Medical Information

Ethanesulfonate Nidanib Soft Capsules (OFEV) are designed for special populations such as pregnancy, lactation, and liver and kidney dysfunction, and require strict adherence to differentiated medication principles. Individualized treatment is achieved through dose adjustment, contraceptive requirements, and risk monitoring.

1. Medication during pregnancy

(1) Risk Warning: Animal studies have shown that it may cause fetal malformations, and the clinically confirmed risk of miscarriage during pregnancy is 15% -20%.

(2) Contraceptive requirements: During the treatment period and at least 3 months after the last dose, efficient contraceptive measures should be used, and non oral contraception should be used when vomiting occurs.

2. Medication during lactation

(1) Drug transfer: Nidanib may be secreted into breast milk. Breastfeeding is prohibited during treatment and for 3 days after discontinuation.

(2) Alternative solution: It is necessary to prepare formula milk powder in advance to avoid drugs affecting infant development through breast milk.

3. Fertility population

(1) Female management: Pregnancy testing is required before treatment, and SSc ILD patients should be aware that diarrhea may reduce the effectiveness of oral contraceptives.

(2) Men's attention: Although there is no direct evidence, it is recommended that spouses take contraceptive measures at the same time to avoid potential risks.

4. Patients with liver dysfunction

(1) Dose adjustment: Reduce dosage to 100mg twice daily for Child Pugh Class A patients, and discontinue use for Class B/C.

(2) Monitoring requirements: ALT/AST testing should be conducted monthly for 3 months before treatment, and screening should be strengthened for high-risk populations such as Asian women.

5. Patients with renal insufficiency

(1) Medication principle: There is no need to adjust the dosage for mild to moderate kidney damage, and patients with end-stage kidney disease should use it with caution due to lack of data.

(2) Attention: When combined with liver injury, comprehensive evaluation is required, and medication may be suspended if necessary.

6. Other special groups

(1) Elderly patients: Those over 65 years old have similar therapeutic effects but are more sensitive to adverse reactions and require close monitoring.

(2) Smokers: Nicotine reduces drug exposure, and smoking cessation and complete abstinence are required before treatment.