sirolimus中国上市时间

Sirolimus was approved by the FDA in 1999 and was officially launched in the United States. It was later approved for sale in China in 2002. That is to say, from that time on, patients can purchase the medicines they need at home without going abroad.

In China, patients usually have to spend about $500 to purchase the sirolimus they need. After being reimbursed by medical insurance, patients generally only need to pay about 20% of the cost to buy sirolimus.

Although the efficacy of this drug has been confirmed by clinical trials, some adverse reactions may still occur during actual treatment. In this regard, patients need to pay high attention to the following precautions:

1. Laboratory examination

Sirolimus whole blood concentrations should be monitored in patients taking sirolimus under concentration monitoring. Sirolimus plasma concentrations must be monitored closely in the following patients: patients with altered drug metabolism, patients aged ≥13 years and weighing less than 40 kg, patients with hepatic impairment, and patients taking concurrently strong inducers and inhibitors of CYP3A4. In patients with severe hepatic impairment, it is recommended to reduce the maintenance dose by half based on decreased clearance. Due to the prolonged half-life in these patients, therapeutic monitoring of the drug product should be extended after loading doses or dose changes until stable concentrations are achieved.

2. Medication for pregnant and lactating women

(1) Pregnancy

①Instructions for effective contraception: general precautions, contraception.

②During pregnancy, this product should be used only when the potential benefits of sirolimus outweigh the potential risks to the embryo/fetus.

(2) Medication during lactation

Sirolimus is excreted in trace amounts in the milk of lactating rats. It is unknown whether sirolimus is excreted in human milk. The pharmacokinetics and safety of sirolimus in infants are also unclear. Considering that many drugs are excreted in human milk and the potential adverse effects of sirolimus in nursing infants, the decision to discontinue breastfeeding or discontinue the drug should be based on the importance of the drug to the mother.

3. Medication for children

The safety and efficacy of sirolimus in pediatric patients under 13 years of age have not been established.

4. Medication for the elderly

In the clinical trials of sirolimus tablets, a sufficient number of patients aged 65 and above were not included to determine whether the safety and efficacy of the drug in this population were different from those in younger patients. Sirolimus blood trough concentration data suggest that for elderly renal transplant patients, dose adjustment based on age is not necessary. Differences in response between younger and older patients were not identified. In general, dosage selection for elderly patients should be cautious, considering the higher frequency of weakened liver and cardiac function or other comorbidities or concomitant use of other drugs in the elderly, and treatment is usually started at the low end of the dosage range.