くすりのしおり

Internal
Revised: 1/2020

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 :
Mekinist Tablets 2mg
 Active ingredient:
Trametinib dimethyl sulfoxide
 Dosage form:
pale red circular tablet, diameter: 7.5 mm, thickness: 3.7 mm
 Print on wrapping:
メキニスト錠2mg

Effects of this medicine

This medicine suppresses cancer cell growth by inhibiting MEK kinase, which is essential to cancer cell growth.
It is usually used to treat malignant melanoma with BRAF gene mutations, or unresectable advanced/recurrent non-small cell lung cancer (NSCLC) with BRAF gene mutations, in combination with dabrafenib.

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 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 1 tablet (2 mg as trametinib) at a time, once a day on an empty stomach. It is used in combination with dabrafenib. For adjuvant therapy, the treatment duration is up to 12 months. The dosage may be decreased according to the symptoms. Strictly follow the instructions.
  • Avoid taking the medicine between 1 hour before and 2 hours after meal, since it may become difficult to be absorbed if taken after meal, resulting in insufficient efficacy.
  • If you miss a dose and have more than 12 hours until the next dose, take the missed dose as soon as possible. If the next dose is within 12 hours, 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

  • Women of reproductive potential should use effective contraception during and certain time period after taking this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include rash, fever, diarrhea, chills, fatigue, edema of limbs, nausea, vomiting and skin dryness. 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.
  • palpitation, shortness of breath, edema [heart disorder]
  • general malaise, loss of appetite, nausea, jaundice [liver dysfunction]
  • fever, dry cough, respiratory distress [interstitial lung disease]
  • muscle pain of limbs, stiffness, numbness, lassitude, reddish brown urine [rhabdomyolysis]
  • regional pain, red rash, blood vessels swell [venous thromboembolism]
  • headache, temporary consciousness disorder, one-sided paralysis of limbs, difficulty speaking [cerebrovascular disorder]
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 in the refrigerator (2 to 8 degrees Celsius). Keep away from light.
  • Store in the original container with the desiccant. Close the cap tightly each time after you take the medicine.
  • Discard the remainder. Do not store them. Ask the pharmacist or medical institution on how to discard the remainder.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.