Zenpep

Pancrelipase is a combination of three enzymes (proteins): lipase, protease, and amylase. These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars.

Pancrelipase is used to replace these enzymes when the body does not have enough of its own. Certain medical conditions can cause this lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts.

Pancrelipase may also be used following surgical removal of the pancreas.

Pancrelipase may also be used for purposes not listed in this medication guide.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

It is very important that your doctor check the progress of you or your child at regular visits. This will allow your doctor to see if the medicine is working properly and to decide if you or your child should continue to take it.

For patients taking the capsules containing the powder:

• If the capsules are opened to mix with food, be careful not to breathe in the powder. To do so may cause harmful effects, such as stuffy nose, shortness of breath, troubled breathing, or tightness in the chest.

For patients taking the powder form of this medicine:

• Avoid breathing in the powder. To do so may cause harmful effects such as stuffy nose, shortness of breath, troubled breathing, or tightness in the chest.

Check with your doctor right away if you or your child have unusual or severe abdominal or stomach pain, trouble passing stool, nausea, or vomiting. These may be symptoms of a rare but serious bowel disorder, called fibrosing colonopathy.

This medicine may cause irritation of the inside of your or your child's mouth if it is not swallowed completely, is crushed or chewed, or is mixed into foods that are not recommended. Follow your doctor's instructions carefully to prevent this.

Pancrelipase may increase uric acid levels in the blood. Check with your doctor if you or your child have joint pain, stiffness, or swelling, lower back, side, or stomach pain, or swelling of the feet or lower legs.

This medicine is made from the pancreas of pigs. The risk of getting a virus from medicines made of pig organs has been greatly reduced in recent years. This is the result of required testing for certain viruses, and testing during manufacture of these medicines. Although the risk of transmitting certain viruses to people who will use the medicine is low, talk with your doctor if you or your child have concerns.

This medicine may cause serious types of allergic reactions, including anaphylaxis, which can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hives, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, mouth, or throat while you or your child are using this medicine.

Tell your doctor if you have a history of abnormal blood glucose levels before taking Zenpep®.

• It is used to help break down food when the pancreas is not working the right way.

• Tell all of your health care providers that you take Zenpep. This includes your doctors, nurses, pharmacists, and dentists.
• Have your blood work checked. Talk with your doctor.
• Follow the diet plan that your doctor told you about.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• There is more than 1 brand of this medicine. One brand cannot safely be used for the other. The doctor will tell you about any needed change.
• Watch for gout attacks.
• This medicine is made from pork (pig) pancreas tissue. There is a very small risk of getting a viral disease from Zenpep. No cases have happened. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

Fibrosing Colonopathy

Fibrosing colonopathy has been reported following treatment with different pancreatic enzyme products. Fibrosing colonopathy is a rare serious adverse reaction initially described in association with high-dose pancreatic enzyme use, usually with use over a prolonged period of time and most commonly reported in pediatric patients with cystic fibrosis. The underlying mechanism of fibrosing colonopathy remains unknown. Doses of pancreatic enzyme products exceeding 6,000 lipase units/kg of body weight per meal have been associated with colonic strictures in children less than 12 years of age.1 Patients with fibrosing colonopathy should be closely monitored because some patients may be at risk of progressing to stricture formation. It is uncertain whether regression of fibrosing colonopathy occurs. It is generally recommended, unless clinically indicated, that enzyme doses should be less than 2,500 lipase units/kg of body weight per meal (or less than 10,000 lipase units/kg of body weight per day) or less than 4,000 lipase units/g fat ingested per day [see Dosage and Administration (2.1)].

Doses greater than 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day) should be used with caution and only if they are documented to be effective by 3-day fecal fat measures that indicate a significantly improved coefficient of fat absorption. Patients receiving higher doses than 6,000 lipase units/kg of body weight per meal should be examined and the dosage either immediately decreased or titrated downward to a lower range.

Potential for Irritation to Oral Mucosa

Care should be taken to ensure that no drug is retained in the mouth. Zenpep should not be crushed or chewed or mixed in foods having a pH greater than 4.5. These actions can disrupt the protective enteric coating resulting in early release of enzymes, irritation of oral mucosa, and/or loss or enzyme activity [see Dosage and Administration (2.2) and Patient Counseling Information (17.1)]. For patients who are unable to swallow intact capsules, the capsules may be carefully opened and the contents added to a small amount of acidic soft food with a pH of 4.5 or less, such as applesauce. The Zenpep-soft food mixture should be swallowed immediately and followed with water or juice to ensure complete ingestion.

Potential for Risk of Hyperuricemia

Caution should be exercised when prescribing Zenpep to patients with gout, renal impairment, or hyperuricemia. Porcine-derived pancreatic enzyme products contain purines that may increase blood uric acid levels.

Potential Viral Exposure from the Product Source

Zenpep is sourced from pancreatic tissue from swine used for food consumption. Although the risk that Zenpep will transmit an infectious agent to humans has been reduced by testing for certain viruses during manufacturing and by inactivating certain viruses during manufacturing, there is a theoretical risk for transmission of viral disease, including diseases caused by novel or unidentified viruses. Thus, the presence of porcine viruses that might infect humans cannot be definitely excluded. However, no cases of transmission of an infectious illness associated with the use of porcine pancreatic extracts have been reported.

Allergic Reactions

Caution should be exercised when administering pancrelipase to a patient with a known allergy to proteins of porcine origin. Rarely, severe allergic reactions including anaphylaxis, asthma, hives, and pruritus, have been reported with other pancreatic enzyme products with different formulations of the same active ingredient (pancrelipase). The risks and benefits of continued Zenpep treatment in patients with severe allergy should be taken into consideration with the overall clinical needs of the patient.

Zenpep (pancrelipase) contains a combination of three enzymes (proteins): lipase, protease, and amylase. These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars.

Zenpep is used to replace these enzymes when the body does not have enough of its own. Certain medical conditions can cause this lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts.

Zenpep may also be used following surgical removal of the pancreas.

You should not take Zenpep if you are allergic to pork proteins.

Call your doctor at once if you have symptoms of a rare but serious bowel disorder: severe or unusual stomach pain, vomiting, bloating, diarrhea, or constipation.

You should not take Zenpep if you are allergic to pork proteins.

To make sure Zenpep is safe for you, tell your doctor if you have ever had:

• kidney disease;

• gout;

• diabetes;

• a blockage or scarring in your intestines;

• trouble swallowing pills; or

• lactose intolerance.

It is not known whether Zenpep will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It is not known whether pancrelipase passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

Other drugs may interact with pancrelipase, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.