Exocrine pancreatic insufficiency (EPI) has been getting more attention recently. In people with EPI, the pancreas does not make enough digestive enzymes. These enzymes are needed to help break down the food you eat.
EPI can lead to symptoms such as diarrhea, oily stools (poop), bloating, stomach pain, and weight loss. EPI is rare, but it can happen in people with certain health conditions that may affect the pancreas. These conditions include cystic fibrosis or chronic pancreatitis (inflammation of the pancreas).
Zenpep (pancrelipase) is one medicine that is approved to treat EPI in adults and children.
How Does Zenpep Work for EPI?
Zenpep helps replace the digestive enzymes that your pancreas does not make if you have EPI. You may also hear it called pancreatic enzyme replacement therapy (PERT).
Zenpep contains a mixture of three types of pancreatic enzymes:
- Lipases (enzymes that break down fat)
- Proteases (enzymes that break down protein)
- Amylases (enzymes that break down carbohydrates or starches)
These enzymes work together to break down the various types of nutrients in foods you eat. Taking PERT can help you get enough nutrients and manage symptoms of EPI.
Zenpep comes in many strengths. Each strength has different amounts of these enzymes. Your health care provider will decide what your dose of Zenpep should be based on your weight or how much fat you eat. Your dose may be adjusted based on your symptoms, whether you have too much fat in your stool (steatorrhea), and the amount of fat you eat.
How Do I Take Zenpep?
You should take Zenpep with every meal and snack. Taking Zenpep with food allows it to act like the digestive enzymes normally made by your pancreas when you eat. Keep in mind that you should also take a dose if your meal or snack is a liquid with nutrients, such as a shake or smoothie.
Zenpep is a capsule that is taken by mouth, and it should be swallowed whole. If you cannot swallow whole capsules, you can open up the capsule and sprinkle the contents onto a small amount of soft food. The food should be acidic, such as applesauce, bananas, or pears. Sprinkling it onto foods that are not acidic may make the medicine not work as well. Swallow the mixture right away after sprinkling it onto the food. Then drink enough liquid to make sure that you swallow the mixture completely. Do not chew or crush the capsule or the contents of the capsule.
If Zenpep is used in an infant up to 12 months of age, you should give it before each breastfeeding session or each time you give 120 milliliters (mL) of formula. For infants, you can also open the capsule, sprinkle it onto soft food (with the same instructions as above), and give it right away, or you can sprinkle it right into the infant’s mouth. Either way, after giving the Zenpep dose, be sure to give enough breast milk or formula so that the entire amount of medicine is swallowed. Check the infant’s mouth to be sure that no medicine is left in the mouth. Do not mix Zenpep right into breast milk or formula.
How Was Zenpep Studied for EPI, and What Benefits Were Seen?
Zenpep was approved by the FDA based on two clinical studies to see if it was safe and effective. One study was in children and adults, and one study was in children aged 1-6.
Study in children aged 7 or older and adults
This study included 34 children and adults between the ages of 7 and 23 years. All people in the study had EPI because of cystic fibrosis. There was an even mix of males and females in the study, the average age was about 15 years, and about 96% of people were White.
People in the study were randomly assigned to take either Zenpep or a placebo containing no medicine. Both groups took the first treatment for six to seven days, then switched to the other treatment. Thirty-two people completed the study. The people and their health care providers did not know whether they were getting Zenpep or a placebo. The average length of time people took Zenpep in this study was 30 days, and the longest duration was 42 days.
The main goal of the study was to see how much fat the body absorbed from food with Zenpep compared to placebo. Since Zenpep helps the body digest and absorb nutrients, measuring fat absorption can show how well the medicine is working. During the study, everyone ate a high-fat diet (over 100 grams of fat per day).
Researchers used a measurement called the coefficient of fat absorption (CFA) to see how much fat was absorbed from food. People in the study had their stool collected for 72 hours, and the amount of fat absorbed and lost was measured. The CFA measurements while taking Zenpep were compared to the results with placebo. A normal CFA is generally considered to be over 93%, meaning less than 7% of fat from the diet is lost in the stool.
The researchers found that people in the study who took Zenpep had an average CFA of about 88%, while the people taking placebo had an average CFA of about 63%. These findings suggest that people taking Zenpep had better fat absorption compared to those taking placebo. The results did not seem to differ based on age or sex.
Study in children aged 1-6
This study included 19 children between the ages of 1 and 6. The average age of children in the study was about 4 years, but about half were between the ages of 1 and 3. Everyone had EPI because of cystic fibrosis, and they were all taking a pancreatic enzyme product already. About 63% of children in this study were male, and 100% were White.
The study aimed to compare the amount of fat in the stool before and after switching to Zenpep. People in the study took their previous pancreatic enzyme medicine for up to 14 days, then switched to Zenpep for 14 days. Everyone in the study knew they were being switched to Zenpep.
The researchers found that the amount of fat in the stool was similar before and after switching to Zenpep at a similar dose to their previous pancreatic enzyme product. These findings suggest that Zenpep is an effective and safe treatment option.
Your results may differ from what was seen in clinical studies.
How Long Does It Take for Zenpep to Work?
Zenpep helps replace digestive enzymes, so it should start working quickly with each dose you take. You should keep track of any symptoms of EPI you have, such as fatty stools, stomach pain, bloating, or weight loss. Your health care provider may change your dose if your symptoms are not getting better or get worse.
Zenpep is used to treat EPI, but it does not treat the underlying condition that may have caused EPI. You should continue all treatments for your other medical conditions while taking Zenpep. Your health care provider may also recommend that you take certain vitamins to be sure you are getting enough nutrients.
What Are Other Unique Considerations to Be Aware Of?
You should not switch from Zenpep to any other product containing pancreatic enzymes without talking with your health care provider. Since these products may contain different amounts of enzymes, the doses are not equal between products, and you may have different effects or side effects if you switch.
Follow your health care provider’s instructions for how to take Zenpep. Your total daily dose of Zenpep will usually be based on three meals and two to three snacks per day. Do not go over your total daily dose, even if you have more meals or snacks per day than usual.
The digestive enzymes in Zenpep come from pig pancreas. Tell your health care provider before using Zenpep if you are allergic to pigs or pork or if you follow a vegetarian or vegan diet.
How Can I Get Zenpep? Is There Any Cost Assistance Available?
Zenpep requires a prescription from a health care provider. Your primary care provider, gastroenterologist, or other provider may prescribe Zenpep. You can get it at any pharmacy.
There is a savings card available from the drugmaker that may allow you to pay as little as $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more at www.zenpep.com/savings-programs or by calling 833-742-0707.
