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Well tolerated in asthma and COPD, with over 2 million years of patient exposure1 2

Relvar Ellipta has amassed a wealth of safety and tolerability data in both asthma and COPD

  • Safety profile similar to other ICS/LABAs1
  • Safety profile consistent with usual care (ICS or ICS/LABA) in everyday clinical practice3
  • Pneumonia risk consistent with known effects of ICS class, and similar to other ICS/LABAs1 4
  • Shown to be comparable to placebo in suppression of cortisol in adolescents and adults with asthma5
  • Minimal effects* on HPA axis comparable to placebo5

* When assessed after 42 days

Relvar Ellipta has a similar safety and tolerability profile to other ICS/LABAs in asthma and COPD**

  • In an integrated analysis of 11 studies in asthma (n=7,034), safety profile was similar to other ICS/LABAs1

** When assessed after 42 days

Relvar Ellipta has a reassuring safety profile consistent with your usual care (ICS or ICS/LABA)3

  • Serious adverse events of special interest were consistent between Relvar Ellipta and usual care in a population reflecting everyday clinical practice: 20% were active smokers, 43% were overweight, and 38% had co-morbidities often excluded from traditional randomised controlled trials (RCTs)3

[Table: number of events (rate per 1,000 patient years): Usual care vs. Relvar Ellipta]


Pneumonia risk consistent with known effects of ICS class, and similar to other ICS/LABAs

  • Pneumonia risk in asthma: In an integrated analysis of 11 studies in asthma (n=7034), the incidence of pneumonia per 1000 patient-years was 18.4 for Relvar Ellipta 184/22 mcg vs. 9.6 for Relvar Ellipta 92/22 mcg and 8.0 for placebo1
  • Pneumonia risk in COPD: In common with other ICS-containing medicines, there is an increased risk of pneumonia in COPD patients treated with these types of medicines. The incidence of pneumonia with Relvar Ellipta is similar to that seen with other ICS/LABA combinations14

The effect of Relvar Ellipta on HPA axis function compared to placebo

  • Relvar Ellipta– minimal effect on HPA axis function with no significant serum cortisol suppression after 42 days5

Both doses of Relvar Ellipta had minimal or no long-term effect on urinary cortisol excretion6

  • 0–24 hour urinary cortisol excretion is a measure of HPA axis function6
  • There was little change in urinary cortisol excretion from baseline values at weeks 12 and 52 with FF/VI 92/22 mcg, FF/VI 184/22 mcg or placebo6

References:

  1. Relvar Ellipta SmPC, 2019 available at www.medicines.ie.
  2. GSK. Data on file. RF/FFT/0101/17.
  3. Woodcock A et al. Lancet 2017; 390:2247–2255.
  4. Kew KM et al. Syst Rev 2014; 3:CD010115.
  5. Allen A et al. Clin Respir J 2013; 7:397-406.
  6. Busse W et al. Thorax 2013; 68:513-520.

RELVAR Ellipta was developed in collaboration with INNOVIVA Inc.

Adverse events should be reported to the Health Products Regulatory Authority (HPRA) using an Adverse Reaction Report Form obtained either from the HPRA or electronically via the website at www.hpra.ie. Adverse events can also be reported to the HPRA by calling: (01) 6764971. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.