Drug updated on 4/16/2024
| Dosage Form | Capsule (oral: 100 mg, 150 mg) |
| Drug Class | Kinase 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
- 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 Title | Year | Source |
|---|---|---|
| Ofev (nintedanib) prescribing information. | 2022 | Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT |
Systematic Reviews / Meta-Analyses
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Idiopathic pulmonary fibrosis (an update) and progressive pulmonary fibrosis in adults: an official ATS/ERS/JRS/ALAT clinical practice guideline. | 2024 | American Journal of Respiratory and Critical Care Medicine |
| Treatment of systemic sclerosis-associated interstitial lung disease: evidence-based recommendations. An official American Thoracic Society clinical practice guideline. | 2024 | American Journal of Respiratory and Critical Care Medicine |
| Idiopathic pulmonary fibrosis (an update) and progressive pulmonary fibrosis in adults. | 2022 | American Journal of Respiratory and Critical Care Medicine |
| Brazilian guidelines for the pharmacological treatment of idiopathic pulmonary fibrosis. Official document of the Brazilian Thoracic Association based on the GRADE methodology. | 2020 | Brazilian Journal of Pulmonology |
| Overview of idiopathic pulmonary fibrosis, evidence-based guidelines, and recent developments in the treatment landscape. | 2019 | The American Journal of Managed Care |