ANORO ELLIPTA SIDE EFFECTS
- Generic Name: umeclidinium and vilanterol inhalation powder
- Brand Name: Anoro Ellipta
- Drug Class: Respiratory Inhalant Combos, Anticholinergics, Respiratory, Beta2 Agonists, Respiratory Inhalant Combos
SIDE EFFECTS
The following adverse reactions are described in greater detail in other sections:
- Serious asthma-related events–hospitalizations, intubations, death. LABA, such as vilanterol (one of the active ingredients in ANORO ELLIPTA), as monotherapy (without ICS) for asthma increase the risk of asthma-related events. ANORO ELLIPTA is not indicated for the treatment of asthma.
- Paradoxical bronchospasm
- Cardiovascular effects
- Worsening of narrow-angle glaucoma
- Worsening of urinary retention
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 clinical program for ANORO ELLIPTA included 8,138 subjects with COPD in four 6-month lung function trials, one 12-month long-term safety study, and 9 other trials of shorter duration. A total of 1,124 subjects have received at least 1 dose of ANORO ELLIPTA (umeclidinium/vilanterol 62.5 mcg/25 mcg), and 1,330 subjects have received a higher dose of umeclidinium/vilanterol (125 mcg/25 mcg). The safety data described below are based on the four 6-month and two 12-month trials. Adverse reactions observed in the other trials were similar to those observed in the confirmatory trials.
6-Month Trials
The incidence of adverse reactions associated with ANORO ELLIPTA in Table 1 is based on four 6-month trials: 2 placebo-controlled trials (Trial 1, NCT #01313650 and Trial 2 NCT #01313637); N = 1,532 and N = 1,489, respectively) and 2 active-controlled trials (Trial 3, NCT #01316900 and Trial 4, NCT #01316913); N = 843 and N = 869, respectively). Of the 4,733 subjects, 68% were male and 84% were white. They had a mean age of 63 years and an average smoking history of 45 pack-years, with 50% identified as current smokers. At screening, the mean postbronchodilator percent predicted forced expiratory volume in 1 second (FEV1) was 48% (range: 13% to 76%), the mean postbronchodilator FEV1/forced vital capacity (FVC) ratio was 0.47 (range: 0.13 to 0.78), and the mean percent reversibility was 14% (range: -45% to 109%).
Subjects received 1 dose once daily of the following: ANORO ELLIPTA, umeclidinium/vilanterol 125 mcg/25 mcg, umeclidinium 62.5 mcg, umeclidinium 125 mcg, vilanterol 25 mcg, active control, or placebo.
Table 1. Adverse Reactions with ANORO ELLIPTA with ≥1% Incidence and More Common than Placebo in Subjects with Chronic Obstructive Pulmonary Disease
| Adverse Reaction | ANORO ELLIPTA (n = 842) % |
Umeclidinium 62.5 mcg (n = 418) % |
Vilanterol 25 mcg (n = 1,034) % |
Placebo (n = 555) % |
| Infections and infestations | ||||
| Pharyngitis | 2 | 1 | 2 | <1 |
| Sinusitis | 1 | <1 | 1 | <1 |
| Lower respiratory tract infection | 1 | <1 | <1 | <1 |
| Gastrointestinal disorders | ||||
| Constipation | 1 | <1 | <1 | <1 |
| Diarrhea | 2 | <1 | 2 | 1 |
| Musculoskeletal and connective tissue disorders | ||||
| Pain in extremity | 2 | <1 | 2 | 1 |
| Muscle spasms | 1 | <1 | <1 | <1 |
| Neck pain | 1 | <1 | <1 | <1 |
| General disorders and administration site conditions | ||||
| Chest pain | 1 | <1 | <1 | <1 |
Other adverse reactions with ANORO ELLIPTA observed with an incidence <1% but more common than placebo included the following: productive cough, dry mouth, dyspepsia, abdominal pain, gastroesophageal reflux disease, vomiting, musculoskeletal chest pain, chest discomfort, asthenia, atrial fibrillation, ventricular extrasystoles, supraventricular extrasystoles, myocardial infarction, pruritus, rash, and conjunctivitis.
12-Month Trials
In a long-term safety trial (Trial 5, NCT #01316887), 335 subjects were treated for up to 12 months with umeclidinium/vilanterol 125 mcg/25 mcg or placebo. The demographic and baseline characteristics of the long-term safety trial were similar to those of the placebo-controlled efficacy trials described above. Adverse reactions observed with a frequency of ≥1% in the group receiving umeclidinium/vilanterol 125 mcg/25 mcg that exceeded that in placebo in this trial were: headache, back pain, sinusitis, cough, urinary tract infection, arthralgia, nausea, vertigo, abdominal pain, pleuritic pain, viral respiratory tract infection, toothache, and diabetes mellitus.
Postmarketing Experience
In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of ANORO ELLIPTA. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. These events have been chosen for inclusion due to either their seriousness, frequency of reporting, or causal connection to ANORO ELLIPTA or a combination of these factors.
Cardiac Disorders Palpitations.
Eye Disorders Blurred vision, glaucoma, increased intraocular pressure.
Immune System Disorders Hypersensitivity reactions, including anaphylaxis, angioedema, and urticaria.
Nervous System Disorders Dysgeusia, tremor.
Psychiatric Disorders Anxiety.
Renal and Urinary Disorders Dysuria, urinary retention.
Respiratory, Thoracic, and Mediastinal Disorders Dysphonia, paradoxical bronchospasm.
SRC: NLM .