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
, 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."
(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.