ACIPHEX® is a proven treatment option for GERD and other indications

  • In a U.S., multicenter, randomized, double-blind, placebo-controlled study, 103 patients were treated for up to eight weeks with placebo, 10 mg, 20 mg, or 40 mg ACIPHEX delayed-release tablets once daily (Figure 1)
Figure 1. Healing of erosive or ulcerative GERD (ACIPHEX vs Placebo)
  • All ACIPHEX groups reported significantly greater rates of complete resolution of GERD daytime heartburn severity compared to placebo at weeks 4 and 8 (p≤0.036)

  • The percentage of patients healed at endoscopy after four and eight weeks of treatment was statistically superior in the patients treated with ACIPHEX delayed-release tablets compared to ranitidine (Figure 2)
Figure 2. Healing of Erosive or Ulcerative GERD (ACIPHEX vs Ranitidine)

  • The long-term maintenance of healing in patients with erosive or ulcerative GERD previously healed with gastric antisecretory therapy was assessed in two U.S., multicenter, randomized, double-blind, placebo-controlled studies of identical design of 52 weeks duration
  • Patient treated with ACIPHEX delayed-release tablets were significantly superior to placebo in both studies with respect to the maintenance of healing of GERD and the proportions of patients remaining free of heartburn symptoms at 52 weeks (Figure 3)
Figure 3. Heartburn symptoms at week 52

  • Two U.S., multicenter, double-blind, placebo-controlled studies were conducted in 316 adult patients with daytime and nighttime heartburn
  • The percentage of heartburn free daytime and/or nighttime periods was greater with 20 mg ACIPHEX delayed-release tablets as compared to placebo over the 4 weeks of study in RAB-USA-2 (47% vs. 23%) and RAB-USA-3 (52% vs. 28%), respectively
  • Combined analysis showed that ACIPHEX significantly improved other GERD-associated symptoms by week 4 compared with placebo (all p values <0.005)

  • A randomized, double-blind, multicenter study assessed the effectiveness of 20 mg and 40 mg of ACIPHEX delayed-release tablets once daily versus placebo for healing endoscopically defined duodenal ulcers
    (Figure 4)
Figure 4. Healing of Duodenal Ulcers (ACIPHEX vs Placebo)
  • At weeks 2 and 4, significantly more patients in the ACIPHEX 20 mg and 40 mg groups reported complete resolution of ulcer pain frequency (p≤0.018), daytime pain severity (p≤0.023), and nighttime pain severity (p≤0.035) compared with placebo patients

  • An international randomized, double-blind, active-controlled trial was conducted in 205 patients comparing 20 mg ACIPHEX delayed-release tablets once daily with 20 mg omeprazole once daily (Figure 5)
Figure 5. Healing of Duodenal Ulcers (ACIPHEX vs Omeprazole)

  • The U.S. multicenter study was a double-blind, parallel-group comparison of ACIPHEX delayed-release tablets, amoxicillin, and clarithromycin (RAC) for 3, 7, or 10 days vs. omeprazole, amoxicillin, and clarithromycin (OAC) for 10 days
  • The eradication rates in the 7-day and 10-day RAC regimens were found to be similar to 10-day OAC regimen using either the Intent-to-Treat (ITT) or Per-Protocol (PP) populations. Eradication rates in the RAC 3-day regimen were inferior to the other regimens
Helicobacter pylori Eradication at ≥6 Weeks After the End of Treatment

  • ACIPHEX 20 mg to 120 mg delayed-release tablets produced satisfactory inhibition of gastric acid secretion in all patients (n=12, with idiopathic gastric hypersecretion or Zollinger-Ellison syndrome) and complete resolution of signs and symptoms of acid-peptic disease where present
  • ACIPHEX also prevented recurrence of gastric hypersecretion and manifestations of acid-peptic disease in all patients

  • In a multicenter, randomized, open-label, parallel-group study, a total of 111 adolescent patients aged 12 to 16 years with a clinical diagnosis of symptomatic GERD, or suspected or endoscopically proven GERD, were randomized to receive either ACIPHEX delayed-release tablets 10 mg or 20 mg once daily for up to 8 weeks for the evaluation of safety and efficacy
  • The adverse reaction profile in adolescent patients was similar to that of adults. The related reported adverse reactions that occurred in ≥2% of patients were headache (5%) and nausea (2%). There were no adverse reactions reported in these studies that were not previously observed in adults

GERD: Gastroesophageal reflux disease; OAC: Omeprazole + Amoxicillin + Clarithromycin; RAC: Rabeprazole + Amoxicillin + Clarithromycin; ITT: Intention to treat; PP: Per protocol

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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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