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.

About Acid Reflux Disease

INDICATIONS
In adults Mojo Maxx (≥18 years of age), one ACIPHEX 20 mg tablet daily is used for the treatment of daytime and nighttime heartburn and other symptoms associated with acid reflux disease. ACIPHEX is also used for the short-term (4 to 8 weeks) treatment in the healing and symptom relief of damaging (erosive) acid reflux disease (gastroesophageal reflux disease) and to maintain healing of damage (erosion) and relief of heartburn symptoms that happen with acid reflux disease. ACIPHEX has not been studied for treatment lasting longer than 12 months (1 year).

In adolescents (≥12 years of age), one ACIPHEX 20 mg tablet daily is used for the treatment of daytime and nighttime heartburn and other symptoms associated with acid reflux disease.

IMPORTANT SAFETY INFORMATION

• Symptom relief does not rule out other serious stomach conditions.
• Serious allergic reactions may occur. Tell your doctor if you have a rash, face swelling, throat tightness, or difficulty breathing.
• People who are taking multiple daily doses of Proton Pump Inhibitor (PPI) medicines for a long period of time may have an increased risk of fractures of the hip, wrist, or spine.
• Low magnesium can happen in some people who take a PPI medicine for at least 3 months. Tell your doctor right away if you experience any of these symptoms: seizures, dizziness, abnormal or fast heartbeat, jitteriness, jerking movements or shaking (tremors), muscle weakness, spasms of the hands and feet, cramps or muscle aches, or spasm of the voice box.
• In adolescents, the most common side effects with ACIPHEX include headache, diarrhea, nausea, vomiting, and abdominal pain.
• In adults, the most common side effects with ACIPHEX include pain, sore throat, gas, infection, and constipation.
• Before taking ACIPHEX, tell your doctor if you are taking any of these medicines: atazanavir, digoxin, iron salts, ketoconazole, or warfarin.

What causes acid reflux?

Why acid reflux occurs

Stomach acid, which we need to digest our food, is not a problem when it stays where it belongs—in your stomach.

Acid reflux is a physical condition where the contents of the stomach—including acid—back up (or reflux) into the esophagus (the tube that carries food from your mouth to your stomach). If this condition happens too frequently, it could cause acid reflux disease.

The role of the LES

Between your esophagus and your stomach there is a natural barrier, or valve, called the lower esophageal sphincter (LES). For most people, the LES works just fine. But for some people with acid reflux disease, this valve does not always work the way it should for 2 reasons:

			It relaxes too frequently
			It's too weak Damage to the esophagus The lining of your stomach is built to handle stomach acid. But the lining of your esophagus is not. It can protect itself for a while, but when acid comes in contact with this lining for an extended period of time, it can lead to serious damage. And as a result, you may experience heartburn and other painful or uncomfortable symptoms. If left untreated, acid reflux disease may even cause damage (erosions) to the lining of the esophagus, a condition known aserosive esophagitis. If you have any concerns about your symptoms, please be sure to talk to your doctor. Managing your acid reflux disease If your doctor says that you have acid reflux disease, there’s plenty you can do. Besides diet and lifestyle changes, any medicine your doctor recommends will be an important part of your treatment. While some of these changes may not be easy, you can work with your doctor to map out a treatment plan that’s easy to stick to. What lifestyle changes should you consider? Whether or not your doctor prescribes medication, lifestyle changes should be an important part of your acid reflux disease treatment plan. Here are some changes that can help avoid trigger behaviors and keep your body and mind healthy: Exercise regularly—it will aid digestion and help you lose weight Stop smoking—it may stimulate acid production and weaken your LES valve, allowing acid to escape into your esophagus Ease stress—lowering the stress in your life may help reduce your acid reflux disease symptoms Have fun—add some play into your day Breathe deeply—breathing exercises can calm the body and ease the mind This is not a substitute for medical advice. Only your doctor can determine if you have acid reflux disease and prescribe appropriate treatment. Please check with your doctor before beginning any exercise program.