Description
Capmatinib is used to treat metastatic (cancer that has already spread) non-small cell lung cancer (NSCLC) in patients whose tumors have an abnormal mesenchymal epithelial transition (MET) gene. Your doctor will perform a test to check for the MET gene before you use this medicine.
Capmatinib belongs to the group of medicines called antineoplastics (cancer medicines). It works by interfering with the growth of cancer cells, which are eventually destroyed.
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 capmatinib 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 capmatinib 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.
- Bacillus of Calmette and Guerin Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Fezolinetant
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
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.
- Abametapir
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Afatinib
- Aliskiren
- Alosetron
- Alpelisib
- Apalutamide
- Apixaban
- Avacopan
- Betrixaban
- Bosentan
- Carbamazepine
- Cenobamate
- Cholera Vaccine
- Clarithromycin
- Clomipramine
- Clozapine
- Colchicine
- Conivaptan
- Cyclosporine
- Dabigatran Etexilate
- Darolutamide
- Digoxin
- Dofetilide
- Doxorubicin
- Doxorubicin Hydrochloride Liposome
- Duloxetine
- Ebola Zaire Vaccine, Live
- Edoxaban
- Efavirenz
- Elagolix
- Ensartinib
- Enzalutamide
- Etravirine
- Everolimus
- Fedratinib
- Fexinidazole
- Fexofenadine
- Fosphenytoin
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
- Levothyroxine
- Mavacamten
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.
- Caffeine
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:
- Liver disease or
- Lung or breathing problems (eg, interstitial lung disease, pneumonitis)—Use with caution. May make these conditions worse.
Proper Use
Medicines used to treat cancer are very strong and can have many side effects. Before receiving 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. 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 tablet whole. Do not crush, break, or chew it. You may take this medicine with or without food.
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 form (tablets):
- For metastatic non-small cell lung cancer:
- Adults—400 milligrams (mg) 2 times a day. Your doctor may adjust your dose as needed and tolerated.
- Children—Use and dose must be determined by your doctor.
- For metastatic non-small cell lung cancer:
Missed Dose
If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
If you vomit after taking your medicine, do not take an extra 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.
This medicine should be used within 6 weeks after opening the bottle. Dispose any unused medicine after 6 weeks.
Precautions
It is very important that your doctor check your progress at regular visits to make sure that 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 bear children, your doctor may give you a pregnancy test before you start using this medicine to make sure you are not pregnant. Use an effective form of birth control during treatment and for at least 1 week after the last dose. Males with female partners who are able to become pregnant should use an effective form of birth control during treatment and for at least 1 week after the last dose. If you think you have become pregnant, tell your doctor right away.
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 from lung cancer. Check with your doctor right away if you have new or worsening cough, fever, or trouble breathing.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, a loss of appetite, nausea, unusual tiredness or weakness, or yellow eyes or skin. These could be symptoms of a serious liver problem.
This medicine may cause pancreas problems. Check with your doctor right away if you have bloating, chills, constipation, darkened urine, fast heartbeat, fever, indigestion, loss of appetite, nausea, pain in the stomach, side, abdomen, or back, vomiting, or yellow eyes or skin.
This medicine may cause serious allergic reactions, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have difficulty breathing or swallowing, fast heartbeat, itching, rash, redness, or swelling of the face, throat, or tongue.
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
- Bloating or swelling of the face, arms, hands, lower legs, or feet
- chest pain or tightness
- chills
- clay colored stools
- cough
- dark urine
- decreased or loss of appetite
- difficult or labored breathing
- fever
- general feeling of discomfort or illness
- headache
- itching
- nausea and vomiting
- rapid weight gain
- skin rash
- stomach pain or tenderness
- swelling of the feet or lower legs
- thickening of bronchial secretions
- tingling of the hands or feet
- unusual weight gain or loss
- unusual tiredness or weakness
- yellow eyes or skin
Less common
- Agitation
- coma
- confusion
- constipation
- decreased urine output
- depression
- dizziness
- fast heartbeat
- hostility
- indigestion
- irritability
- lethargy
- muscle twitching
- pain, redness, swelling, tenderness, warmth on the skin
- pains in the stomach, side, or abdomen, possibly radiating to the back
- seizures
- sore throat
- stupor
- swelling of the face, ankles, or hands
Incidence not known
- Black, tarry stools
- bleeding gums
- blood in the urine or stools
- difficulty in swallowing
- increased sensitivity of the skin to sunlight
- pinpoint red spots on the skin
- redness or other discoloration of the skin
- severe sunburn
- swelling of the face, throat, or tongue
- unusual bleeding or bruising
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
- Back pain
- diarrhea
Less common
- Hives or welts
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.
DRG-20488162
