くすりのしおり

Internal
Revised: 8/2017

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 :
Prograf Granules 0.2mg [for transplantation]
 Active ingredient:
Tacrolimus hydrate
 Dosage form:
white granule
 Print on wrapping:
(Face) プログラフ顆粒0.2mg, 有効成分0.2mg/包(0.1g), house-mark, 0.2mg, Prograf

Effects of this medicine

This medicine inhibits the production of proteins called cytokines associated with organ transplant rejection, and thus suppresses refusal response.
It is usually used to prevent organ transplant rejection (kidney, liver, heart, lung, pancreas, small intestine, bone marrow) or graft-versus-host reaction (bone-marrow transplantation only).

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 hepatic disorder, renal disorder, or infections.
  • 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))
  • For kidney transplantation: In general, take 0.15 mg/kg of tacrolimus at a time twice daily from 2 days before transplantation. In the early stage after operation, take 0.15 mg/kg at a time twice daily. Subsequently, tacrolimus should be gradually decreased. The standard maintenance dose is 0.06 mg/kg twice daily. The dosage may be adjusted according to the patients symptoms.
    For liver transplantation
    : In general, take initially 0.15 mg/kg of tacrolimus at a time twice daily. Subsequently, tacrolimus should be gradually decreased. The standard maintenance dose is 0.10 mg/kg daily. The dosage may be adjusted according to the patients symptoms.
    For heart transplantation
    : In general, take initially 0.03 to 0.15 mg/kg of tacrolimus at a time twice daily. When tacrolimus is used after development of organ rejection, take 0.075 to 0.15 mg/kg at a time twice daily. Subsequently, the dosage may be adjusted according to the patients symptoms. After stable condition is achieved, the dosage should be gradually decreased and maintained at the minimal effective dose.
    For lung transplantation
    : In general, take initially 0.05 to 0.15 mg/kg of tacrolimus at a time twice daily. Subsequently, the dosage may be adjusted according to the patients symptoms. After stable condition is achieved, the dosage should be gradually decreased and maintained at the minimal effective dose.
    For pancreas transplantation
    : In general, take initially 0.15 mg/kg of tacrolimus at a time twice daily. Subsequently, the dosage should be gradually decreased and maintained at the minimal effective dose.
    For small intestine transplantation: In general, take initially 0.15 mg/kg of tacrolimus at a time twice daily. Subsequently, the dosage should be gradually decreased and maintained at the minimal effective dose.
    For bone marrow transplantation: In general, take 0.06 mg/kg of tacrolimus at a time twice daily from 1 day before transplantation. In the early stage after transplantation, take 0.06 mg/kg at a time twice daily and it should be gradually decreased. When used after the development of GVHD, take 0.15 mg/kg at a time twice daily. The dosage may be adjusted according to the patients symptoms.
    This medicine contains 0.2 mg of tacrolimus in each packet. Strictly follow the instructions.
  • If you miss a dose, take a dose as soon as possible. However, the next dose should be at least 5 hours apart. 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

  • Since you are likely to become infected, wash hands and gargle and regulate your daily life.
  • Grapefruit (juice) may enhance this medicines effect, resulting in renal disorder. Avoid intake of grapefruit (juice) together with the medicine.
  • Foods/drinks containing Hypericum perforatum (St. Johns wort) may reduce this medicines effect. Avoid intake of these foods/drinks together with the medicine.

Possible adverse reactions to this medicine

The most commonly reported adverse reactions include increased blood pressure, tremor (tremble of hands/feet), diarrhea, fever, vomiting, headache, renal disorder, chest pain, hot flush, abdominal enlarged feeling, infections and central nervous system disorder. 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, see your doctor immediately.
  • decrease in urinary output, general edema, thirst [acute renal disorder, nephrotic syndrome]
  • palpitations, shortness of breath, chest distress, general edema, chest pain [heart failure, arrhythmia, myocardial infarction, angina pectoris, pericardial effusion, myocardial disorder]
  • convulsion, consciousness disorder, language disorder [central nervous system disorders including reversible posterior leukoencephalopathy syndrome, hypertensive encephalopathy, progressive multifocal leukoencephalopathy]
  • headache, temporary conscious disorder, paralyzation on either side of the body [cerebrovascular disorder]
  • respiratory distress, breathing difficulty [respiratory distress]
  • fever, general malaise, cold-like symptoms  [infections]
  • dry mouth, excessive drinking/urination, getting tired easily  [diabetes mellitus, hyperglycemia]
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 infants and children. Store away from direct sunlight, heat and moisture.
  • Discard the remainder. Do not store them. Ask the pharmacist or medical facility how to discard them.
  • Do not receive vaccination without an approval of your doctor.

For healthcare professional use only : Day Month Year

For further information, talk to your doctor or pharmacist.