Safety Profile for NEXIUM

Proven Safety Profile for NEXIUM

NEXIUM^® (esomeprazole magnesium) is generally well tolerated and has a proven safety profile

• The safety of NEXIUM was evaluated in over 15,000 patients (aged 18 to 84 years) in clinical trials worldwide, including over 8500 patients in the United States and over 6500 patients in Europe and Canada. In general, NEXIUM was well tolerated
• The safety of NEXIUM was evaluated in 316 pediatric patients and adolescent patients aged 1 to 17 years in 4 clinical trials for the treatment of symptomatic GERD. No new safety concerns were identified in pediatric patients
• In over 1000 patients treated with NEXIUM for up to 6 to 12 months, the prevalence of Enterochromaffin-like (ECL) cell hyperplasia increased with time and dose.¹ No patient developed ECL cell carcinoids, dysplasia, or neoplasia in the gastric mucosa

NEXIUM should be used only for the conditions, dosages, and durations specified in the Prescribing Information. Before prescribing NEXIUM, please see the full Prescribing Information (PDF – 303 KB).

Drug Interactions

Drug interaction studies have shown that NEXIUM does not have any clinically significant interactions with¹

• phenytoin
• warfarin
• quinidine
• clarithromycin
• amoxicillin

Postmarketing reports of changes in prothrombin measures have been received among patients on concomitant warfarin and esomeprazole therapy. Patients treated with proton pump inhibitors and warfarin concomitantly 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.

For more information, click here to see the full Prescribing Information (PDF – 303 KB).

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

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