Frequently asked questions

This page covers a diverse range of frequently asked questions about the dosing, efficacy and clinical trial data of CYENDIV® (nintedanib) in idiopathic pulmonary fibrosis (IPF).

General questions about Cyendiv®

In which countries is Nintedanib® approved in IPF?

Nintedanib® in IPF is approved for adults for the treatment of idiopathic pulmonary fibrosis (IPF) in 62 countries worldwide, including India, the United States of America, Canada, EU countries and Japan. This information is correct as of September 2017.1

Is Nintedanib® also indicated for treatment in oncology?

CYENDIV® active component Nintedanib® has also been approved in India in combination with docetaxel for the treatment of adult patients with locally advanced, metastatic or locally recurrent non-small cell lung cancer (NSCLC) of adenocarcinoma tumour histology after first-line chemotherapy.1

What are the contraindications for Cyendiv®?

Cyendiv® is contraindicated in patients with known hypersensitivity to Nintedanib®, peanut, soya, or any of the excipients.1

Clinical trial data

What were the INPULSIS® and INPULSIS-ON® clinical trial programs?

The INPULSIS® clinical trial program consisted of two replicate Phase III, randomized, double-blind, studies comparing the efficacy and safety of Nintedanib® 150 mg twice daily with placebo in patients with IPF.2,4

INPULSIS®-ON is an open-label extension of the INPULSIS® trials with the aim to assess the long-term efficacy and safety of CYENDIV® (Nintedanib®) in patients with IPF.3

What were the key features of the INPULSIS® and INPULSIS-ON® clinical trial programs?

The primary endpoint in the INPULSIS® trials was the annual rate of decline in FVC. The key secondary endpoints were changed from baseline in the total score on the St. George's Respiratory Questionnaire (SGRQ) over 52 weeks and time to first acute exacerbation.2,4

Patients who completed the 52-week treatment period and follow-up visit 4 weeks later in an INPULSIS® trial were eligible to enter the open-label extension trial, INPULSIS®-ON.3

What change in FVC from baseline was shown in long-term data?

The data shows that CYENDIV® (Nintedanib®) consistently slows disease progression with an ~50% reduction in FVC decline across a broad range of IPF patient types1,5–11

Also including patients with:

  • Minimal impairment of lung function (FVC >90% predicted)
  • No honeycombing on HRCT
  • Concomitant emphysema

What were the most common adverse events in the INPULSIS® and INPULSIS®-ON clinical trial programs?

The most common adverse events were gastrointestinal in nature. The most common adverse events were defined as those with an incidence of >10% in either study group.1,5,12

How do I manage side effects of CYENDIV®?

CYENDIV® (nintedanib) has not been associated with photosensitivity but is contraindicated in patients with known hypersensitivity to nintedanib, peanut, soya, or any of the excipients.1

CYENDIV® safety profile

How do I manage side effects of Cyendiv®?

Cyendiv® (Nintedanib®) has not been associated with photosensitivity but is contraindicated in patients with known hypersensitivity to Nintedanib®, peanut, soya, or any of the excipients.1

CYENDIV ® safety profile

Does Cyendiv® reduce the risk of acute IPF exacerbations?

Only Cyendiv® significantly reduces acute IPF exacerbations by ~50% in the pooled analysis.13‡ In the pooled analysis of 3 clinical trials, 4.6% of patients treated with Cyendiv® experienced ≥1 acute IPF exacerbation vs 8.7% of patients in the placebo group (HR=0.53 [95% CI=0.34, 0.83] P=0.0047).13

Annual rate of decline in FVC in patients treated with CYENDIV®

Acute IPF exacerbations in patients treated with CYENDIV®

Dosing questions

What is the recommended dose of Cyendiv®?

The recommended dose for IPF is: Cyendiv® (Nintedanib®) one 150 mg capsule taken orally twice daily.1

CYENDIV® dosing

What is the maximum daily dose of Cyendiv®?

The maximum daily dose of Cyendiv® (Nintedanib®) is 300mg and should not be exceeded.1

CYENDIV® (Nintedanib®) capsules should be taken approximately 12 hours apart with food and swallowed whole with a glass of water.1

CYENDIV® dosing

What if a dose of Cyendiv® is missed?

If a dose is missed, treatment should resume at the next scheduled time and at the recommended dose.1

CYENDIV® dosing

How do I manage side effects of Cyendiv®?

In addition to symptomatic treatment, if applicable, adverse reactions can be managed by dose reduction or temporary treatment interruption until the specific adverse reaction has resolved to levels that allow continuation of therapy.1

CYENDIV® (Nintedanib®) may be resumed at the full dose (150 mg twice daily) or a reduced dose (100 mg twice daily) which subsequently may be increased to the full dose (150 mg twice daily).1

If a patient does not tolerate 100 mg twice daily, treatment with CYENDIV® should be discontinued.1

Management of adverse events

Does the time of dosing affect the efficacy of Cyendiv®?

To ensure optimal efficacy, each dose of Cyendiv® (Nintedanib®) should be taken orally, at approximately 12-hour intervals with food.1

References

  1. CYENDIV® India pack insert version dated 10th August 2018.
  2. Richeldi L. et al. Design of the INPULSIS trials: two phase 3 trials of nintedanib in patients with idiopathic pulmonary fibrosis. Respir Med 2014;108:1023–1030.
  3. Crestani B., et al. Long-term safety and tolerability of nintedanib in patients with idiopathic pulmonary fibrosis: results from the open-label extension study, INPULSIS-ON. Lancet Respir Med 2018; published online Sept 14. http://dx.doi.org/10.1016/S2213-2600(18)30339-4.
  4. Richeldi L. et al. Efficacy and Safety of Nintedanib in Idiopathic Pulmonary Fibrosis. N Engl J Med 2014;370:2071–2082.
  5. Costabel U. Effect of baseline FVC on decline in lung function with nintedanib: Results from the INPULSIS trials. European Respiratory Journal. 2014:1907.
  6. Kolb M. et al. Effect of Baseline FVC on Decline in Lung Function with Nintedanib in Patients with IPF: Results from The INPULSIS Trials. Am J Respir Crit Care Med 2015;191:A1021.
  7. Raghu G. et al. Consistent Effect of Nintedanib on Decline in FVC in Patients Across Subgroups Based on HRCT Diagnostic Criteria: Results from The INPULSIS? Trials in IPF. Am J Respir Crit Care Med 2015;191:A1022.
  8. Cottin V. et al. Effect of baseline emphysema on reduction in FVC decline with nintedanib in the INPULSIS trials. Abstr Present Int Colloq Lung Airw Fibros Mont Tremblant Can 20–24 Sept 2014 2014. Available at:
    http://www.iclaf.com/conference/index.php/2014/ICLAF/paper/view/151. Accessed July 17, 2017.
  9. Keating GM. Nintedanib: A Review of Its Use in Patients with Idiopathic Pulmonary Fibrosis. Drugs 2015;75:1131–1140.
  10. Costabel U. et al. Efficacy of Nintedanib in Idiopathic Pulmonary Fibrosis across Prespecified Subgroups in INPULSIS. Am J Respir Crit Care Med 2016;193:178–185.
  11. 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 July 17, 2017.
  12. Richeldi L. et al. Nintedanib in patients with idiopathic pulmonary fibrosis: Combined evidence from the TOMORROW and INPULSIS(®) trials. Respir Med 2016;113:74–79.