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nintedanib; vargatef (Ofev, BIBF-1120)

Indications: - idiopathic pulmonary fibrosis* - progressive interstitial lung disease [5] * on list of drugs to avoid; no survival benefit [3] * FDA-approved [4] * slows progression of disease on pulmonary function tests [4] * does not elevate patients' perceived quality of life,[4] Contraindications: - liver failure - pregnancy Dosage: - 150 mg PO BID Adverse effects: - diarrhea (common) - nausea, vomiting - abdominal pain - hepatotoxicity [3] - abnormal liver function tests - anorexia - headache - weight loss - hypertension - risk of thromboembolism [3] Mechanism of action: - tyrosine kinase inhibitor - may attenuate lung-function decline & acute exacerbations in patients with idiopathic pulmonary fibrosis [1]

Interactions

drug adverse effects of tyrosine kinase inhibitor(s)

General

small inhibitory antineoplastic agent (ib drug) antineoplastic tyrosine kinase inhibitor

Database Correlations

PUBCHEM correlations

References

  1. Richeldi L et al Efficacy and Safety of Nintedanib in Idiopathic Pulmonary Fibrosis. N Engl J Med. May 18, 2014 PMID: 24836310 http://www.nejm.org/doi/full/10.1056/NEJMoa1402584
  2. FDA News Release. October 15, 2014 FDA approves Ofev to treat idiopathic pulmonary fibrosis http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm418994.htm
  3. Therapeutics Letter #108. Therapeutics Initiative Drugs to Avoid. http://www.ti.ubc.ca/2018/01/04/108-drugs-avoid/
  4. Dempsey TM, Sangaralingham LR, Yao Xet al. Clinical effectiveness of antifibrotic medications for idiopathic pulmonary fibrosis. Am J Respir Crit Care Med 2019 Jul 15; 200:168 PMID: 31150266 https://www.atsjournals.org/doi/10.1164/rccm.201902-0456OC
  5. FDA News Release. March 9, 2020 FDA Approves First Treatment for Group of Progressive Interstitial Lung Diseases. https://www.fda.gov/news-events/press-announcements/fda-approves-first-treatment-group-progressive-interstitial-lung-diseases