くすりのしおり

Internal
Revised: 8/2020

The information on this sheet is based on approvals granted by the Japanese regulatory authority. Approval details may vary by country. Medicines have adverse reactions (risks) as well as efficacies (benefits). It is important to minimize adverse reactions and maximize efficacy. To obtain a better therapeutic response, patients should understand their medication and cooperate with the treatment.
Brand name :
TABRECTA tablets 200mg
 Active ingredient:
Capmatinib hydrochloride hydrate
 Dosage form:
film-coated yellow oval tablet, major axis: 20.3 mm, minor axis: 8.1 mm, thickness: 6.9 mm
 Print on wrapping:
タブレクタ200mg, TABRECTA 200mg, NVR LO

Effects of this medicine

This medicine inhibits activity of mesenchymal epithelial transition factor (MET), that is a receptor tyrosine kinase, and suppresses proliferation of cancer cells.
It is usually used to treat unresectable, advanced/recurrent non-small cell lung cancer with mutation that leads MET Exon 14 skipping.

Before using this medicine, be sure to tell your doctor and pharmacist

  • If you have previously experienced any allergic reactions (itch, rash, etc.) to any medicines.
    If you have interstitial lung disease or its history, liver dysfunction, or renal dysfunction.
  • If you are pregnant or breastfeeding.
  • If you are taking any other medicinal products. (Some medicines may interact to enhance or diminish medicinal effects. Beware of over-the-counter medicines and dietary supplements as well as other prescription medicines.)

Dosing schedule (How to take this medicine)

  • Your dosing schedule prescribed by your doctor is ((        to be written by a healthcare professional))
  • In general, for adults, take 2 tablets (400 mg of capmatinib) at a time, twice a day. The dosage may be decreased according to the symptoms. Strictly follow the instructions.
  • If you miss a dose and remember within 4 hours after the usual time, take the missed dose as soon as possible. However, if more than 4 hours have passed since the usual time, skip the missed dose and continue your regular dosing schedule. You should never take two doses at one time.
  • If you accidentally take more than your prescribed dose, consult with your doctor or pharmacist.
  • Do not stop taking this medicine unless your doctor instructs you to do so.

Precautions while taking this medicine

  • If you have a possibility of pregnancy, avoid pregnancy during taking this medicine and for a certain period after completion of this medication.
  • If your partner is pregnant or has a possibility of pregnancy, use condom during taking this medicine and for a certain period after completion of this medication, since this medicine may have harmful effects to fetus via the sperm.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, vomiting, fatigue, loss of appetite and diarrhea. If any of these symptoms occur, consult with your doctor or pharmacist.
The symptoms described below are rarely seen as initial symptoms of the adverse reactions indicated in brackets. If any of these symptoms occur, stop taking this medicine and see your doctor immediately.
  • shortness of breath, breathing difficulty, dry cough  [interstitial lung disease]
  • acute weight gain, breathing difficulty  [body fluid retention]
  • general malaise, loss of appetite, nausea [liver dysfunction]
  • decreased urine output, edema, general malaise [renal dysfunction]
The above symptoms do not describe all the adverse reactions to this medicine. Consult with your doctor or pharmacist if you notice any symptoms of concern other than those listed above.

Storage conditions and other information

  • Keep out of the reach of children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. Ask the pharmacist and the medical institution how to discard them.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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