Frequently Asked Questions

ACIPHEX^®, or rabeprazole sodium, is a proton pump inhibitor (PPI). This class of drugs works by inhibiting
gastric acid secretion. ACIPHEX^® is available in the form of ACIPHEX^® 20 mg delayed-release tablets.¹

• In adults (≥18 years of age), ACIPHEX^® 20 mg is indicated for: treatment of daytime and nighttime heartburn and other symptoms associated with GERD; short-term, up to 4 weeks, treatment in the healing and symptomatic relief of duodenal ulcers; short-term, 4 to 8 weeks, treatment in the healing and symptomatic relief of erosive GERD; and maintenance of healing and reduction in relapse rates of heartburn symptoms in erosive GERD (controlled maintenance studies do not extend beyond 12 months)
• In adults, ACIPHEX^® 20 bid, in combination with amoxicillin 1000 mg bid and clarithromycin 500 mg bid, for 7 days is indicated for H. pylori eradication to reduce the risk of duodenal ulcer recurrence
• In adolescent patients 12 years of age and above, ACIPHEX^® 20 mg is indicated for: short-term, up to 8 weeks, treatment of daytime and nighttime heartburn and other symptoms associated with GERD
• ACIPHEX^® is also indicated for the long-term treatment of pathological hypersecretory conditions, including Zollinger-Ellison syndrome. Dosage varies with the individual patient; recommended adult oral starting dose is 60 mg QD. Doses up to 100 mg QD and 60 mg bid have been administered

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IMPORTANT SAFETY INFORMATION

Contraindications:

• ACIPHEX^® is contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles, or to any component of the formulation

Warnings and Precautions:

• Symptomatic response to therapy does not preclude the presence of gastric malignancy
• As with all PPIs, patients treated concomitantly with warfarin may need to be monitored for increases in INR and prothrombin time. Increases in INR and prothrombin time may lead to abnormal bleeding and even death
• Long-term and multiple daily dose 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 PPIs. Serious adverse events include tetany, arrhythmias, and seizures. Consider monitoring magnesium levels in patients on prolonged PPI therapy or concomitant medications such as digoxin or medications that may cause hypomagnesemia (eg, diuretics)

Adverse Events:

• In adolescents, the related reported adverse reactions that occurred in ≥2% of patients were headache and nausea. The adverse reactions reported without regard to relationship to ACIPHEX^® that occurred in ≥2% of patients were headache, diarrhea, nausea, vomiting, and abdominal pain
• In adults, clinical trials revealed the following adverse reactions appearing in ≥2% of ACIPHEX^® patients and with a frequency greater than placebo: pain, pharyngitis, flatulence, infection, and constipation

Drug Interactions:

• ACIPHEX^® inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, iron salts and digoxin)
• ACIPHEX^® may reduce the plasma levels of atazanavir
• Rabeprazole has been shown to inhibit cyclosporine metabolism in vitro

Use of ACIPHEX^® for H. pylori Eradication:

• In H. pylori clinical trials using combination therapy with rabeprazole sodium plus amoxicillin and clarithromycin (RAC), no adverse events unique to this drug combination were observed. In the US multicenter study, the most frequently reported drug-related adverse events for patients who received RAC therapy for 7 days were diarrhea (8%) and taste perversion (6%)
• No clinically significant laboratory abnormalities particular to the drug combinations were observed
• Clarithromycin is contraindicated in patients taking cisapride or pimozide; or in patients with a known hypersensitivity to clarithromycin or any macrolide antibiotic. Clarithromycin may elevate digoxin serum concentrations. Serum digoxin levels should be carefully monitored while digoxin and clarithromycin are taken concomitantly. Clarithromycin should not be used in pregnant women except in circumstances where no alternative therapy is appropriate. (See WARNINGS and Drug Interactions in Prescribing Information for clarithromycin.) Amoxicillin is contraindicated in patients who are allergic to any penicillin
• For more information on adverse events or laboratory changes with amoxicillin or clarithromycin, refer to their respective full Prescribing Information

For more information about ACIPHEX^®, see full Prescribing Information.

Click here to view full Prescribing Information for ACIPHEX^®.

Of the total number of subjects in clinical studies of ACIPHEX^®, 19% were 65 years and over, while 4% were 75 years and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.¹

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One ACIPHEX^® 20 mg tablet daily is indicated for the treatment of daytime and nighttime heartburn and other symptoms associated with GERD in adults and adolescents 12 years of age and above. Use of ACIPHEX^® in adolescent patients 12 years of age and above for short-term treatment of GERD is supported by extrapolation of results from adequate and well-controlled studies that supported the approval of ACIPHEX^® for adults and safety and pharmacokinetic studies performed in adolescent patients. The safety and effectiveness of ACIPHEX^® for the treatment of GERD patients <12 years of age have not been established. The safety and effectiveness of ACIPHEX^® for other uses in patients <18 years of age have not been established.

In a multicenter, randomized, open-label, parallel-group study, 111 adolescent patients 12 to 16 years of age with a clinical diagnosis of symptomatic GERD or suspected or endoscopically proven GERD were randomized and treated with either ACIPHEX^® 10 mg^* or ACIPHEX^® 20 mg once daily for up to 8 weeks for the evaluation of safety and efficacy.

The adverse event profile in adolescent patients was similar to that of adults. The related reported adverse reactions that occurred in ≥2% of patients were headache (5.4%) and nausea (1.8%). There were no adverse reactions reported in these studies that were not previously observed in adults.¹

*ACIPHEX^® 10 mg is not approved for use in the United States.

In 2 US multicenter, double-blind, randomized, parallel-group studies (N=209; N=285; P<0.001 vs placebo), 90% and 86% of patients with previously healed erosive or ulcerative GERD remained healed at 1 year. Of patients taking placebo, 29% remained healed at 1 year in both studies.

In these same studies (N=209, P=0.001 vs placebo; N=285, 0.001<P<0.05 vs placebo, respectively), 98% and 91% of patients with previously healed erosive or ulcerative GERD were without relapse of nighttime heartburn severity at 1 year. Of patients taking placebo, 66% and 74% were without relapse of nighttime heartburn severity. In the same 2 clinical trials, results for ACIPHEX^® were similarly significant at 1 year in preventing relapse of daytime heartburn severity—97% and 94% (P=0.001) vs 69% and 74% for placebo. Controlled studies do not extend beyond 12 months.¹

Unlike other PPIs, ACIPHEX^® is not solely metabolized by the cytochrome P450 system. In addition to being metabolized by this system in the liver, a substantial portion of ACIPHEX^® is systemically metabolized via nonenzymatic reduction. The 2 primary metabolites of ACIPHEX^® are thioether and sulphone. The correlation of these data to clinical effect has not been established.^1,2

Yes, ACIPHEX^® triple therapy (ACIPHEX^® 20 mg bid, amoxicillin 1000 mg bid and clarithromycin 500 mg bid) is the first and only 7-day treatment for the eradication of H. pylori.¹ Please refer to the full Prescribing Information for ACIPHEX^®.

ACIPHEX^® can conveniently be taken with or without food.¹

No. ACIPHEX^® is available only by prescription.

• The ACIPHEX^® Patient Assistance Program (PAP) is a resource that helps eligible patients afford their ACIPHEX^® prescription. To learn more or to request application materials on behalf of your patients in need, please call 1-800-523-5870. In most cases, an application will be sent by fax to your office
• The Partnership for Prescription Assistance (PPA) helps qualifying patients who lack prescription coverage get the medicines they need through the public or private program that is right for them. For more information, visit www.pparx.org or call toll-free 1-888-4PPA-NOW (1-888-477-2669). Qualified patients will receive application materials by mail—these materials must be completed by you and your patient. Once enrolled, patients will be directed to pick up their medicine (in this case, ACIPHEX^®) at your office

Healthcare professionals can call Eisai Inc. Medical Services at 1-888-422-4743 or Janssen Medical Information at 1-800-JANSSEN (1-800-526-7736) 9 AM—5 PM ET, Monday through Friday. For more information, click here.