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Important Safety Information

Indication

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.

Important Safety Information

Contraindication

Xopenex HFA is contraindicated in patients with a history of hypersensitivity to levalbuterol, racemic albuterol, or any other component of Xopenex HFA Inhalation Aerosol.

Warnings and Precautions

Xopenex HFA and other β-agonists can cause paradoxical bronchospasm, which may be life threatening. Discontinue Xopenex HFA immediately and treat with alternative therapy.
Need for more doses of Xopenex HFA than usual may be a sign of deterioration of asthma and requires reevaluation of treatment.
Xopenex HFA is not a substitute for corticosteroids.
Cardiovascular effects may occur. Consider discontinuation of Xopenex HFA if these effects occur. Use with caution in patients with underlying cardiovascular disorders.
Excessive use may be fatal. Do not exceed recommended dose.
Immediate hypersensitivity reactions may occur. Discontinue Xopenex HFA immediately.
Hypokalemia and changes in blood glucose may occur.

Adverse Reactions

In patients aged 4 to 11 years, the most common adverse events (occurring in ≥2% of patients receiving Xopenex HFA 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 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.

To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceuticals at +1 866‑587‑4617 or at drugsafety@lupin.com or FDA at 1‑800‑FDA‑1088 or www.fda.gov/medwatch.

References

1. Xopenex HFA® [Prescribing Information]. Lupin Pharmaceuticals, Inc.: Baltimore, MD; July 2023.

2. Lötvall J, Palmqvist M, Arvidsson P, Maloney A, Ventresca GP, Ward J. The therapeutic ratio of R-albuterol is comparable with that of RS-albuterol in asthmatic patients. J Allergy Clin Immunol. 2001 Nov;108(5):726-31. doi: 10.1067/mai.2001.119152.

3. Data on file. CSR 051-354. Sunovion Pharmaceuticals, Inc.