*On Day 1, the median duration of effect was 3 to 4 hours, with a duration of effect in some patients of up to 6 hours.
Data from 2 double-blind, randomized, placebo- and active-controlled, multicenter, parallel-group, 8-week trials of patients aged ≥12 years (N=748) with moderate-to-severe asthma (FEV1 was ≥45% to ≤75% predicted). Primary endpoint was peak percent change from visit predose in FEV1 averaged over the double-blind period.
Adverse event information concerning XOPENEX HFA® (levalbuterol tartrate) Inhalation Aerosol in adults and adolescents is derived from two 8-week, multicenter, randomized, double-blind, active- and placebo-controlled trials in 748 adult and adolescent patients with asthma that compared XOPENEX HFA Inhalation Aerosol, a marketed albuterol HFA inhaler, and an HFA-134a placebo inhaler.
1. XOPENEX HFA Inhalation Aerosol [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals Inc.; June 2009.
2. Data on file, NCT00073840. CSR 051-355. Sunovion Pharmaceuticals Inc.
3. Data on file, NCT00073827. CSR 051-353. Sunovion Pharmaceuticals Inc.
XOPENEX HFA is contraindicated in patients with a history of hypersensitivity to levalbuterol tartrate, racemic albuterol, or any component of the drug product.
Patients receiving the highest dose of XOPENEX HFA should be monitored closely for adverse effects, and the risk of such effects should be balanced against the potential for improved efficacy.
XOPENEX HFA and other β-agonists can cause paradoxical bronchospasm, which may be life threatening.
XOPENEX HFA like other β-adrenergic agonists, can produce clinically significant cardiovascular effects in some patients as measured by heart rate, blood pressure, and/or symptoms.
Potential drug interactions include: β-blockers, which can block the pulmonary effect of β-agonists and can cause severe bronchospasm in asthmatic patients; diuretics (non-potassium-sparing), whose ECG changes and/or hypokalemia side effects can worsen with administration of β-agonists; digoxin, where serum levels can decrease 16% to 22% with administration of β-agonists; monoamine oxidase inhibitors and tricyclic antidepressants, which can potentiate the action of albuterol on the vascular system.
If additional adrenergic drugs, including other short-acting sympathomimetic bronchodilators or epinephrine, are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.
Due to the cardiovascular side effects associated with β-agonists, caution is generally recommended for patients with cardiovascular disorders (especially coronary insufficiency, cardiac arrhythmias, and hypertension), diabetes, hyperthyroidism, or convulsive disorders.
In patients aged 4 to 11 years, the most common adverse events (occurring in ≥2% of patients receiving XOPENEX HFA at 90 mcg and more frequently than patients receiving placebo) were vomiting, accidental injury, pharyngitis, and bronchitis.
In patients 12 years and older, the most common adverse events (occurring in ≥2% of patients receiving XOPENEX HFA at 90 mcg and more frequently than patients receiving placebo) were asthma, pharyngitis, rhinitis, pain, and dizziness.
For more information about XOPENEX HFA (levalbuterol tartrate) Inhalation Aerosol, please see the full Prescribing Information including Patient's Instructions for Use or visit www.xopenex.com.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
XOPENEX HFA® (levalbuterol tartrate) Inhalation Aerosol is indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 4 years of age and older with reversible obstructive airway disease.