Frequently Asked Questions
About Xopenex HFA® (levalbuterol tartrate)

Xopenex HFA 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.

Xopenex HFA is not a substitute for corticosteroids in patients requiring anti-inflammatory therapy.¹

The recommended dose for adults and children 4 years of age and older is 2 inhalations (90 mcg of levalbuterol free based) repeated every 4 to 6 hours as needed. In some patients, 1 inhalation (45 mcg) every 4 hours as needed may be sufficient. More frequent administration or a larger number of inhalations is not routinely recommended. Patients should use Xopenex HFA as directed by their healthcare provider and according to the Prescribing Information.¹

Xopenex HFA is an FDA-approved short-acting β2-agonist option for bronchospasm in patients ≥4 years of age and older, with pediatric clinical trial evidence supporting efficacy and tolerability in children 4 years and older.¹

Levalbuterol is the pure (R)-enantiomer of racemic albuterol, while racemic albuterol contains both the R- and S-isomers; the R-isomer is responsible for bronchodilatory effects, while the S-isomer may contribute to adverse effects.¹

Clinical studies in adults and pediatric patients with asthma have demonstrated lower mean heart rates with levalbuterol versus racemic albuterol, though the magnitude of this difference is modest. This cardiovascular profile may be clinically meaningful in patients with concurrent arrhythmias, structural heart disease, or conditions that could worsen with tachycardia.^1-3

In adults and adolescents, the median time to onset of a 15% increase in FEV1 ranged from 5.5 to 10.2 minutes, with a median time to peak effect of 76 to 78 minutes following a 90 mcg dose. In the responder population, the median duration of effect was 3 to 4 hours, with some patients experiencing bronchodilation for up to 6 hours.¹

In pediatric patients aged 4 to 11 years, the median time to onset of a 15% FEV1 increase was 4.5 minutes, with a median peak effect at 77 minutes.¹

Xopenex HFA is contraindicated in patients with a history of hypersensitivity to levalbuterol, racemic albuterol, or any other component of the inhalation aerosol formulation. Documented hypersensitivity reactions have included urticaria, angioedema, rash, bronchospasm, anaphylaxis, and oropharyngeal edema.¹

Other short-acting sympathomimetic aerosol bronchodilators or epinephrine should not be used concomitantly with Xopenex HFA. If additional adrenergic drugs are to be administered by any route, they should be used with caution to avoid deleterious cardiovascular effects.¹

Beta-blockers: Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-adrenergic agonists such as Xopenex HFA, but may produce severe bronchospasm in patients with asthma. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances (e.g., as prophylaxis after myocardial infarction), there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers should be considered, although they should be administered with caution.¹

Diuretics: The ECG changes or hypokalemia that may result from the administration of non-potassium-sparing diuretics (such as loop and thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta agonists with non-potassium-sparing diuretics. Consider monitoring potassium levels.¹

Digoxin: Mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single-dose intravenous and oral administration of racemic albuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical significance of these findings for patients with obstructive airway disease who are receiving Xopenex HFA and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and Xopenex HFA.¹

Monoamine Oxidase Inhibitors or Tricyclic Antidepressants: Xopenex HFA should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of albuterol on the vascular system may be potentiated. Consider alternative therapy in patients taking MAO inhibitors or tricyclic antidepressants.¹

A need for more doses of Xopenex HFA than usual may be a marker of asthma destabilization and requires reevaluation of the patient and treatment regimen, including consideration of initiating or intensifying anti-inflammatory therapy. Clinicians should reassess inhaled corticosteroid adequacy and adherence when rescue bronchodilator demand escalates.¹

Xopenex HFA can produce clinically significant cardiovascular effects, including changes in heart rate, blood pressure, and ECG findings, and should be used with caution in patients with underlying cardiovascular disorders such as coronary insufficiency, cardiac arrhythmias, and hypertension. Discontinuation of Xopenex HFA should be considered if these cardiovascular effects occur.¹

The inhaler must be primed before first use or after 3 or more days of non-use. To prime the inhaler, take the cap off the mouthpiece of the actuator. Check inside the mouthpiece for objects before use. Hold the inhaler in the upright position away from the face and shake the inhaler well. Press down fully on the center of the dose indicator to release a spray of medicine from the mouthpiece.⁴

Xopenex HFA has broad coverage under both commercial and public plans, making it an accessible option for appropriate patients.

With the savings card, patients covered by commercial insurance may pay $25 for their prescription and patients not using insurance may pay $40. The savings card is not valid for patients eligible for reimbursement under state or federally funded programs, including Medicare, Medigap, or Medicaid.⁵