INDICATIONS AND USAGE（适应症）

Idiopathic Pulmonary Fibrosis

Nintedanib is indicated for the treatment of idiopathic pulmonary fibrosis (IPF).

Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype

Nintedanib is indicated for the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.

Systemic Sclerosis-Associated Interstitial Lung Disease

Nintedanib is indicated to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).

DOSAGE（服用剂量）

The recommended dosage of nintedanib is 150 mg twice daily administered approximately 12 hours apart.

Nintedanib capsules should be taken with food and swallowed whole with liquid. Nintedanib capsules should not be chewed or crushed because of a bitter taste. The effect of chewing or crushing of the capsule on the pharmacokinetics of nintedanib is not known.

If a dose of nintedanib is missed, the next dose should be taken at the next scheduled time. Advise the patient to not make up for a missed dose. Do not exceed the recommended maximum daily dosage of 300 mg.

In patients with mild hepatic impairment (Child Pugh A), the recommended dosage of nintedanib is 100 mg twice daily approximately 12 hours apart taken with food.

ADVERSE REACTIONS（不良反应）

Elevated Liver Enzymes and Drug-Induced Liver Injury

Gastrointestinal Disorders

Embryo-Fetal Toxicity

Arterial Thromboembolic Events

Risk of Bleeding

Gastrointestinal Perforation

For full information, please refer to:

https://nctr-crs.fda.gov/fdalabel/services/spl/set-ids/da1c9f37-779e-4682-816f-93d0faa4cfc9/spl-doc?hl=Nintedanib

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