*Based on data averaged over 4 weeks.
A multicenter, randomized, double-blind, parallel-group, 4-week trial of pediatric patients (N=150). Patients were randomized to receive XOPENEX HFA® (levalbuterol tartrate) Inhalation Aerosol 90 mcg, albuterol HFA 180 mcg, or placebo. The primary endpoint was peak percent change in FEV1 from visit predose averaged over the double-blind period.1
Onset was defined as the postdose time point at which a response of ≥15% FEV1 first occurred. The time of onset was calculated by linear interpolation between the last time point of nonresponse and the first time point of response. The median time to achieve FEV1 response ≥15% after the first dose was 4.5 minutes for XOPENEX HFA® (levalbuterol tartrate) Inhalation Aerosol 90 mcg and 4.9 minutes for albuterol HFA 180 mcg at Week 0; and 40.1 minutes for XOPENEX HFA 90 mcg and 102.1 minutes for albuterol HFA180 mcg at Week 4.
Adverse event information concerning XOPENEX HFA Inhalation Aerosol in children is derived from a 4-week, randomized, double-blind trial of XOPENEX HFA Inhalation Aerosol, a marketed albuterol HFA inhaler, and an HFA-134a placebo inhaler in 150 children aged 4 to 11 years with asthma.
1. Berger WE, Milgrom H, Skoner DP, Tripp K, Parsey MV, Baumgartner RA; for the Xopenex Pediatric Asthma Group. Evaluation of levalbuterol metered dose inhaler in pediatric patients with asthma: a double-blind, randomized, placebo- and active-controlled trial. Curr Med Res Opin. 2006;22(6):1217-1226.
2. Data on file, NCT00073814. CSR 051-354. Sunovion Pharmaceuticals Inc.
3. XOPENEX HFA Inhalation Aerosol [prescribing information]. Marlborough, MA: Sunovion Pharmaceuticals Inc.; June 2009.
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.