Nintedanib

(Ofev®)

Ofev®

Latest News

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Drug updated on 4/16/2024

Dosage FormCapsule (oral: 100 mg, 150 mg)
Drug ClassKinase inhibitors
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • Indicated for the treatment of idiopathic pulmonary fibrosis (IPF).
  • Indicated for the treatment of chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype.
  • Indicated for the slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).

Summary
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  • Nintedanib (Ofev) is used for the management of idiopathic pulmonary fibrosis (IPF), chronic fibrosing interstitial lung diseases (ILDs) with a progressive phenotype, and for slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD).
  • Seventeen studies systematically reviewed and analyzed provide insights into the efficacy and safety of this drug.
  • Compared to pirfenidone, another frontline therapy for IPF and ILDs, nintedanib significantly slows the decline in forced vital capacity, indicating a slower disease progression.
  • In patients with SSc-ILD, nintedanib, alone or in combination with mycophenolate, notably reduces disease progression but leads to an increase in gastrointestinal side effects, resulting in higher discontinuation rates.
  • The safety analysis indicates no significant differences in the safety profiles among various antifibrotic medications, including nintedanib. Conversely, warfarin and ambrisentan display poorer safety profiles, underscoring nintedanib's relative advantage in treating IPF.
  • Nintedanib and pirfenidone have shown effectiveness in reducing the progression of Rheumatoid Arthritis-associated ILD compared to placebo treatments.
  • Adverse effects of Nintedanib encompass gastrointestinal issues such as diarrhea, nausea, vomiting, along with weight loss, yet it has a lower incidence of coughing or dyspnea compared to placebos.
  • The efficacy and tolerability of Nintedanib seem to be consistent across different subpopulations based on age, gender, and ethnicity; however, body mass index has been identified as a factor influencing mortality rates, hospitalizations, and toxicity levels during treatment.

Product Monograph / Prescribing Information

Document TitleYearSource
Ofev (nintedanib) prescribing information.2022Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT

Systematic Reviews / Meta-Analyses

Document TitleYearSource
A comparison of the effectiveness of nintedanib and pirfenidone in treating idiopathic pulmonary fibrosis: a systematic review. 2024Cureus
A comprehensive comparison of the safety and efficacy of drugs in the treatment of idiopathic pulmonary fibrosis: a network meta-analysis based on randomized controlled trials. 2024BioMed Central Pulmonary Medicine
Nintedanib therapy alone and combined with mycophenolate in patients with systemic sclerosis-associated interstitial lung disease: systematic reviews and meta-analysis.2024Annals of the American Thoracic Society
Efficacy of pirfenidone and nintedanib in interstitial lung diseases other than idiopathic pulmonary fibrosis: a systematic review.2023International Journal of Molecular Sciences
A systematic review of the prognostic significance of the body mass index in idiopathic pulmonary fibrosis.2023Journal of Clinical Medicine.
Safety and tolerability of combination treatment with pirfenidone and nintedanib in patients with idiopathic pulmonary fibrosis: a systematic review and meta-analysis. 2023Journal of Thoracic Disease
Antifibrotic agents in rheumatoid arthritis-associated interstitial lung disease: a systematic review and meta-analysis.2023Life
Medical treatments for idiopathic pulmonary fibrosis: a systematic review and network meta-analysis2022BMJ Journals
Efficacy and safety of antifibrotic agents in the treatment of CTD-ILD and RA-ILD: a systematic review and meta-analysis.2022Respiratory Medicine
Pharmacological treatments for SSc-ILD: systematic review and critical appraisal of the evidence. 2021Autoimmunity Reviews
Impact of antifibrotic therapy on mortality and acute exacerbation in idiopathic pulmonary fibrosis.2021Chest Journal
Efficacy of antifibrotic drugs, nintedanib and pirfenidone, in treatment of progressive pulmonary fibrosis in both idiopathic pulmonary fibrosis (IPF) and non-IPF: a systematic review and meta-analysis.2021BMC Pulmonary Medicine
An update on targeted therapies in systemic sclerosis based on a systematic review from the last 3 years.2021Arthritis Research & Therapy
The safety of nintedanib for the treatment of interstitial lung disease: a systematic review and meta-analysis of randomized controlled trials.2021PLoS One
Systematic review and meta-analysis of pirfenidone, nintedanib, and pamrevlumab for the treatment of idiopathic pulmonary fibrosis. 2020Annals of Pharmacotherapy
Efficacy, safety, and tolerability of treatments for systemic sclerosis-related interstitial lung disease: a systematic review and network meta-analysis.2020Journal of Clinical Medicine
Systematic review and network meta-analysis of approved medicines for the treatment of idiopathic pulmonary fibrosis.2019Journal of Drug Assessment
Comparative survival benefit of currently licensed second or third line treatments for epidermal growth factor receptor (EGFR) and anaplastic lymphoma kinase (ALK) negative advanced or metastatic non-small cell lung cancer: a systematic review and secondary analysis of trials.2019BMC Cancer

Clinical Practice Guidelines