About PANCREAZE®
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What is Pancreatic Enzyme Replacement Therapy (PERT)?

Normally, the pancreas releases a mixture of enzymes (called lipases, proteases and amylases) to digest the fats, proteins and carbohydrates in food. In patients with Cystic Fibrosis or Chronic Pancreatitis, the pancreas does not make enough enzymes to digest food.

PERT replaces the digestive enzymes you or your child needs. It comes in the form of capsules. Inside, there are several tiny “beads” that contain enzymes. Each bead is covered with a special enteric coating. When the capsule enters the small intestine, the pH triggers the coating to dissolve and release the enzymes to help digest food.

PANCREAZE® is a type of PERT that your doctor has prescribed based on your child’s or your needs.

What is PANCREAZE®?

PANCREAZE® (pancrelipase) 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 or other conditions. It contains a mixture of digestive enzymes, including lipases, proteases, and amylases, to help the body use fats, proteins, and carbohydrates from food.

Pancreaze capsules 5 doses

Capsules shown are not actual size and do not represent exact color.

PANCREAZE® is safe and effective in adults and children when taken as prescribed by your doctor. It is available in 5 doses – your doctor will advise you on the optimal dose for you or your child.

How does PANCREAZE® help?

By replacing enzymes the pancreas is unable to produce, PANCREAZE® helps you or your child digest food properly and absorb the fat, protein and carbohydrates needed for healthy growth, weight gain and improved nutritional health. PANCREAZE® has been studied in several clinical trials and used for over 30 years around the world.

Why is targeted dosing important?

Because the needs of patients change (e.g., weight, meal intake), it is important to have flexible dosing options to ensure targeted dosing to each patient’s unique needs

Pancreaze patients dosing

For example:

  • An infant with Cystic Fibrosis gains weight rapidly within the first few months:
    The dose of PANCREAZE® needs to be carefully adjusted as he/she grows – and shifts from liquids to solids. PANCREAZE® has the lowest lipase dose available, so your doctor can “start low and go slow” to ensure just the right amount of enzymes.
  • An adult with Chronic Pancreatitis who has a busy lifestyle and irregular eating habits:
    With PANCREAZE®, there are 5 doses, so your doctor can recommend a targeted dose based on the meals and snacks consumed over the course of a day.
Your doctor will tell you how many capsules to take, and when, to help ensure you get the pancreatic enzymes you need, when you need it.
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 breast-feeding or plan to breast-feed

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.