SIDE EFFECTS

Adults And Adolescents ≥ 12 Years Old

Adverse events reported in ≥ 2% of patients receiving Xopenex Inhalation Solution or racemic albuterol and more frequently than in patients receiving placebo in a 4-week, controlled clinical trial are listed in Table 3.

Table 3: Adverse Events Reported in a 4-Week, Controlled Clinical Trial in Adults and Adolescents ≥ 12 years old

The incidence of certain systemic beta-adrenergic adverse effects (e.g., tremor, nervousness) was slightly less in the Xopenex 0.63 mg group compared with the other active treatment groups. The clinical significance of these small differences is unknown.

Changes in heart rate 15 minutes after drug administration and in plasma glucose and potassium 1 hour after drug administration on day 1 and day 29 were clinically comparable in the Xopenex 1.25 mg and racemic albuterol 2.5 mg groups (see Table 4). Changes in heart rate and plasma glucose were slightly less in the Xopenex 0.63 mg group compared with the other active treatment groups (see Table 4). The clinical significance of these small differences is unknown. After 4 weeks, effects on heart rate, plasma glucose, and plasma potassium were generally diminished compared with day 1 in all active treatment groups.

Table 4: Mean Changes from Baseline Heart Rate at 15 Minutes and Glucose and Potassium at 1 Hour after First Dose (Day 1) in Adults and Adolescents ≥ 12 years old

No other clinically relevant laboratory abnormalities related to administration of Xopenex Inhalation Solution were observed in this study.

In the clinical trials, a slightly greater number of serious adverse events, discontinuations due to adverse events, and clinically significant ECG changes were reported in patients who received Xopenex 1.25 mg compared with the other active treatment groups. The following adverse events, considered potentially related to Xopenex, occurred in less than 2% of the 292 subjects who received Xopenex and more frequently than in patients who received placebo in any clinical trial:

Body as a Whole: chills, pain, chest pain

Cardiovascular System: ECG abnormal, ECG change, hypertension, hypotension, syncope

Digestive System: diarrhea, dry mouth, dry throat, dyspepsia, gastroenteritis, nausea

Hemic and Lymphatic System: lymphadenopathy

Musculoskeletal System: leg cramps, myalgia

Nervous System: anxiety, hypesthesia of the hand, insomnia, paresthesia, tremor

Special Senses: eye itch

The following events, considered potentially related to Xopenex, occurred in less than 2% of the treated subjects but at a frequency less than in patients who received placebo: asthma exacerbation, cough increased, wheezing, sweating, and vomiting.

Adverse reactions (children 6-11 years old)

Adverse events reported in ≥ 2% of patients in any treatment group and more frequently than in patients receiving placebo in a 3-week, controlled clinical trial are listed in Table 5.

Table 5: Most Frequently Reported Adverse Events ( ≥ 2% in Any Treatment Group) and Those Reported More Frequently Than in Placebo during the Double-Blind Period (ITT Population, 6-11 Years Old)

Note: Subjects may have more than one adverse event per body system and preferred term.

Changes in heart rate, plasma glucose, and serum potassium are shown in Table 6. The clinical significance of these small differences is unknown.

Table 6: Mean Changes from Baseline Heart Rate at 30 Minutes and Glucose and Potassium at 1 Hour after First Dose (Day 1) and Last Dose (Day 21) in Children 6-11 years old

Postmarketing Adverse Reactions

In addition to the adverse events reported in clinical trials, the following adverse events have been observed in postapproval use of Xopenex Inhalation Solution. These events have been chosen for inclusion due to their seriousness, their frequency of reporting, or their likely beta-mediated mechanism: angioedema, anaphylaxis, arrhythmias (including atrial fibrillation, supraventricular tachycardia, extrasystoles), asthma, chest pain, cough increased, dyspnea, metabolic acidosis, nausea, nervousness, rash, tachycardia, tremor, urticaria. Because these events have been reported spontaneously from a population of unknown size, estimates of frequency cannot be made.

Read the entire FDA prescribing information for Xopenex (Levalbuterol) »