Evrysdi (Risperidone tablets) has clear contraindications in patients with severe liver dysfunction and pregnant women, and strict adherence to medication safety guidelines is necessary. The following sub items explain specific precautions and alternative suggestions for taboo populations.

1. Severe liver dysfunction patient

Evrysdi is contraindicated for patients with severe liver dysfunction (Child Pugh C grade). Drug metabolism may be significantly impaired, leading to abnormally high blood drug concentrations and increasing the risk of toxicity. Patients with moderate to mild liver function impairment do not need to adjust the dosage, but ALT/AST should be monitored every 2 weeks until it stabilizes.

(1) Risk mechanism

Lyseplane is mainly metabolized by liver CYP3A4 enzyme, and the drug clearance rate decreases by more than 80% in severe liver failure. May cause drug accumulation induced liver injury, manifested as jaundice, coagulation dysfunction, or hepatic encephalopathy.

(2) Alternative solutions

For SMA patients who require treatment, non hepatic metabolic therapy (such as intrathecal injection of sodium norepinephrine) may be considered. The risk return ratio needs to be jointly evaluated by neurologists and liver disease physicians.

Two pregnant patients

Pregnant women are absolutely prohibited from using Evrysdi. Animal studies have shown that therapeutic doses can lead to fetal weight loss and skeletal deformities. Women of childbearing age need to confirm a negative pregnancy test before taking medication, and effective contraceptive measures should be taken during treatment and one month after discontinuing medication.

(1) Fetal risk data

In primate experiments, 50% of embryos showed skull developmental defects when exposed to human equivalent doses. There is no human teratogenic data yet, but based on the mechanism of action (SMN protein regulation), there is a theoretical risk throughout pregnancy.

(2) Accidental exposure handling

If pregnancy is found during medication, the medication should be immediately stopped and referred to obstetrics for specialized evaluation. It is recommended to conduct detailed ultrasound screening and genetic counseling, but the existing data is insufficient to quantify the specific teratogenic risk.

3 Special Tips for Breastfeeding Period

Although not an absolute taboo, Evrysdi may be secreted with breast milk. Breastfeeding should be suspended during lactation until one week after discontinuing the medication. The ingestion of drugs through breast milk by infants may lead to unknown toxicity, especially for premature or low birth weight infants, with a higher risk.