MAINTENANCE

In previously healed erosive or ulcerative GERD patients…
ACIPHEX® Maintained Healing and Symptom Relief at 1 Year
Study design: 2 US multicenter, double-blind, randomized, parallel-group studies of patients with previously healed erosive or ulcerative GERD
treated for 1 year (N=209; N=285)1,2

Endoscopic healing of erosive GERD maintained
at 1 year with ACIPHEX®1-3

  

Endoscopic Healing GERD Chart

CONTROLLED STUDIES DO NOT EXTEND BEYOND 12 MONTHS

Patients with previously healed erosive GERD were without
relapse of nighttime heartburn severity at 1 year with ACIPHEX®1

Patients Previously healed Chart
  • In the same 2 clinical trials, results for ACIPHEX® were similarly significant at 1 year in preventing relapse of daytime heartburn severity—97% and 94% vs 69% and 74% for placebo in studies 1 and 2, respectively (P≤0.001)1

CONTROLLED STUDIES DO NOT EXTEND BEYOND 12 MONTHS

  
 
INDICATIONS
  • In adults (≥18 years of age), ACIPHEX® 20 mg is indicated for: treatment of daytime and nighttime heartburn and other symptoms associated with GERD; short-term, up to 4 weeks, treatment in the healing and symptomatic relief of duodenal ulcers; short-term, 4 to 8 weeks, treatment in the healing and symptomatic relief of erosive GERD; and maintenance of healing and reduction in relapse rates of heartburn symptoms in erosive GERD (controlled maintenance studies do not extend beyond 12 months)
  • In adolescent patients 12 years of age and above, ACIPHEX® 20 mg is indicated for: short-term, up to 8 weeks, treatment of daytime and nighttime heartburn and other symptoms associated with GERD
IMPORTANT SAFETY INFORMATION
Contraindications:
  • ACIPHEX® is contraindicated in patients with known hypersensitivity to rabeprazole, substituted benzimidazoles, or to any component of the formulation
Warnings and Precautions:
  • Symptomatic response to therapy does not preclude the presence of gastric malignancy
  • As with all PPIs, patients treated concomitantly with warfarin may need to be monitored for increases in INR and prothrombin time. Increases in INR and prothrombin time may lead to abnormal bleeding and even death
  • 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. Serious adverse events include tetany, arrhythmias, and seizures. Consider monitoring magnesium levels in patients on prolonged PPI therapy or concomitant medications such as digoxin or medications that may cause hypomagnesemia (eg, diuretics)
Adverse Events:
  • 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
Drug Interactions:
  • ACIPHEX® inhibits gastric acid secretion and may interfere with the absorption of drugs where gastric pH is an important determinant of bioavailability (eg, ketoconazole, iron salts and digoxin)
  • ACIPHEX® may reduce the plasma levels of atazanavir
  • Rabeprazole has been shown to inhibit cyclosporine metabolism in vitro

For more information about ACIPHEX®, see full Prescribing Information.

Click here to view full Prescribing Information for ACIPHEX®.

References: 1. ACIPHEX® Prescribing Information. Raritan, NJ: Janssen Pharmaceuticals, Inc. 2011. 2. Caos A, Moskovitz M, Dayal Y, Perdomo C, Niecestro R, Barth J; Rabeprazole Study Group. Rabeprazole for the prevention of pathologic and symptomatic relapse of erosive or ulcerative gastroesophageal reflux disease. Am J Gastroenterol. 2000;95(11):3081-3088. 3. Birbara C, Breiter J, Perdomo C, Hahne W; Rabeprazole Study Group. Rabeprazole for the prevention of recurrent erosive or ulcerative gastro-oesophageal reflux disease. Eur J Gastroenterol Hepatol. 2000;12(8):889-897.

 
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