NEXIUM Pediatric GERD Information

The primary objective of the pediatric development program was to evaluate the safety profile of NEXIUM in patients 1 to 11 years of age1

  • No new safety concerns were identified in patients 1 to 11 years of age1-2
  • No clinically important safety findings and trends in hematology, clinical chemistry, urinalysis, vital signs, or physical examination were observed (n=108)1 

Experience with NEXIUM in pediatric patients with erosive esophagitis (EE)

  • In 34 pediatric patients with EE who had baseline and follow-up endoscopies, 85% had resolution of EE after 8 weeks on NEXIUM 10 mg or 20 mg daily1
  • Although most of the patients who had a follow-up endoscopy at the end of 8 weeks were healed, spontaneous healing cannot be ruled out

Pediatric data of healing erosive esophagitis

Data from a phase III, multicenter, randomized, open-label to treatment, double-blinded to dose, parallel-group study evaluating the safety and clinical outcome of NEXIUM in patients aged 1 to 11 years with GERD, treated once daily with NEXIUM 5 mg, NEXIUM 10 mg, or NEXIUM 20 mg for 8 weeks. Dosing was determined by patient weight. A total of 109 patients of both sexes with endoscopically proven GERD were enrolled, with 101 patients completing the study. Of the 109 patients, 53 had EE at baseline (51 had mild, 1 moderate, and 1 severe).1

Patients were considered healed if their final follow-up endoscopy showed no signs of erosions.

†Among all patients studied who had a follow-up endoscopy (n=45), overall resolution of EE was 88.9% (n=40) across varying grades of EE.

Next: NEXIUM I.V. for Injection

1000104-2067505 Last updated 2/13

Have a Question?

Talk to your Personal Account Specialist to get answers about NEXIUM.

Get Connected

Patient Support

Help eligible patients save on NEXIUM prescriptions with The NEXIUM Savings Card.

Learn More

Sign Up

Receive updates and offers from the maker of NEXIUM.

Register Now

Visit the AstraZeneca medical affairs Web site to get answers to questions about NEXIUM.

Go to AZ US Medical Information

Important Safety Information

  • NEXIUM is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles
  • Symptomatic response to therapy does not rule out the presence of gastric malignancy
  • Atrophic gastritis has occasionally been noted with long-term therapy with omeprazole
  • PPI therapy may be associated with increased risk of Clostridium difficile-associated diarrhea
  • Avoid concomitant use of NEXIUM with clopidogrel, due to a reduction in plasma concentrations of the active metabolite of clopidogrel. When using NEXIUM consider alternative anti-platelet therapy
  • Long-term and multiple daily dose proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine
  • Hypomagnesemia has been reported rarely with prolonged treatment with PPI therapy and may require discontinuing PPI therapy 
  • Concomitant use of NEXIUM and St. John’s wort or rifampin can substantially decrease NEXIUM concentrations. Avoid concomitant use
  • Concomitant use of NEXIUM and atazanavir or nelfinavir is not recommended. NEXIUM may increase the plasma levels of saquinavir. Dose reduction of saquinavir should be considered
  • Patients treated with PPIs and warfarin concomitantly may need to be monitored for increases in INR and prothrombin time. Esomeprazole may interfere with the absorption of drugs for which gastric pH affects bioavailability (eg, ketoconazole, iron salts, and digoxin)
  • NEXIUM may increase systemic exposure of cilostazol and one of its active metabolites. Consider dose reduction
  • NEXIUM I.V. should be used only when oral therapy with NEXIUM is not possible or appropriate
  • In adults, the most frequently reported adverse reactions (ARs) with NEXIUM include headache, diarrhea, and abdominal pain
  • The ARs reported at a frequency of 1% or greater with NEXIUM I.V. in clinical trials were headache, flatulence, nausea, abdominal pain, injection site reaction, diarrhea, dry mouth, dizziness/vertigo, constipation, and pruritus
  • In pediatric patients 1 to 17 years of age, the most frequently reported ARs with NEXIUM include headache, diarrhea, abdominal pain, nausea, and somnolence

Indications

NEXIUM 40 mg and 20 mg are indicated for short-term treatment (4 to 8 weeks) in healing and symptomatic resolution of diagnostically confirmed erosive esophagitis (EE). NEXIUM 20 mg is indicated to maintain symptom resolution and healing of EE (controlled studies did not extend beyond 6 months), and for short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD.

Prescribing Information with Medication Guide for NEXIUM. (PDF – 303 KB)

Prescribing Information for NEXIUM I.V. (PDF – 72 KB)

References

1.     Data on file, eSTaR #263720.

2.     Prescribing Information for NEXIUM, AstraZeneca Pharmaceuticals LP, Wilmington, DE.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.