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Well tolerated in asthma and COPD, with over 2 million years of patient exposure 12
Relvar Ellipta has amassed a wealth of safety and tolerability data in both asthma and COPD
- Safety profile similar to other ICS/LABAs 1
- Safety profile consistent with usual care (ICS or ICS/LABA) in everyday clinical practice 3
- Pneumonia risk consistent with known effects of ICS class, and similar to other ICS/LABAs 1 4
- Shown to be comparable to placebo in suppression of cortisol in adolescents and adults with asthma 5
- Minimal effects on HPA axis comparable to placebo 5
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Safety profile
Relvar 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/LABAs 1
Relvar 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 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 RCTs 3
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Pneumonia risk
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 184/22 mcg vs. 9.6 for Relvar 92/22 mcg and 8.0 for placebo 1
- 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 is similar to that seen with other ICS/LABA combinations 14
The effect of Relvar on HPA axis function is comparable to placebo
- Relvar – minimal effect on HPA axis function with no significant serum cortisol suppression after 42 days 5
24-Hour Serum Cortisol at Day 42
Both doses of Relvar have minimal or no long-term effect on urinary cortisol excretion 6
- 0–24 hour urinary cortisol excretion is a measure of HPA axis function 6
- 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 placebo 6
Relvar — with an ICS dose below the threshold estimated for 20% cortisol suppression † 17
Footnotes:
Patient cases are fictional for illustrative purposes only.
†Based on PK/PD Modelling; model uses 20% cortisol suppression as the lowest boundary of detectable systemic exposure for corticosteroids serving as a cut-off point above which the adverse events of corticosteroids become more likely.
Relvar Ellipta is indicated for the maintenance treatment of asthma.
Dosage:
The recommended dose of Relvar Ellipta is:
One inhalation of Relvar Ellipta 100/25 micrograms once daily or
One inhalation of Relvar Ellipta 200/25 micrograms once daily
Safety Information:
Contraindications: Relvar Ellipta is contraindicated in patients with severe milk-protein allergy or who have demonstrated hypersensitivity to either fluticasone furoate, vilanterol or any of the excipients.
Warnings and Precautions:
Exacerbations:
Relvar Ellipta should not be used to treat acute asthma symptoms or an acute exacerbation in COPD, for which a short-acting bronchodilator is required. Increasing use of short-acting bronchodilators to relieve symptoms indicates deterioration of control and patients should be reviewed by a physician.
Adverse Reactions: Very common: Headache, Nasopharyngitis.
References:
- Local Relvar Prescribing Information based on GDS 10.
- GSK. Data on file. RF/FFT/0101/17.
- Woodcock A et al. Lancet 2017; 390:2247–2255.
- Kew KM et al. Syst Rev 2014; 3:CD010115.
- Allen A et al. Clin Respir J 2013; 7:397-406.
- Busse W et al. Thorax 2013; 68:513-520.
- Daley-Yates PT. Br J Clin Pharmacol 2015; 10.1111/bcp.12637.
- Local Seretide Prescribing Information based on GDS 35.
- Fostair 200/6 Summary of Product Characteristics, 2017.
- Symbicort 400/12 Turbohaler, Summary of Product Characteristics, 2017.
Relvar Ellipta was developed in collaboration with INNOVIVA
Trade marks are owned by or licensed to the GSK group of companies.
©2021 GSK group of companies or its licensor.
