Generic name: Ceritinib

Chemocare.com uses trade names in all descriptions of drugs. Zykadia™ is the trade name for the generic chemotherapy drug ceritinib. In some cases, health care professionals may use the generic name ceritinib when referring to the trade drug Zykadia™.

Drug type: Zykadia™ is a targeted therapy. It is an oral tyrosine kinase inhibitor - (For more detail, see "How this drug works," below.)

What Zykadia Is Used For:

For the treatment of non-small cell lung cancer that is caused by a defect in a gene called ALK (anaplastic lymphoma kinase). The cancer must be (ALK)-positive as indicated by an FDA-approved test.

Note: If a drug has been approved for one use, physicians may elect to use this same drug for other problems if they believe it may be helpful.

How Zykadia Is Given:

• Zykadia™ is a capsule, taken by mouth: the standard starting dose is 3 capsules, once daily with food.
• Take Zykadia™ exactly as prescribed.
• Swallow Zykadia™ capsules whole. Do not crush, dissolve or open capsules.
• Do not change your dose or stop Zykadia™ unless your health care provider tells you to.
• If you miss a dose, take it as soon as you remember. If your next dose is due within 12 hours, then skip the missed dose. Take the next dose at the regular time.
• Do not take more than 1 dose of Zykadia™ at one time. Call your health care provider right away if you take too much.
• You should not drink grapefruit juice or eat grapefruit during your treatment with Zykadia™. It may make the amount of Zykadia™ in your blood increase to a harmful level.
• The amount of Zykadia™ that you will receive depends on many factors, your general health or other health problems, and the type of cancer or condition being treated.

Side Effects:

Important things to remember about the side effects of Zykadia™:

• Most people do not experience all of the side effects listed.
• Side effects are often predictable in terms of their onset and duration.
• Side effects are almost always reversible and will go away after treatment is complete.
• There are many options to help minimize or prevent side effects.
• There is no relationship between the presence or severity of side effects and the effectiveness of the medication.

The following side effects are common (occurring in greater than 30%) for patients taking Zykadia™:

• Diarrhea
• Hemoglobin decreased
• Increase in liver enzymes
• Nausea
• Vomiting
• Increase in creatinine
• Abdominal pain
• Fatigue
• Glucose increased
• Decrease in phosphate
• Decreased appetite

These side effects are less common side effects (occurring in about 10-29%) of patients receiving Zykadia™:

• Constipation
• Lipase increased
• Esophageal disorder (Heart burn, dyspepsia, dysphagia)
• Rash
• Bilirubin (total) increased

A serious, but very uncommon side effect of Zykadia™ is pneumonitis (swelling of the lungs). When this side effect occurred, it was often accompanied by breathing difficulty with cough or a low-grade fever requiring hospitalization. Symptoms may be similar to those symptoms from lung cancer. Contact your health care provider right away if you have any new or worsening symptoms.

Another serious but very uncommon side effect of Zykadia™ is EKG changes.

Not all side effects are listed above. Some that are rare (occurring in less than 10% of patients) are not listed here. However, you should always inform your health care provider if you experience any unusual symptoms.

When to contact your doctor or health care provider:

Contact your health care provider immediately, day or night, if you should experience any of the following symptoms:

• Fever of 100.4° F (38° or higher, chills)
• Sudden onset of shortness of breath, chest pain, accompanied by cough (with or without mucus)

The following symptoms require medical attention, but are not an emergency. Contact your health care provider within 24 hours of noticing any of the following:

• Diarrhea (4-6 episodes in a 24-hour period)
• Nausea (interferes with ability to eat and unrelieved with prescribed medication).
• Vomiting (vomiting more than 4-5 times in a 24 hour period)
• Unable to eat or drink for 24 hours or have signs of dehydration: tiredness, thirst, dry mouth, dark and decrease amount of urine, or dizziness
• Skin or the whites of your eyes turn yellow
• Itchy skin
• Urine turns dark or brown (tea color)
• Decreased appetite
• Pain on the right side of your stomach
• Bleed or bruise more easily than normal
• Itching
• Cough with or without mucus
• Fast or abnormal heartbeats, dizziness or lightheadedness
• Increase in blood sugar, increased thirst, increased hunger, headaches, trouble thinking or concentrating, increased urination, blurred vision, tiredness or breath that smells like fruit

Always inform your health care provider if you experience any unusual symptoms.

Precautions:

• Before starting Zykadia™ treatment, make sure you tell your doctor about any other medications you are taking (including prescription, over-the-counter, vitamins, herbal remedies, etc.).
• People who have diabetes or glucose intolerance or who take a corticosteroid medicine have an increased risk of high blood sugar. Follow your healthcare provider’s instructions about monitoring your blood sugar.
• Do not receive any kind of immunization or vaccination without your doctor's approval while taking Zykadia™.
• Inform your health care professional if you are pregnant or may be pregnant prior to starting this treatment. Pregnancy category D (Zykadia™ may be hazardous to the fetus. Women who are pregnant or become pregnant must be advised of the potential hazard to the fetus.)
• For both men and women: Do not conceive a child (get pregnant) while taking Zykadia™. Barrier methods of contraception, such as condoms, are recommended during treatment and for at least 2 weeks after completing therapy. Discuss with your doctor when you may safely become pregnant or conceive a child after therapy.
• Do not breast feed while taking this medication.
• You should not drink grapefruit juice or eat grapefruit during your treatment with Zykadia™. It may make the amount of Zykadia™ in your blood increase to a harmful level.

Self-Care Tips:

• Drink at least two to three quarts of fluid every 24 hours, unless you are instructed otherwise.
• If you should experience nausea, take anti-nausea medications as prescribed by your doctor, and eat small frequent meals. Sucking on lozenges and chewing gum may also help.
• Avoid sun exposure. Wear SPF 15 (or higher) sun block and protective clothing.
• In general, drinking alcoholic beverages should be kept to a minimum or avoided completely. You should discuss this with your doctor.
• Get plenty of rest.
• Maintain good nutrition.

· You may be at risk of infection so try to avoid crowds or people with colds, and report fever or any other signs of infection immediately to your healthcare provider.

· Wash your hands often. Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.

· Ask your doctor or nurse before scheduling dental appointments or procedures.

· Use an electric razor to minimize bleeding.

· If you experience symptoms or side effects, be sure to discuss them with your health care team. They can prescribe medications and/or offer other suggestions that are effective in managing such problems.

Monitoring and Testing:

You will be checked regularly by your health care professional while you are taking Zykadia™, to monitor side effects and check your response to therapy.

How Zykadia Works:

Targeted therapy is the result of about 100 years of research dedicated to understanding the differences between cancer cells and normal cells. To date, cancer treatment has focused primarily on killing rapidly dividing cells because one feature of cancer cells is that they divide rapidly. Unfortunately, some of our normal cells divide rapidly too, causing multiple side effects.

Targeted therapy is about identifying other features of cancer cells. Scientists look for specific differences in the cancer cells and the normal cells. This information is used to create a targeted therapy to attack the cancer cells without damaging the normal cells, thus leading to fewer side effects. Each type of targeted therapy works a little bit differently but all interfere with the ability of the cancer cell to grow, divide, repair and/or communicate with other cells.

There are different types of targeted therapies, defined in three broad categories. Some targeted therapies focus on the internal components and function of the cancer cell. The targeted therapies use small molecules that can get into the cell and disrupt the function of the cells, causing them to die. There are several types of targeted therapy that focus on the inner parts of the cells. Other targeted therapies target receptors that are on the outside of the cell. Therapies that target receptors are also known as monoclonal antibodies. Antiangiogenesis inhibitors target the blood vessels that supply oxygen to the cells, ultimately causing the cells to starve.

Zykadia™ is a targeted therapy that targets and binds to the tyrosine kinase receptors and inhibits ALK, insulin-like growth factor 1 receptor (IGF-1R), insulin receptor (InsR), and ROS1on the surface of the cell. By binding to these receptors Zykadia™ blocks an important pathway that promotes cell division.

Research continues to identify which cancers may be best treated with targeted therapies and to identify additional targets for more types of cancer.

Note: We strongly encourage you to talk with your health care professional about your specific medical condition and treatments. The information contained in this website is meant to be helpful and educational, but is not a substitute for medical advice.

Chemocare.com is designed to provide the latest information about chemotherapy to patients and their families, caregivers and friends. For information about the 4th Angel Mentoring Program visit www.4thangel.org