal anaplastic lymphoma kinase (ALK) gene. It is used in patients who have already received crizotinib, but their condition got worse or the medicine was not tolerated. Ceritinib is an antineoplastic (cancer) agent. It interferes with the growth of cancer cells, which are eventually destroyed by the body.

This medicine is available only with your doctor's prescription.

• It is used to treat lung cancer.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Hard stools (constipation).
• Heartburn.
• Not hungry.
• Weight loss.
• Feeling tired or weak.
• Back pain.
• Muscle pain.
• Cough.
• Headache.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Zykadia 150 mg capsules

Hard gelatin capsule with opaque blue cap and opaque white body; opaque blue cap marked in black ink with “LDK 150MG”, opaque white body marked in black ink with “NVR”. Available in:

Bottles of 70 capsules…………………………………………………………………………………….NDC 0078-0640-70

Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

You should not use Zykadia if you are allergic to ceritinib.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• heart disease, a heart rhythm disorder, or long QT syndrome;

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood);

• a pancreas disorder;

• diabetes or high blood sugar; or

• liver disease.

Zykadia can harm an unborn baby. Use effective birth control to prevent pregnancy while you are using this medicine, whether you are a man or a woman. Men should use condoms. Ceritinib use by either parent may cause birth defects.

If you are a woman, keep using birth control for at least 6 months after your last dose of Zykadia. If you are a man, keep using condoms for at least 3 months after your last dose. Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Zykadia.

It is not known whether ceritinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine and for at least 2 weeks after your last dose.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with ceritinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide. Tell your doctor about all your current medicines and any medicine you start or stop using.

More common side effects

The more common side effects of Zykadia can include:

• nausea

• vomiting

• diarrhea

• constipation

• stomach pain

• decreased appetite

• tiredness

If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious side effects

Call your doctor right away if you have serious side effects. Call 9-1-1 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

• Stomach and intestinal problems. Symptoms can include severe and persistent:

  • diarrhea
  • nausea
  • vomiting
  • stomach pain

• Liver problems. Symptoms can include:

  • yellowing of your skin or the whites of your eyes
  • dark or tea-colored urine
  • pain in the upper right side of your stomach
  • nausea
  • vomiting
  • decreased appetite
  • itchy skin
  • bleeding or bruising more easily than normal
  • tiredness

• Lung problems. Symptoms can include:

  • trouble breathing or shortness of breath
  • chest pain
  • cough
  • fever

• Heart problems. Symptoms can include:

  • chest pain or discomfort
  • dizziness or lightheadedness
  • fainting
  • very fast, very slow, or abnormal heart rate

• Hyperglycemia (high blood sugar). People who have diabetes or glucose intolerance, or who take a corticosteroid drug, have an increased risk of high blood sugar while taking this drug. Symptoms can include:

  • increased thirst
  • increased hunger
  • urinating more often than normal
  • fruity-smelling breath
  • blurred vision
  • tiredness
  • headaches
  • trouble thinking or concentrating

• Pancreatitis (inflammation of your pancreas). Symptoms can include:

  • pain in your upper stomach area that may spread to your back
  • stomach pain that gets worse with eating