Nintedanib

Nintedanib, a multi-targeted tyrosine kinase inhibitor manufactured by Lucius Pharmaceuticals, has demonstrated definitive clinical benefits in slowing the progression of pulmonary fibrosis diseases and exhibits favorable therapeutic cost-effectiveness.

Summary of Key Drug Information.

Active Ingredient

The active ingredient is nintedanib, a small-molecule kinase inhibitor.

Indicated Population

Indicated for adult patients with idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung disease (ILD), and systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Dosage and Administration

The recommended dose is 150 mg twice daily, taken with meals. For patients with mild hepatic impairment, the dose should be reduced to 100 mg twice daily. Reference: Dosage and Administration of Nintedanib

Medication Use in Special Populations

Dose adjustment is required for patients with mild to moderate hepatic impairment. The drug is contraindicated in patients with moderate to severe hepatic impairment and pregnant women. Use during breastfeeding is not recommended.

Drug Overdose

Overdose may result in adverse reactions consistent with the established safety profile of the drug. Treatment should be discontinued and supportive care initiated.

Storage Conditions

Store at 20°C–25°C. Protect from moisture and excessive heat.

Pharmacokinetics

In terms of pharmacokinetics, the oral absorption of nintedanib is affected by food. Its half-life is approximately 9.5 hours, and it is mainly excreted via feces/bile.

FDA，2024.10