Powerful Relief in Seasonal Allergic Rhinitis1

XYZAL® demonstrated significant improvement in a 4-week, open-label study.

  1. After taking XYZAL, patients experienced a 68% symptom reduction from baseline at 4 weeks in Total 4 Symptom Score (T4SS)—the sum of nasal pruritus, ocular pruritus, rhinorrhea, and sneezing

REDUCTION IN OVERALL T4SS

†Four-week, open-label, uncontrolled, multicenter study conducted in 1,290 patients with seasonal allergic rhinitis who had a T4SS of ≥6 upon enrollment. Enrolled patients were either without treatment or on another antihistamine experiencing inefficacy or excessive adverse events. The primary endpoints included efficacy as measured by T4SS. Patients were not monitored or observed on treatments prior to taking XYZAL®. No information is available regarding efficacy, safety, duration, or compliance with previous treatments. The secondary endpoint was treatment-related adverse events.

1. Jorissen M, Bertrand B, Stiels B, Vandenbulcke K. Levocetirizine as treatment for symptoms of seasonal allergic rhinitis. B-ENT. 2006;2:55-62.

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Indications

XYZAL® (levocetirizine dihydrochloride) is indicated for the relief of symptoms associated with perennial allergic rhinitis and the treatment of uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 months of age and older, and for relief of symptoms of seasonal allergic rhinitis in adults and children 2 years of age and older.

Important Safety Information

The use of XYZAL is contraindicated in: patients with a known hypersensitivity to levocetirizine or any of the ingredients of XYZAL or to cetirizine (observed reactions range from urticaria to anaphylaxis); patients with end-stage renal disease with a creatinine clearance less than 10 mL/min or patients undergoing hemodialysis; and pediatric patients aged 6 months to 11 years with renal impairment.

Patients should be cautioned against engaging in hazardous occupations requiring complete mental alertness such as driving or operating machinery when taking XYZAL. Concurrent use of XYZAL with alcohol or other central nervous system (CNS) depressants should be avoided. In clinical trials, the most common adverse reactions in ≥2% of adult and adolescent patients (12 years of age and older) taking XYZAL 2.5 mg or XYZAL 5 mg once daily or placebo were somnolence (5%, 6%, 2%), nasopharyngitis (6%, 4%, 3%), fatigue (1%, 4%, 2%), dry mouth (3%, 2%, 1%), and pharyngitis (2%, 1%, 1%), respectively.

In clinical trials, the most common adverse reactions in ≥2% of pediatric patients 6 to 12 years of age taking XYZAL 5 mg once daily or placebo were pyrexia (4%, 2%), cough (3%, <1%), somnolence (3%, <1%), and epistaxis (2%, <1%), respectively. The most common adverse reactions in ≥2% of pediatric patients 1 to 5 years of age taking XYZAL 1.25 mg twice daily or placebo were pyrexia (4%, 2%), diarrhea (4%, 3%), vomiting (4%, 3%), and otitis media (3%, 0%), respectively. The most common adverse reactions in pediatric patients 6 to 11 months of age taking XYZAL 1.25 mg once daily or placebo were diarrhea (13%, 4%) and constipation (7%, 4%), respectively.

XYZAL is a trademark of UCB Group of companies.
© 2009 UCB, Inc. and sanofi-aventis U.S. LLC. All rights reserved. X1257-1109
Last Updated: January 2010