くすりのしおり

Internal
Published: 12/2014

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 :
IMATINIB Tablets 100mg "SAWAI"
 Active ingredient:
Imatinib mesilate
 Dosage form:
smoky yellowish red to dark yellowish red tablet, diameter: 9.2 mm, thickness: 3.9 mm
 Print on wrapping:
イマチニブ100mg「サワイ」, SW IT-100, Imatinib 100mg「SAWAI」

Effects of this medicine

This medicine suppresses proliferation of cancer cells by inhibiting abnormal action of tyrosine kinases involved in proliferation of cells.
It is usually used to treat chronic myelogenous leukemia and Philadelphia chromosome-positive acute lymphocytic leukemia.

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, breastfeeding or possibly pregnant.
  • 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))
  • For chronic myelogenous leukemia: (chronic phase) In general, for adults, take 4 tablets (400 mg of imatinib) at a time, once a day after a meal. The dosage may be adjusted according to your blood test results, age or symptoms. However, the dosage may be increased up to 6 tablets (600 mg) at a time, once a day. (accelerated phase or blast crisis) In general, for adults, take 6 tablets (600 mg) at a time, once a day after a meal. The dosage may be adjusted according to your blood test results, age or symptoms. However, the dosage may be increased up to 4 tablets (400 mg) at a time, twice a day.
    For Philadelphia chromosome-positive acute lymphocytic leukemia: In general, for adults, take 6 tablets (600 mg of imatinib) at a time, once a day after a meal. However, the dosage may be decreased according to your blood test results, age or symptoms.
    In any case, strictly follow the instructions.
  • Take this medicine after meals with a large amount of water.
  • If you miss a dose, skip the missed dose and follow 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

  • Measure your weight on a regular basis, and contact your doctor if you notice abnormal weight gain.
  • For early detection of adverse reactions, you need to undergo tests including liver and blood function tests on a regular basis or depending on your condition.
  • This medicine may cause dizziness, drowsiness or foggy vision (blurring of eyes). Pay close attention when working at heights or operating dangerous machinery, such as driving a car.
  • Refrain from taking any food containing St. John's wort, since it may diminish medicinal effects.
  • Avoid taking grapefruit juice while taking this medicine, since it may intensify medicinal effects.
  • If you have a capable of becoming pregnant, you should use birth control while taking this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include rash, muscular cramps, nausea, vomiting, diarrhea, loss of appetite, superficial edema (face/eyelids), edema of lower limbs and malaise. 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.
  • anemic symptoms, fever, bleeding tendency [bone marrow suppression]
  • headache, nausea/vomiting, consciousness disorder [bleeding (cerebral bleeding, subdural bleeding)]
  • abdominal pain, vomiting of blood, melena [gastrointestinal bleeding, gastric antral vascular ectasia, gastrointestinal perforation, tumor bleeding]
  • general malaise, loss of appetite, yellow discoloration of the skin and the white of eyes [liver dysfunction, jaundice, liver failure]
  • rapid increase in body weight, respiratory distress, chest pain [serious body fluid retention (pleural effusion, ascites, pulmonary edema, pericardial exudate, congestive heart failure, cardiac tamponade)]
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 your pharmacy 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.

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