Zykadia is used to treat metastatic (cancer that has already spread) non-small cell lung cancer that is caused by a defect in a gene called anaplastic lymphoma kinase.
It is used in patients who have already received crizotinib, but their condition got worse or the medicine was not tolerated.
Zykadia 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. This product is available in the following dosage forms:
2 What to Know Before Using
Before using Zykadia, you must know all about the risks and complications associated with it. This is a decision you and your doctor will make.
For this medicine, the following should be considered:
Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric Population: Appropriate studies have not been performed on the relationship of age to the effects of ceritinib in the pediatric population. Safety and efficacy have not been established.
Geriatric Population: Although appropriate studies on the relationship of age to the effects of ceritinib in the geriatric population have not been performed, no geriatric-specific problems have been documented to date.
Pregnancy: All Trimesters: Category D: Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease may outweigh the potential risk.
Breastfeeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose or other precautions may be necessary.
When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Other Interactions: Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine or give you special instructions about the use of food, alcohol, or tobacco.
Other Medical Problems: The presence of other medical problems may affect the use of this medicine.
Make sure you tell your doctor if you have any other medical problems, especially:
Proper usage of Zykadia requires strict adherence to your doctor’s orders. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.
This medicine comes with a patient information leaflet. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.
Swallow the capsule whole. Do not crush, break, chew, or open it. Take this medicine on an empty stomach, at least 2 hours before or after a meal.
Dosing: The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
Children—Use and dose must be determined by your doctor.
Missed Dose: If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.
Do not double doses. If it has been more than 12 hours since your regularly scheduled dose, skip the missed dose.
Storage: Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing. Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed. Ask your healthcare professional how you should dispose of any medicine you do not use.
4 Precautions to Take
Before using Zykadia, there are some precautions you must take. It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control during therapy and for at least 2 weeks after the last dose. If a pregnancy occurs while you are using this medicine, tell your doctor right away.
These could be symptoms of a serious liver problem. This medicine may cause swelling of the lungs (pneumonitis) or interstitial lung disease. These are life-threatening conditions and require immediate medical attention.
Contact your doctor right away if you have any changes to your heart rhythm
You might feel dizzy or faint, or you might have a slow, fast, pounding, or uneven heartbeat. Make sure your doctor knows if you or anyone in your family has ever had a heart rhythm problem such as QT prolongation. Pancreatitis may occur while you are using this medicine.
Check with your doctor if you have sudden and severe
Do not use grapefruit products while you are using this medicine. Grapefruit and grapefruit juice may change the amount of medicine that is absorbed in the body.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
5 Potential Side Effects
As with many medications, there are several potential side effects associated with Zykadia. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
pain or discomfort in the chest, upper stomach, or throat
seeing flashes or sparks of light
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
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