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 short-trem 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 – 303 KB) for NEXIUM.

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