XOPENEX HFA® (levalbuterol tartrate)

Xopenex is the only product offering a rapid onset of action for the treatment or prevention of bronchospasm in patients greater than 4 years of age or older that delivers just the R-isomer of albuterol, providing needed bronchodilation.1,2

XOPENEX HFA®
(levalbuterol tartrate)

Xopenex is the only product offering a rapid onset of action for the treatment or prevention of bronchospasm in patients greater than 4 years of age or older that delivers just the R-isomer of albuterol, providing needed bronchodilation.1,2

INDICATION
INDICATION XOPENEX HFA (levalbuterol tartrate) is an inhalation aerosol indicated for the treatment or prevention of bronchospasm in adults, adolescents, and children 4 years of age and older with reversible obstructive airway disease.
— CLINICAL EFFICACY —
Xopenex HFA is an effective, trusted option for the treatment of appropriate patients with reversible obstructive airway disease, offering clinical efficacy and rapid onset of response in adults and adolescents, as well as in children 4 years and older.1-3
Efficacy in Adolescents and Adults
85% of asthmatic adolescents and adults exhibited a change in FEV1 greater than 15% from pre-dose.3
MEDIAN ONSET RESPONSE
5.5-10.2 minutes1
MEDIAN TIME TO PEAK EFFECT
76-78 minutes
DURATION OF EFFECT
up to 6 hours
Efficacy in Children 4 Years and Older
82% of asthmatic children 4 to 11 years of age exhibited a change in FEV1 greater than 15% from pre-dose.3
MEDIAN ONSET RESPONSE
4.5 minutes1
MEDIAN TIME TO PEAK EFFECT
77 minutes
DURATION OF EFFECT
up to 6 hours
Efficacy in Adolescents and Adults
Efficacy in Children 4 Years and Older
85% of asthmatic adolescents and adults exhibited a change in FEV1 greater than 15% from pre-dose.3
82% of asthmatic children 4 to 11 years of age exhibited a change in FEV1 greater than 15% from pre-dose.3
MEDIAN ONSET RESPONSE
5.5-10.2
minutes1
4.5
minutes1
MEDIAN TIME TO PEAK EFFECT
76-78
minutes
77
minutes
DURATION OF EFFECT
up to 6 hours
up to 6 hours
— ACCESSIBILITY & AFFORDABILITY —
Xopenex HFA offers favorable commercial and public insurance coverage, making it an affordable option for appropriate patients who:
May have concerns about costs or coverage
Depend on Medicaid state drug plans for their prescription coverage
Depend on Medicare Part D for their prescription coverage

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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. PMID: 11692096.
  3. Data on file. CSR 051-354. Sunovion Pharmaceuticals, Inc.
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. PMID: 11692096. 3. Data on file. CSR 051-354. Sunovion Pharmaceuticals, Inc.