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 :
Graceptor Capsules 0.5mg
 Active ingredient:
Tacrolimus hydrate
 Dosage form:
pale yellow/orange capsule (length: 11.0mm)
 Print on wrapping:
(Face) グラセプター0.5mg, 647, (Back) グラセプター0.5mg, タクロリムス, 徐放性(slow-release preparation), 免疫抑制剤(immunosuppressant)

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 to 0.20mg/kg of tacrolimus at a time, once daily in the morning, from 2 days before transplantation. Subsequently, the dosage may be adjusted according to the patient's symptoms.
    For liver transplantation
    : In general, take 0.10 to 0.15mg/kg of tacrolimus at a time, once daily in the morning, in the early stage after operation. Subsequently, the dosage may be adjusted according to the patient's symptoms.
    For switching from Prograf (transplantation of kidney, liver, heart, lung, pancreas, small intestine, bone marrow)
    : In general, take the same daily dosage as Prograf once daily in the morning.
    One capsule of this preparation contains 0.5mg of tacrolimus. Strictly follow the instructions.
  • If you miss a dose, take a dose as soon as possible. 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 medicine's effect, resulting in renal disorder. Avoid intake of grapefruit (juice) together with the medicine.
  • Foods/drinks containing Hypericum perforatum (St. John's wort) may reduce this medicine's 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), cytomegalus virus infection, BK virus infection, diabetes mellitus, renal disorder, herpes zoster, diarrhea, fever, vomiting and headache. 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.