NEXIUM
Works for Me*

Learn more about NEXIUM healing rates versus omeprazole, lansoprazole, and pantoprazole.

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NEXIUM Data

Fewer Hassles
in 2009†‡

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

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*NEXIUM Works for Me

  • In 5 different studies, NEXIUM demonstrated excellent erosive esophagitis (EE) healing rates vs omeprazole§, lansoprazole, or pantoprazole (n>13,500, of whom >7000 received NEXIUM)1-5
  • §In 2 other studies, NEXIUM vs omeprazole, P=NS.8,9
  • Maintained healing of EE in 5 different studies vs lansoprazole, pantoprazole, or placebo (n>5500,of whom >2500 received NEXIUM)1,10-13

†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.14

Source: Wolters Kluwer Health, Dynamic Claims, September 2007 through August 2008 (last accessed October 20, 2008). Based on monthly out-of-pocket retail pharmacy costs for commercial insurance and Medicare Part D standard eligible patients. Excluding claims for 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 61.89% to 67.37% during the most recent 12-month period. Data included claims covering 4100 plans.

**Source: Wolters Kluwer Health, Dynamic Claims, July through September 2008. Database included over 1 million NEXIUM pharmacy benefit claims during the 3rd quarter of 2008 (last accessed December 2, 2008).

Approved Uses and Important Safety Information about NEXIUM

Treatment of Gastroesophageal Reflux Disease (GERD)

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.

Safety and effectiveness for the treatment of symptomatic GERD in patients less than 1 year of age have not been established. 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

Please click here for the full Prescribing Information pdf (PDF – 303 KB) for NEXIUM.

Please see the full Prescribing Information available at the web site for NEXIUM.

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, September 2007 through August 2008 (last accessed October 20, 2008).
  7. Data on file, eSTaR #268197: Wolters Kluwer Health, Dynamic Claims, July through September 2008 (last accessed December 2, 2008).
  8. Schmitt C, Lightdale CJ, Hwang C, et al. Dig Dis Sci. 2006;51:844-850.
  9. Lightdale CJ, Schmitt C, Hwang C, et al. Dig Dis Sci. 2006;51:852-857.
  10. Lauritsen K, Deviere J, Bigard MA, et al. Aliment Pharmacol Ther. 2003;17:333-341.
  11. DeVault KR, Johanson JF, Johnson DA, et al. Clin Gastroenterol Hepatol. 2006;4:852-859.
  12. Johnson DA, Benjamin SB, Vakil NB, et al. Am J Gastroenterol. 2001;96:27-34.
  13. Vakil NB, Shaker R, Johnson DA, et al. Aliment Pharmacol Ther. 2001;15:927-935.
  14. Data on file, eSTaR #269188: Fingertip Formulary database as of December 2008.