Nintedanib

(Ofev®)

Nintedanib

Drug updated on 11/1/2024

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).

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Summary
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  • This summary is based on the review of nine systematic review(s)/meta-analysis(es). [1-9]
  • Nintedanib demonstrated effectiveness in slowing the progression of interstitial lung disease (ILD) across multiple types, including idiopathic pulmonary fibrosis (IPF), systemic sclerosis-associated ILD (SSc-ILD), rheumatoid arthritis-associated ILD (RA-ILD), and connective tissue disease-associated ILD (CTD-ILD), by reducing the rate of forced vital capacity (FVC) decline.
  • In IPF, nintedanib and pirfenidone were both effective in decreasing FVC decline, with meta-analyses confirming nintedanib’s consistent role in lung function preservation. Both drugs displayed similar efficacy for IPF, while in RA-ILD, nintedanib showed a significant reduction in FVC decline compared to placebo.
  • In subgroup analyses, nintedanib’s benefits extended to various ILD subtypes, including usual interstitial pneumonia (UIP) and non-UIP patterns, and across demographic variables such as age, gender, and ethnicity in IPF patients, with some variability in response observed among subtypes like fibrotic hypersensitivity pneumonitis and fibrotic sarcoidosis.
  • Nintedanib treatment in interstitial lung disease (ILD) commonly led to gastrointestinal side effects, including diarrhea, nausea, vomiting, and weight loss, with a higher rate of these events resulting in treatment discontinuation compared to placebo.
  • Severe adverse events were not significantly more frequent with nintedanib than with placebo, and fatal adverse events were also comparable between treatment and placebo groups.
  • There is no population type or subgroup information available in the reviewed studies.

Product Monograph / Prescribing Information

Document TitleYearSource
Ofev (nintedanib) Prescribing Information.2024Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines