Astellas "Prograf" 1mg х 100 caps

Astellas "Prograf" 1mg  х 100  caps

Prograf^® is an immunosuppressant used to prevent rejection in organ transplants.

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 Capsules 1mg [for implantation]

　Active ingredient: -Tacrolimus hydrate 　Dosage form: -white capsule (length: 11.5mm) 　Print on wrapping:

(Face) house-mark, f617, プログラフ1, (Back) 1mgプログラフ, プログラフ1, タクロリムス(Tacrolimus), house-mark

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 reaction (itch, rash etc.) to any medicine.

If you have liver 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 renal transplantation: In general, take 0.15 mg/kg of tacrolimus at a time, twice daily 2 days before transplantation. In the early stage after operation, take 0.15 mg/kg twice daily. Subsequently, tacrolimus should be gradually decreased to a standard maintenance dose of 0.06 mg/kg twice daily. The dosage may be adjusted according to the patient's 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 to a standard maintenance dose of 0.10 mg/kg daily. The dosage may be adjusted according to the patient's 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 twice daily. Subsequently, the dosage may be adjusted according to the patient's 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 patient's 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 initial stage of transplantation, take 0.06 mg/kg twice daily and it should be gradually decreased. When used after the development of GVHD, take 0.15 mg/kg twice daily. The dosage may be adjusted according to the patient's symptoms.

One capsule of this preparation contains 1 mg of tacrolimus.

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.

Do not receive vaccination without an approval of your doctor.

Grapefruit (juice) may enhance this medicine's effect, resulting in renal disorder. Refrain from intake of grapefruit and its juice together with the medicine.

The foods/drinks containing Hypericum perforatum (St. John's wort) may reduce this medicine's effect. Refrain from 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 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, stop taking this medicine and see your doctor immediately.

decrease in urinary output, general edema, thirst [acute renal failure, nephrotic syndrome]

palpitations, general edema, chest pain [heart failure, arrhythmia, myocardial infarction, angina pectoris]

cramps or spasms, disturbance of consciousness, language disorder [central nervous system disorders including reversible posterior leukoencephalopathy syndrome, hypertensive encephalopathy]

bleeding tendency, getting tired easily, edema [thrombotic microangiopathy]

fever, erythema, water blister/erosion [oculomucocutaneous syndrome]

difficulty with breathing, breathlessness [dyspnea] fever, general malaise, cold-like symptoms [infections]

severe upper abdominal pain, fever, queasiness [pancreatitis]

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.