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Additional Information/
References

More preferred formulary coverage for NEXIUM than before.*¹ Formulary coverage will vary by health plan.
*Preferred coverage is based on data showing coverage of NEXIUM at Tier 1 or Tier 2, and may include prior authorization, quantity limits, step therapy, and other restrictions. Based on the percent of covered lives with access at Tier 1 or Tier 2 status, measured monthly from June, 2006 through December 2009. "Covered lives" includes Commercial, Medicare and Medicaid coverage.

Source: Fingertip Formulary^® database (accessed January 7, 2010). The formulary information reported by Fingertip Formulary covers 95% of the covered lives in the US.

Reference:
1. Data on file, eSTaR #294430: Fingertip Formulary (last accessed January 7, 2010).
The majority of patients with prescription drug coverage for NEXIUM, including Medicare Part D patients, pay $1 or less per day.*¹ 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 54.97% to 62.66% during the most recent twelve-month period. Data included claims covering 4,100 plans.

Source: Wolters Kluwer Health, Dynamic Claims, October 2008 through September 2009 (accessed November 24, 2009).

Reference:
1. Data on file, eSTaR #271299: Wolters Kluwer Health, Dynamic Claims, October 2008 through September 2009, last accessed November 24, 2009.
NEXIUM is available with Preferred formulary status at all 3 of the nation's largest prescription benefit providers—Caremark*, Express Scripts^®† and Medco.^‡1 Individual benefit design may vary. Tier 2 = Preferred; Tier 3 = Non-Preferred, as defined by Express Scripts, Caremark, and Medco Health.
Source: Fingertip Formulary^®, January 12, 2010.

*Caremark Formularies (Primary and Performance).

^†Express Scripts 2010 National Preferred Formulary: Express Scripts 2010 Prime Formulary.

^‡Medco Standard Formularies (Preferred Prescriptions^® and Rx Selections^™).

Reference:
1. Data on file, eSTaR #269188: Fingertip Formulary January 12, 2010.
NEXIUM is available on Tier 2 at all 5 of the nation's largest Medicare Part D plans.¹ Individual plans may vary.
Source: Fingertip Formulary^® database, 1/28/10. Fingertip Formulary data covers 95% of the covered lives in the US.

Reference:
1. Data on file, eSTaR #273833: Fingertip Formulary (last accessed January 28, 2010).
The majority of NEXIUM prescriptions written require no prior authorization.¹ Individual plans may vary.
Source: Wolters Kluwer Health, Dynamic Claims, July through September 2009. Database included over 1 million NEXIUM pharmacy benefit claims during the 3rd quarter of 2009 (last accessed December 15, 2009).

Reference:
1. Data on file, eSTaR #268197: Wolters Kluwer Health, Dynamic Claims, July through September 2009 (last accessed December 15, 2009).

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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

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
Patients treated with proton pump inhibitors and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time. 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 may increase systemic exposure of cilostazol and an active metabolite. Consider dose reduction.
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.

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Source: Fingertip Formulary^® Database, 07/28/10. Fingertip Formulary data covers 95% of the Covered Lives in the U.S.

Tier 1 = generic; Tier 2 = preferred; Tier 3-6 = non-preferred; N/A = not available; NC = not covered; PA = prior authorization; QL = quantity limits; ST = step therapy; OR = other restrictions.

AstraZeneca does not endorse any individual plan or plans.

The list of medications under the "Other Products" menu is provided by Fingertip Formulary^® and does not imply comparable efficacy, safety, or FDA-approved indications. All registered trademarks are registered to their respective companies and are not licensed or manufactured by AstraZeneca.

Fingertip Formulary is a registered trademark of Fingertip Formulary, LLC.

Please visit our Web site at www.NexiumTouchPoints.com/formulary

Please see accompanying Approved Uses and Important Safety Information.

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

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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

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
Patients treated with proton pump inhibitors and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time. 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 may increase systemic exposure of cilostazol and an active metabolite. Consider dose reduction.
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.

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