How should I take CREON?

Tips for giving enzymes to your baby

Most babies who have cystic fibrosis need to take pancreatic enzymes.

Pancreatic enzymes help your child digest breast milk or formula so that nutrients like fats, carbohydrates, and proteins can be absorbed.

Since nutrition in infancy is so important, your baby needs to be given enzymes with every breast- or bottle-feeding to help them digest breast milk or formula into nutrients.

All it takes is a little practice to get into the routine of giving your baby enzymes with every breast- or bottle-feeding.

CREON is a pancreatic enzyme replacement therapy used to treat people who cannot digest food normally because their pancreas does not make enough enzymes.

One method dietitians teach for giving enzymes like CREON 3000 to infants is to sprinkle the beads onto applesauce.

Hold the capsule upright so that you can read the word CREON on the capsule.

Carefully twist off the top portion of the capsule.

Open the capsules and mix the contents in a small amount of room-temperature acidic soft food, such as applesauce. The food should be the kind found in baby food jars that you buy at the store, or other food recommended by your doctor.

It’s important to use acidic food to allow the enzymes to work properly.

Give the CREON with soft food to your child and then breast- or bottle-feed right away.

Do not store CREON that is mixed with food.

If the mixture sits too long, the enzymes will no longer be active.

If your child spits out the enzyme-applesauce mixture, don’t worry; just keep trying to spoon the mixture back into your child’s mouth until it’s swallowed. Eventually your baby will get used to the new texture and it will become easier.

If you don’t want to mix CREON with food, you can also sprinkle the contents directly into your infant’s mouth.

Do not mix CREON directly into a bottle of formula or breast milk.

No matter which method you choose, make sure to give your child enough liquid to completely swallow the CREON contents or the CREON and food mixture.

To avoid irritation, care should be taken to ensure no medicine is left in the mouth. After the feeding, look in your child’s mouth to make sure all the medicine has been swallowed, including under the tongue and inside the cheeks.

...and make sure to wipe away any enzymes that may have spilled onto your baby’s face or neck.

If you forget to give CREON to your baby, call your doctor or wait until the next feeding and give the usual number of capsules.

Do not make up for missed doses.

It’s easy to make sure that you’re prepared to give your baby CREON at every feeding.

When you’re at home, make sure that you have plenty of CREON and applesauce (or the acidic soft food your baby prefers).

When you’re away from home it can be helpful to make feeding kits that contain CREON capsules, prepackaged applesauce, a baby spoon, and wet wipes—so that when you breast- or bottle-feed, you have everything you need to give your child enzymes.

And always remember, CREON should be kept at room temperature, and sprinkling on food should occur just prior to feeding your baby.

Remember, taking enzymes at every feeding will help your child digest the important nutrients they need from breast milk or formula.

As your child grows, taking enzymes with meals and snacks will continue to help them get the nutrition they need.

If you have any questions about giving your baby enzymes, be sure to reach out to your child’s doctor or dietitian.

For quick tips and more information about giving CREON to your baby, go to CREON.com/infants

Use

CREON^® (pancrelipase) is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes.

Important Safety Information
What is the most important information I should know about CREON?
CREON may increase your chance of having a rare bowel disorder called fibrosing colonopathy. The risk of having this condition may be reduced by following the dosing instructions that your healthcare professional (HCP) gave you. Call your HCP right away if you have any unusual or severe: stomach area (abdominal) pain, bloating, trouble passing stool, nausea, vomiting, or diarrhea.

What should I tell my HCP before taking CREON?
Before taking CREON, tell your HCP about all the medicines you take and all your medical conditions, including if you are allergic to pork (pig) products; have a history of intestinal blockage or scarring or thickening of your bowel wall (fibrosing colonopathy), gout, kidney disease, or high blood uric acid (hyperuricemia); or are pregnant, plan to become pregnant, are breastfeeding, or plan to breastfeed.

How should I take CREON?
Take CREON exactly as your HCP tells you. Always take CREON with a meal or snack and enough liquid to swallow CREON completely. Do not crush or chew the CREON capsule or its contents, as this may cause irritation in your mouth or change the way CREON works in your body. Talk to your HCP or consult the CREON Medication Guide for how to take CREON if you have trouble swallowing capsules.

What are the possible side effects of CREON?
CREON may cause additional serious side effects, including:

• Increase in blood uric acid levels (hyperuricemia), including pain, stiffness, redness or swelling of your joints.
• Allergic reactions, including trouble with breathing, skin rashes, swollen lips, or itching.

Call your HCP right away if you have any of these symptoms.

The most common side effects of CREON include blood sugar increase (hyperglycemia) or decrease (hypoglycemia), pain in your stomach, frequent or abnormal bowel movements, gas, vomiting, dizziness, sore throat, and cough.

CREON 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.

These are not all the possible side effects of CREON. For more information, ask your HCP or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1‑800‑FDA‑1088.

If you are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/PatientAccessSupport to learn more.

Please see full Prescribing Information, including Medication Guide, or visit www.rxabbvie.com/pdf/creon_pi.pdf.