Frequently Asked Questions

In patients with EE, NEXIUM provided day and night symptom relief over 24 hours.^1-3

The percent of heartburn-free* days with NEXIUM 40 mg at Week 4 ranged from 73%–75%, based on patient diaries from 3 studies.^†1-3

With NEXIUM 20 mg, the percent of heartburn-free^† days at Week 4 ranged from 69%–73%, based on patient diaries from 2 studies.^†2,4

*Heartburn-free defined as patient-recorded symptom of “none.”

^†Secondary end points from 4 multicenter, randomized, double-blind trials comparing oral doses of NEXIUM vs omeprazole, administered once daily to patients with endoscopically diagnosed EE. Primary end point was healing of EE at week 8 (N=2425),¹ (N=1960),² (N=1148),³ (N=1175).⁴

NEXIUM 20 mg is the FDA-approved dose for the symptom relief of GERD.

NEXIUM 40 mg and NEXIUM 20 mg are the FDA-approved doses for the healing of EE. There is no correlation between symptom relief and the healing of EE with NEXIUM.

Review data for Symptom Relief.

References

1. Richter JE, Kahrilas PJ, Johanson J, et al. Am J Gastroenterol. 2001;96:656–665.
2. Kahrilas PJ, Falk GW, Johnson DA, et al. Aliment Pharmacol Ther. 2000;14:1249–1258.
3. Schmitt C, Lightdale CJ, Hwang C, et al. Dig Dis Sci. 2006;51:844–850.
4. Lightdale CJ, Schmitt C, Hwang C, et al. Dig Dis Sci. 2006;51:852–857.

In patients with EE, NEXIUM provided day and night symptom relief over 24 hours.^1-3

The percent of heartburn-free* nights with NEXIUM 40 mg at week 4 ranged from 85%–91%, based on patient diaries from 3 studies.^†1-3

With NEXIUM 20 mg, the percent of heartburn-free^† nights at week 4 ranged from 84%–86%, based on patient diaries from 2 studies.^†2,4

*Heartburn-free defined as patient-recorded symptom of “none.”

^†Secondary end points from 4 multicenter, randomized, double-blind trials comparing oral doses of NEXIUM vs omeprazole, administered once daily to patients with endoscopically diagnosed EE. Primary end point was healing of EE at week 8 (N=2425),¹ (N=1960),² (N=1148),³ (N=1175).⁴

NEXIUM 20 mg is the FDA-approved dose for the symptom relief of GERD.

NEXIUM 40 mg and NEXIUM 20 mg are the FDA-approved doses for the healing of EE. There is no correlation between symptom relief and the healing of EE with NEXIUM.

Review data for Symptom Relief.

References

1. Richter JE, Kahrilas PJ, Johanson J, et al. Am J Gastroenterol. 2001;96:656–665.
2. Kahrilas PJ, Falk GW, Johnson DA, et al. Aliment Pharmacol Ther. 2000;14:1249–1258.
3. Schmitt C, Lightdale CJ, Hwang C, et al. Dig Dis Sci. 2006;51:844–850.
4. Lightdale CJ, Schmitt C, Hwang C, et al. Dig Dis Sci. 2006;51:852–857.

In 7 different studies vs omeprazole,* lansoprazole, or pantoprazole (n>16,000, of whom >8000 received NEXIUM), NEXIUM demonstrated excellent erosive esophagitis (EE) healing rates.^1-7

*In 2 of those studies, NEXIUM vs omeprazole, P=NS.

View Healing Data for Erosive Esophagitis and NEXIUM.

References

1. Richter JE, Kahrilas PJ, Johanson J, et al. Am J Gastroenterol. 2001;96:656–665.
2. Kahrilas PJ, Falk GW, Johnson DA, et al. Aliment Pharmacol Ther. 2000;14:1249–1258.
3. Schmitt C, Lightdale CJ, Hwang C, et al. Dig Dis Sci. 2006;51:844–850.
4. Lightdale CJ, Schmitt C, Hwang C, et al. Dig Dis Sci. 2006;51:852–857.
5. Castell DO, Kahrilas PJ, Richter JE, et al. Am J Gastroenterol. 2002;97:575–583.
6. Fennerty MB, Johanson JF, Hwang C, et al. Aliment Pharmacol Ther. 2005;21:455–463.
7. Labenz J, Armstrong D, Lauritsen K, et al. Aliment Pharmacol Ther. 2005;21:739–746.

In one study, healing rates in GERD patients with varying degrees of LA grades A-D of erosive esophagitis (EE)* through 8 weeks were 94% NEXIUM 40 mg vs 84% omeprazole 20 mg (n=2425; P<.001).^†1,2

In another study, healing rates in GERD patients with varying grades of EE* through 8 weeks were 94% NEXIUM 40 mg (P<.001 vs omeprazole 20 mg) vs 90% NEXIUM 20 mg (P<.05 vs omeprazole 20 mg) vs 87% omeprazole 20 mg (n=1960).^†1,3

In 2 additional studies, one with NEXIUM 20 mg and one with NEXIUM 40 mg, NEXIUM healing rates vs omeprazole were compared: 92% NEXIUM 40 mg vs 90% omeprazole 20 mg (n=1148; P=NS), and 91% NEXIUM 20 mg vs 88% omeprazole 20 mg (n=1176; P=NS).^†4,5

*Varying grades of EE defined as LA grades A, B, C, and D erosive esophagitis. 

^†Data from multicenter, randomized, double-blind trials comparing oral doses of NEXIUM vs omeprazole, administered once daily to patients with endoscopically diagnosed EE.^1-5

NEXIUM 40 mg, NEXIUM 20 mg, and omeprazole 20 mg are the FDA-approved doses for the healing of EE.

View Healing Data for Erosive Esophagitis and NEXIUM.

References

1. Prescribing Information for NEXIUM.
2. Richter JE, Kahrilas PJ, Johanson J, et al. Am J Gastroenterol. 2001;96:656–665.
3. Kahrilas PJ, Falk GW, Johnson DA, et al. Aliment Pharmacol Ther. 2000;14:1249–1258.
4. Schmitt C, Lightdale CJ, Hwang C, et al. Dig Dis Sci. 2006;51:844–850.
5. Lightdale CJ, Schmitt C, Hwang C, et al. Dig Dis Sci. 2006;51:852–857.

In one study, healing rates in GERD patients with varying degrees of LA grades A-D of erosive esophagitis (EE)* through 8 weeks were 93% NEXIUM 40 mg vs 89% lansoprazole 30 mg (n=5241; P=.0001).^†1

^†Primary end point from a multicenter, randomized, double-blind, parallel-group, 8-week trial comparing oral doses of NEXIUM 40 mg with lansoprazole 30 mg administered once daily to patients with endoscopically diagnosed EE.¹

In a further study, healing rates in GERD patients with moderate-to-severe (LA grades C-D) EE^‡ through 8 weeks were 82% NEXIUM 40 mg vs 78% lansoprazole 30 mg (n=999; P=.007).^§2 

^‡Primary end point from a multicenter, randomized, double-blind, parallel-group, 8-week trial comparing oral doses of NEXIUM 40 mg with lansoprazole 30 mg administered once daily to patients with endoscopically diagnosed EE.²

In 2 of the 4 pivotal studies, NEXIUM vs omeprazole for the healing of EE, P=NS.

NEXIUM 40 mg, NEXIUM 20 mg, and lansoprazole 30 mg are the FDA-approved doses for the healing of EE.

Get more information on Maintenance & Healing of NEXIUM.

References

1. Castell DO, Kahrilas PJ, Richter JE, et al. Am J Gastroenterol. 2002;97:575–583.
2. Fennerty MB, Johanson JF, Hwang C, et al. Aliment Pharmacol Ther. 2005;21:455–463.

Two multicenter, randomized, double-blind, placebo-controlled, 4-arm trials were conducted in patients with endoscopically confirmed, healed erosive esophagitis (EE) to evaluate NEXIUM 40 mg (n=174), 20 mg (n=180), 10 mg (n=168), or placebo (n=171) once daily over 6 months of treatment.¹

No additional clinical benefit was seen with NEXIUM 40 mg over NEXIUM 20 mg.

Patients remained in remission significantly longer and the number of recurrences of EE was significantly less in patients treated with NEXIUM compared to placebo.¹

In both studies, the proportion of patients on NEXIUM who remained in remission and were free of heartburn and other GERD symptoms was well differentiated from placebo.¹

No additional clinical benefit was seen with NEXIUM 40 mg over NEXIUM 20 mg.

Review “Maintenance of Healing Rates by Month” in figures 2 and 3 on pages 8 and 9 in the Prescribing Information.

NEXIUM 20 mg is the FDA-approved dose for the maintenance of healing of EE.

NEXIUM 40 mg and NEXIUM 20 mg are the FDA-approved doses for the healing of EE.

Read the full Prescribing Information for NEXIUM.

Reference

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

The severity of GERD symptoms may not be a good indicator of erosive esophagitis (EE) severity.^1,2

Review more information on the Prevalence of EE.

References

1. Data on file, eSTaR #267390.
2. Data on file, eSTaR #267405.

In adults, the most frequently reported adverse reactions (ARs) with NEXIUM include headache, diarrhea, and abdominal pain.¹

Review the Safety Profile of NEXIUM and read Important Safety Information for NEXIUM.

Reference

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

In pediatric patients 1 to 17 years of age, the most frequently reported ARs with NEXIUM include headache, diarrhea, abdominal pain, nausea, and somnolence.¹

Review the Safety Profile of NEXIUM and read Important Safety Information for NEXIUM

Reference

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

Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated. Patients at risk for osteoporosis-related fractures should be managed according to established treatment guidelines.¹

Read the Important Safety Information and the full Prescribing Information for NEXIUM

Reference

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

The steady-state pharmacokinetics of esomeprazole obtained after administration of 40 mg once daily to 4 patients each with mild (Child Pugh A), moderate (Child Pugh Class B), or severe (Child Pugh Class C) liver insufficiency were compared to those obtained in 36 male and female GERD patients with normal liver function. In patients with mild and moderate hepatic insufficiency, the AUCs were within the range that could be expected in patients with normal liver function. In patients with severe hepatic insufficiency, the AUCs were 2 to 3 times higher than in the patients with normal liver function. No dosage adjustment is recommended for patients with mild-to-moderate hepatic insufficiency (Child Pugh Classes A and B). However, in patients with severe hepatic insufficiency (Child Pugh Class C), a dose of 20 mg once daily should not be exceeded.¹

Read the Important Safety Information and the full Prescribing Information for NEXIUM

Reference

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

• 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

Read the full Prescribing Information for NEXIUM.

Read the full Prescribing Information for NEXIUM I.V.

May affect plasma levels of antiretroviral drugs—use with atazanavir and nelfinavir is not recommended; if saquinavir is used with NEXIUM, monitor for toxicity and consider saquinavir dose reduction. See section 7.1 of the Prescribing Information.

May interfere with drugs for which gastric pH affects bioavailability (eg, ketoconazole, iron salts, erlotinib, and digoxin). See section 7.2 of the Prescribing Information.

Combined inhibitor of CYP 2C19 and 3A4 may raise esomeprazole levels. See section 7.3 of the Prescribing Information.

Clopidogrel is metabolized to its active metabolite in part by CYP2C19. Concomitant use of esomeprazole 40 mg results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition. Avoid concomitant administration of NEXIUM with clopidogrel. When using NEXIUM, consider use of alternative anti-platelet therapy See section 7.3 of the Prescribing Information.

May increase systemic exposure of cilostazol and an active metabolite. Consider dose reduction. See section 7.3 of the Prescribing Information.

Please refer to the full Prescribing Information for NEXIUM for more information.

Esomeprazole inhibits gastric acid secretion. Therefore, esomeprazole may interfere with the absorption of drugs where gastric pH is an important determinant of bioavail­ability (eg, ketoconazole, atazanavir, iron salts, erlotinib, and digoxin).¹

Read the full Prescribing Information for NEXIUM.

Reference

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

For eligible patients with commercial prescription insurance or without prescription insurance, The NEXIUM Savings Card will cover the first $50 of the cost for each of their next 12 fills of NEXIUM.

This offer is not valid for prescriptions purchased under Medicaid, Medicare, or similar state or federally funded health care programs and is void where prohibited by law, taxed, or restricted.

Get more information about The NEXIUM Savings Card.

There is no generic equivalent of NEXIUM.

However, with The NEXIUM Savings Card, most patients will pay only $18 per month.*^†‡§

Learn more.

*ELIGIBILITY: This offer is good for eligible patients purchasing at least a 30-day supply of NEXIUM^® (esomeprazole magnesium) and may not be used for any other product. This offer is good for the purchase of NEXIUM manufactured for AstraZeneca Pharmaceuticals LP and lawfully purchased from an authorized retailer or distributor in the United States or its territories. This offer is not insurance and is not valid for mail order or prescriptions purchased under Medicaid, Medicare, or similar federal or state programs or for patients who are Medicare eligible and enrolled in an employer-sponsored group waiver health plan or government-subsidized prescription drug benefit program for retirees or for patients younger than one month of age. Offer not valid where prohibited by law, taxed or restricted. Offer is not transferable, is limited to one per person and may not be combined with any other offer. Offer must be presented along with a valid prescription for NEXIUM at the time of purchase.

OFFER: If you have commercial insurance, and your co-pay is more than $18, you may receive up to $50 in savings on each prescription up to 12 prescription fills. If you pay cash for your prescription, you may receive up to $50 in savings on your out-of-pocket costs on each prescription up to 12 prescription fills. This offer expires 14 months from the date of first use. Offer good for up to 12 prescription fills. AstraZeneca reserves the right to change or discontinue this offer at any time without notice. If you have any questions regarding this offer, please call 1-800-236-9933.

^† Source: Wolters Kluwer Pharma Solutions, Dynamic Claims, 6 months ending February 2012.

^‡ Individual out-of-pocket costs may vary. Wolters Kluwer Pharma Solutions retail pharmacy claims data for commercial insurance patients were pulled for 6 months ending February 2012.

^§ The number of approved claims for NEXIUM with a patient‐pay of $68 or less was tallied for each month and divided by the total number of approved claims for NEXIUM each month to determine the percent of the total approved claims for NEXIUM that were for $68 or less. Data included claims covering ~4,100 plans.

If eligible, you can order samples of NEXIUM online, with 24/7 direct access and in-office mail delivery.

Find out more about Online Sampling

You may connect with a representative through AZ Connect, or if you would like additional information regarding AstraZeneca products, you may contact the Information Center at AstraZeneca in the US at 1-800-236-9933, Monday through Friday, 8 AM to 6 PM ET, excluding holidays.

Use the Formulary Finder tool for up-to-date information about health coverage and formulary status.