西罗莫司片说明书

[Product name]:

[Product name]: Rapamune

[All names]: Rapamune, sirolimus tablets, sirolimus, Rapamune

[Characteristics of sirolimus tablets]

Sirolimus tablets are triangular white or off-white sugar-coated tablets.

[Functions and Indications of Sirolimus Tablets]

Sirolimus tablets are suitable for patients receiving kidney transplants to prevent organ rejection. Recommended for use in combination with cyclosporine and corticosteroids. 

[Usage and dosage of sirolimus tablets]

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 of sirolimus tablets]

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. 

[Contraindications for sirolimus tablets]

It is contraindicated for use in patients who are allergic to sirolimus, sirolimus derivatives, or any component of this drug's oral solution, and to pregnant and lactating women. 

[Precautions for sirolimus tablets]

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). 

[Sirolimus tablets for children]

The safety and efficacy of this drug in pediatric patients under 13 years of age have not been established. When using this drug in pediatric patients under 13 years of age, blood drug trough concentration should be monitored. 

[Sirolimus Tablets 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 sirolimus trough concentrations suggest that age-based dose adjustment is not required in elderly patients with renal disease. 

[Sirolimus tablets for pregnant and lactating women]

Not suitable for pregnant and lactating women. 

[Drug interactions with sirolimus tablets]

Sirolimus tablets are known to be substrates of cytochrome CYP3A4 and P-glycoprotein. When taken simultaneously with some drugs, the pharmacokinetic interactions are as follows. Interactions with other drugs have not been studied.