Eisai Announces Availability of ACIPHEX® Sprinkle™ (Rabeprazole Sodium) for Treatment of GERD in Children Ages 1 to 11

WOODCLIFF LAKE, N.J., Nov. 8, 2013 /PRNewswire/ -- Eisai Inc. announced today that ACIPHEX® Sprinkle™ Delayed-Release Capsules 5mg and 10mg will be available to eligible patients by prescription in the United States by November 8, 2013.

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ACIPHEX Sprinkle Delayed-Release Capsules 5mg and 10mg was approved by the U.S. Food and Drug Administration on March 26, 2013 for the treatment of Gastroesophageal Reflux Disease (GERD) in children 1 to 11 years of age for up to 12 weeks.  

"The availability of this sprinkle formulation represents a new treatment option for young children who suffer from GERD," said Lonnel Coats, president and CEO of Eisai Inc. "Eisai is committed to making ACIPHEX Sprinkle available to appropriate patients as part of our human health care (hhc) corporate mission of keeping patients' medical needs at the forefront of all that we do."

ACIPHEX Sprinkle Delayed-Release Capsules 5mg and 10mg will be available in U.S. pharmacies only with a prescription. Eisai will manufacture, market and distribute ACIPHEX Sprinkle in the United States.

Indication for ACIPHEX Sprinkle
ACIPHEX Sprinkle is indicated for the treatment of GERD in children 1 to 11 years of age for up to 12 weeks. 

Important Safety Information about ACIPHEX Sprinkle:

  • 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.
  • Proton Pump Inhibitor (PPI) medicines may increase your risk of getting severe diarrhea. This diarrhea may be caused by an infection (Clostridium difficile) in your intestines. If you have watery stool, stomach pain, and fever that does not go away, call your doctor immediately.
  • People who are taking multiple daily doses of 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 children 1-11 years of age, the most common side effects with ACIPHEX include abdominal pain, diarrhea and headache.
  • Before taking ACIPHEX, tell your doctor if you are taking any of these medicines:  atazanavir, digoxin, iron salts, ketoconazole, warfarin, or methotrexate.

For more information about ACIPHEX Sprinkle (rabeprazole sodium), see full Prescribing Information or go to www.ACIPHEX.com.

About Gastroesophageal Reflux Disease (GERD)
Acid reflux is what happens when stomach acid flows back (or refluxes) into your esophagus (the tube that carries food from your mouth to your stomach). When this happens again and again along with symptoms like heartburn—occurring 2 or more times a week—you may have acid reflux disease. Another term used to describe acid reflux disease is gastroesophageal reflux disease, or GERD.

The most common symptom of acid reflux disease is persistent, frequent heartburn, or what you might refer to as "that burning in your chest." But there are other symptoms of acid reflux disease, like a bad taste in your throat (or regurgitation), and belching.

About Eisai Inc.
At Eisai Inc., human health care is our goal. We give our first thoughts to patients and their families, and helping to increase the benefits health care provides. As the U.S. pharmaceutical subsidiary of Tokyo-based Eisai Co., Ltd., we have a passionate commitment to patient care that is the driving force behind our efforts to help address unmet medical needs. We are a fully integrated pharmaceutical business with discovery, clinical, manufacturing and marketing capabilities. Our key areas of commercial focus include oncology and specialty care (Alzheimer's disease, epilepsy and metabolic disorders). To learn more about Eisai Inc., please visit us at www.eisai.com/US

Eisai Inc. has affiliates that are part of a global product creation organization that includes R&D facilities in Massachusetts, New Jersey, North Carolina and Pennsylvania, as well as a global demand chain organization that includes manufacturing facilities in Maryland and North Carolina. Eisai's global areas of R&D focus include neuroscience; oncology; metabolic disorders; vascular, inflammatory and immunological reaction; and antibody-based programs.




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SOURCE Eisai Inc.

Type Press Release

Date Released November 08, 2013

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