Could you or someone in your family have EXOCRINE PANCREATIC INSUFFICIENCY (EPI) DUE TO CYSTIC FIBROSIS (CF)

or other conditions?IMPORTANT RISK INFORMATIONWhat is the most important information I should know about ZENPEP?ZENPEP® (pancrelipase) may increase your chance of having a rare bowel disorder called fibrosing colonopathy. This condition is serious and may require surgery. The risk of having fibrosing colonopathy may be reduced by following the dosing instructions your doctor gave you. 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.Please see Important Risk Information throughout and click here for full Prescribing Information.

What is EPI?

EPI occurs when the pancreas doesn’t make enough of the enzymes necessary to digest the food you eat.

Symptoms of EPI may include:

• Stomach pain/cramps

• Weight loss

• Bloating

• Gas

• Loose, oily, foul-smelling stools that are difficult to flush (steatorrhea)

• Diarrhea

The pancreas produces the main digestive enzymes lipase,

protease, and amylase

• When you have EPI, your body cannot properly absorb nutrients from fats, proteins, and carbohydrates.

• People with EPI suffer from a number of gastrointestinal (GI) symptoms and may not get the necessary nutrition from their diet.

• EPI can go undetected because the signs and symptoms are similar to other GI diseases.

of patients with CF have EPI.85%

The following tests are commonly used to help diagnose EPI:

EPI can be tough to diagnose since symptoms are similar to those of

other GI diseases.

Doctor Discussions

Do you have any of these symptoms?

Be sure to talk to your doctor about all your symptoms. Your doctor may be able to provide an accurate diagnosis and discuss treatment options, or refer you to a doctor who specializes in treating disorders of the GI tract.

How is EPI Diagnosed?

Stool Test• Fecal elastase test: Measures the

amount of an enzyme (elastase) produced by the pancreas, in your stool

• Fecal fat test : Measures the amount of fat in your stool

Blood Test Measures the concentration of a protein (trypsinogen) produced by the pancreas that is found in your blood

Endoscopic retrograde cholangiopancreatography (ERCP):Takes pictures of the pancreas to look for damage, using a flexible tube that is inserted through the mouth and travels through the stomach

Your doctor may recommend the following ways to manage your condition:

• Lifestyle and dietary modifications

• Vitamin and nutrient supplementation

• Pancreatic enzyme replacement therapy

Goals for EPI Management

Your doctor may take a number of approaches to manage the

symptoms of EPI.

ZENPEP® (pancrelipase) is a prescription medicine for people who cannot digest food normally because their pancreas does not make enough

enzymes. ZENPEP may help your body use fats, proteins, and sugars from food. ZENPEP contains a mixture of digestive enzymes (lipases, proteases, and amylases) from pig pancreas. ZENPEP is safe and effective in children.

ZENPEP MAY HELP YOUR BODY USE FATS, PROTEINS, AND SUGARS FROM FOOD

ZENPEP:• Helps improve your ability to digest and absorb the

nutrients you need from the fats you eat• Offers a range of dosage strengths to help meet

your individual EPI management needs

What Is ?

IMPORTANT RISK INFORMATION (continued)

What is the most important information I should know about ZENPEP? (continued)Take ZENPEP exactly as prescribed. Do not take more or less ZENPEP than directed by your doctor. Please see Important Risk Information throughout and click here for full Prescribing Information.

3,000 USP units

5,000 USP units

10,000 USP units

15,000 USP units

20,000 USP units

25,000 USP units

40,000 USP units

10,000 USP units

17,000 USP units

34,000 USP units

51,000 USP units

68,000 USP units

85,000 USP units

136,000 USP units

Lipase AmylaseProtease

16,000 USP units

27,000 USP units

55,000 USP units

82,000 USP units

109,000 USP units

136,000 USP units

218,000 USP units40

25

20

15

10

5

3

Each ZENPEP capsule strength contains the specified amount of the enzymes lipase, protease, and amylase

The 40,000 lipase unit capsule may help reduce the number of pills you need to take

Your doctor will calculate an individualized dose of ZENPEP based on your age,

weight, symptoms, and diet.

ZENPEP capsules offer the widest range of dosing options,

including the highest strength available: 40,000 lipase units

Dosing

Capsules not actual size.

IMPORTANT RISK INFORMATION (continued)

Before you take ZENPEP, 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.

How to Take

Giving ZENPEP to infants (0-12 months)

Give ZENPEP right before each feeding of formula or breast milk.

Do not mix ZENPEP capsule contents directly into formula or breast milk.

Open the capsule and sprinkle the contents on a small amount of applesauce, pureed bananas or pears. These foods should be the kind found in baby food jars that you buy at the store, or other food recommended by your doctor. You may also sprinkle the contents directly into your child’s mouth.

If you sprinkle the ZENPEP on food, give the ZENPEP and food mixture to your child right away.

Give your child enough liquid to completely swallow the ZENPEP contents or the ZENPEP and food mixture.

Look in your child’s mouth to make sure that all of the medicine has been swallowed.

Giving ZENPEP to children and adults

Swallow ZENPEP capsules whole and take with enough liquid to swallow right away.

For trouble swallowing capsules: Open ZENPEP capsules and sprinkle the beads on a small amount of acidic food such as applesauce, pureed bananas or pears.

If you sprinkle ZENPEP on food, swallow it right after you mix it. Do not store ZENPEP mixed with food.

Swallow the ZENPEP and food mixture right away, followed with water or juice. Make sure the medicine is swallowed completely.

If you forget to take ZENPEP, call your doctor or wait until your next meal and take your usual number of capsules. Do not make up for missed doses. Take your next dose at the usual time.

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IMPORTANT RISK INFORMATION (continued)

Before you take ZENPEP, tell your doctor: (continued)About all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.Please see Important Risk Information throughout and click here for full Prescribing Information.

IMPORTANT RISK INFORMATION (continued)

How should I take ZENPEP?Take ZENPEP exactly as your doctor tells you.Do not crush or chew the ZENPEP capsule or its contents, and do not hold the capsule or contents in your mouth. This may cause irritation in your mouth or change the way ZENPEP works in your body. See Medication Guide and talk to your doctor for additional directions.

Side EffectsZENPEP may cause serious side effects, including worsening of swollen, painful joints (gout) caused by an increase in blood uric acid levels and allergic reactions including trouble with breathing, skin rashes, or swollen lips. Call your doctor right away if you have any of these symptoms.Please see Important Risk Information throughout and click here for full Prescribing Information.

IMPORTANT RISK INFORMATION (continued)

Side Effects (continued)The most common side effects of ZENPEP include belly pain, gas, and headache.ZENPEP and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs.Please see Important Risk Information throughout and click here for full Prescribing Information.

PRESCRIBING INFORMATION

& MEDICATION

GUIDE

Allergan® and its design are trademarks of Allergan, Inc.ZENPEP® and its design are registered trademarks of Allergan Pharmaceuticals International Limited.

© 2017 Allergan. All rights reserved. ZEN110326 08/17

Helps Manage EPI due to CF, or Other Conditions

ZENPEP may help your body use fats, proteins, and sugars from food

ZENPEP capsules offer the widest range of dosing options, including the highest strength available: 40,000 lipase units

IMPORTANT RISK INFORMATION (continued)

Side Effects (continued)Tell your doctor if you have any side effect that bothers you or does not go away. These are not all the possible side effects of ZENPEP. For more information, ask your doctor or pharmacist.Please see Important Risk Information throughout and click here for full Prescribing Information.