Drugplain

Ofev 100 mg/1

nintedanib · CAPSULE · Boehringer Ingelheim Pharmaceuticals, Inc.

No Recall History
Plain English

Ofev (nintedanib) is a prescription capsule taken by mouth that is used to treat certain types of progressive lung disease, including idiopathic pulmonary fibrosis. It works by slowing down the scarring and damage that occurs in the lungs.

Key Facts

Brand Name
Ofev
Generic Name
nintedanib
NDC Code (Product)
0597-0143
Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.
Strength
100 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
NDA205832
Marketing Start
10/15/2014

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

diarrhoea9,711 reports
nausea4,565 reports
dyspnoea3,892 reports
cough3,102 reports
death3,059 reports
decreased appetite2,995 reports
weight decreased2,913 reports
fatigue2,854 reports
vomiting2,675 reports
idiopathic pulmonary fibrosis2,012 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE OFEV 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 OFEV is indicated for the treatment of adults with idiopathic pulmonary fibrosis (IPF). 1.2 Chronic Fibrosing Interstitial Lung Diseases with a Progressive Phenotype OFEV 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 OFEV 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 OFEV Administration Conduct liver function tests in all patients and a pregnancy test in females of reproductive potential prior to initiating treatment with OFEV [see Warnings and Precautions (5.2 , 5.4) ]. 2.2 Recommended Dosage The recommended dosage of OFEV is 150 mg taken orally twice daily administered approximately 12 hours apart. Administration Information OFEV capsules should be taken with food [see Clinical Pharmacology (12.3) ] and swallowed whole with liquid. OFEV capsules should not be chewed because of a bitter taste. OFEV capsules should not be opened …

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 OFEV. ( 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 OFEV may increase exposure to nintedanib [see Clinical Pharmacology (12.3) ] . In such cases, patients should be monitored closely for tolerability of OFEV. Management of adverse reactions may require interruption, dose reduction, or discontinuation of therapy with OFEV [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 OFEV should be avoided as these drugs may decrease exposure to nintedanib [see Clinical Pharmacology (12.3) ]. 7.2 Anticoagulants Nintedanib is a VEGFR i…

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 Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 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 …

Frequently Asked Questions

What is Ofev used for?

Ofev (nintedanib) is a prescription capsule taken by mouth that is used to treat certain types of progressive lung disease, including idiopathic pulmonary fibrosis. It works by slowing down the scarring and damage that occurs in the lungs.

Is Ofev a controlled substance?

Ofev is not classified as a controlled substance by the DEA.

What is the generic name for Ofev?

The generic name for Ofev is nintedanib. There are 10 other brand versions of nintedanib.

What is the NDC code for Ofev 100 mg/1?

The NDC (National Drug Code) for Ofev 100 mg/1 is 0597-0143, listed by Boehringer Ingelheim Pharmaceuticals, Inc..

Product NDC

0597-0143

Package NDC

0597-0143-60

Other Ofev Dosages

Other Nintedanib Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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