Frequently Asked Questions
1. What is ACIPHEX?
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
2. What are the indicated uses for ACIPHEX?
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 or 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.
3. How safe is ACIPHEX for use in geriatric patients?
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
Click here for Important Safety Information.
4. Can ACIPHEX be used to treat symptomatic GERD in adolescent patients?
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
5. How effective is ACIPHEX when used as maintenance therapy?
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, 1-year daytime heartburn results for ACIPHEX were similarly significant—97% and 94% (P≤0.001) vs 69% and 74% for placebo. Controlled studies do not extend beyond 12 months.1
6. How is ACIPHEX metabolized?
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
7. Can I use ACIPHEX as part of a treatment regimen for eradication of H. pylori?
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.
8. Does ACIPHEX need to be taken with food?
ACIPHEX can conveniently be taken with or without food.1
9. Is ACIPHEX available without a prescription?
No. ACIPHEX is available only by prescription.
10. What if my patients cannot afford ACIPHEX?
- The ACIPHEX Patient Assistance Program (PAP) is provided to patients as a financial resource to help them 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 (taking multiple medicines) 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
11. How can I obtain more information about ACIPHEX?
Healthcare professionals can call Eisai Inc. Medical Services at 1-888-422-4743 or Ortho-McNeil Janssen Scientific Affairs, LLC at 1-800-526-7736 for more information, or click here.
