Dosing & administration for patients with EPI due to cystic fibrosis

CREON has multiple dosage strengths to help meet your patient’s changing lipase needs
CREON dosing should be individualized for each patient and adjusted based on clinical symptoms, degree of steatorrhea present, and dietary fat content.¹

3,000

lipase units

6,000

lipase units

12,000

lipase units

24,000

lipase units

36,000

lipase units

Capsules shown are not actual size and do not represent the exact color shade. For illustrative purposes only. The active ingredient in CREON evaluated in clinical trials is lipase.

CREON infant dosing is based on CFF Guidelines^1*

3,000 lipase units/120 mL of formula or per breastfeeding immediately prior to each feeding

Capsules shown are not actual size and do not represent the exact color shade. For illustrative purposes only. The active ingredient in CREON evaluated in clinical trials is lipase.
*CFF Guidelines recommend doses of 2,000 to 4,000 lipase units in infants up to 12 months. CREON is available in a 3,000 lipase unit capsule.

Infant administration

Caregivers should administer CREON immediately prior to every feeding
The CREON capsule or its contents should not be crushed or chewed
Do not mix CREON capsule contents directly into formula or breast milk
Contents of the CREON 3,000 lipase unit capsule may be put directly in the infant’s mouth right before feeding with formula or breast milk

The contents of the CREON capsule can be mixed into a small amount of room-temperature, acidic, soft food, such as applesauce or select jarred baby food. Do not store CREON that has been mixed with food
Give the child enough formula or breast milk to completely swallow the CREON capsule contents or CREON food mixture
Care should be taken to ensure that the entire dose is swallowed and not left in the mouth, as it can cause irritation of the oral mucosa

Help caregivers remember how to appropriately give enzymes to infants.

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Sprinkling instructions

Hand holding CREON® (pancrelipase) Delayed Release Capsule upright.

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

Hand twisting off the top of CREON® (pancrelipase) Delayed Release Capsules.

Carefully twist off the top portion of the capsule.

Person adding the contents of CREON® (pancrelipase) Delayed Release Capsules to food.

Sprinkle the contents of the capsule directly into the infant’s mouth, or mix the contents in a small amount of room-temperature, acidic, soft food, such as applesauce or select jarred baby food. Do not mix CREON with formula or bottled breast milk. If you sprinkled CREON on soft food, feed it to the child immediately. Do not store CREON that is mixed with food.

Mother feeding her baby a bottle after giving CREON® (pancrelipase) Delayed Release Capsules.

Give the child enough liquid to completely swallow the CREON contents or the CREON and food mixture. Look in the child’s mouth to make sure that all of the medicine has been swallowed. Any medicine left in the mouth may cause irritation.

CREON dosing recommendations are based on CFF Guidelines¹

Per-meal dosing range guidelines^1†

12 months to 4 year dosing for CREON® (pancrelipase) Delayed Release Capsules.minimum of 1,000 and maximum of 2,500 lipase units per kg of boy weight.

4 year dosing for CREON® (pancrelipase) Delayed Release Capsules.minimum of 500 and maximum of 2,500 lipase units per kg of boy weight.

^†Per-day maximum lipase units should not exceed 10,000 per kg of body weight for patients >12 months. The CFF Guidelines also provide a dietary fat-based maximum lipase dose of less than 4,000 lipase units per g of fat ingested per day.¹ Refer to the full CREON Prescribing Information for dosing guidelines for patients younger than 12 months.

Usually, half of the prescribed CREON dose for an individualized full meal should be given with each snack¹

CREON should be taken with every meal and snack, with sufficient fluid. Capsules should not be crushed or chewed.¹

After starting your patient on CREON, follow up as early as 7 days^‡ to assess the need for a dose adjustment¹

CREON dosage should be individualized and adjusted based on¹:

Clinical symptoms

Degree of steatorrhea present

Dietary fat content

^‡In clinical studies, improvement in fat absorption after treatment with CREON was assessed as early as 5-7 days.

Dosing and administration considerations

CREON should always be taken with food. CREON should not be crushed or chewed.
Total daily dose should not exceed 10,000 lipase units/kg body weight/day unless clinically indicated.^§

Fibrosing colonopathy has been reported in patients with cystic fibrosis taking high-dose pancreatic enzyme replacement therapy.
CREON should be initiated at the lowest recommended dose based on patient’s weight.

^§The CFF Guidelines also provide a dietary fat-based maximum lipase dose of less than 4,000 lipase units per g of fat ingested per day.¹

Instructions for patients who have a hard time swallowing capsules

If your patients have problems swallowing CREON capsules, you can guide them with the following steps:

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

Carefully twist off the top portion of the capsule over the food you plan to eat.

Sprinkle the contents of the capsule on a small amount of room-temperature, acidic food, such as applesauce. Ask your doctor about other foods you can mix with CREON. Do not crush the contents of the capsules.

Woman drinking water after taking CREON® (pancrelipase) Delayed Release Capsules.

Swallow the CREON soft-food mixture right away without chewing, and drink enough water or juice to make sure the contents of the capsules are swallowed completely. Do not store CREON that is mixed with food.

How soon do you follow up with patients after CREON treatment initiation?

You answered within the first month

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You answered between 1 and 6 months

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Hear from gastroenterologist Shahab Mehdizadeh, MD, as he shares CREON dosing tips.

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You answered 6 months to a year

Review how to set treatment expectations with patients and what to discuss at follow-up appointments.

Get treatment-initiation tips

Hear from gastroenterologist Shahab Mehdizadeh, MD, as he shares CREON dosing tips.

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You answered never

Review how to set treatment expectations with patients and what to discuss at follow-up appointments.

Get treatment-initiation tips

Hear from gastroenterologist Shahab Mehdizadeh, MD, as he shares CREON dosing tips.

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Encourage your patients to fill out the Treatment Tracker and share it with you during their next appointment. This can help you assess how their treatment plan is going.

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Get educational resources, support program details, and prescription savings information for your patients and practice.

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CFF = Cystic Fibrosis Foundation; EPI = exocrine pancreatic insufficiency.

Dosing & administration for patients with EPI due to cystic fibrosis

CREON has multiple dosage strengths to help meet your patient’s changing lipase needs
CREON dosing should be individualized for each patient and adjusted based on clinical symptoms, degree of steatorrhea present, and dietary fat content.¹

CREON infant dosing is based on CFF Guidelines^1*

Infant administration

Sprinkling instructions

CREON dosing recommendations are based on CFF Guidelines¹

After starting your patient on CREON, follow up as early as 7 days^‡ to assess the need for a dose adjustment¹