Nintedanib Capsules, 100 mg and 150 mg 150 mg/1
Nintedanib · CAPSULE · EXELAN PHARMACEUTICALS INC.
Nintedanib Capsules, 100 mg and 150 mg is a capsule containing nintedanib at 150 mg/1, taken oral. Manufactured by EXELAN PHARMACEUTICALS INC..
Key Facts
- Brand Name
- Nintedanib Capsules, 100 mg and 150 mg
- Generic Name
- Nintedanib
- NDC Code (Product)
76282-787- Manufacturer
- EXELAN PHARMACEUTICALS INC.
- Strength
- 150 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA212609
- Marketing Start
- 05/07/2026
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Nintedanib is a kinase inhibitor indicated in adults for: Treatment of idiopathic pulmonary fibrosis (IPF). ( 1.1 ) Treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype. ( 1.2 ) Slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). ( 1.3 ) 1.1 Idiopathic Pulmonary Fibrosis Nintedanib capsule is indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF). 1.2 Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype Nintedanib capsule is indicated for the treatment of adults with chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype [see Clinical Studies ( 14.2 )] . 1.3 Systemic Sclerosis-Associated Interstitial Lung Disease Nintedanib capsule is indicated to slow the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
Dosage & Administration
2 DOSAGE AND ADMINISTRATION Recommended dosage: 150 mg taken orally twice daily approximately 12 hours apart taken with food. ( 2.2 ) Recommended dosage in patients with mild hepatic impairment (Child Pugh A): 100 mg taken orally twice daily approximately 12 hours apart taken with food. ( 2.3 , 8.6 ) Consider temporary dose reduction to 100 mg, treatment interruption, or discontinuation for management of adverse reactions. ( 2.4 , 5.2 , 5.3 , 6 ) Prior to treatment initiation, conduct liver function tests in all patients and a pregnancy test in females of reproductive potential. ( 2.1 , 5.2 , 5.4 ) 2.1 Testing Prior to Nintedanib Capsules Administration Conduct liver function tests in all patients and a pregnancy test in females of reproductive potential prior to initiating treatment with nintedanib capsules [see Warnings and Precautions ( 5.2 , 5.4 )]. 2.2 Recommended Dosage The recommended dosage of nintedanib capsule is 150 mg taken orally twice daily administered approximately 12 hours apart. Administration Information Nintedanib capsules should be taken with food [see Clinical Pharmacology ( 12.3 )] and swallowed whole with liquid. Nintedanib capsules should not be chewed beca…
Contraindications
4 CONTRAINDICATIONS None None (4)
Drug Interactions
7 DRUG INTERACTIONS Coadministration of P-gp and CYP3A4 inhibitors may increase nintedanib exposure. Monitor patients closely for tolerability of nintedanib. ( 7.1 ) 7.1 P-glycoprotein (P-gp) and CYP3A4 Inhibitors and Inducers Nintedanib is a substrate of P-gp and, to a minor extent, CYP3A4 [see Clinical Pharmacology ( 12.3 )] . Coadministration with oral doses of a P-gp and CYP3A4 inhibitor, ketoconazole, increased exposure to nintedanib by 60%. Concomitant use of P-gp and CYP3A4 inhibitors (e.g., erythromycin) with nintedanib capsules may increase exposure to nintedanib [see Clinical Pharmacology ( 12.3 )] . In such cases, patients should be monitored closely for tolerability of nintedanib capsules. Management of adverse reactions may require interruption, dose reduction, or discontinuation of therapy with nintedanib capsules [see Dosage and Administration ( 2.4 )] . Coadministration with oral doses of a P-gp and CYP3A4 inducer, rifampicin, decreased exposure to nintedanib by 50%. Concomitant use of P-gp and CYP3A4 inducers (e.g., carbamazepine, phenytoin, and St. John's wort) with nintedanib capsules should be avoided as these drugs may decrease exposure to nintedanib [see Clini…
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Elevated Liver Enzymes and Drug-Induced Liver Injury [see Warnings and Precautions ( 5.2 )] Gastrointestinal Disorders [see Warnings and Precautions ( 5.3 )] Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.4 )] Arterial Thromboembolic Events [see Warnings and Precautions ( 5.5 )] Risk of Bleeding [see Warnings and Precautions ( 5.6 )] Gastrointestinal Perforation [see Warnings and Precautions ( 5.7 )] Nephrotic Range Proteinuria [ see Warnings and Precautions ( 5.8 ) ] Most common adverse reactions (≥5%) are: diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight decreased, and hypertension. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd at 1-866-604-3268 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the ra…
Frequently Asked Questions
What is Nintedanib Capsules, 100 mg and 150 mg used for?
Nintedanib Capsules, 100 mg and 150 mg contains Nintedanib. It is a capsule taken oral. Consult your doctor for specific uses.
Is Nintedanib Capsules, 100 mg and 150 mg a controlled substance?
Nintedanib Capsules, 100 mg and 150 mg is not classified as a controlled substance by the DEA.
What is the generic name for Nintedanib Capsules, 100 mg and 150 mg?
The generic name for Nintedanib Capsules, 100 mg and 150 mg is Nintedanib. There are 10 other brand versions of Nintedanib.
What is the NDC code for Nintedanib Capsules, 100 mg and 150 mg 150 mg/1?
The NDC (National Drug Code) for Nintedanib Capsules, 100 mg and 150 mg 150 mg/1 is 76282-787, listed by EXELAN PHARMACEUTICALS INC..