Does sirolimus affect pregnancy?

According to animal studies and mechanism of action, sirolimus (sirolimus) taken by pregnant women can cause harm to the fetus. Women using sirolimus may develop ovarian cysts and menstrual disorders (including amenorrhea and menorrhagia). Therefore, it is recommended that women of reproductive potential use highly effective contraceptive methods, which must be started before sirolimus treatment, during treatment, and within 12 weeks after sirolimus treatment is stopped.

Sirolimus crosses the placenta and is toxic to the fetus. In rat embryo-fetal development studies, sirolimus was administered orally to pregnant rats during the period of organogenesis (gestation days 6-15). Sirolimus produced embryo-fetal lethality at 0.5 mg/kg (2.5 times the clinical dose of 2 mg on a body surface area basis) and reduced fetal weight at 1 mg/kg. The no observed adverse effect level (NOAEL) for rat embryotoxicity is 0.1 mg/kg. Maternal toxicity (weight loss) was observed at 2 mg/kg. The no observed adverse effect level for maternal toxicity is 1 mg/kg. Rat embryo-fetal mortality increased with coadministration of cyclosporine compared with sirolimus alone.

SirolimusThe original drug has been launched in China and has entered the scope of Class B medical insurance. SpecificationsThe price of each box of 1mg*10 tablets is about 400 yuan. The domestic drug is only available to patients with anti-rejection reactions in organ transplantation. Patients who do not meet the conditions may not be able to purchase this drug. The original sirolimus drug has also been launched overseas. The price of the Turkish version of Specifications1mg*100 tablets per box is around RMB 2,000 (the price may fluctuate due to exchange rates). The ingredients of the original drugs marketed in China are basically the same as those of foreign original drugs. Currently, there are no generic sirolimus drugs produced in other countries.