Pronunciation:

pan-kre-LYE-pase, AM-i-lase, LYE-pase, PROE-tee-ase

Classifications:

Pharmacologic—

Enzyme

Uses of This Medicine:

Pancrelipase is used to treat patients who cannot digest food normally because their pancreas does not make enough enzymes (exocrine pancreatic insufficiency). Pancrelipase tablet is used in combination with a proton pump inhibitor (PPI) in patients who have long-term swelling of the pancreas (chronic pancreatitis) or who have had some or all of their pancreas removed (pancreatectomy).

Pancrelipase contains a mixture of digestive enzymes (eg, lipases, proteases, and amylases) needed for the digestion of proteins, starches, and fats.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of pancrelipase delayed-release capsules in children. Safety and efficacy have been established.

Appropriate studies have not been performed on the relationship of age to the effects of pancrelipase tablets in the pediatric population. This medicine may cause unwanted effects (eg, weight gain, malnutrition) in children. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of pancrelipase in the elderly.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Allergy to pork products or
• Fibrosing colonopathy (scarring or thickening of your bowel wall), history of or
• Gout or
• Hyperuricemia (high uric acid levels in the blood) or
• Intestinal blockage, history of or
• Kidney disease or
• Lactose intolerant—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

This medicine should come with a Medication Guide and patient instructions. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

Take this medicine with food.

Swallow the capsule or tablet whole with enough fluid (eg, water or juice) to prevent irritation of the mouth. Do not crush or chew it.

For patients taking the tablets:

• Viokace™ tablet is used in combination with certain medicines for stomach ulcer called proton pump inhibitors (eg, esomeprazole, lansoprazole, omeprazole, Nexium®, Prevacid®, Prilosec®).
• Swallow the tablets quickly with some liquid, without chewing, to avoid mouth irritation.

For patients taking the delayed-release capsules:

• Swallow the capsule whole.
• Do not crush, break, or chew before swallowing. Do not hold the capsule in your mouth.
• When given to adults or children who can not swallow the capsule, the capsule may be opened and sprinkled onto a small amount (about 10 mL or less) of soft acidic food (eg, applesauce, bananas, or plain Greek yogurt). Mix the contents evenly. Do not crush the capsule contents while mixing. This mixture must be swallowed immediately and followed with a glass of water or juice. This will ensure complete swallowing of the contents of the capsule and avoid mouth irritation.
• When given to infants, the contents of the capsule may be put directly into the infant's mouth or mixed with a small amount (about 10 mL or less) of soft acidic food (eg, applesauce, pureed bananas, or pears), followed by 4 ounces (120 mL) of formula or breastfeeding. Do not mix the contents of the capsule directly into a bottle of breast milk or formula. This could reduce the effect of the medicine.
• Pertzye® capsules may also be given through a gastrostomy tube with a diameter of 14 French or larger.
  • Mix the contents of the capsule with soft food (eg, applesauce).
  • Remove the plunger and carefully spoon the mixture into the syringe. Replace the plunger partially back.
  • Connect the syringe into the tube feeding port and inject the medicine for 10 to 12 seconds.
  • Flush the tube with 10 mL of water to rinse all of the medicine into the stomach.
• Throw away any unused portions of the mixture. Do not save for later use.

Do not change the brands or dosage forms of pancrelipase without first checking with your doctor. Different products may not work in the same way. If you refill your medicine and it looks different, check with your pharmacist.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For the treatment patients who cannot digest food normally:
  • For oral dosage form (Creon® and Zenpep® delayed-release capsules):
    • Adults and children 4 years of age and older—500 lipase units per kilograms (kg) per meal. Your doctor may adjust your dose as needed and tolerated.
    • Children 12 months to younger than 4 years of age—1000 lipase units per kg per meal. Your doctor may adjust your dose as needed and tolerated.
    • Children from birth to 12 months of age—3000 lipase units per 120 milliliters (mL) of formula or per breastfeeding.
  • For oral dosage form (Pancreaze® delayed-release capsules):
    • Adults and children 4 years of age and older—500 lipase units per kilograms (kg) per meal. Your doctor may adjust your dose as needed and tolerated.
    • Children 12 months to younger than 4 years of age—1000 lipase units per kg per meal. Your doctor may adjust your dose as needed and tolerated.
    • Children from birth to 12 months of age—2600 lipase units per 120 milliliters (mL) of formula or per breastfeeding.
  • For oral dosage form (Pertzye® delayed-release capsules):
    • Adults and children 4 years of age and older—500 lipase units per kilograms (kg) per meal. Your doctor may adjust your dose as needed and tolerated.
    • Children 12 months to younger than 4 years of age—1000 lipase units per kg per meal. Your doctor may adjust your dose as needed and tolerated.
    • Children from birth to 12 months of age—4000 lipase units per 120 milliliters (mL) of formula or per breastfeeding.
  • For oral dosage form (tablets):
    • Adults—At first, 500 lipase units per kilograms (kg) per meal. Your doctor may adjust your dose as needed and tolerated.
    • Children—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

You may store repacked Zenpep® for up to 6 months.

Throw away unused Pertzye® mixture.

Do not eat or throw away the drying agent (desiccant) in your medicine bottle. The drying agent will protect your medicine from moisture.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

This medicine may cause a serious bowel disorder called fibrosing colonopathy, especially if taken at a high dose for a long time in children with cystic fibrosis. Check with your doctor right away if you have bloating, constipation, diarrhea, nausea, stomach pain, or vomiting.

This medicine may increase the uric acid levels in the blood (hyperuricemia). Check with your doctor right away if you have joint pain, stiffness, or swelling, lower back, side, or stomach pain, or swelling of the feet or lower legs.

This medicine is made from the pancreas of pigs. Some pigs organs have transmitted certain viruses to people who have received them, although the risk is low. All are tested for viruses to keep the transmission risk low. Talk with your doctor if you have concerns about this risk.

This medicine may cause serious allergic reactions, including anaphylaxis and asthma, which can be life-threatening and require immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, or trouble breathing or swallowing after using this medicine.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Anxiety

blurred vision

chills

cold sweats

coma

confusion

cool, pale skin

depression

dizziness

dry mouth

fast heartbeat

increased hunger

increased thirst

increased urination

nausea

nervousness

nightmares

seizures

shakiness

slurred speech

stomach pain

sweating

trouble breathing

unexplained weight loss

unusual tiredness or weakness

vomiting

Less common

Bloating or swelling of the face, arms, hands, lower legs, or feet

cold flu-like symptoms

cough or hoarseness

fever

indigestion

pale skin

rapid weight gain

stomach bloating

tingling of the hands or feet

unusual bleeding or bruising

Incidence not known

Chest tightness

constipation

diarrhea

difficulty swallowing

excess air or gas in the stomach or intestines

full feeling

hives, itching, skin rash

inflammation of the mouth

passing gas

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Acid or sour stomach

belching

burning or itching around the anus

headache

heartburn

Incidence not known

Difficulty in moving

joint pain or swelling

muscle aches, cramps, pains, or stiffness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.