FDA Approves Nintedanib Capsules (nintedanib esylate) for Idiopathic Pulmonary Fibrosis and Progressive Fibrosing ILDs

Not reported in label.

Nintedanib Capsules is indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF). It is also indicated for the treatment of adults with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.

The recommended dosage is 150 mg taken orally twice daily, approximately 12 hours apart, taken with food. The capsules should be swallowed whole with liquid and not chewed, opened, or crushed. For patients with mild hepatic impairment (Child Pugh A), the recommended dosage is 100 mg orally twice daily. Treatment is not recommended for patients with moderate or severe hepatic impairment. Dose reduction to 100 mg twice daily, treatment interruption, or discontinuation should be considered for management of adverse reactions. Prior to treatment initiation, conduct liver function tests in all patients and a pregnancy test in females of reproductive potential. If a dose is missed, the next dose should be taken at the next scheduled time; do not make up for a missed dose. Do not exceed 300 mg daily.

The clinical efficacy of nintedanib capsules for IPF was studied in 1,231 patients in one phase 2 and two phase 3 studies. These were randomized, double-blind, placebo-controlled studies comparing nintedanib capsules 150 mg twice daily to placebo for 52 weeks. The primary endpoint was the annual rate of decline in Forced Vital Capacity (FVC). Time to first acute IPF exacerbation was a key secondary endpoint in the two phase 3 studies and a secondary endpoint in the phase 2 study. Trial data for the ILD indication is referenced but not detailed in the provided label text.

Not reported in label.

Not reported in label.