NEXIUM PACKETS

FOR DELAYED-RELEASE ORAL SUSPENSION

ONCE-DAILY NEXIUM PACKETS

With NEXIUM Packets, the relief you know is available for pediatric and adult patients who have difficulty swallowing pills

  • An FDA-approved treatment
  • Proven effectiveness of NEXIUM in the treatment of symptomatic GERD and the healing of erosive esophagitis (EE) in pediatric patients as young as 1 year old and in adults[1-8],[a]
  • Savings support for eligible commercially insured patients is available

a ^ Use of NEXIUM in pediatric and adolescent patients 1 month to 17 years of age for short-term treatment (up to 6 and up to 8 weeks) of GERD is supported by extrapolation of results from adequate and well-controlled studies for adults as well as safety, pharmacokinetic, and pharmacodynamic studies performed in pediatric and adolescent patients. The safety and effectiveness of NEXIUM have not been established in patients <1 month of age.[1] Please see label for specific dosing and indications.

INDICATIONS[1]

Pediatric Indications

  • Short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD, with or without EE, in pediatric and adolescent patients 1 year of age and older
  • Short-term treatment (up to 6 weeks) in infants aged 1 month to under 1 year with EE due to acid-mediated GERD

The safety and effectiveness of NEXIUM for patients younger than 1 month has not been established.

Adult Indications

  • Short-term treatment (4 to 8 weeks) in healing and symptomatic resolution of diagnostically confirmed EE
    • Maintenance of symptom resolution and healing of EE (controlled studies did not extend
      beyond 6 months)
  • Short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD
See Dosage and Administration

NEXIUM Savings Card—May reduce out-of-pocket costs

NEXIUM Packets for Delayed-Release Oral Suspension is simple to mix and administer

For oral administration:

  • Empty the contents of the packet with the directed amount of water[a]

  • Mix

  • Leave 2-3 minutes to thicken, then stir and administer within 30 minutes

a ^ Additional studies have shown that NEXIUM Packets may also be mixed with apple or orange juice. It can be mixed with applesauce, but should not be mixed with other foods.[9]

For administration through a nasogastric (NG) or gastric tube

Please see the Medication Guide for administration details.

Efficacy

Clinical outcomes in patients aged 1 to 11 years old[a]

In an 8-week study, NEXIUM significantly reduced symptoms of endoscopically confirmed GERD[2],[10],[b]

Mean GERD symptom scores at baseline and final visit[10],[c],[d]

In children with weight <20 kg, mean symptom scores at baseline and final visit with NEXIUM 5 mg (0.3-0.6 mg/kg; n=26) for heartburn, epigastric pain and acid regurgitation were 1.50 vs 0.35 (P<0.001),[c] 1.71 vs 0.52 (P<0.001)[c] and 1.69 vs 0.27 (P<0.001)[c] respectively. In children with weight <20 kg, mean symptom scores at baseline and final visit with NEXIUM 10 mg (0.6-1.0 mg/kg; n=23) for heartburn, epigastric pain and acid regurgitation were 1.70 vs 0.61 (P<0.001),[d] 1.64 vs 0.31 (P<0.001)[c] and 1.38 vs 0.36 (P<0.001)[c] respectively.[10]

In children with weight ≥20 kg, mean symptom scores at baseline and final visit with NEXIUM 10 mg (0.2-0.5 mg/kg; n=31) for heartburn, epigastric pain and acid regurgitation were 1.42 vs 0.11 (P<0.001),[c] 1.50 vs 0.26 (P<0.001)[c] and 1.53 vs 0.23 (P<0.001)[c] respectively. In children with weight ≥20 kg, mean symptom scores at baseline and final visit with NEXIUM 20 mg (0.3-1.0 mg/kg; n=23) for heartburn, epigastric pain and acid regurgitation were 1.46 vs 0.24 (P<0.001),[c] 1.55 vs 0.17 (P<0.001)[c] and 1.67 vs 0.30 (P<0.001)[c] respectively.[10]

NEXIUM improved GERD symptoms from baseline in all of the treatment groups[2]

NEXIUM had an effect on symptom resolution of EE across dosage strengths[2]:

  • 100% in patients taking 5 mg, with weight <20 kg
  • 82% in patients taking 10 mg, with weight <20 kg
  • 90% in patients taking 10 mg, weight ≥20 kg
  • 85% in patients taking 20 mg, with weight ≥20 kg
  • a ^ Use of NEXIUM in pediatric and adolescent patients 1 month to 17 years of age for short-term treatment (up to 6 and up to 8 weeks) of GERD is supported by extrapolation of results from adequate and well-controlled studies for adults as well as safety, pharmacokinetic, and pharmacodynamic studies performed in pediatric and adolescent patients. The safety and effectiveness of NEXIUM have not been established in patients <1 month of age.[1] Please see label for specific dosing and indications.
  • b ^ Data from a Phase III, multicenter, randomized, 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.[2],[10],[11] Dosing was determined by patient weight.[2] 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 Los Angeles (LA) Classification grade A and B, 1 had LA grade C, and 1 had LA grade D).[2],[10] LA EE disease score classification = Grade A: ≥1 mucosal break ≤5 mm and that does not extend between the tops of 2 mucosal folds; Grade B: ≥1 mucosal break ≥5 mm that does not extend between the tops of 2 mucosal folds; Grade C: ≥1 mucosal break that is continuous between the tops of ≥2 mucosal folds but involves <75% of the circumference; Grade D: ≥1 mucosal break that involves ≥75% of the circumference.[2] In this study, A and B grades were considered “mild,” a C grade was considered “moderate,” and a D was considered “severe.”[12]
  • c ^ Mean GERD symptom scores were reported by the parent/guardian of the intention-to-treat population. Scores were recorded as 0 (none) to 3 (severe).[10]
  • d ^ Baseline assessment was conducted for the previous 72 hours and at final visit (average of final week scores).[10]

Approved for infants 1 month to less than 1 year old

Use of NEXIUM in pediatric patients 1 month to less than 1 year of age for treatment (up to 6 weeks) of EE due to acid-mediated GERD is supported by extrapolation of results from adequate and well-controlled studies for adults and safety, pharmacokinetic, and pharmacodynamic studies performed in pediatric patients. Please see label for specific dosing and Indications. The safety and effectiveness of NEXIUM have not been established in patients <1 month of age.[1]

In patients aged 12 to 17 years old

Significant improvement in GERD symptom scores[13],[e]

  • Patient-reported symptom scores were significantly reduced from baseline at Week 8 after treatment with NEXIUM 20 mg or 40 mg (P<.0001)
    • Heartburn
    • Epigastric pain
    • Acid regurgitation

e ^ Data from an international, Phase III, multicenter, randomized, double-blind study of 149 adolescent patients of both sexes, 12 to 17 years of age inclusive, with clinically diagnosed GERD treated with either NEXIUM 20 mg or NEXIUM 40 mg once daily for up to 8 weeks.[13],[14] The primary endpoint of this study was to evaluate the safety and tolerability of once-daily esomeprazole (20 mg or 40 mg). The secondary endpoint included assessment of the clinical outcome of daily esomeprazole therapy in the treatment of GERD-related symptoms in these patients. Patients were not endoscopically characterized as to the presence or absence of EE.[13]

In adults

Proven healing of EE:

In GERD patients with varying grades of EE[f] through 8 weeks[1],[3],[4],[g]

  • 92%–94% of patients healed with NEXIUM 40 mg QD vs omeprazole 20 mg QD patients in 3 of 4 pivotal trials (94% vs 84%, respectively, P<.001, N=2425[1],[3]; 94% vs 87%, respectively, P<.001, and 90% NEXIUM 20 mg QD vs 87% omeprazole 20 mg QD, P<.05, N=1960[1],[4])

Healing of EE in other studies

  • 92% of patients were healed with NEXIUM 40 mg QD (n=576) vs 90% with omeprazole 20 mg QD (n=572) (P=NS)[5],[g]
  • 91% of patients were healed with NEXIUM 20 mg QD (n=587) compared to 88% on omeprazole 20 mg QD (n=588) (P=NS)[6],[g]
  • 93% of patients were healed with NEXIUM 40 mg QD (89% with lansoprazole 30 mg QD, P=.0001, N=5241)[7],[f],[h]
  • In patients with moderate-to-severe EE,[f] 82% of patients on NEXIUM 40 mg QD healed (78% with lansoprazole 30 mg QD, P=.007, N=999)[8],[h]
  • f ^ Varying grades of EE defined as LA grades A, B, C, and D. Moderate-to-severe EE defined as LA grades C and D.[1-8],[3],[4],[7],[8]
  • g ^ Data from multicenter, randomized, double-blind trials comparing oral doses of NEXIUM vs omeprazole, administered once-daily to patients with endoscopically diagnosed EE.[1],[3]
  • h ^ Primary endpoints from multicenter, randomized, double-blind, parallel-group, 8-week trials comparing oral doses of NEXIUM 40 mg vs lansoprazole 30 mg, administered once daily to patients with endoscopically diagnosed EE.[7],[8]

Proven, 24-hour symptom relief in patients with EE[3]

  • 85%–91% heartburn-free nights[i]
  • 73%–75% heartburn-free days[i]

There is no correlation between symptom relief and the healing of EE with NEXIUM.

i ^ Secondary endpoints from 4 multicenter, randomized, double-blind trials comparing oral doses of NEXIUM vs omeprazole, administered once-daily to patients with endoscopically diagnosed EE. Primary endpoint was healing of EE at Week 8 (N=2425)[3], (N=1960)[4], (N=1148)[5], (N=1175).[6] At Week 4: With NEXIUM 40 mg, percent of heartburn-free nights ranged from 85%–91% and heartburn-free days from 73%–75%, based on patient diaries from 3 studies.[3],[5] With NEXIUM 20 mg, percent of heartburn-free nights ranged from 84%–86% and heartburn-free days from 69%–73%, based on patient diaries from 2 studies.[4],[6]

Safety

In a clinical trial of 109 patients aged 1 to 11 years[1],[10]:

  • In this study, the most frequently reported 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)
  • No new safety concerns were identified in pediatric trials vs trials in adults

The safety of NEXIUM was evaluated in 141 pediatric patients aged 1 month to 1 year of age in two clinical trials[1]:

  • For 43 patients aged 1 to 11 months the most frequently reported (≥5%) adverse reactions were irritability and vomiting
  • In this clinical study, pneumonia was not amongst the most common treatment-related adverse reactions reported
  • 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%)
  • No new safety concerns were identified in pediatric trials vs trials in adults

In a clinical trial of 149 pediatric patients aged 12 to 17 years[1]:

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