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Systemic and local corticosteroid use may result in the following:

  • Candida albicans infection [see WARNINGS AND PRECAUTIONS]
  • Immunosuppression [see WARNINGS AND PRECAUTIONS]
  • Hypercorticism and adrenal suppression [see WARNINGS AND PRECAUTIONS]
  • Reduction in BMD [see WARNINGS AND PRECAUTIONS]
  • Growth effects in pediatrics [see WARNINGS AND PRECAUTIONS]
  • Glaucoma and cataracts [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

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.

The safety of ARNUITY ELLIPTA was evaluated in 10 double-blind, parallel-group, controlled trials (7 with placebo) of 8 to 76 weeks' duration, which enrolled 6,219 subjects with asthma. Doses of fluticasone furoate studied ranged from 25 to 800 mcg.

ARNUITY ELLIPTA 100 mcg was studied in 1,663 subjects, and ARNUITY ELLIPTA 200 mcg was studied in 608 subjects. Subject ages ranged from 12 to 84 years, 65% were female, and 75% were Caucasian.

In these trials, the proportion of subjects who discontinued study treatment early due to adverse reactions was 2% for subjects treated with both ARNUITY ELLIPTA 100 mcg and ARNUITY ELLIPTA 200 mcg and less than or equal to 1% for placebo-treated subjects. Serious adverse events, whether considered drug-related or not by the investigators, that occurred in more than 1 subject and in a greater percentage of subjects treated with ARNUITY ELLIPTA than placebo included hypertension, abscess, breast cancer, traumatic limb amputation, subarachnoid hemorrhage, and intervertebral disc protrusion; all events occurred at rates less than or equal to 1%.

The incidence of adverse reactions associated with ARNUITY ELLIPTA 100 mcg is shown in Table 1 and is based on one 24-week trial (Trial 1) in adolescent and adult subjects with asthma.

Table 1: Adverse Reactions with ARNUITY ELLIPTA 100 mcg with Greater than or Equal to 3% Incidence and More Common than Placebo (Trial 1, Intent-to-Treat Population)

Adverse Event ARNUITY ELLIPTA 100 mcg
n = 114 %
Placebo
n = 115 %
Bronchitis 7 6
Headache 6 4
Nasopharyngitis 8 5
Upper respiratory tract infection 6 5
Pharyngitis 4 3
Sinusitis 4 < 1
Oropharyngeal pain 3 0
Toothache 3 < 1
Gastroenteritis viral 3 0
Oral candidiasis 3 0
Oropharyngeal candidiasis 3 0

The incidence of adverse reactions associated with ARNUITY ELLIPTA 200 mcg is shown in Table 2 and is based on one 24-week trial (Trial 3) in adolescent and adult subjects with asthma. This trial did not have a placebo arm.

Table 2: Adverse Reactions with ARNUITY ELLIPTA 200 mcg with Greater than or Equal to 3% Incidence (Trial 3, Safety Population)

Adverse Event ARNUITY ELLIPTA 200 mcg
n = 119 %
ARNUITY ELLIPTA100 mcg
n = 119 %
Nasopharyngitis 13 12
Headache 13 10
Bronchitis 7 12
Influenza 7 4
Upper respiratory tract infection 6 2
Sinusitis 4 7
Oropharyngeal pain 4 3
Pharyngitis 3 6
Back pain 3 3
Dysphonia 3 2
Oral candidiasis 3 < 1
Procedural pain 3 < 1
Rhinitis 3 < 1
Throat irritation 3 < 1
Abdominal pain 3 0
Cough 3 0

Adverse reactions observed in the other trials were consistent with those described in Tables 1 and 2.

Long-Term Safety

Long-term safety data are based on 2 trials in adolescent and adult subjects with asthma. In one 52-week trial, subjects received fluticasone furoate 100 mcg (n = 201) or fluticasone furoate 200 mcg (n = 202) in combination with a LABA. Subjects had a mean age of 39 years (adolescents made up 16% of the population), 63% were female, and 67% were Caucasian. In addition to the events shown in Table 1 and Table 2, adverse events occurring in greater than or equal to 3% of the subjects treated with fluticasone furoate 100 mcg or fluticasone furoate 200 mcg, in combination with a LABA, included pyrexia, extrasystoles, upper abdominal pain, respiratory tract infection, diarrhea, and allergic rhinitis.

In a second 24-to 76-week trial, subjects received fluticasone furoate 100 mcg (n = 1,010). Subjects participating in this trial had a history of one or more asthma exacerbations that required treatment with oral/systemic corticosteroids or emergency department visit or in-patient hospitalization for the treatment of asthma within the previous 12 months. Subjects had a mean age of 42 years (adolescents made up 14% of the population), 67% were female, and 73% were Caucasian. In addition to the events shown in Table 1 and Table 2, adverse events occurring in greater than or equal to 3% of subjects treated with fluticasone furoate 100 mcg for up to 76 weeks included allergic rhinitis, nasal congestion, and arthralgia.