INCRUSE ELLIPTA SIDE EFFECTS
- Generic Name: umeclidinium inhalation powder
- Brand Name: Incruse Ellipta
- Drug Class: Anticholinergics, Respiratory
SIDE EFFECTS
The following adverse reactions are described in greater detail in other sections:
- Paradoxical bronchospasm
- 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.
In the 8 clinical trials conducted to support initial approval of INCRUSE 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 INCRUSE ELLIPTA in Table 1 is based upon 2 placebo-controlled efficacy trials: one 24-week trial (Trial 1, NCT #01313650) and one 12-week trial (Trial 2, NCT #01772147).
Table 1. Adverse Reactions with INCRUSE ELLIPTA with ≥1% Incidence and More Common than Placebo in Subjects with Chronic Obstructive Pulmonary Disease
| Adverse Reaction | INCRUSE 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 INCRUSE ELLIPTA observed with an incidence <1% but more common than placebo included atrial fibrillation.
In a long-term safety trial (Trial 3, NCT #01316887), 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 INCRUSE ELLIPTA in combination with an inhaled corticosteroid/long-acting beta2-adrenergic agonist (ICS/LABA) were also evaluated in four 12-week clinical trials (Trial 4, NCT #01957163; Trial 5, NCT #02119286; Trial 6, NCT #01772134; and Trial 7, NCT #01772147). A total of 1,637 subjects with COPD across four 12-week, randomized, double-blind clinical trials received at least 1 dose of INCRUSE 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 INCRUSE ELLIPTA in combination with fluticasone furoate/vilanterol (FF/VI) 100 mcg/25 mcg administered once daily, and 2 trials (Trials 6 and 7) evaluated INCRUSE ELLIPTA administered once daily in combination with fluticasone propionate/salmeterol (FP/SAL) 250 mcg/50 mcg administered twice daily. Adverse reactions that occurred with INCRUSE ELLIPTA in combination with an ICS/LABA were similar to those reported with INCRUSE ELLIPTA as monotherapy. In addition to the umeclidinium monotherapy adverse reactions reported above, Adverse Reactions occurring with INCRUSE ELLIPTA in combination with an ICS/LABA, at an incidence of ≥1% and exceeding ICS/LABA alone, were oropharyngeal pain and dysgeusia.
Postmarketing Experience
In addition to adverse reactions reported from clinical trials, the following adverse reactions have been identified during postapproval use of INCRUSE 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 INCRUSE 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.
SRC: NLM .