Pediatric patients

No new safety concerns were identified in pediatric trials vs trials in adults1

1 month to <1 year old

The safety of NEXIUM was evaluated in 141 pediatric patients aged 1 month to <1 year of age in two clinical trials1:

  • For 43 patients aged 1 to 11 months the most frequently reported (≥5%) adverse reactions were irritability and vomiting
  • In 98 patients aged 1 to 11 months, treatment-related adverse reactions were as follows: abdominal pain (1%), regurgitation (1%), tachypnea (1%), and increased alanine aminotransferase (ALT) (1%)
  • In these clinical studies, pneumonia was not among the most common treatment-related adverse events reported

1-11 years old

In a clinical trial of 109 patients aged 1-11 years1,2:

  • The most frequently reported (at least 1%) treatment-related adverse reactions were diarrhea (2.8%), headache (1.9%), and somnolence (1.9%)
  • No clinically important safety findings and trends in hematology, clinical chemistry, urinalysis, vital signs, or physical examination were observed (n=108)

12-17 years old

In a clinical trial of 149 pediatric patients aged 12-17 years1:

  • The most frequently reported (at least 2%) treatment-related adverse reactions in these patients were headache (8.1%), abdominal pain (2.7%), diarrhea (2%), and nausea (2%)
 
 

Important Safety Information

  • NEXIUM is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles and in patients receiving rilpivirine-containing products
  • 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 and magnesium replacement
  • Drugs which induce CYP2C19 or CYP3A4 (such as St. John’s Wort or rifampin) can substantially decrease esomeprazole concentrations. Avoid concomitant use of NEXIUM with St. John's wort or rifampin
  • 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
  • PPI use is associated with an increased risk of fundic gland polyps that increases with long-term use, especially beyond one year. Use shortest duration of PPI therapy appropriate to the condition being treated
  • The effect of NEXIUM on antiretroviral drugs is variable. Decreased exposure of some antiretroviral drugs (eg, rilpivirine, nelfinavir, and atazanavir) and increased exposure of other antiretroviral drugs (eg, saquinavir) are possible when used concomitantly with esomeprazole. Avoid concomitant use of rilpivirine or nelfinavir with NEXIUM
  • Monitor INR and prothrombin time in patients treated with warfarin and NEXIUM, as increases in INR and prothrombin times have been seen
  • NEXIUM may impact systemic exposure of CYP2C19 substrates (eg, citalopram, cilostazol, digoxin, diazepam). Consider dose adjustment and monitor
  • Esomeprazole may interfere with the absorption of drugs for which gastric pH affects bioavailability (eg, erlotinib, dasatinib, nilotinib, ketoconazole, itraconazole, mycophenolate mofetil, and iron salts). Use NEXIUM with caution in transplant patients receiving mycophenolate mofetil
  • NEXIUM may potentially increase exposure of tacrolimus. Monitor tacrolimus concentrations and consider reducing the dose
  • NEXIUM I.V. should be used only when oral therapy with NEXIUM is not possible or appropriate
  • In adults, the most frequently reported (≥1%) adverse reactions (ARs) with oral NEXIUM include headache, diarrhea, nausea, flatulence, abdominal pain, constipation, and dry mouth
  • In pediatric patients 1 to 17 years of age, the most frequently reported (≥2%) ARs with oral NEXIUM include headache, diarrhea, abdominal pain, nausea, and somnolence
  • In pediatric patients 1 to 11 months the most frequently reported (1%) ARs with oral NEXIUM include abdominal pain, regurgitation, tachypnea, and increased ALT
  • 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

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.

Please read full Prescribing Information, Medication Guide and Instructions for Use for NEXIUM Packets.

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