Product information

CYENDIV® is a twice daily soft capsule containing nintedanib, which is indicated in adults for the treatment of Idiopathic Pulmonary Fibrosis (IPF). Treatment with CYENDIV® should be initiated by physicians experienced in the diagnosis and treatment of IPF.1

Introducing Cyendiv® for IPF

Cyendiv® is indicated in adults for the treatment of IPF and is a recommended treatment according to the 2015 ATS/ERS/JRS/ALAT guidelines. Clinicians are encouraged to discuss preferences with their patients when making treatment decisions.1-2

Mechanism of Action

CYENDIV® (nintedanib) is a small molecular tyrosine kinase inhibitor known to alter pathways involved in fibrosis. CYENDIV® has demonstrated effect on receptors such as platelet-derived growth factor receptor (PDGFR) α and β, fibroblast growth factor receptor (FGFR) 1-3, and vascular endothelial growth factor receptor (VEGFR).1,3-5

Efficacy

The clinical efficacy of CYENDIV ® has been studied in two replicate phase 3, randomized, double-blind, placebo-controlled trials of 1066 patients with idiopathic pulmonary fibrosis (IPF) across 24 countries (INPULSIS®-1 and INPULSIS®-2).6

Safety

CYENDIV® demonstrated a favourable risk-benefit profile, with comparable serious adverse events across treatment groups. CYENDIV® side effects can be effectively managed in most patients.1,6,7

Dosing & Administration

CYENDIV® ensures ease of dosing with only 1 capsule, twice daily. The active ingredient in CYENDIV® is nintedanib. The recommended dose is 150 mg nintedanib twice daily administered approximately 12 hours apart.1

Dose Modifications

Dose modification with CYENDIV® (nintedanib) allows for the management of gastrointestinal (GI) and liver side effects without compromising efficacy. For those patients who did not tolerate the 150mg dose, temporary dose reduction to 100mg twice daily was demonstrated to be beneficial.8

References

  1. CYENDIV® India pack insert version dated 10th August 2018.
  2. Raghu G., et al. An Official ATS/ERS/JRS/ALAT Clinical Practice Guideline: Treatment of Idiopathic Pulmonary Fibrosis. An Update of the 2011 Clinical Practice Guideline. Am J Respir Crit Care Med 2015;192:e3–e19.
  3. Hilberg F., et al. BIBF 1120: triple angiokinase inhibitor with sustained receptor blockade and good antitumor efficacy. Cancer Res 2008;68:4774–4782.
  4. Wollin L., et al. Antifibrotic and anti-inflammatory activity of the tyrosine kinase inhibitor nintedanib in experimental models of lung fibrosis.J Pharmacol Exp Ther 2014;349:209–220.
  5. Wollin L., et al. Mode of action of nintedanib in the treatment of idiopathic pulmonary fibrosis. Eur Respir J 2015;45:1434–1445.
  6. Richeldi L., et al. Efficacy and safety of nintedanib in idiopathic pulmonary fibrosis. N Engl J Med 2014;370:2071–2082.
  7. Corte T., et al. Safety, tolerability and appropriate use of nintedanib in idiopathic pulmonary fibrosis. Respir Res 2015;16. Available at:
    http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4581488/. Accessed January 11, 2016.
  8. Richeldi L., et al. Effect of dose reductions, treatment interruptions and dose intensity on decline in lung function with nintedanib in patients with idiopathic pulmonary fibrosis (IPF): results from the INPULSIS® trials (Poster). PFF Summit 2015;Washington DC, US.