NEXIUM PEDIATRIC GERD INFORMATION
spacer

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
NEXIUM Pediatric Efficacy

*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.

2031108-3281229 Last Updated 8/16

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. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a proton pump inhibitor (PPI). In older patients, also consider an endoscopy
  • Acute interstitial nephritis has been observed in patients taking PPIs including NEXIUM. Discontinue NEXIUM if acute interstitial nephritis develops
  • PPI therapy may be associated with increased risk of Clostridium difficile-associated diarrhea. This diagnosis should be considered for diarrhea that does not improve
  • PPI therapy may be associated with an increased risk of osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose (multiple daily doses) and long-term (a year or longer) therapy
  • Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including esomeprazole. These events included both new onset and exacerbations. If signs or symptoms consistent with CLE or SLE are noted with NEXIUM, discontinue and refer the patient to a specialist. Most patients improve with discontinuation of the PPI alone in 4 to 12 weeks
  • 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
  • Daily treatment with any acid-suppressing medications over a long period of time (eg, longer than 3 years) may lead to malabsorption of cyanocobalamin (vitamin B12). Rare reports of cyanocobalamin deficiency occurring with acid-suppressing therapy have been reported in the literature
  • 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
  • Literature suggests that concomitant use of PPIs with methotrexate (primarily at high dose; see methotrexate prescribing information) may elevate and prolong serum levels of methotrexate and/or its metabolite, possibly leading to methotrexate toxicities. In high-dose methotrexate administration, a temporary withdrawal of the PPI may be considered in some patients
  • Concomitant use of NEXIUM and atazanavir or nelfinavir is not recommended. NEXIUM is expected to increase the plasma levels of saquinavir. Consider dose reduction of saquinavir
  • 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 of cilastozol
  • 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
  • In pediatric patients 1 to 11 months the most frequently reported ARs with NEXIUM include abdominal pain, regurgitation, tachypnea, and increased ALT

Approved Uses

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.