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New Drug Reviews

Levalbuterol Tartrate (Xopenex HFA) for the Treatment of Bronchospasm



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Am Fam Physician. 2007 Jan 15;75(2):247-248.

Levalbuterol tartrate (Xopenex hFa) is a beta2-agonist, hydrofluoroalkane inhalation aerosol labeled for the treatment or prevention of bronchospasm in patients with reversible obstructive airway disease. Levalbuterol is the active R-isomer of albuterol (Proventil), which contains both the R- and S-isomers.

Name Starting dosage Dose form Approximate monthly cost*

Levalbuterol tartrate (Xopenex HFA)

Two inhalations every four to six hours in persons four years or older; in some patients, one inhalation every four hours issufficient.

15-g metered-dose inhaler providing 45 mcg per actuation

$50 for one inhaler (200 metered actuations)


*— Average wholesale cost, based on Red Book, Montvale, N.J.: Medical Economics Data, 2006.

Name Starting dosage Dose form Approximate monthly cost*

Levalbuterol tartrate (Xopenex HFA)

Two inhalations every four to six hours in persons four years or older; in some patients, one inhalation every four hours issufficient.

15-g metered-dose inhaler providing 45 mcg per actuation

$50 for one inhaler (200 metered actuations)


*— Average wholesale cost, based on Red Book, Montvale, N.J.: Medical Economics Data, 2006.

SAFETY

Levalbuterol tartrate shares the same safety concerns as albuterol and other drugs in this class. Class labeling on safety includes warnings about paradoxical bronchospasm, cardiovascular effects (because of the concern about a heightened risk of cardiovascular complications from long-acting beta2 agonist use), and use in patients with worsening or deteriorating asthma. However, these effects have not been demonstrated with albuterol and levalbuterol tartrate specifically. Levalbuterol tartrate is a U.S. Food and drug administration pregnancy category C drug.

TOLERABILITY

Levalbuterol tartrate is well tolerated and seems to have a side-effect profile similar to that of albuterol; studies have not demonstrated any reduction in side effects with levalbuterol tartrate at equivalent doses. Dizziness (2.7 percent), pharyngitis (7.9 percent), and rhinitis (7.4 percent) occur infrequently but more often than with albuterol or placebo.1

EFFECTIVENESS

Results from clinical trials in adults show levalbuterol tartrate to be as effective as albuterol in improving lung function as measured by percent change in forced expiratory volume in one second (FEV1).1,2 The duration of action is approximately four hours in most persons and is similar to that of albuterol. Improved lung function is sustained over at least two months of continuous dosing. Based on one small study, the effect in children seems to be similar.1 pre-dose FEV1 values during chronic dosing (compared with baseline) have been significantly lower in patients receiving racemic albuterol compared with levalbuterol tartrate, suggesting a role of the S-isomer in the declining lung function observed during albuterol therapy.3

No research has compared levalbuterol tartrate inhalers and albuterol inhalers with regard to reduction in acute exacerbations, normalization of physical activity, symptom-free days, improvements in quality of life, control of airway hyperresponsiveness, normalization of chronic airway inflammation, or avoidance of adverse effects. However, there are studies that show comparable effectiveness in the nebulized forms of levalbuterol and albuterol.4

PRICE

One levalbuterol tartrate inhaler (200 metered actuations) will cost patients approximately $50 for a typical one-month supply. This is higher than the cost of a generic albuterol inhaler, which ranges from $5 to $30. Levalbuterol tartrate currently is considered a nonformulary medication by most managed care insurers.

SIMPLICITY

The usual dose of levalbuterol tartrate is two inhalations (90 mcg) every four to six hours in persons four years or older.2 In some patients, one inhalation every four hours may be sufficient. As with all inhalers, it is important to remind patients to prime the inhaler before initial use and after three days of inactivity. The mouthpiece also should be washed weekly to maintain proper medication dosing.

Bottom Line

Levalbuterol tartrate appears to be no more effective and offers no improvement in the side-effect profile compared with albuterol. The higher cost may make it appropriate for only a limited group of patients.

Author disclosure: Nothing to disclose.

Address correspondence to Michelle L. Hilaire, PHARM.D., C.D.E., at mhilaire@uwyo.edu. Reprints are not available from the authors.

REFERENCES

1. Xopenex HFA (levalbuterol tartrate) inhalation aerosol [prescribing information]. Sepracor Inc. September 2005. Accessed October 12, 2006, at: http://www.xopenex.com/xopenexProviders/XopenexMDI_PI.pdf.

2. Milgrom H, Berger W, Kim K, Tripp K, Maier G, Baumgartner R. Levalbuterol HFA MDI for treatment of pediatric asthma: a double-blind, randomized, placebo- and active-controlled trial. Poster presented at: American College of Allergy, Asthma, and Immunology (ACAAI); November 4–9, 2005; Anaheim, Calif.

3. Nelson HS, Bensch G, Pleskow WW, DiSantostefano R, DeGraw S, Reasner DS, et al. Improved bronchodilation with levalbuterol compared with racemic albuterol in patients with asthma. J Allergy Clin Immunol. 1998;1026 pt 1943–52.

4. Nowak R, Emerman C, Hanrahan JP, Parsey MV, Hanania NA, Claus R, et al., for XOPENEX Acute Severe Asthma Study Group. A comparison of levalbuterol with racemic albuterol in the treatment of acute severe asthma exacerbations in adults. Am J Emerg Med. 2006;24:259–67.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

The series coordinator for AFP is Allen F. Shaughnessy, Pharm.D., Tufts University Family Medicine Residency Program, Malden, Mass.



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