Proven Relief in Perennial Allergic Rhinitis1

  1. XYZAL was statistically superior to placebo over the first week and over 4 weeks of treatment
  2. XYZAL demonstrated a significant relative improvement over placebo over week 1 in Total 4 Symptom Score (T4SS)—the sum of nasal pruritus, ocular pruritus, rhinorrhea, and sneezing
Improvement in Combined Symptoms

Six-week, placebo-controlled, randomized, double-blind, multicenter study in 294 patients 12 years of age or older with perennial allergic rhinitis who were previously sensitized to house dust mites. The primary objective was to show whether XYZAL® 5 mg once-daily at bedtime would provide a statistically superior improvement vs placebo in 24-hour reflective T4SS over treatment weeks 1 and 4, and a ≥50% relative improvement from baseline vs placebo over treatment week 1. Secondary efficacy variables measured were mean T4SS over the total 6-week treatment period and mean individual symptom scores over treatment weeks 1, 4, and 6.

1. Potter PC. Levocetrizine is effective for symptom relief including nasal congestion in adolescent and adult (PAR) sensitized to house dust mites. Allergy. 2003;58:893-899.

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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