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Fewer Hassles in 2009*

See how much NEXIUM can cost the majority of your patients with prescription drug coverage.

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*Fewer Hassles in 2009

  • The majority of patients with prescription drug coverage for NEXIUM pay $1 or less per day‡§6
  • Individual out-of-pocket costs may vary.
  • The majority of NEXIUM prescriptions written require no prior authorization//¶7
  • //Individual plans may vary.

Effective January 1, 2009, NEXIUM is the preferred brand in its class on Express Scripts®  National Preferred Formulary. Express Scripts 2009 National Preferred Formulary; Express Scripts 2009 Prime Formulary.8

§Source: Wolters Kluwer Health, Dynamic Claims, April 2008 - March 2009 (last accessed May 13, 2009). 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-ofpocket costs ranged from 55.97% to 65.85% during the most recent twelve-month period. Data included claims covering 4,100 plans.

Source: 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).

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

  • NEXIUM® (esomeprazole magnesium) is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles
  • In adult patients, the most frequently reported adverse events (AEs) with NEXIUM include headache, diarrhea, and abdominal pain
  • In pediatric patients 1 to 17 years of age, the most frequently reported AEs with NEXIUM include headache, diarrhea, abdominal pain, nausea, and somnolence
  • Symptomatic response to therapy does not preclude the presence of gastric malignancy
  • Atrophic gastritis has been noted occasionally in gastric corpus biopsies from patients treated long-term with omeprazole, of which NEXIUM is an enantiomer
  • As with all PPIs, patients treated concomitantly with warfarin may need to be monitored for increases in INR and prothrombin time. Like other PPIs, esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, iron salts, and digoxin)
  • Concomitant use of NEXIUM and atazanavir or nelfinavir is not recommended because the plasma concentrations and therapeutic effects of those antiretroviral drugs may be reduced
  • NEXIUM may increase the plasma levels of saquinavir. Dose reduction of saquinavir should be considered
  • NEXIUM should be used only for the conditions, dosages, and durations specified in the Prescribing Information. Dosing for adults and pediatrics is provided in the Prescribing Information

References
  1. Labenz J, Armstrong D, Lauritsen K, et al. Aliment Pharmacol Ther. 2005;21:739-746.
  2. Kahrilas PJ, Falk GW, Johnson DA, et al. Aliment Pharmacol Ther. 2000;14:1249-1258.
  3. Fennerty MB, Johanson JF, Hwang C, et al. Aliment Pharmacol Ther. 2005;21:455-463.
  4. Castell DO, Kahrilas PJ, Richter JE, et al. Am J Gastroenterol. 2002;97:575-583.
  5. Richter JE, Kahrilas PJ, Johanson J, et al. Am J Gastroenterol. 2001;96:656-665.
  6. Data on file, eSTaR #271299: Wolters Kluwer Health, Dynamic Claims, April 2008 - March 2009 (last accessed May 13, 2009).
  7. Data on file, eSTaR# 268197: Wolters Kluwer Health, Dynamic Claims, January - March 2009 (last accessed May 11, 2009).
  8. Data on file, eSTaR# 269188: Fingertip Formulary, July 9, 2009.