Medical Information

Enasidenib, as an IDH2 inhibitor, needs to be adjusted according to physiological status and organ function when used in special populations, with a focus on risk management for pregnancy, lactation, liver and kidney dysfunction, and other populations. The following categories provide detailed medication precautions, emphasizing individualized treatment principles and monitoring requirements.

1. Medication during pregnancy

(1) Based on animal studies showing embryonic toxicity, it may cause bone deformities and growth retardation, and is contraindicated for pregnant women.

(2) Before treatment, it is necessary to confirm the pregnancy status and take effective contraceptive measures during the medication period and at least 2 months after discontinuation.

2. Medication during lactation

(1) It is not yet clear whether the drug is secreted into human milk, but potential risks need to be considered. It is recommended to suspend breastfeeding during the treatment period and within 2 weeks after the last administration.

(2) If continuous medication is required, the necessity of breastfeeding should be evaluated or alternative feeding methods should be adopted.

3. Pediatric medication

(1) The safety and effectiveness of children under 12 years old have not been established, and it is not recommended to use it.

(2) The medication data for adolescents aged 12-18 is limited, and strict evaluation of the benefit risk ratio is needed.

4. Elderly medication

(1) There is no significant difference in therapeutic efficacy between patients aged 65 and above and young people, but attention should be paid to liver dysfunction and increased risk of infection.

(2) It is recommended to strengthen blood routine and liver function monitoring, and adjust the dosage if necessary.

5. Liver dysfunction

(1) Patients with mild to moderate impairment (Child Pugh A/B grade) do not require dose adjustment, but transaminase monitoring is required weekly.

(2) Patients with severe impairment (Child Pugh C grade) are contraindicated as it may increase the risk of elevated bilirubin levels.

6. Renal insufficiency

(1) Mild to moderate damage (eGFR30-89ml/min) does not require dose adjustment.

(2) Due to severe damage or insufficient data on dialysis patients, it is recommended to use with caution and monitor for adverse reactions.

7. The impact on fertility

(1) Animal experiments have shown that it may impair female fertility, and male patients should use contraception during medication.

(2) It is recommended to undergo fertility assessment before treatment and consult reproductive medicine experts if necessary.