SAFETY AND TOLERABILITY PROFILE OF ACIPHEX®

ACIPHEX® in Adult Patients with Erosive or Ulcerative GERD, Duodenal Ulcers, and Gastric Ulcers

Results from placebo- and active-controlled trials

Adverse reactions appearing in ≥2% of patients treated with ACIPHEX delayed-release tablets versus placebo
  • ADVERSE REACTIONS
  • ACIPHEX vs PLACEBO
  • Pain
  • 3%   vs   1%
  • Pharyngitis
  • 3%   vs   2%
  • Flatulence
  • 3%   vs   1%
  • Infection
  • 2%   vs   1%
  • Constipation
  • 2%   vs   1%

Results from three long-term maintenance studies

The safety profile of rabeprazole in the maintenance studies in adults was consistent with what was observed in the acute studies. Less common adverse reactions seen in controlled clinical trials (<2% of patients treated with ACIPHEX delayed-release tablets) and for which there is a possibility of a causal relationship to rabeprazole, include the following: headache, abdominal pain, diarrhea, dry mouth, dizziness, peripheral edema, hepatic enzyme increase, hepatitis, hepatic encephalopathy, myalgia, and arthralgia.

ACIPHEX in combination with amoxicillin and clarithromycin

  • In clinical trials using combination therapy with rabeprazole plus amoxicillin and clarithromycin (RAC), no adverse reactions unique to this drug combination were observed
  • The most frequently reported drug-related adverse reactions for patients who received RAC therapy for 7 or 10 days were diarrhea (8% and 7%) and taste perversion (6% and 10%), respectively

Safety of ACIPHEX in pediatric patients

  • In a multicenter, open-label study of adolescent patients 12 to 16 years of age with a clinical diagnosis of symptomatic GERD or endoscopically proven GERD, the adverse event profile was similar to that of adults
  • Adverse reactions reported in ≥2% of patients
  • Without regard to relationship to ACIPHEX delayed-release tablets
  • Headache (9.9%), diarrhea (4.5%), nausea (4.5%), vomiting (3.6%), and abdominal pain (3.6%)
  • Related to ACIPHEX delayed-release tablets
  • Headache (5.4%) and nausea (1.8%)

GERD - Gastroesophageal reflux disease, RAC- Rabeprazole + Amoxicillin + Clarithromycin

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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.

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.

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