Cystic Fibrosis and EPI

Cystic fibrosis (CF) is an inherited disease that affects approximately 30,000 people in the United States. CF can be diagnosed at birth through newborn screening, which is performed in the first 2 or 3 days after birth. The majority of CF patients are diagnosed by age 2.

Baby with Cystic Fibrosis (CF) on Pancreaze medication

Hallmark Characteristics

The hallmark characteristic of CF is the production of thick, sticky mucus that plugs up important passageways, like the airways and pancreatic ducts. This mucus also allows bacteria to grow, damaging cells in organs of the body. Approximately 2/3 of CF patients develop exocrine pancreatic insufficiency (EPI) shortly after birth. This number jumps to 85% by one year of age. Left untreated, EPI leads to maldigestion, malabsorption of nutrients, bothersome symptoms (e.g., bloating, abdominal discomfort, diarrhea, excessive gas), weight loss and impaired growth. This is why many CF patients require pancreatic enzyme replacement therapy (PERT).

PERTs like PANCREAZE® relieve these symptoms by replacing the enzymes the body cannot make, allowing for digestion of food and absorption of nutrients. This helps reduce the risk of developing potentially serious malnutrition-related consequences. Your doctor will determine the right amount of PANCREAZE® for you or your child, and when to take the doses.

IMPORTANT SAFETY INFORMATION
What is the most important information I should know about PANCREAZE®?​

PANCREAZE® may increase your chance of having a serious, rare bowel disorder called fibrosing colonopathy that may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your healthcare provider gave you.

Take PANCREAZE® exactly as prescribed by your doctor. Do not take more or less PANCREAZE® than directed by your doctor.

Call your doctor right away if you have any unusual or severe stomach area (abdominal) pain, bloating, trouble passing stool (having bowel movements), nausea, vomiting, or diarrhea.

What should I tell my doctor before taking PANCREAZE®?

Tell your doctor if you:

  • are allergic to pork (pig) products
  • have a history of blockage of your intestines, or scarring or thickening of your bowel wall (fibrosing colonopathy)
  • have gout, kidney disease, or high blood uric acid (hyperuricemia)
  • have trouble swallowing capsules
  • have any other medical condition
  • are pregnant or plan to become pregnant
  • are breastfeeding or plan to breastfeed

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

What are the possible side effects of PANCREAZE®?

PANCREAZE® may cause serious side effects, including:

  • A rare bowel disorder called fibrosing colonopathy.
  • Irritation of the inside of your mouth. This can happen if PANCREAZE® is not swallowed completely.
  • Increase in blood uric acid levels. This may cause worsening of swollen, painful joints (gout) caused by an increase in your blood uric acid levels.
  • Allergic reactions including trouble with breathing, skin rashes, or swollen lips.

The most common side effects include pain in your stomach (abdominal pain) and gas.

These are not all the side effects of PANCREAZE®. Talk to your doctor about any side effect that bothers you or does not go away. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to VIVUS, Inc. at 1-888-998-4887.

How do I take PANCREAZE®?
  • Do not crush or chew the PANCREAZE® capsules or their contents, and do not hold the capsule or contents in your mouth. Take PANCREAZE® exactly as your doctor tells you. Read the Medication Guide for directions on how to give PANCREAZE® to adults and children (children older than 12 months).
  • Read the Medication Guide for directions on how to give PANCREAZE® to infants (children up to 12 months).
Please read the PANCREAZE® Medication Guide and PANCREAZE® Product Information and discuss any questions you have with your doctor.

Struyvenberg et al. BMC Medicine. 2017;15:29
The Cystic Fibrosis Foundation