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NEXIUM Packets for Infants

When your patients need the proven effectiveness* of NEXIUM in an oral suspension form

CHOOSE NEXIUM PACKETS!

Order Samples Here
 

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 first-line treatment

  • Proven effectiveness of NEXIUM in the treatment of symptomatic GERD and the healing of erosive esophagitis in pediatric patients as young as 1 year old and in adults*

  • The only proton pump inhibitor (PPI) for oral suspension approved for children as young as 1 month old1-5

  • Savings support for eligible commercially insured patients is available

Order Samples

Online product sample request for NEXIUM Packets

Confirm your eligibility to access samples.

Register with AZ TouchPoints to confirm your sample eligibility. If you are eligible, you can:

  • Check sample availability and select quantities

  • Place an order for AstraZeneca samples of NEXIUM Packets

  • Have samples delivered directly to your office

REGISTER NOW      

Already registered?

Access the sample center by logging in using your e-mail address and password.

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

Commercially insured patients may save with the NEXIUM Packets Savings Card

NEXIUM Packets Coupon Savings Card
 
Patients can download a NEXIUM Packets Savings Card at www.nexiumpackets.com

  • With the Savings Card, most commercially insured patients pay just $15 a month, or $30 for a 90-day supply

  • NEXIUM Packets has Preferred access for the majority of Commercial and Medicare Part D patients nationwide6‡§

Patients can get their Savings Card at www.nexiumpackets.com

Indications

Pediatric Indications

  • Short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD, with or without erosive esophagitis, 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 erosive esophagitis 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 erosive esophagitis

    1. — Maintenance of symptom resolution and healing of erosive esophagitis (controlled studies did not extend beyond 6 months)

  • Short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD

NEXIUM Packets dosing—Greatest dosing flexibility among PPIs1
  • Once-daily dosing

  • NEXIUM Packets comes in 5 pre-measured doses: 2.5 mg, 5 mg, 10 mg, 20 mg, and 40 mg

    1. — Flexible pediatric dosing based on patient weight or age, including 2.5-mg dose for infants weighing as little as 3 kg to 5 kg

  • NEXIUM Packets does not require refrigeration and is easy to store

  • Mixes with water

    1. — Additional studies have shown that NEXIUM Packets may also be prepared with orange juice or apple juice instead of water7

    2. — NEXIUM Packets can be mixed with applesauce, but should not be mixed with other foods7

NEXIUM Packets has no generic equivalent.8

Recommended dosage schedule

NEXIUM Packets Dosing Chart NEXIUM Packets Dosing Chart
 

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

NEXIUM Packets for oral administration

For administration through a nasogastric (NG) or gastric tube

Please see the Medication Guide for administration details.

NEXIUM Efficacy

Clinical outcomes in patients aged 1-11 years old

In an 8-week study, NEXIUM significantly reduced symptoms of endoscopically confirmed GERD#9,10

Symptom improvement bar chart from pediatric pcva split 

	into <20 kg and >20 kg results

Symptom improvement bar chart from pediatric pcva split 

	into <20 kg and >20 kg results

  • Parent/guardian-reported mean GERD symptom scores at baseline assessment (for the previous 72 h) and at the final visit (average of final-week scores) for the intention-to-treat population. Scores were recorded as 0 (none) to 3 (severe)

NEXIUM significantly improved GERD symptoms from baseline in all of the treatment groups10

NEXIUM had a significant effect on symptom resolution of erosive esophagitis across dosage strengths:

  • 100% in patients taking 5 mg

  • 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

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 erosive esophagitis 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.

In patients aged 12 to 17 years old

Significant improvement in GERD symptom scores12††
  • Patient-reported symptom scores were significantly reduced from baseline at Week 8 after treatment with NEXIUM 20 mg or 40 mg (P<.0001)

    1. — Heartburn

    2. — Epigastric pain

    3. — Acid regurgitation

In adults

Proven healing of erosive esophagitis:

In GERD patients with varying grades of erosive esophagitis‡‡ through 8 weeks1,13,14§§

  • 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=24251,13; 94% vs 87%, respectively, P<.001, and 90% NEXIUM 20 mg QD vs 87% omeprazole 20 mg QD, P<.05, N=19601,14)

Healing of erosive esophagitis 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)15§§

  • 91% of patients were healed with NEXIUM 20 mg QD (n=587) compared to 88% on omeprazole 20 mg QD (n=588) (P=NS)16§§

  • 93% of patients were healed with NEXIUM 40 mg QD (89% with lansoprazole 30 mg QD, P=.0001, N=5241)17||||

  • In patients with moderate-to-severe erosive esophagitis,‡‡ 82% of patients on NEXIUM 40 mg QD healed (78% with lansoprazole 30 mg QD, P=.007, N=999)18||||

Proven, 24-hour symptom relief in patients with erosive esophagitis13-15

  • 85%-91% heartburn-free nights¶¶##

  • 73%-75% heartburn-free days¶¶##


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

Safety#

In a clinical trial of 109 patients aged 1-11 years1,9:

  • In this study, the most frequently reported treatment-related adverse events 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 trials1:

  • 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 events 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 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 for NEXIUM

  • NEXIUM is contraindicated in patients with known hypersensitivity to any component ... Read Moreof 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 ... Read More

  • Acute interstitial nephritis has been observed in patients taking PPIs including NEXIUM. Discontinue NEXIUM if acute interstitial nephritis develops

  • 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

  • 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

  • NEXIUM I.V. should be used only when oral therapy with NEXIUM is not possible or appropriate

  • 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 a pediatric study of 98 patients, age 1 to 11 months, the most frequently reported adverse reactions (incidence 1%) include abdominal pain, regurgitation, tachypnea, and increased ALT. In a pediatric study of 43 patients, age 1 to 11 months, the most frequently reported adverse reactions (incidence ≥5%) irrespective of causality were irritability and vomiting

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

  • NEXIUM is indicated for the short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year and older

  • NEXIUM is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. In infants 1 month to less than 1 year, NEXIUM is indicated for the short-term treatment (up to 6 weeks) of erosive esophagitis due to acid mediated gastroesophageal reflux disease (GERD)

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

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

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.

References:

1. Prescribing Information for NEXIUM. AstraZeneca Pharmaceuticals LP, Wilmington, DE.
2. Prescribing Information for Aciphex. Management Co, Ltd, Eisai Inc, Woodcliff Lake, NJ.
3. Prescribing Information for Protonix. Wyeth Pharmaceuticals, Inc, a subsidiary of Pfizer Inc, Philadelphia, PA.
4. Prescribing Information for Prilosec. Procter & Gamble, Inc, Cincinnati, OH.
5. Prescribing Information for Prevacid. Novartis Consumer Health, Inc, Parsippany, NJ.
6. Fingertip Formulary®.12/11/15.
7. Bladh N, Blychert E, Johansson K, et al. A new esomeprazole packet (sachet) formulation for suspension: In vitro characteristics and comparative pharmacokinetics versus intact capsules/tablets in healthy volunteers. Clin Ther. 2007:29(4):640-649.
8. Food and Drug Administration. Approved drug products with therapeutic equivalence evaluations. 35th Ed. http://www.fda.gov/downloads/%20Drugs/DevelopmentApprovalProcess/UCM071436.pdf. Updated December 31, 2014. Accessed January 4, 2016.
9. Gilger MA, Tolia V, Vandenplas Y, et al. Safety and tolerability of esomeprazole in children with gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr. 2008,46(5):524-533.
10. Tolia V, Youssef NN, Gilger MA, Traxler B, Illueca M. Esomeprazole for the treatment of erosive esophagitis in children: An international, multicenter, randomized, parallel-group, double-blind (for dose) study. BMC Pediatr. 2010:10:41.
11. AstraZeneca. A phase III, multicentre, randomized, double-blind parallel-group study to evaluate the safety and clinical outcome of once daily esomeprazole for the treatment of gastroesophageal reflux disease (GERD) in pediatric patients 1 to 11 years of age, inclusive. 2006; Clinical study report #D9614C00097.
12. Gold BD, Gunasekaran T, Tolia V, et al. Safety and symptom improvement with esomeprazole in adolescents with gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr. 2007;45:520-529.
13. Richter JE, Kahrilas PJ, Johanson J, et al. Efficacy and safety of esomeprazole compared with omeprazole in GERD patients with erosive esophagitis: A randomized controlled trial. Am J Gastroenterol. 2001;96:656-665.
14. Kahrilas PJ, Falk GW, Johnson DA, et al. Esomeprazole improves healing and symptom resolution as compared with omeprazole in reflux oesophagitis patients: A randomized controlled trial. The Esomeprazole Study Investigators. Aliment Pharmacol Ther. 2000;14:1249-1258.
15. Schmitt C, Lightdale CJ, Hwang C, et al. A multicenter, randomized, double-blind, 8 week comparative trial of standard doses of esomeprazole (40 mg) and omeprazole (20 mg) for the treatment of erosive esophagitis. Dig Dis Sci. 2006;51:844-850.
16. Lightdale CJ, Schmitt C, Hwang C, et al. A multicenter, randomized, double-blind, 8-week comparative trial of low-dose esomeprazole (20 mg) and standard-dose omeprazole (20 mg) in patients with erosive esophagitis. Dig Dis Sci. 2006;51:852-857.
17. Castell DO, Kahrilas PJ, Richter JE, et al. Esomeprazole (40 mg) compared with lansoprazole (30 mg) in the treatment of erosive esophagitis. Am J Gastroenterol. 2002;97:575-583.
18. Fennerty MB, Johanson JF, Hwang C, et al. Efficacy of esomeprazole 40 mg vs. lansoprazole 30 mg for healing moderate to severe erosive oesophagitis. Aliment Pharmacol Ther. 2005;21:455-463.

AZ&me

Important Safety Information for NEXIUM

  • NEXIUM is contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any component of the formulation... Read More

  • 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

  • Acute interstitial nephritis has been observed in patients taking proton pump inhibitors including NEXIUM, and may occur at any time. Discontinue NEXIUM if acute interstitial nephritis develops

  • 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

  • Proton pump inhibitor therapy may be associated with increased risk of Clostridium difficile-associated diarrhea, especially in hospitalized patients

  • 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

  • Proton pump inhibitors (PPI) may be associated with an increased risk or osteoporosis-related fractures of the hip, wrist, or spine. The risk was increased in patients who received high-dose, defined as multiple daily doses and year or longer PPI therapy

  • Hypomagnesemia has been reported rarely in patients treated with proton pump inhibitors for at least 3 months and in most cases over a year of therapy. Serious adverse events include tetany, arrhythmias, and seizures. Treatment required magnesium replacement and discontinuation of the proton pump inhibitor

  • 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 proton pump inhibitors 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)

  • In pediatric patients 1 to 17 years of age, the most frequently reported adverse reactions (incidence ≥2%) include headache, diarrhea, abdominal pain, nausea, and somnolence

  • In a pediatric study of 98 patients, age 1 to 11 months, the most frequently reported adverse reactions (incidence 1%) include abdominal pain, regurgitation, tachypnea, and increased ALT. In pediatric study of 43 patients, age 1 to 11 months, the most frequently reported adverse reactions (incidence ≥5%) irrespective of causality were irritability and vomiting

Indications

  • NEXIUM is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. In infants 1 month to less than 1 year, NEXIUM is indicated for the short-term treatment (up to 6 weeks) of erosive esophagitis due to acid mediated gastroesophageal reflux disease (GERD)

  • NEXIUM is indicated for the short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year and older

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

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

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.

< BACK to NEXIUMtouchpoints.com

NEXIUM Packets for Infants

When your patients need the proven effectiveness* of NEXIUM in an oral suspension form

CHOOSE NEXIUM PACKETS!

Order Samples Here
 
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 first-line treatment

  • Proven effectiveness of NEXIUM in the treatment of symptomatic GERD and the healing of erosive esophagitis in pediatric patients as young as 1 year old and in adults*

  • The only proton pump inhibitor (PPI) for oral suspension approved for children as young as 1 month old1-5

  • Savings support for eligible commercially insured patients is available

Order Samples

Online product sample request
for NEXIUM Packets

Confirm your eligibility to access samples.

Register with AZ TouchPoints to confirm your sample eligibility. If you are eligible, you can:

  • Check sample availability and select quantities

  • Place an order for AstraZeneca samples of NEXIUM Packets

  • Have samples delivered directly to your office

REGISTER NOW      

Already registered?

Access the sample center by logging in using your e-mail address and password.

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

Commercially insured patients may save with the NEXIUM Packets Savings Card

NEXIUM Packets Coupon Savings Card

Patients can download a NEXIUM Packets Savings Card at www.nexiumpackets.com

 
  • With the Savings Card, most commercially insured patients pay just $15 a month, or $30 for a 90-day supply

  • NEXIUM Packets is covered for the majority of Commercial and Medicare Part D patients nationwide6‡§

Indications

Pediatric Indications

  • Short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD, with or without erosive esophagitis, 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 erosive esophagitis 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 erosive esophagitis

    1. — Maintenance of symptom resolution and healing of erosive esophagitis (controlled studies did not extend beyond 6 months)

  • Short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD

NEXIUM Packets dosing—Greatest dosing flexibility among PPIs1
  • Once-daily dosing

  • NEXIUM Packets comes in 5 pre-measured doses: 2.5 mg, 5 mg, 10 mg, 20 mg, and 40 mg

    1. — Flexible pediatric dosing based on patient weight or age, including 2.5-mg dose for infants weighing as little as 3 kg to 5 kg

  • NEXIUM Packets does not require refrigeration and is easy to store

  • Mixes with water

    1. — Additional studies have shown that NEXIUM Packets may also be prepared with orange juice or apple juice instead of water7

    2. — NEXIUM Packets can be mixed with applesauce, but should not be mixed with other foods7

NEXIUM Packets has no generic equivalent.8

Recommended dosage schedule

NEXIUM Packets Dosing Chart
 

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

NEXIUM Packets for 

	oral administrationNEXIUM Packets 

	for oral administration
NEXIUM Packets for oral administration

For administration through a nasogastric (NG) or gastric tube

Please see the Medication Guide for administration details.

NEXIUM Efficacy

Clinical outcomes in patients aged 1-11 years old

In an 8-week study, NEXIUM significantly reduced symptoms of endoscopically confirmed GERD#9,10

Symptom improvement bar chart from pediatric pcva split 

	into <20 kg and >20 kg results

Symptom improvement bar chart from pediatric pcva split 

	into <20 kg and >20 kg results

  • Parent/guardian-reported mean GERD symptom scores at baseline assessment (for the previous 72 h) and at the final visit (average of final-week scores) for the intention-to-treat population. Scores were recorded as 0 (none) to 3 (severe)

NEXIUM significantly improved GERD symptoms from baseline in all of the treatment groups10

NEXIUM had a significant effect on symptom resolution of erosive esophagitis across dosage strengths:

  • 100% in patients taking 5 mg

  • 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

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 erosive esophagitis 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.

In patients aged 12 to 17 years old

Significant improvement in GERD symptom scores12††
  • Patient-reported symptom scores were significantly reduced from baseline at Week 8 after treatment with NEXIUM 20 mg or 40 mg (P<.0001)

    1. — Heartburn

    2. — Epigastric pain

    3. — Acid regurgitation

In adults

Proven healing of erosive esophagitis:

In GERD patients with varying grades of erosive esophagitis‡‡ through 8 weeks1,13,14§§

  • 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=24251,13; 94% vs 87%, respectively, P<.001, and 90% NEXIUM 20 mg QD vs 87% omeprazole 20 mg QD, P<.05, N=19601,14)


Healing of erosive esophagitis 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)15§§

  • 91% of patients were healed with NEXIUM 20 mg QD (n=587) compared to 88% on omeprazole 20 mg QD (n=588) (P=NS)16§§

  • 93% of patients were healed with NEXIUM 40 mg QD (89% with lansoprazole 30 mg QD, P=.0001, N=5241)17||||

  • In patients with moderate-to-severe erosive esophagitis,‡‡ 82% of patients on NEXIUM 40 mg QD healed (78% with lansoprazole 30 mg QD, P=.007, N=999)18||||

Proven, 24-hour symptom relief in patients with erosive esophagitis13-15
  • 85%-91% heartburn-free nights¶¶##

  • 73%-75% heartburn-free days¶¶##


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

Safety

In a clinical trial of 109 patients aged 1-11 years1,9:

  • In this study, the most frequently reported treatment-related adverse events 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 trials1:

  • 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 events 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 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 for NEXIUM

  • NEXIUM is contraindicated in patients with known hypersensitivity to any component of the formulation or to substituted benzimidazoles... Read More

  • 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

  • Acute interstitial nephritis has been observed in patients taking PPIs including NEXIUM. Discontinue NEXIUM if acute interstitial nephritis develops

  • 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

  • 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

  • In a pediatric study of 98 patients, age 1 to 11 months, the most frequently reported adverse reactions (incidence 1%) include abdominal pain, regurgitation, tachypnea, and increased ALT. In a pediatric study of 43 patients, age 1 to 11 months, the most frequently reported adverse reactions (incidence ≥5%) irrespective of causality were irritability and vomiting

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

  • NEXIUM is indicated for the short-term treatment (4 to 8 weeks) of heartburn and other symptoms associated with GERD in adults and children 1 year and older

  • NEXIUM is indicated for the short-term treatment (4 to 8 weeks) in the healing and symptomatic resolution of diagnostically confirmed erosive esophagitis. In infants 1 month to less than 1 year, NEXIUM is indicated for the short-term treatment (up to 6 weeks) of erosive esophagitis due to acid mediated gastroesophageal reflux disease (GERD)

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

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

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.

References:

1. Prescribing Information for NEXIUM. AstraZeneca Pharmaceuticals LP, Wilmington, DE.
2. Prescribing Information for Aciphex. Management Co, Ltd, Eisai Inc, Woodcliff Lake, NJ.
3. Prescribing Information for Protonix. Wyeth Pharmaceuticals, Inc, a subsidiary of Pfizer Inc, Philadelphia, PA.
4. Prescribing Information for Prilosec. Procter & Gamble, Inc, Cincinnati, OH.
5. Prescribing Information for Prevacid. Novartis Consumer Health, Inc, Parsippany, NJ.
6. Fingertip Formulary®.12/11/15.
7. Bladh N, Blychert E, Johansson K, et al. A new esomeprazole packet (sachet) formulation for suspension: In vitro characteristics and comparative pharmacokinetics versus intact capsules/tablets in healthy volunteers. Clin Ther. 2007:29(4):640-649.
8. Food and Drug Administration. Approved drug products with therapeutic equivalence evaluations. 35th Ed. http://www.fda.gov/downloads/%20Drugs/ DevelopmentApprovalProcess/UCM071436.pdf. Updated December 31, 2014. Accessed January 4, 2016.
9. Gilger MA, Tolia V, Vandenplas Y, et al. Safety and tolerability of esomeprazole in children with gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr. 2008,46(5):524-533.
10. Tolia V, Youssef NN, Gilger MA, Traxler B, Illueca M. Esomeprazole for the treatment of erosive esophagitis in children: An international, multicenter, randomized, parallel-group, double-blind (for dose) study. BMC Pediatr. 2010:10:41.
11. AstraZeneca. A phase III, multicentre, randomized, double-blind parallel-group study to evaluate the safety and clinical outcome of once daily esomeprazole for the treatment of gastroesophageal reflux disease (GERD) in pediatric patients 1 to 11 years of age, inclusive. 2006; Clinical study report #D9614C00097.
12. Gold BD, Gunasekaran T, Tolia V, et al. Safety and symptom improvement with esomeprazole in adolescents with gastroesophageal reflux disease. J Pediatr Gastroenterol Nutr. 2007;45:520-529.
13. Richter JE, Kahrilas PJ, Johanson J, et al. Efficacy and safety of esomeprazole compared with omeprazole in GERD patients with erosive esophagitis: A randomized controlled trial. Am J Gastroenterol. 2001;96:656-665.
14. Kahrilas PJ, Falk GW, Johnson DA, et al. Esomeprazole improves healing and symptom resolution as compared with omeprazole in reflux oesophagitis patients: A randomized controlled trial. The Esomeprazole Study Investigators. Aliment Pharmacol Ther. 2000;14:1249-1258.
15. Schmitt C, Lightdale CJ, Hwang C, et al. A multicenter, randomized, double-blind, 8 week comparative trial of standard doses of esomeprazole (40 mg) and omeprazole (20 mg) for the treatment of erosive esophagitis. Dig Dis Sci. 2006;51:844-850.
16. Lightdale CJ, Schmitt C, Hwang C, et al. A multicenter, randomized, double-blind, 8-week comparative trial of low-dose esomeprazole (20 mg) and standard-dose omeprazole (20 mg) in patients with erosive esophagitis. Dig Dis Sci. 2006;51:852-857.
17. Castell DO, Kahrilas PJ, Richter JE, et al. Esomeprazole (40 mg) compared with lansoprazole (30 mg) in the treatment of erosive esophagitis. Am J Gastroenterol. 2002;97:575-583.
18. Fennerty MB, Johanson JF, Hwang C, et al. Efficacy of esomeprazole 40 mg vs. lansoprazole 30 mg for healing moderate to severe erosive oesophagitis. Aliment Pharmacol Ther. 2005;21:455-463.

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1891304-3189608 Last updated 11/15

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