Trelegy Ellipta (Page 4 of 10)

5.18 Effect on Growth

Orally inhaled corticosteroids may cause a reduction in growth velocity when administered to children and adolescents. The safety and effectiveness of TRELEGY have not been established in pediatric patients (aged 17 years and younger) and TRELEGY is not indicated for use in this population. [See Use in Specific Populations (8.4).]

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in labeling:

Serious asthma-related events – hospitalizations, intubations, death [see Warnings and Precautions (5.1)]
Candida albicans infection [see Warnings and Precautions (5.4)]
Increased risk of pneumonia in COPD [see Warnings and Precautions (5.5)]
Immunosuppression and risk of infections [see Warnings and Precautions (5.6)]
Hypercorticism and adrenal suppression [see Warnings and Precautions (5.8)]
Paradoxical bronchospasm [see Warnings and Precautions (5.10)]
Cardiovascular effects [see Warnings and Precautions (5.12)]
Reduction in bone mineral density [see Warnings and Precautions (5.13)]
Worsening of narrow-angle glaucoma [see Warnings and Precautions (5.14)]
Worsening of urinary retention [see Warnings and Precautions (5.15)]

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

6.1 Clinical Trials Experience in Chronic Obstructive Pulmonary Disease

The safety of TRELEGY ELLIPTA in COPD is based on the safety data from two 12-week treatment trials with coadministration of umeclidinium and the fixed-dose combination of fluticasone furoate/vilanterol and a 52-week long-term trial of TRELEGY ELLIPTA 100/62.5/25 mcg compared with the fixed-dose combinations of fluticasone furoate/vilanterol and umeclidinium/vilanterol [see Clinical Studies (14.1)].

Trials 1 and 2

Two 12-week treatment trials (Trial 1 and Trial 2) evaluated the coadministration of umeclidinium + fluticasone furoate/vilanterol, the components of TRELEGY ELLIPTA, compared with placebo + fluticasone furoate/vilanterol. A total of 824 subjects with COPD across two 12-week, randomized, double-blind clinical trials received at least 1 dose of umeclidinium 62.5 mcg + fluticasone furoate/vilanterol 100/25 mcg or placebo + fluticasone furoate/vilanterol 100/25 mcg administered once daily (mean age: 64 years, 92% White, 66% male across all treatments) [see Clinical Studies (14.1)]. The incidence of adverse reactions associated with the use of umeclidinium 62.5 mcg + fluticasone furoate/vilanterol 100/25 mcg presented in Table 2 is based on the two 12-week trials.

Table 2. Adverse Reactions with Umeclidinium + Fluticasone Furoate/Vilanterol with ≥1% Incidence and More Common than Placebo + Fluticasone Furoate/Vilanterol in Subjects with COPD (Trials 1 and 2)
Umec = Umeclidinium, FF/VI = Fluticasone Furoate/Vilanterol.

Adverse Reaction

Umec + FF/VI

(n = 412)

%

Placebo + FF/VI

(n = 412)

%

Nervous system disorders

Headache

4

3

Dysgeusia

2

<1

Musculoskeletal and connective tissue disorders

Back pain

4

2

Respiratory, thoracic, and mediastinal disorders

Cough

1

<1

Oropharyngeal pain

1

0

Gastrointestinal disorders

Diarrhea

2

<1

Infections and infestations

Gastroenteritis

1

0

Trial 3 – Long-term Safety Data

A 52-week trial (Trial 3) evaluated the long-term safety of TRELEGY ELLIPTA 100/62.5/25 mcg compared with the fixed-dose combinations of fluticasone furoate/vilanterol 100/25 mcg and umeclidinium/vilanterol 62.5/25 mcg. A total of 10,355 subjects with COPD with a history of moderate or severe exacerbations within the prior 12 months were randomized (2:2:1) to receive TRELEGY ELLIPTA 100/62.5/25 mcg, fluticasone furoate/vilanterol, or umeclidinium/vilanterol administered once daily in a double‑blind clinical trial (mean age: 65 years, 77% White, 66% male across all treatments) [see Clinical Studies (14.1)].

The incidence of adverse reactions in the long-term trial were consistent with those in Trials 1 and 2. However, in addition to the adverse reactions shown in Table 2, adverse reactions occurring in ≥1% of the subjects treated with TRELEGY ELLIPTA 100/62.5/25 mcg (n = 4,151) for up to 52 weeks also included upper respiratory tract infection, pneumonia [see Warnings and Precautions (5.5)] , bronchitis, oral candidiasis [see Warnings and Precautions (5.4)] , arthralgia, influenza, sinusitis, pharyngitis, rhinitis, constipation, urinary tract infection, and dysphonia.

6.2 Clinical Trials Experience in Asthma

The safety of TRELEGY ELLIPTA in asthma is based on a randomized, double-blind, parallel‑group, active-controlled trial of 24 to 52 weeks’ duration (Trial 4) that enrolled 2,436 adult subjects inadequately controlled on their current treatment of combination therapy (ICS plus a LABA) [see Clinical Studies (14.2)]. In the overall population, 62% were female and 80% were White; mean age was 53 years. The incidence of adverse reactions occurring in ≥1% of the subjects treated with TRELEGY ELLIPTA 100/62.5/25 mcg or TRELEGY ELLIPTA 200/62.5/25 mcg is shown in Table 3. Adverse reactions observed for the groups treated with TRELEGY ELLIPTA were similar to those observed for the fluticasone furoate/vilanterol arms.

Table 3. Adverse Reactions with TRELEGY ELLIPTA with ≥1% Incidence in Subjects with Asthma (Trial 4)
FF/VI = Fluticasone Furoate/Vilanterol.

Adverse Reaction

TRELEGY ELLIPTA

200/62.5/25 mcg

(n = 408)

%

TRELEGY ELLIPTA

100/62.5/25 mcg

(n =406)

%

FF/VI

200/25 mcg

(n = 406)

%

FF/VI

100/25 mcg

(n = 407)

%

Infections and infestations

Pharyngitis/nasopharyngitis

15

17

16

16

Upper respiratory tract infection/viral upper respiratory tract infection

7

5

6

7

Bronchitis

5

4

5

3

Respiratory tract infection/viral respiratory tract infection

3

4

2

4

Sinusitis/acute sinusitis

3

2

2

3

Urinary tract infection

2

<1

<1

1

Rhinitis

1

2

2

3

Influenza

1

4

2

3

Pneumonia

<1

1

2

2

Nervous system disorders

Headache

5

9

6

7

Musculoskeletal and connective tissue disorders

Back pain

2

3

1

4

Respiratory, thoracic, and mediastinal disorders

Dysphonia

1

1

2

1

Oropharyngeal pain

1

1

<1

<1

Cough

1

<1

1

1

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