雷帕鸣片罗莫司说明书

Instructions

Generic name: sirolimus tablets

Product name: Rapamune

Full names: rapamune, sirolimus, rapamune

Indications:

It is suitable for patients aged 13 or above who have received kidney transplants to prevent organ rejection. Recommended for use in combination with cyclosporine and corticosteroids.

Usage and dosage:

Take orally, once daily.

Concomitant use with cyclosporine and corticosteroids is recommended.

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 of rapamin (sirolimus) daily was better than that of patients taking 5 mg of rapamin (sirolimus) daily.

Adverse reactions:

Cardiovascular: peripheral edema (≥20%-58%), hypertension (49%), edema (18%-20%), chest pain (LAM lymphangioleiomyomatosis), deep vein thrombosis, pulmonary embolism, tachycardia;

Central nervous system: headache (≥20%-34%), pain (29%-33%), dizziness (LAM, lymphangioleiomyomatosis);

Dermatology: acne vulgaris (≥20%-22%), rash (10%-20%);

Endocrine metabolism: hypertriglyceridemia (45%-57%), hypercholesterolemia (20%-46%), amenorrhea, diabetes, menorrhagia, hypervolemia, hypokalemia, elevated lactate dehydrogenase, menstrual diseases, ovarian cysts;

Gastrointestinal tract: constipation (36%-38%), abdominal pain (≥20%-36%), diarrhea (≥20%-35%), nausea (≥20%-31%), stomatitis (3%->20%);

Genitourinary system: urinary tract infection (33%);

Blood and tumors: anemia (23%-33%), thrombocytopenia (14%-30%), lymphoproliferative disorders (≤3%; including lymphoma), skin cancer (≤3%; including basal cell carcinoma, squamous cell carcinoma, melanoma), hemolytic uremic syndrome, leukopenia, lymphocele, thrombotic thrombocytopenic purpura;

Infections: Herpes simplex infection, shingles, sepsis;

Neuromuscular and skeletal: arthralgia (25%-31%), myalgia (LAM, lymphangioleiomyomatosis), osteonecrosis; Kidney: elevated serum creatinine (39%-40%), pyelonephritis;

Respiratory tract: nasopharyngitis (LAM), epistaxis, pneumonia, upper respiratory tract infection (LAM, lymphangioleiomyomatosis) Other: Wound healing impairment.

Taboo:

It is contraindicated in those who are allergic to rapamin (sirolimus) or any component of the preparation.

Storage:

It needs to be shaded and sealed.