About ACIPHEX

Learning about ACIPHEX just got easier. In this section you will find:

• Information about ACIPHEX by navigating through an overview, important safety information and dosing information
• How ACIPHEX is metabolized
• Frequently asked questions about ACIPHEX

Overview

Relief of heartburn and other symptoms of nonerosive Erectalis GERD—regurgitation, belching and early satiety.

• At 4 weeks, ACIPHEX significantly reduced the severity of nighttime and daytime heartburn as well as the severity of regurgitation, belching and early satiety (as compared with placebo in patients with nonerosive GERD).¹

Maintenance of healed erosive GERD and relief of heartburn severity at 1 year.

• With ACIPHEX, a majority of patients with previously healed erosive GERD were without relapse of nighttime heartburn severity at 1 year.^2-4
• ACIPHEX maintained endoscopic healing of erosive GERD at 1 year in a majority of patients.^2-4

Potent acid suppression.

• ACIPHEX maintained gastric pH≥4 for a significant portion of a 24-hour period.^1,2
• ACIPHEX maintained esophageal pH≥4 for the majority of the day.^1,2

THE CORRELATION OF THESE PHARMACODYNAMIC DATA TO CLINICAL EFFECT HAS NOT BEEN ESTABLISHED.

• Acid Suppression
• Dosing
• Metabolism
• Important Safety Information
• Frequently Asked Questions

Acid Suppression

Potent gastric acid suppression^1,2

A single-center, double-blind, placebo-controlled, randomized crossover study in healthy H. pylori-negative male subjects (N=24). Analysis was performed in 23 evaluable subjects.

ACIPHEX significantly maintained gastric pH>4 for 44% and 60% of the 24-hour period on day 1 and day 8, respectively.^1,2

THE CORRELATION OF THESE PHARMACODYNAMIC DATA TO CLINICAL EFFECT HAS NOT BEEN ESTABLISHED.

Esophageal pH≥4 on day 7^1,2

A single-center, double-blind, randomized, 2-way crossover study of 20- and 40-mg rabeprazole in GERD patients (N=20). In the 20-mg arm, percentage of time esophageal pH<4 decreased from a baseline of 24.7% to 5.1% on day 7.

THE CORRELATION OF THESE PHARMACODYNAMIC DATA TO CLINICAL EFFECT HAS NOT BEEN ESTABLISHED.

Convenient Once-Daily Dosing²

ACIPHEX 20-mg delayed-release tablet

Small tablet Can be taken with or without food Tablet should be swallowed whole—tablet should not be chewed, crushed or split

Image may not be actual size. Tablet is approximately 0.308 inches in diameter.

Indication	Dose	Treatment Duration
Treatment of symptomatic GERD	20 mg once daily	Up to 4 weeks*
Healing of erosive or ulcerative GERD	20 mg once daily	4-8 weeks*
Maintenance of healing of erosive or ulcerative GERD	20 mg once daily
Healing of duodenal ulcers	20 mg once daily	Up to 4 weeks*

*For those patients who have not healed after the allotted treatment duration, an additional course of ACIPHEX may be considered.

Metabolism

ACIPHEX is not solely metabolized
by the cytochrome P450 system^2,5

A significant portion of ACIPHEX is systemically metabolized via nonenzymatic reduction.

Rabeprazole thioether and rabeprazole sulphone are the 2 primary metabolites of ACIPHEX.

THE CORRELATION OF THESE DATA TO CLINICAL EFFECT HAS NOT BEEN ESTABLISHED.

Important Safety Information

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

As with all PPIs, patients treated concomitantly with warfarin may need to be monitored for increases in INR and prothrombin time, which may lead to abnormal bleeding and even death.

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.

Symptomatic response to therapy does not preclude the presence of gastric malignancy.

ACIPHEX inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (e.g., ketoconazole, iron salts and digoxin).

ACIPHEX may reduce the plasma levels of atazanavir.

Rabeprazole has been shown to inhibit cyclosporine metabolism in vitro.

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.