Label: OFEV- nintedanib capsule

  • NDC Code(s): 0597-0143-60, 0597-0145-60
  • Packager: Boehringer Ingelheim Pharmaceuticals, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated April 29, 2025

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use OFEV safely and effectively. See full prescribing information for OFEV. OFEV® (nintedanib capsules), for oral use - Initial U.S ...
  • Table of Contents
    Table of Contents
  • 1 INDICATIONS AND USAGE
    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 ...
  • 2 DOSAGE AND ADMINISTRATION
    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 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Capsules: 150 mg, brown, opaque, oblong, soft capsules marked in dark gray with the Boehringer Ingelheim company symbol and "150". 100 mg, peach, opaque, oblong, soft capsules marked in dark gray ...
  • 4 CONTRAINDICATIONS
    None
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Hepatic Impairment - Treatment with OFEV is not recommended in patients with moderate (Child Pugh B) or severe (Child Pugh C) hepatic impairment [see Use in Specific Populations (8.6) and ...
  • 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 ...
  • 7 DRUG INTERACTIONS
    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 ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Risk Summary - Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1)], OFEV can cause fetal harm when administered to a pregnant ...
  • 10 OVERDOSAGE
    In IPF trials, one patient was inadvertently exposed to a dose of 600 mg daily for a total of 21 days. A non-serious adverse event (nasopharyngitis) occurred and resolved during the period of ...
  • 11 DESCRIPTION
    OFEV capsules contain nintedanib, a kinase inhibitor [see Mechanism of Action (12.1)]. Nintedanib is presented as the ethanesulfonate salt (esylate), with the chemical name 1H-Indole-6-carboxylic ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Nintedanib is a small molecule that inhibits multiple receptor tyrosine kinases (RTKs) and non-receptor tyrosine kinases (nRTKs). Nintedanib inhibits the following ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Two-year oral carcinogenicity studies of nintedanib in rats and mice have not revealed any evidence of carcinogenic potential ...
  • 14 CLINICAL STUDIES
    14.1 Idiopathic Pulmonary Fibrosis - The clinical efficacy of OFEV has been studied in 1231 patients with IPF in one phase 2 (Study 1 [NCT00514683]) and two phase 3 studies (Study 2 ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    150 mg: brown, opaque, oblong, soft capsules marked in dark gray with the Boehringer Ingelheim company symbol and "150". They are packaged in HDPE bottles with a child-resistant closure ...
  • 17 PATIENT COUNSELING INFORMATION
    Advise the patient to read the FDA-approved patient labeling (Patient Information). Elevated Liver Enzymes and Drug-Induced Liver Injury - Advise patients that they will need to undergo liver ...
  • SPL UNCLASSIFIED SECTION
    Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA - Licensed from: Boehringer Ingelheim International GmbH - OFEV is a registered trademark of and used under license ...
  • PATIENT PACKAGE INSERT
    This Patient Information has been approved by the U.S. Food and Drug Administration.Revised: May 2025               Patient Information - OFEV® (OH-fev) (nintedanib capsules) What is the ...
  • PRINCIPAL DISPLAY PANEL - 150 mg Capsule Bottle Carton
    NDC 0597-0145-60 - Ofev® (nintedanib - capsules) 150 mg* Rx only - SAME MEDICATION - NEW IMPRINT COLOR - 60 capsules - Boehringer - Ingelheim
  • PRINCIPAL DISPLAY PANEL - 100 mg Capsule Bottle Carton
    NDC 0597-0143-60 - Ofev® (nintedanib capsules) 100 mg* Rx only - SAME MEDICATION - NEW IMPRINT COLOR - 60 capsules - Boehringer - Ingelheim
  • INGREDIENTS AND APPEARANCE
    Product Information