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NEXIUM Pediatric GERD Information

    The primary objective was to evaluate the safety profile of NEXIUM in patients 1 to 11 years of age1

    — No new safety concerns were identified in patients 1 to 11 years of age2
    — No clinically important safety findings and trends in hematology, clinical chemistry, urinalysis, vital signs, or physical examination were observed (n=108)*2

    * One patient was not evaluable for safety because the patient did not have any post-baseline safety data.

    NEXIUM healed most patients 1 to 11 years of age with erosive esophagitis (EE)

  • Among patients studied in the 10-mg and 20-mg dose groups who had EE at baseline and follow-up endoscopies (n=34), 85.3% of patients had resolution of EE1
  • Although most of the patients who had a follow-up endoscopy at the end of 8 weeks were healed, spontaneous healing cannot be ruled out
across varying grades of EE Pediatric patients healed through 8 weeks(ITT analysis)

Data from a phase III, multicenter, randomized, open-label to treatment, double-blinded to dose, parallel-group study evaluating the safety and clinical outcome of NEXIUM in patients aged 1 to 11 years with GERD, treated once daily with NEXIUM 5 mg, NEXIUM 10 mg, or NEXIUM 20 mg for 8 weeks. Dosing was determined by patient weight. A total of 109 patients of both sexes with endoscopically proven GERD were enrolled, with 101 patients completing the study. Of the 109 patients, 53 had EE at baseline (51 had mild, 1 moderate, and 1 severe).1

Patients were considered healed if their final follow-up endoscopy showed no signs of erosions.

Among all patients studied who had a follow-up endoscopy (n=45), overall resolution of EE was 88.9% (n=40) across varying grades of EE.

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Approved Uses

Healing of Erosive Esophagitis (EE)

NEXIUM 40 mg and NEXIUM 20 mg are indicated for short-term treatment (4 to 8 weeks) in healing and symptomatic resolution of diagnostically confirmed EE.

Maintenance of Healing of EE

NEXIUM 20 mg is indicated to maintain symptom resolution and healing of EE. Controlled studies did not extend beyond 6 months.

Symptomatic GERD

NEXIUM 20 mg is indicated for the short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD.

Pediatric Use

NEXIUM is indicated for the short-term treatment (up to 8 weeks) of GERD (symptomatic GERD and healing of EE) in patients 1 to 17 years of age. Pediatric use is supported by extrapolation of results from studies that supported the approval for NEXIUM for adults and safety and pharmacokinetic studies performed in pediatric and adolescent patients.

Effectiveness has not been demonstrated in patients less than 1 year of age. Safety and effectiveness for other pediatric uses have not been established.

Important Safety Information

References
  1. Data on file, eSTaR #263720.
  2. Prescribing Information for NEXIUM.