Relvar Ellipta Adverse Reactions

Clinical trial data: Data from large asthma and COPD clinical trials were used to determine the frequency of adverse reactions associated with Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta). In the asthma clinical development program a total of 7,034 patients were included in an integrated assessment of adverse reactions. In the COPD clinical development program a total of 6,237 subjects were included in an integrated assessment of adverse reactions.
With the exception of pneumonia and fractures, the safety profile was similar in patients with asthma and COPD. During clinical studies, pneumonia and fractures were more frequently observed in patients with COPD.
These adverse reactions are listed by system organ class and frequency. The following convention has been used for the classification of adverse reactions: Very common: ≥1/10; Common: ≥1/100 to <1/10; Uncommon: ≥1/1000 to <1/100; Rare ≥1/10000 to <1/1000; Very rare <1/10000. (See Table 2.)

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Description of selected adverse reactions: *Pneumonia: In two replicate 12 month studies in a total of 3,255 patients with COPD who had experienced a COPD exacerbation in the previous year, there was a higher incidence of pneumonia (6%-7%) reported in patients receiving the fluticasone furoate (at strengths of 50, 100, and 200 micrograms)/vilanterol 25 micrograms combination than in those receiving vilanterol 25 micrograms alone (3%). Pneumonia which required hospitalisation occurred in 3% of patients receiving Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta) (all strengths) and in <1% of patients receiving vilanterol. In these studies, nine fatal cases of pneumonia were reported. Of these, seven were reported during treatment with Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta) 200/25 micrograms, one during treatment with Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta) 100/25 micrograms and one post-treatment with vilanterol monotherapy. Risk factors for pneumonia observed in these studies included current smokers, patients with a history of prior pneumonia, patients with a body mass index <25 kg/m² and patients with an FEV₁ <50% predicted (see Precautions).
In an integrated analysis of 11 studies in asthma (7,034 patients), the incidence of pneumonia (adjusted for exposure, due to low numbers and limited number of patients on placebo) seen with Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta) 100/25 microgram strength (9.6/1000 patient years) was similar to placebo (8.0/1000 patient years). There was a higher incidence of pneumonia in the 200/25 microgram strength (18.4/1000 patient years) compared to the 100/25 microgram strength. Few of the pneumonia events led to hospitalisation with either strength, and there were no observed differences in the incidence of serious events between the two treatment strengths.
**Fractures: In two replicate 12 month studies in a total of 3,255 patients with COPD the incidence of bone fractures overall was low in all treatment groups, with a higher incidence in all Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta) groups (2%) compared with the vilanterol 25 micrograms group (<1%). Although there were more fractures in the Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta) groups compared with the vilanterol 25 micrograms group, fractures typically associated with corticosteroid use (e.g., spinal compression/thoracolumbar vertebral fractures, hip and acetabular fractures) occurred in <1% of the Fluticasone furoate + Vilanterol (as trifenatate) (Relvar Ellipta) and vilanterol treatment arms.
In an integrated analysis of 11 studies in asthma (7,034 patients), the incidence of fractures was <1%, and usually associated with trauma.
Post-marketing data: see Table 3.

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