YUPELRI SIDE EFFECTS
- Generic Name: revefenacin inhalation solution
- Brand Name: Yupelri
- Drug Class: Anticholinergics, Inhaled
SIDE EFFECTS
The following potential adverse reactions are described in greater detail in other sections:
- Paradoxical bronchospasm
- Worsening of narrow-angle glaucoma
- Worsening of urinary retention
- Immediate hypersensitivity reactions
Clinical Trial 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The YUPELRI safety database included 2,285 subjects with COPD in two 12-week efficacy studies and one 52-week long-term safety study. A total of 730 subjects received treatment with YUPELRI 175 mcg once daily. The safety data described below are based on the two 12-week trials and the one 52-week trial.
12-Week Trials
YUPELRI was studied in two 12-week replicate placebo-controlled trials in patients with moderate to very severe COPD (Trials 1 and 2). In these trials, 395 patients were treated with YUPELRI at the recommended dose of 175 mcg once daily.
The population had a mean age of 64 years (range from 41 to 88 years), with 50% males, 90% Caucasian, and had COPD with a mean post-bronchodilator forced expiratory volume in one second (FEV1) percent predicted of 55%. Of subjects enrolled in the two 12-week trials, 37% were taking concurrent LABA or ICS/LABA therapy. Patients with unstable cardiac disease, narrow-angle glaucoma, or symptomatic prostatic hypertrophy or bladder outlet obstruction were excluded from these trials.
Table 1 shows the most common adverse reactions that occurred with a frequency of greater than or equal to 2% in the YUPELRI group and higher than placebo in the two 12-week placebo-controlled trials.
The proportion of subjects who discontinued treatment due to adverse reactions was 13% for the YUPELRI-treated subjects and 19% for placebo-treated subjects.
Table 1: Adverse Events with YUPELRI ≥2% Incidence and Higher than Placebo
| Placebo (N = 418) |
YUPELRI 175 mcg (N = 395) |
|
| Respiratory, Thoracic and Mediastinal Disorders | ||
| Cough | 17 (4%) | 17 (4%) |
| Infections and Infestations | ||
| Nasopharyngitis | 9 (2%) | 15 (4%) |
| Upper respiratory tract infection | 9 (2%) | 11 (3%) |
| Nervous System Disorders | ||
| Headache | 11 (3%) | 16 (4%) |
| Musculoskeletal and Connective Tissue Disorders | ||
| Back pain | 3 (1%) | 9 (2%) |
Other adverse reactions defined as events with an incidence of ≥1.0%, less than 2.0%, and more common than with placebo included the following: hypertension, dizziness, oropharyngeal pain, and bronchitis.
52-Week Trial
YUPELRI was studied in one 52-week, open-label, active-control (tiotropium 18 mcg once daily) trial in 1,055 patients with COPD. In this trial, 335 patients were treated with YUPELRI 175 mcg once daily and 356 patients with tiotropium. The demographic and baseline characteristics of the long-term safety trial were similar to those of the placebo-controlled 12week studies described, with the exception that concurrent LABA or LABA/ICS therapy was used in 50% of patients. The adverse reactions reported in the long-term safety trial for YUPELRI were consistent with those observed in the placebo-controlled studies of 12-weeks.
SRC: NLM .