NORTH CHICAGO, Ill., May 30, 2013 /PRNewswire/ -- AbbVie (NYSE: ABBV) today announced that a new, higher-dose capsule of CREON® (pancrelipase) Delayed-Release Capsules is commercially available in the United States. The U.S. Food and Drug Administration (FDA) recently approved CREON in a 36,000 lipase-unit dose to treat patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis, swelling of the pancreas that lasts a long time (chronic pancreatitis), removal of some or all of the pancreas (pancreatectomy), or other conditions. This new strength is the highest dose of pancreatic enzyme replacement therapy (PERT) currently available and approved by the FDA.
"Patients with EPI require replacement of enzymes to help them break down food into nutrients," said Dr. David C. Whitcomb, Chief, Division of Gastroenterology, Hepatology and Nutrition, University of Pittsburgh. "Obtaining adequate lipase doses, however, often means taking a large number of capsules with each meal. A higher lipase capsule dose is an option for some patients, and it may help reduce the number of capsules they take when compared to lower lipase products."
Exocrine pancreatic insufficiency (EPI) is the inability of the pancreas to produce enzymes that help in the digestion of food. Patients living with cystic fibrosis, chronic pancreatitis, pancreatectomy, and other conditions may develop EPI. Symptoms of EPI may include steatorrhea (foul-smelling, greasy stools), gas, bloating, stomach pain, frequent bowel movements and weight loss. Pancreatic enzymes work directly in the small intestines to help break down fats, proteins and carbohydrates, allowing the body to better digest the nutrients from food.
"We are pleased to be able to offer healthcare professionals increased choices in dosing options for their patients," said Maria Rivas, M.D., vice president, Global Medical Affairs, AbbVie. "With the launch of this new CREON strength, healthcare professionals and patients now have access to the broadest range of dosage strengths in the PERT class."
Uses CREON® (pancrelipase) Delayed-Release Capsules is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis, swelling of the pancreas that lasts a long time (chronic pancreatitis), removal of some or all of the pancreas (pancreatectomy), or other conditions.
Important Safety Information CREON may increase the chance of having a rare bowel disorder called fibrosing colonopathy. The risk of having this condition may be reduced by following the dosing instructions given by the doctor.
CREON capsules or the contents of the capsules should not be crushed, chewed, or held in the mouth because this may cause mouth irritation. CREON should always be taken with a meal or snack and enough liquid to swallow CREON completely.
CREON can cause worsening of painful, swollen joints (gout) or allergic reactions including trouble with breathing, skin rashes, or swollen lips.
The most common side effects include: blood sugar increase (hyperglycemia) or decrease (hypoglycemia); pain in your stomach (abdominal area); frequent or abnormal bowel movements; gas; vomiting; dizziness; and sore throat and cough.
CREON and other pancreatic enzyme products are made from the pancreas of pigs-the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs.
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This is the most important information to know about CREON. For more information, talk with a healthcare provider.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
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About AbbVie AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. In 2013, AbbVie employs approximately 21,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.