くすりのしおり

Internal
Revised: 10/2014

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 "NIPRO"
 Active ingredient:
Imatinib mesilate
 Dosage form:
smoky yellowish red to dark yellowish red tablet with split line on one side, diameter: 8.2 mm, thickness: 4.7 mm
 Print on wrapping:
(Face)イマチニブ100mg「ニプロ」, イマチニブ, 100, (Back)IMATINIB 100mg「NIPRO」, イマチニブ100, NP-222

Effects of this medicine

This medicine inhibits abnormal action of tyrosine kinases (Bcr-Abl, KIT, FIP1L1-PDGFRα) involved in cell growth and suppresses the growth of cancer cells.
It is usually used to treat chronic myelogenous leukemia, 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, possibly 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))
  • Chronic myelogenous leukemia: In general, for adults, take 4 tablets (400 mg of imatinib) at a time in chronic phase, or take 6 tablets (600 mg of imatinib) at a time, in accelerated phase or blast crisis, once a day after meals. It should be adjusted according to your blood test result, age or symptoms. The dose could be increased up to 6 tablets (600 mg) at a time, once a day in chronic phase, or 4 tablets (400 mg) at a time, twice a day in accelerated phase or blast crisis, respectively.
    Philadelphia chromosome-positive acute lymphocytic leukemia: In general, for adults, take 6 tablets (600 mg of imatinib) at a time, once a day after meals. It should be adjusted according to your blood test result, age or symptoms.
    In any case, strictly follow the instructions.
  • Take it with a glass of water (about 200 cc) or lukewarm water after meals.
  • If you miss a dose, 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

  • Keep prescribed test schedule. Measure your weight periodically, and consult with your doctor if there is abnormal weight gain.
  • This medicine may cause dizziness, drowsiness or blurred vision. Pay attention when you work at heights or operate dangerous machinery such as driving a car.
  • Avoid taking hypericum perforatum (Saint John's wort)-contained supplements, etc. with this medicine, since it may weaken the therapeutic effects.
  • Avoid taking grapefruit juice with this medicine, since it may intensify the therapeutic effects.
  • Sexually active females should use birth control while taking this medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea, diarrhea, loss of appetite, abdominal pain, rash, superficial swelling (on face, eyelid or lower limb, etc.), malaise, muscular cramps and fever. 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.
  • anemia, fever, bleeding tendency [bone marrow suppression]
  • headache, conscious disorder, hemiplegia [bleeding (cerebral/subdural haemorrhage)]
  • melena/vomiting of blood, stomachache, abdomen enlarged feeling [gastrointestinal haemorrhage, gastric antral vascular ectasia, gastrointestinal perforation, tumour haemorrhage]
  • general malaise, loss of appetite, yellowing of the skin and the whites of the eyes [liver dysfunction, jaundice, hepatic failure]
  • weight increase, breathing difficulty, chest pain [serious 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 the pharmacist or medical institution how to discard.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.

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