くすりのしおり

Internal
Revised: 10/2021

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 200mg "TOWA"
 Active ingredient:
Imatinib mesilate
 Dosage form:
smoky yellowish red to deep yellowish red oblong tablet with split line, major axis: 16.0 mm, minor axis:7.4 mm,thickness: 4.7 mm
 Print on wrapping:
Tw545, イマチニブ200mg「トーワ」,200mg

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, KIT (CD117)-positive gastrointestinal stromal tumor, 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))
  • Chronic myelogenous leukemia: In general, for adults, take 2 tablets (400 mg of Imatinib) in chronic phase, or take 3 tablets (600 mg of Imatinib) in accelerated phase or blast crisis, once a day after a meal. It may be adjusted according to your blood test result, age or symptoms. The dose could be increased up to 3 tablets (600 mg) once a day in chronic phase, or 2 tablets (400 mg) twice a day in accelerated phase or blast crisis, respectively.
    KIT (CD117)-positive gastrointestinal stromal tumor: In general, for adults, take 2 tablets (400 mg of Imatinib) once a day after a meal. It may be reduced according to your age or symptoms.
    Philadelphia chromosome-positive acute lymphocytic leukemia: In general, for adults, take 3 tablets (600 mg of Imatinib) once a day after a meal. It may be reduced according to your blood test result, age or symptoms.
    Strictly follow the instructions in any case.
  • Take it with a glass of water (about 200 cc) or lukewarm water after a meal.
  • 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.
  • Avoid taking grapefruit juice with this medicine, since it may intensify the therapeutic effects.
  • Avoid taking hypericum perforatum (Saint John's wort)-contained supplements, etc. with this medicine, since it may weaken the therapeutic effects.
  • 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.
  • Sexually active females should use birth control while taking this medicine and for a certain period after stopping.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include nausea/vomiting, diarrhea, loss of appetite, rash, superficial swelling (on face, eyelid or lower limb, etc.), anemia, malaise, muscular cramps, 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.
  • anemic symptoms, fever, bleeding tendency [bone marrow suppression]
  • headache, conscious disorder, hemiplegia [cerebral/subdural haemorrhage]
  • melena/vomiting of blood, stomachache, abdomen enlarged feeling, anemia [gastrointestinal haemorrhage, gastric antral vascular ectasia, gastrointestinal perforation, tumour haemorrhage]
  • weight increase, chest pain, breathing difficulty [serious fluid retention]
  • fever, dry cough, breathing difficulty [interstitial pneumonia, pulmonary fibrosis]
  • pallor, breathing difficulty, conscious disorder [shock, anaphylaxis]
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.