- Side Effects
- Drug Interactions
What is Tabrecta (capmatinib), and what is it used for?
- has spread to other parts of the body or cannot be removed by surgery (metastatic), and
- whose tumors have an abnormal mesenchymal epithelial transition (MET) gene
It is not known if Tabrecta is safe and effective in children.
What are the side effects of Tabrecta?
Tabrecta may cause serious side effects, including:
- lung or breathing problems. Tabrecta may cause inflammation of the lungs that can cause death. Tell your healthcare provider right away if you develop any new or worsening symptoms, including:
Your healthcare provider may temporarily stop or permanently stop treatment with Tabrecta if you develop lung or breathing problems during treatment.
- liver problems. Tabrecta may cause abnormal liver blood test results. Your healthcare provider will do blood tests to check your liver function before you start treatment and during treatment with
Tabrecta. Tell your healthcare provider right away if you develop any signs and symptoms of liver problems, including:
- your skin or the white part of your eyes turns yellow (jaundice)
- loss of appetite for several days or longer
- dark or &lduqo;tea-colored&rduqo; urine
- nausea and vomiting
- light-colored stools (bowel movements)
- pain, aching, or tenderness on the right side of your stomach-area (abdomen)
- swelling in your stomach-area
Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with Tabrecta if you develop liver problems during treatment.
- risk of sensitivity to sunlight (photosensitivity).
The most common side effects of Tabrecta include:
- swelling of your hands or feet
- tiredness and weakness
- loss of appetite
- changes in certain blood tests
These are not all of the possible side effects of Tabrecta. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is the dosage for Tabrecta?
Select patients for treatment with Tabrecta based on the presence of a mutation that leads to MET exon 14 skipping in tumor specimens. Information on FDA-approved tests is available at: http://www.fda.gov/CompanionDiagnostics
The recommended dosage of Tabrecta is 400 mg orally twice daily with or without food.
Swallow Tabrecta tablets whole. Do not break, crush or chew the tablets.
If a patient misses or vomits a dose, instruct the patient not to make up the dose, but to take the next dose at its scheduled time.
Dosage Modifications For Adverse Reactions
The recommended dose reductions for the management of adverse reactions are listed in Table 1.
Table 1: Recommended Tabrecta Dose Reductions for Adverse Reactions
|Dose Reduction||Dose and Schedule|
|First||300 mg orally twice daily|
|Second||200 mg orally twice daily|
Permanently discontinue Tabrecta in patients who are unable to tolerate 200 mg orally twice daily.
The recommended dosage modifications of Tabrecta for adverse reactions are provided in Table 2.
Table 2: Recommended Tabrecta Dosage Modifications for Adverse Reactions
|Adverse Reaction||Severity||Dosage Modification|
|Interstitial Lung Disease (ILD)/Pneumonitis||Any grade||Permanently discontinue Tabrecta.|
|Increased ALT and/or AST without increased total bilirubin||Grade 3||Withhold Tabrecta until recovery to baseline ALT/AST. If recovered to baseline within 7 days, then resume Tabrecta at the same dose; otherwise resume Tabrecta at a reduced dose.|
|Grade 4||Permanently discontinue Tabrecta.|
|Increased ALT and/or AST with increased total bilirubin in the absence of cholestasis or hemolysis||ALT and/or AST greater than 3 times ULN with total bilirubin greater than 2 times ULN||Permanently discontinue Tabrecta.|
|Increased total bilirubin without concurrent increased ALT and/or AST||Grade 2||Withhold Tabrecta until recovery to baseline bilirubin. If recovered to baseline within 7 days, then resume Tabrecta at the same dose; otherwise resume Tabrecta at a reduced dose.|
|Grade 3||Withhold Tabrecta until recovery to baseline bilirubin. If recovered to baseline within 7 days, then resume Tabrecta at a reduced dose; otherwise permanently discontinue Tabrecta.|
|Grade 4||Permanently discontinue Tabrecta.|
|Other Adverse Reactions||Grade 2||Maintain dose level. If intolerable, consider withholding Tabrecta until resolved, then resume Tabrecta at a reduced dose.|
|Grade 3||Withhold Tabrecta until resolved, then resume Tabrecta at a reduced dose.|
|Grade 4||Permanently discontinue Tabrecta.|
|Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; ILD, interstitial lung disease; ULN, upper limit of normal.
Grading according to CTCAE Version 4.03 (CTCAE = Common Terminology Criteria for Adverse Events).
What drugs interact with Tabrecta?
Effect Of Other Drugs On Tabrecta
Strong CYP3A Inhibitors
- Coadministration of Tabrecta with a strong CYP3A inhibitor increased capmatinib exposure, which may increase the incidence and severity of adverse reactions of Tabrecta. Closely monitor patients for adverse reactions during coadministration of Tabrecta with strong CYP3A inhibitors.
Strong And Moderate CYP3A Inducers
- Coadministration of Tabrecta with a strong CYP3A inducer decreased capmatinib exposure. Coadministration of Tabrecta with a moderate CYP3A inducer may also decrease capmatinib exposure. Decreases in capmatinib exposure may decrease Tabrecta anti-tumor activity. Avoid coadministration of Tabrecta with strong and moderate CYP3A inducers.
Effect Of Tabrecta On Other Drugs
- Coadministration of Tabrecta increased the exposure of a CYP1A2 substrate, which may increase the adverse reactions of these substrates. If coadministration is unavoidable between Tabrecta and CYP1A2 substrates where minimal concentration changes may lead to serious adverse reactions, decrease the CYP1A2 substrate dosage in accordance with the approved prescribing information.
P-glycoprotein (P-gp) And Breast Cancer Resistance Protein (BCRP) Substrates
- Coadministration of Tabrecta increased the exposure of a P-gp substrate and a BCRP substrate, which may increase the adverse reactions of these substrates. If coadministration is unavoidable between Tabrecta and P-gp or BCRP substrates where minimal concentration changes may lead to serious adverse reactions, decrease the P-gp or BCRP substrate dosage in accordance with the approved prescribing information.
MATE1 And MATE2K Substrates
- Coadministration of Tabrecta may increase the exposure of MATE1 and MATE2K substrates, which may increase the adverse reactions of these substrates. If coadministration is unavoidable between Tabrecta and MATE1 or MATE2K substrates where minimal concentration changes may lead to serious adverse reactions, decrease the MATE1 or MATE2K substrate dosage in accordance with the approved prescribing information.
Tabrecta contraindications, and pregnancy and breastfeeding safety
Before taking Tabrecta, tell your healthcare provider about all of your medical conditions, including if you:
- have or have had lung or breathing problems other than your lung cancer
- have or have had liver problems
- are pregnant or plan to become pregnant. Tabrecta can harm your unborn baby.
Females who are able to become pregnant:
- Your healthcare provider should do a pregnancy test before you start your treatment with Tabrecta.
- You should use effective birth control during treatment and for 1 week after your last dose of Tabrecta. Talk to your healthcare provider about birth control choices that might be right for you during this time.
- Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Tabrecta.
Males who have female partners who can become pregnant:
- You should use effective birth control during treatment and for 1 week after your last dose of Tabrecta.
Tabrecta (capmatinib) is a prescription medicine used to treat adults with a kind of lung cancer called non-small cell lung cancer (NSCLC). Serious side effects of Tabrecta include lung, breathing, or liver problems.
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.