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 :
ICLUSIG Tablets 15mg
 Active ingredient:
Ponatinib hydrochloride
 Dosage form:
white tablet, diameter: 6.4 mm, thickness: 3.2 mm
 Print on wrapping:
(Front)アイクルシグ錠, Otsuka, 15mg, A5, (Back)アイクルシグ錠15mg

Effects of this medicine

This medicine acts on tyrosine kinase to inhibit its activity. It consequently suppresses leukemia cell proliferation.
It is usually used to treat chronic myeloid leukemia resistant or intolerant to prior treatment and relapsed or treatment-resistant Philadelphia chromosome-positive acute lymphoblastic 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 have a history of myocardial infarction, peripheral arterial occlusive disease, or venous thromboembolism.
    If you have a risk factor of cardiovascular disease (hypertension, diabetes mellitus, dyslipidemia, etc.).
  • 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))
  • In general, for adults, take 3 tablets (45 mg of ponatinib) at a time, once a day. The dosage may be adjusted according to your condition. Strictly follow the instructions.
  • If you miss a dose, skip the missed dose and continue your regular dosing schedule from the next day. 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

  • Periodic liver function tests are required while taking this medicine. Follow the instructions of your doctor.
  • Females with a possibility of pregnancy or males whose partner have a possibility of pregnancy should avoid pregnancy while using this medicine and for a certain period of time after its completion.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include liver dysfunction, hypertension, anemia, headache, abdominal pain, constipation, nausea, rash, dry skin, muscle pain, joint pain, fatigue 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.
  • chest pain, pressure in chest, cold sweat [coronary artery disease]
  • headache, transient consciousness disorder, paralysis of one side of limbs [cerebrovascular disorder]
  • cold feeling of limbs, pain of limbs, numbness of limbs [peripheral arterial occlusive disease]
  • local pain, edema, erythema [venous thromboembolism]
  • general malaise, loss of appetite, yellow discoloration of skin and/or conjunctiva [liver 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 light, heat and moisture.
  • Discard the remainder. Do not store them. Ask your pharmacist or medical institution about 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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