Xopenex HFA (levalbuterol tartrate) Inhalation Aerosol
I’m an HCP I’m a Patient

Xopenex HFA® (levalbuterol tartrate) Clinical Efficacy

Xopenex HFA delivers high clinical response rates across treatment populations.1*

*Clinical response defined as a change in FEV1 greater than 15% from pre-dose.1

Clinical Efficacy

Xopenex HFA is an effective, trusted option for the treatment of appropriate patients with reversible obstructive airway disease.

It offers clinical efficacy and rapid onset of response for1-3:

  • adults and adolescents
  • children 4 years and older

  • Adolescents and Adults

    85% of asthmatic adolescents and adults in one study exhibited a change in FEV1 greater than 15% from pre-dose on day 1.3

  • 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 on day 1.3

Rapid Onset

With a rescue inhaler, rapid onset is a key clinical consideration.

Xopenex HFA delivers rapid onset of response and a favorable duration of effect for the treatment of bronchospasm2:

Adolescents and Adults

  • Median Onset Response
    Scale from 0 to 20 minutes with the range 5.5 to 10.2 minutes highlighted

    5.5-10.2 minutes1

  • Median Time to Peak Effect
    Response curve peaking between 76 and 78 minutes on a 0 to 120 minute axis

    76-78 minutes

  • Duration of Effect
    Scale from 0 to 6 hours with the full range highlighted

    up to 6 hours

Children 4 Years and Older

  • Median Onset Response
    Scale from 0 to 20 minutes with 4.5 minutes highlighted

    4.5 minutes1

  • Median Time to Peak Effect
    Response curve peaking at 77 minutes on a 0 to 120 minute axis

    77 minutes

  • Duration of Effect
    Scale from 0 to 6 hours with the full range highlighted

    up to 6 hours

Continue to Respond

Patients continue to respond to treatment with Xopenex HFA far beyond day 1.1

Xopenex HFA demonstrated a sustained rate of response over time.1

Percentage of Adolescent and Adult Responders1‡

Xopenex HFA
Group A§¶ 90mcg QID 		Xopenex HFA
Group B§ 90mcg QID 		Albuterol
180mcg QID 		Placebo
Day 1 77.00% 72.60% 83.30% 35.60%
Week 4 75.00% 70.90% 66.70% 28.30%
Week 8 75.90% 57.40% 62.70% 25.50%
Decrease in percentage of responders from Day 1 to Week 8 1.1% 15.2% 20.6% 10.1%
  • ‡ Short acting beta 2 agonists were administered 2 puffs QID over the 8-week duration of the study
  • § Group A - Xopenex HFA manufactured at Site A
  • ¶ Group B - Xopenex HFA manufactured at Site B

Delivers Needed Bronchodilation

Xopenex HFA delivers needed bronchodilation with only the R-isomer of albuterol.2,3

Xopenex HFA is well-tolerated, with a low incidence of beta-mediated side effects.2

Therapeutic activity of albuterol comes from the r-isomer; the s-isomer may have pro-inflammatory effects.3

References

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

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

3. Nowak R. Single-isomer levalbuterol: a review of the acute data. Curr Allergy Asthma Rep. 2003 Mar;3(2):172-8. doi: 10.1007/s11882-003-0031-8.

Access & Affordability

Broad coverage and savings support for appropriate patients

Access can help keep the right rescue inhaler for your patient within reach.

$25* for eligible commercially insured patients.

$40* for eligible Direct Access patients.

Learn more

*Per fill. Not valid for any person eligible for reimbursement of prescriptions, in whole or in part, by any state or federally funded program, including Medicare, Medigap, or Medicaid, or where prohibited, taxed or otherwise restricted by law. Eligibility requirements and terms and conditions apply. See Terms and Conditions for full details.

A hand holding the Xopenex HFA Savings Card

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.