Description
Ceritinib is used to treat metastatic (cancer that has already spread) non-small cell lung cancer in patients who have a certain type of abnormal anaplastic lymphoma kinase (ALK) gene. Your doctor will test for the presence of this gene. 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.
This product is available in the following dosage forms:
- Tablet
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. 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
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
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ceritinib in the elderly.
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 not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
- Alprazolam
- Bepridil
- Cisapride
- Colchicine
- Conivaptan
- Dihydroergotamine
- Dronedarone
- Eplerenone
- Ergotamine
- Finerenone
- Flibanserin
- Gepirone
- Isavuconazonium Sulfate
- Ivabradine
- Levoketoconazole
- Lomitapide
- Lonafarnib
- Lovastatin
- Lurasidone
- Mavacamten
- Mesoridazine
- Naloxegol
- Pacritinib
- Pimozide
- Piperaquine
- Saquinavir
- Silodosin
- Simvastatin
- Sparfloxacin
- Terfenadine
- Thioridazine
- Tolvaptan
- Ubrogepant
- Voclosporin
- Ziprasidone
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.
- Abemaciclib
- Acalabrutinib
- Acebutolol
- Aceclofenac
- Adagrasib
- Alfentanil
- Alfuzosin
- Amiodarone
- Amisulpride
- Amitriptyline
- Amlodipine
- Amprenavir
- Anagrelide
- Apixaban
- Apomorphine
- Aprepitant
- Aripiprazole
- Aripiprazole Lauroxil
- Arsenic Trioxide
- Asciminib
- Asenapine
- Astemizole
- Atazanavir
- Atenolol
- Atorvastatin
- Avacopan
- Axitinib
- Azilsartan
- Azilsartan Medoxomil
- Azithromycin
- Bedaquiline
- Benzhydrocodone
- Berotralstat
- Betaxolol
- Bictegravir
- Bisoprolol
- Boceprevir
- Bosutinib
- Brentuximab Vedotin
- Brigatinib
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.
- Grapefruit Juice
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:
- Bradycardia (slow heartbeat) or
- Congenital long QT syndrome (heart rhythm problem) or
- Congestive heart failure or
- Electrolyte or mineral imbalance or
- QT prolongation (abnormal heart rhythm)—Use with caution. May cause side effects to become worse.
- Diabetes or
- Hyperglycemia (high blood sugar) or
- Lung disease or breathing problems (eg, interstitial lung disease, pneumonitis)—Use with caution. May make these conditions worse.
- Liver disease, severe—Use with caution. The effects may be increased because of slower removal of the medicine from the body.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before using this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
Take this medicine exactly as directed by your doctor. 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. Read and follow these instructions carefully. Ask your doctor if you have any questions.
Take this medicine with food.
Do not eat grapefruit or drink grapefruit juice while you are using this medicine. Grapefruit and grapefruit juice may change the amount of medicine that is absorbed in the body.
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.
- For oral dosage forms (capsule, tablet):
- For treatment of non-small cell lung cancer:
- Adults—450 milligrams (mg) once a day. Your doctor may adjust your dose as needed or tolerated.
- Children—Use and dose must be determined by your doctor.
- For treatment of non-small cell lung cancer:
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 you miss a dose and it is less than 12 hours until your next regular dose, skip the missed dose and take your next dose at the regular time.
If you miss a dose and it is more than 12 hours until your next regular dose, take the missed dose as soon as possible, and then go back to your regular schedule.
If you vomit after taking a dose, take the next dose at the regular time.
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.
Precautions
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. If you are a woman who can get pregnant, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Female patients should use effective birth control during treatment and for at least 6 months after the last dose. Male patients who have female partners should use effective birth control during treatment and for at least 3 months after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.
Cancer medicines can cause diarrhea, nausea, vomiting, or stomach pain in most people, sometimes even after receiving medicines to prevent it. Ask your doctor or nurse about other ways to control these unwanted effects.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. 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. The symptoms may be similar to the symptoms of lung cancer. Check with your doctor right away if you have new or worsening cough, fever, or trouble breathing.
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 had a heart rhythm problem, including QT prolongation.
This medicine may increase your blood sugar levels. Check with your doctor right away if you have confusion, nausea, vomiting, increased hunger, thirst or urination, or unusual tiredness or weakness.
Pancreatitis (swelling of the pancreas) may occur while you are using this medicine. Check with your doctor right away if you have loss of appetite, nausea, or pains in the stomach, side, or abdomen, possibly radiating to the back.
This medicine may make your skin more sensitive to sunlight. Use a sunscreen and protective clothing when you are outdoors. Avoid sunlamps and tanning beds.
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 or vitamin supplements.
Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. 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:
More common
- Blurred vision
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- clay-colored stools
- dark urine
- decreased appetite
- dry mouth
- fever
- flushed, dry skin
- fruit-like breath odor
- headache
- increased hunger
- increased thirst
- increased urination
- itching, skin rash
- loss of appetite
- nausea
- stomach pain or tenderness
- sweating
- swelling of the feet or lower legs
- trouble breathing
- unexplained weight loss
- unsteadiness or awkwardness
- unusual tiredness or weakness
- vomiting
- weakness in the arms, hands, legs, or feet
- yellow eyes or skin
Less common
- Chest pain
- chills
- cough
- fainting
- general feeling of discomfort or illness
- irregular heartbeat, recurrent
- thickening of bronchial secretions
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:
More common
- Blurred vision or other changes in vision
- diarrhea
- difficulty having a bowel movement
- heartburn
- pain or discomfort in the chest, upper stomach, or throat
- seeing flashes or sparks of light
Incidence not known
- Increased sensitivity of the skin to sunlight
- redness or other discoloration of the skin
- severe sunburn
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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