Umeclidiniumside effects

The following adverse reactions are described in greater detail in other sections:

Paradoxical bronchospasm

Worsening of narrow-angle glaucoma

Worsening of urinary retention Most common adverse reactions (incidence ≥2% and more common than placebo) include nasopharyngitis, upper respiratory tract infection, cough, arthralgia. To report SUSPECTED ADVERSE REACTIONS, contact Prasco Laboratories at 1-866-525-0688 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 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. In the 8 clinical trials conducted to support initial approval of Umeclidinium ELLIPTA, a total of 1,663 subjects with COPD (mean age: 62.7 years; 89% white; 65% male across all treatments, including placebo) received at least 1 inhalation dose of umeclidinium at doses of 62.5 or 125 mcg. In the 4 randomized, double-blind, placebo- or active-controlled, efficacy clinical trials, 1,185 subjects received umeclidinium for up to 24 weeks, of which 487 subjects received the recommended dose of umeclidinium 62.5 mcg. In a 12-month, randomized, double-blind, placebo-controlled, long-term safety trial, 227 subjects received umeclidinium 125 mcg for up to 52 weeks. The incidence of adverse reactions associated with umeclidinium ELLIPTA in Table 1 is based upon 2 placebo-controlled trials: one 24-week trial (Trial 1) and one 12-week trial (Trial 2). Table 1. Adverse Reactions with Umeclidinium ELLIPTA with ≥1% Incidence and More Common than Placebo in Subjects with Chronic Obstructive Pulmonary Disease Adverse Reaction Umeclidinium ELLIPTA (n = 487) % Placebo (n = 348) % Infections and infestations Nasopharyngitis 8% 7% Upper respiratory tract infection 5% 4% Pharyngitis 1% <1% Viral upper respiratory tract infection 1% <1% Respiratory, thoracic, and mediastinal disorders Cough 3% 2% Musculoskeletal and connective tissue disorders Arthralgia 2% 1% Myalgia 1% <1% Gastrointestinal disorders Abdominal pain upper 1% <1% Toothache 1% <1% Injury, poisoning, and procedural complications Contusion 1% <1% Cardiac disorders Tachycardia 1% <1% Other adverse reactions with umeclidinium ELLIPTA observed with an incidence <1% but more common than placebo included atrial fibrillation. In a long-term safety trial (Trial 3), 336 subjects (n = 227 umeclidinium 125 mcg, n = 109 placebo) were treated for up to 52 weeks with umeclidinium 125 mcg or placebo. The demographic and baseline characteristics of the long-term safety trial were similar to those of the efficacy trials described above. Adverse reactions that occurred with a frequency ≥1% in subjects receiving umeclidinium 125 mcg that exceeded that in placebo in this trial were: nasopharyngitis, upper respiratory tract infection, urinary tract infection, pharyngitis, pneumonia, lower respiratory tract infection, rhinitis, supraventricular tachycardia, supraventricular extrasystoles, sinus tachycardia, idioventricular rhythm, headache, dizziness, sinus headache, cough, back pain, arthralgia, pain in extremity, neck pain, myalgia, nausea, dyspepsia, diarrhea, rash, depression, and vertigo. The safety and efficacy of umeclidinium ELLIPTA in combination with an inhaled corticosteroid/long-acting beta 2 -adrenergic agonist (ICS/LABA) were also evaluated in four 12‑week clinical trials (Trial 4, Trial 5, Trial 6, and Trial 7). A total of 1,637 subjects with COPD across four 12‑week, randomized, double-blind clinical trials received at least 1 dose of umeclidinium ELLIPTA (62.5 mcg) or placebo administered once daily in addition to background ICS/LABA (mean age: 64 years, 88% white, 65% male across all treatments). Two trials (Trials 4 and 5) evaluated umeclidinium ELLIPTA in combination with fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg administered once daily, and 2 trials (Trials 6 and 7) evaluated umeclidinium ELLIPTA administered once daily in combination with fluticasone propionate/salmeterol (FP/SAL) 250 mcg/50 mcg administered twice daily. Adverse reactions that occurred with umeclidinium ELLIPTA in combination with an ICS/LABA were similar to those reported with umeclidinium ELLIPTA as monotherapy. In addition to the umeclidinium monotherapy adverse reactions reported above, adverse reactions occurring with umeclidinium ELLIPTA in combination with an ICS/LABA, at an incidence of ≥1% and exceeding ICS/LABA alone, were oropharyngeal pain and dysgeusia.

6.2 Postmarketing

Experience In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of Umeclidinium 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 Umeclidinium ELLIPTA or a combination of these factors. Eye Disorders Eye pain, glaucoma, vision blurred. Immune System Disorders Hypersensitivity reactions, including anaphylaxis, angioedema, pruritus, and urticaria. Renal and Urinary Disorders Dysuria, urinary retention. Respiratory, Thoracic and Mediastinal Disorders Dysphonia, oropharyngeal pain.