Important Safety Information

ACIPHEX (rabeprazole sodium) should not be taken by patients who are allergic to rabeprazole sodium or any of its ingredients. Patients should disclose any medications, such as Methotrexate or Warfarin, that they are taking before taking ACIPHEX, as ACIPHEX can affect how certain oral medications work in the body.

Indication and Usage

ACIPHEX delayed-release tablets are a proton pump inhibitor (PPI) indicated in adults for:

• Healing of Erosive or Ulcerative Gastroesophageal Reflux Disease (GERD)
• Maintenance of Healing of Erosive or Ulcerative GERD.
• Treatment of Symptomatic GERD.
• Healing of Duodenal Ulcers.
• Helicobacter pylori Eradication to Reduce Risk of Duodenal Ulcer Recurrence.
• Treatment of Pathological Hypersecretory Conditions, Including
  • Zollinger-Ellison Syndrome
• In adolescent patients 12 years of age and older for:
  • Short-term Treatment of Symptomatic GERD.

Side Effects

Common side effects of ACIPHEX may include:

• Rash or itching
• Upset stomach
• Diarrhea
• Gas
• Sore throat
• Headache
• Insomnia
• Nervousness

Serious side effects are as follows. Patients taking ACIPHEX are advised to contact their healthcare provider if they experience any of the following symptoms:

• Hepatitis,
• Abnormal brain function or structure (encephalopathy),
• Dizziness,
• Swelling,
• Joint pain, and
• Muscle pains.

Contraindications

• Patients with a history of hypersensitivity to rabeprazole.
• PPIs, including ACIPHEX delayed-release tablets, are contraindicated in patients receiving rilpivirine-containing products.
• Refer to the Contraindications section of the prescribing information for clarithromycin and amoxicillin, when administered in combination with ACIPHEX.

Warnings

• Symptomatic response to therapy with rabeprazole does not preclude the presence of gastric malignancy.
• Use with warfarin: Monitor for increases in INR and prothrombin time.
• Acute interstitial nephritis has been observed in patients taking PPIs.
• Cyanocobalamin (vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin.
• PPI therapy may be associated with increased risk of Clostridium difficile associated diarrhea.
• Bone fracture: 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.

To report SUSPECTED ADVERSE REACTIONS, contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

See Full Prescribing Information for ACIPHEX.

Reference:

1. ACIPHEX [Prescribing information]. Wixom, MI, Woodward Pharma Services LLC, 2021.