雷帕鸣（西罗莫司片）说明书

Rapamune (sirolimus tablets) instructions [all names]: Rapamune, sirolimus tablets, sirolimus, Rapamune

[Indications] Sirolimus tablets are suitable for patients undergoing kidney transplantation to prevent organ rejection. Recommended for use in combination with cyclosporine and corticosteroids.

【Usage and Dosage】

Concomitant use with cyclosporine and corticosteroids is recommended. Take orally, once daily. It should be started as soon as possible after transplantation. For new transplant recipients, the loading dose that should be taken for the first time is three times the maintenance dose. The recommended loading dose for kidney transplant patients is 6 mg and the maintenance dose is 2 mg/day. Although the loading dose of 15 mg and the maintenance dose of 5 mg/day used in clinical trials are safe and effective, the therapeutic benefits of doses above 2 mg are unclear for kidney transplant patients. The overall safety profile of patients taking 2 mg sirolimus tablets daily was better than that of patients taking 5 mg sirolimus tablets daily.

【Adverse reactions】

Very common (incidence >10% according to the International Council of Medical Organization frequency classification): lymphocele, peripheral edema, abdominal pain, diarrhea, hypokalemia, increased lactate dehydrogenase, acne, urinary tract infection; very common at higher doses: anemia, hypercholesterolemia, thrombocytopenia, hypertriesteremia (hyperlipidemia). Store in a cool, dry, dark environment.

【Notes】

Grapefruit juice slows the metabolism of this drug, which is regulated by CYP3A4, and should not be used to administer or dilute this drug. It is recommended to take sirolimus 4 hours after taking cyclosporine oral solution (modified version) and/or cyclosporine capsules (modified version).

【Drug use for special groups】

Pediatric Medication: The safety and efficacy of rapamin (sirolimus tablets) in pediatric patients under 13 years of age have not been determined. When using this drug in pediatric patients under 13 years of age, blood drug trough concentration should be monitored.

Medication for elderly patients: In the clinical trials of this drug, there were not enough cases of patients aged 65 and above to determine whether the safety and efficacy of the drug in this population are different from those in younger patients. Data on trough concentrations of rapamin (sirolimus tablets) indicate that this drug does not require dose adjustment based on age in elderly patients with renal disease.

Pregnant and lactating women: Rapamin (sirolimus tablets) is contraindicated in pregnant and lactating women.