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NEXIUM Pediatric GERD Information

NEXIUM® (esomeprazole magnesium) is approved to treat kids as young as 1 year old for the short-term treatment of GERD for up to 8 weeks,1 helping to address an important need for pediatric patients.

Generally well tolerated in kids

Demonstrated safety profile in pediatric patients aged 1 to 11 years with GERD in an open-label study.1

Proven healing

NEXIUM healed most patients aged 1 to 11 years with varying grades of erosive esophagitis in an open-label study.*2

*Although most of the patients who had a follow-up endoscopy at the end of 8 weeks healed, spontaneous healing cannot be ruled out.

In patients aged 1 to 17 years, the use of NEXIUM is supported by extrapolation of results from adequate and well-controlled studies in adults.1

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

Excellent formulary coverage

The majority of patients with prescription drug coverage for NEXIUM pay $1 or less per day.†‡3

Individual out-of-pocket costs may vary.
 

The majority of NEXIUM prescriptions written require no prior authorization,§//4 which can clear obstacles for medical staff.

§Individual plans may vary.
Details

Individual out-of-pocket costs may vary. Based on monthly out-of-pocket retail pharmacy costs for Commercial Insurance and Medicare Part D Standard Eligible patients. Excluding claims from Medicare Part D Low Income Subsidy and Dual Eligibles, Cash (uninsured), and Medicaid, the percentage of beneficiaries paying $30 or less per month in out-of-pocket costs ranged from 55.97% to 65.85% during the most recent twelve-month period. Data included claims covering 4,100 plans.

//Wolters Kluwer Health, Dynamic Claims, January - March 2009. Database included over 1 million NEXIUM pharmacy benefit claims during the 1st quarter of 2009 (last accessed May 11, 2009).

Patient Support

Help patients get the most from their prescribed treatment through the Purple Plus™ Program.

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Educational Resources

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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 treatment 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. Prescribing Information for NEXIUM.
  2. Data on file, eSTaR #263720.
  3. Data on file, eSTaR #271299: Wolters Kluwer Health, Dynamic Claims, April 2008 - March 2009 (last accessed May 13, 2009).
  4. Data on file, eSTaR# 268197: Wolters Kluwer Health, Dynamic Claims, January - March 2009 (last accessed May 11, 2009).