Zenpep side effects and how to avoid them

Zenpep is the brand name for an FDA-approved (U.S. Food and Drug Administration) medication manufactured by Eurand Pharmaceuticals, Inc. It is a pancreatic enzyme product for the treatment of exocrine pancreatic insufficiency (EPI) associated with cystic fibrosis (CF).

While Zenpep is generally well tolerated, there are some potential side effects that people should be aware of. The most common side effects of Zenpep include stomach pain and flatulence. Less common, but more serious side effects, can include allergic reactions.

Learn more about the side effects of Zenpep and what you can do to avoid them.

Why do I have to take Zenpep?

Cystic fibrosis is a genetic disorder that makes your body produce fluids, like mucus, sweat, and digestive juices that are too thick. Over time this disrupts and damages parts of your body, usually your lungs, liver and kidneys, pancreas, and digestive system. The disorder can interfere with food digestion by affecting your pancreas and causing a condition called exocrine pancreatic insufficiency. Your pancreas produces digestive enzymes, which are substances that help your digestive system break down food. Thick mucus in your pancreas can block these enzymes from entering your digestive system, making it harder for you to digest food.

EPI can cause gastrointestinal problems, such as stomach cramps, bloating, pain, flatulence, and diarrhea. Problems digesting food can also mean you don’t get the calories and the nutrition you need to be healthy. It can lead to weight loss and fatigue, as well as conditions caused by dietary deficiencies like anemia, bleeding disorders, or metabolic bone disease. Zenpep helps with EPI by improving your ability to digest food. The medication contains a mixture of digestive enzymes that can help top up the enzymes you’re lacking, allowing you to digest food normally.

The active ingredient in Zenpep is called pancrelipase. Pancrelipase is a mixture of three groups of digestive enzymes called amylases, lipases, and proteases. These enzymes are derived from the pancreas of pigs, but they are safe and effective for children and adults to use. Once in your digestive system, they help your body break down and absorb the proteins, carbohydrates, sugars, and fats in your food.

How often can I take Zenpep?

Zenpep is available in a delayed-release capsule dosage form, in the following doses:

• 5,000 USP units of lipase, 17,000 USP units of protease, 27,000 USP units of amylase
• 10,000 USP units of lipase, 34,000 USP units of protease, and 55,000 USP units of amylase
• 15,000 USP units of lipase, 51,000 USP units of protease, and 82,000 USP units of amylase
• 20,000 USP units of lipase, 68,000 USP units of protease, and 109,000 USP units of amylase

Zenpep is not interchangeable with any other pancrelipase product.

• Infants (up to 12 months) – 2,000 to 4,000 lipase units per 120 mL of formula or per breast-feeding
• Children older than 12 months and younger than 4 years – initiate with 1,000 lipase units/kg of body weight per meal up to a maximum of 2,500 lipase units/kg of body weight per meal, or less than 4,000 lipase units/g fat ingested per day
• Children 4 years and older and adults – begin with 500 lipase units/kg of body weight per meal to a maximum of 2,500 lipase units/kg of body weight per meal, or less than 4,000 lipase units/g fat ingested per day

For those who cannot swallow capsules whole, open the capsule and mix with applesauce. Swallow the mixture immediately. Do not chew and do not mix capsules with infant formula or breast milk. If you miss a dose of Zenpep, do not take the missed dose. Go back to your normal dosing routine. Do not double your doses.

Please see the full prescribing information and medication guide and always speak with your healthcare provider about any changes to your dose so they can monitor and evaluate your condition.

What are the side effects of Zenpep?

The most common possible side effects of Zenpep in clinical trials compared to placebo-controlled trials include:

• Abdominal pain
• Constipation
• Flatulence
• Headaches

More serious side effects of Zenpep include:

• Worsening of gout
• Joint pain
• Allergic reactions – hives, trouble breathing, swelling of the face, lips, tongue, or throat
• Fibrosing colonopathy – a rare bowel disorder
• Difficult bowel movements
• Severe stomach pain
• Renal cyst

These aren’t all the side effects Zenpep can cause. You can find more details in the patient leaflet that comes with your medication. If you have any concerns about side effects, talk to your physician or pharmacist. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

Do Zenpep side effects go away?

Some side effects of Zenpep that do not need medical attention may go away as your body adjusts to treatment.

How long does it take for Zenpep to work?

Zenpep can begin to work within 15 minutes of being taken.

What happens if you take Zenpep and you don’t need it?

Excess pancreatic enzymes not needed will pass through your body. One or two extra capsules than needed will not be a problem. Taking lots more than needed may cause itching around your anus.

What can I take instead of Zenpep?

Alternative treatments to Zenpep include Creon, Palcaps, Pancreaze, Pancrelipase, Pertzye, and Viokace. Speak to your healthcare provider if you are considering changing your treatment.

What happens if you take too much Zenpep?

Excess pancreatic enzymes not needed will pass through your body. One or two extra capsules than needed will not be a problem. Taking lots more than needed may cause itching around your anus.

Is Zenpep addictive?

Zenpep is not addictive and reports of withdrawal symptoms have been reported in very low numbers.

Does Zenpep cause weight gain?

Zenpep does not cause weight gain, in fact, it has actually been seen to cause a slight decrease in weight.

Zenpep drug interactions

Zenpep can interact with other medications. These include:

• Calcium carbonate
• Ferrous fumarate, ferrous gluconate, ferrous sulfate
• Folic acid
• Multivitamins with iron, multivitamins with iron and fluoride, and multivitamins with minerals
• Sodium bicarbonate

Zenpep contraindications

You should not use Zenpep if you:

• Are allergic to pork or any pig products
• Are allergic to any of the other ingredients in Zenpep

Talk to your doctor before using Zenpep if you:

• Have kidney disease, gout, or high blood uric acid levels (hyperuricemia)
• Have ever had a blockage in your intestines
• Have problems swallowing tablets
• Have ever had scarring or thickening of your bowel wall (fibrosing colonopathy)
• Are pregnant or plan to become pregnant
• Are breastfeeding or plan to breastfeed

How to avoid Zenpep side effects

The best way to avoid side effects is to take Zenpep as directed by your doctor. Follow your doctor’s instructions carefully and do not take more or less than prescribed.

If you experience any side effects, talk to your doctor or pharmacist. They may be able to recommend ways to help reduce or prevent some of the side effects.

1. Stick to the recommended dosage

Take your prescribed dose of Zenpep that has been recommended by your healthcare professional. Do not take more or less than prescribed.

2. Monitor your blood sugar levels

If you have diabetes, it is important to monitor your blood sugar levels closely while taking Zenpep. Check your blood sugar levels as directed by your doctor and report any changes to your doctor immediately.

3. Drink plenty of fluids

Drink eight to 10 glasses of water or fluids every day to help prevent dehydration, which can make side effects worse.

4. Avoid alcohol

Interactions between alcohol and Zenpep have not been reported, however you should drink in moderation when taking Zenpep to reduce the risk of side effects.

5. Don’t skip meals

Eating regular meals and snacks will help to prevent low blood sugar levels (hypoglycemia).

6. Check your feet

If you have diabetes, check your feet for any cuts, sores, or redness regularly. Tell your doctor if you experience any problems with your feet while taking Zenpep.

7. Know the signs and symptoms of Zenpep side effects

Signs and symptoms of side effects include nausea, stomach pain, and flatulence. If you experience any of these symptoms speak to your doctor for medical advice.

8. Tell your doctor about all medications you’re taking

Be sure to tell your doctor about all other medications you’re taking, including over-the-counter drugs, vitamins, and herbal supplements, as they can interact with Zenpep.

9. Get regular medical check ups

It is important to get regular medical check ups and monitor your medical conditions. Your doctor will monitor your side effects and may adjust your dose of Zenpep as needed.