Capmatinib

Capmatinib is a prescription medication used for the treatment of non-small cell lung cancer. 

• Capmatinib is available under the following different brand names: Tabrecta.

Common side effects of Capmatinib include:

1. swelling of extremities,
2. nausea,
3. fatigue,
4. vomiting,
5. shortness of breath,
6. decreased appetite,
7. non-cardiac chest pain,
8. back pain,
9. fever,
10. weight loss,
11. constipation,
12. diarrhea, and
13. cough

Serious side effects of Capmatinib include:

• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

Rare side effects of Capmatinib include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet

• 150 mg
• 200 mg

Non-Small Cell Lung Cancer

Adult dosage

• 400 mg orally twice daily
• Continue until disease progression or unacceptable toxicity

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Capmatinib has minor interactions with no other drugs.
• Capmatinib has minor interactions with the following drugs:
  • abametapir
  • amobarbital
  • apalutamide
  • bosentan
  • carbamazepine
  • conivaptan
  • dabrafenib
  • efavirenz
  • enzalutamide
  • fosphenytoin
  • lorlatinib
  • mifepristone
  • mitotane
  • nafcillin
  • phenobarbital
  • phenytoin
  • primidone
  • rifabutin
  • rifampin
  • rifapentine
  • ritonavir
  • secobarbital
• Capmatinib has minor interactions with at least 23 other drugs.
• Capmatinib has minor interactions with the following drugs:
  • acetazolamide
  • anastrozole
  • cyclophosphamide
  • larotrectinib

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, health questions, or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Capmatinib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Capmatinib?”

Cautions

• ILD/pneumonitis, which can be fatal, occurred during clinical trials; monitor for new or worsening pulmonary symptoms indicative of ILD/pneumonitis
• Hepatotoxicity occurred; monitor liver function tests (including ALT, AST, and total bilirubin) before initiation, every 2 weeks during the first 3 months of treatment, and then once monthly or as clinically indicated, with more frequent testing in patients who develop increased transaminases or bilirubin
• Elevations in amylase and lipase levels occurred in patients receiving therapy; monitor amylase and lipase at baseline and regularly during treatment; based on the severity of adverse drug reaction, temporarily withhold, dose reduce, or permanently discontinue therapy
• Serious hypersensitivity reactions reported with use; signs and symptoms of hypersensitivity included pyrexia, chills, pruritus, rash, decreased blood pressure, nausea, and vomiting; based on the severity of the adverse reaction, temporarily withhold or permanently discontinue therapy
• May cause photosensitivity reactions; advise patients to limit direct ultraviolet exposure; limit direct ultraviolet exposure by using sunscreen or protective clothing during treatment
• Fetal harm may occur
• Drug interaction overview
  • Capmatinib is a CYP3A4 substrate and inhibits CYP1A2, P-glycoprotein (P-gp), breast cancer resistance protein (BCRP), MATE 1, and MATE2K
  • Strong CYP3A Inhibitors
    • Coadministration with a strong CYP3A inhibitor increased capmatinib exposure, which may increase the incidence and severity of adverse reactions of capmatinib
    • Closely monitor for adverse reactions
  • Strong and moderate CYP3A inducers
  • Avoid coadministration
• Concomitant use with capmatinib a strong or moderate CYP3A inducer decreased capmatinib exposure and efficacy
  • Substrates of CYP1A2, P-gp, BCRP, MATE1 or MATE2K
  • Coadministration with CYP1A2, P-gp, BCRP, MATE1 or MATE2K substrates increased the exposure and adverse reactions of these substrates
  • If coadministration is unavoidable, reduce the dose of CYP1A2, P-gp, BCRP, MATE1 or MATE2K substrate in accordance with the approved prescribing information

Pregnancy and Lactation

• Based on animal studies and its mechanism of action, fetal harm may occur when administered to pregnant females
• No available data on use in pregnant females
• Verify pregnancy status for females of reproductive potential before starting treatment
• Contraception
  • Females of reproductive potential: Use effective contraception during treatment and for 1 week after the final dose
  • Males with female partners of reproductive potential: Use effective contraception during treatment and for 1 week after the final dose
• Lactation
  • No data available on the presence of capmatinib or its metabolites in either human or animal milk or its effects on breastfeeding, or milk production
  • Advise females not to breastfeed during treatment and for 1 week after the final dose