LONHALA MAGNAIR SIDE EFFECTS

SIDE EFFECTS

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

• Paradoxical bronchospasm
• Immediate hypersensitivity reactions
• 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The LONHALA MAGNAIR safety database included 2379 subjects with COPD in two 12-week efficacy studies and one 48-week long-term safety study. A total of 431 subjects received treatment with LONHALA MAGNAIR 25 mcg twice-daily (BID). The safety data described below are based on the two 12-week trials and the one 48-week trial.

12-Week Trials

LONHALA MAGNAIR was studied in two 12-week placebo-controlled trials in subjects with COPD. In these trials, 431 subjects were treated with LONHALA MAGNAIR at the recommended dose of 25 mcg twice daily. The population had a mean age of 63 years (ranging from 40 to 87 years), with 56% males, 90% Caucasian, and a mean post-bronchodilator forced expiratory volume in one second (FEV₁) percent predicted of 52% of predicted normal value (20%-80%) at study entry. The study population also included subjects with pre-existing cardiovascular disease as well as subjects with continued use of stable long-acting bronchodilator (LABA) ± inhaled corticosteroid (ICS) and ipratropium bromide background therapy. Subjects with unstable cardiac disease, narrow-angle glaucoma, or symptomatic prostatic hypertrophy or bladder outlet obstruction were excluded from these studies.

Table 1 shows the most common adverse reactions incidence greater than or equal to 2.0% in the LONHALA MAGNAIR 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 5% for the LONHALA MAGNAIR-treated subjects and 9% for placebo-treated subjects.

Table 1. Adverse Reactions with LONHALA MAGNAIR ≥2.0% Incidence and Higher than Placebo

Other adverse reactions defined as events with an incidence of ≥1.0% but less than 2.0% with LONHALA MAGNAIR but more common than with placebo included the following: wheezing, upper respiratory tract infection, nasopharyngitis, oedema peripheral, and fatigue.

48-Week Trial

In a long-term open-label safety trial, 1086 subjects were treated for up to 48-weeks with LONHALA MAGNAIR 50 mcg twice-daily (N=620) or tiotropium (N=466). The demographic and baseline characteristics of the long-term safety trial were similar to those of the placebo-controlled efficacy studies described above. The adverse reactions reported in the long-term safety trial were consistent with those observed in the placebo-controlled studies of 12-weeks. Adverse reactions that occurred at a frequency greater than that seen in either active treatment dose in the pooled 12-week placebo controlled studies and ≥ 2.0% were: diarrhea, edema peripheral, bronchitis, nasopharyngitis, pneumonia, sinusitis, upper respiratory tract infection, urinary tract infection, back pain, headache, Chronic Obstructive Pulmonary Disease, cough, dyspnea, oropharyngeal pain, and hypertension.

SRC: NLM .