Pancreaze

INDICATIONS

PANCREAZE (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

DOSAGE AND ADMINISTRATION

Dosage

PANCREAZE is not interchangeable with other pancrelipase products.

PANCREAZE is orally administered. Therapy should be initiated at the lowest recommended dose and gradually increased. The dosage of PANCREAZE should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet (see Limitations on Dosing below).

Dosage recommendations for pancreatic enzyme replacement therapy were published following the Cystic Fibrosis Foundation Consensus Conferences.1,2,3 PANCREAZE should be administered in a manner consistent with the recommendations of the Conferences provided in the following paragraphs. Patients may be dosed on a fat ingestion-based or actual body weight-based dosing scheme.

Infants (up to 12 months)

Infants may be given 2,000 to 4,000 lipase units per 120 mL of formula or per breast-feeding. Do not mix PANCREAZE capsule contents directly into formula or breast milk prior to administration [see ADMINISTRATION].

Children Older than 12 Months and Younger than 4 Years

Enzyme dosing should begin with 1,000 lipase units/kg of body weight per meal for children less than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

Children 4 Years and Older and Adults

Enzyme dosing should begin with 500 lipase units/kg of body weight per meal for those older than age 4 years to a maximum of 2,500 lipase units/kg of body weight per meal (or less than or equal to 10,000 lipase units/kg of body weight per day), or less than 4,000 lipase units/g fat ingested per day.

Usually, half of the prescribed PANCREAZE dose for an individualized full meal should be given with each snack. The total daily dose should reflect approximately three meals plus two or three snacks per day.

Enzyme doses expressed as lipase units/kg of body weight per meal should be decreased in older patients because they weigh more but tend to ingest less fat per kilogram of body weight.

Limitations on Dosing

Dosing should not exceed the recommended maximum dosage set forth by the Cystic Fibrosis Foundation Consensus Conferences Guidelines.1,2,3

If symptoms and signs of steatorrhea persist, the dosage may be increased by a healthcare professional. Patients should be instructed not to increase the dosage on their own. There is great inter-individual variation in response to enzymes; thus, a range of doses is recommended. Changes in dosage may require an adjustment period of several days. If doses are to exceed 2,500 lipase units/kg of body weight per meal, further investigation is warranted.

Doses greater than 2,500 lipase units/kg of body weight per meal (or greater than 10,000 lipase units/kg of body weight per day) should be used with caution and only if they are documented to be effective by 3-day fecal fat measures that indicate a significantly improved coefficient of fat absorption. Doses greater than 6,000 lipase units/kg of body weight per meal have been associated with colonic strictures, indicative of fibrosing colonopathy, in children with cystic fibrosis less than 12 years of age [see WARNINGS AND PRECAUTIONS]. Patients currently receiving higher doses than 6,000 lipase units/kg of body weight per meal should be examined and the dosage either immediately decreased or titrated downward to a lower range.

Administration

PANCREAZE should always be taken as prescribed by a healthcare professional.

Infants (up to 12 months)

PANCREAZE should be administered to infants immediately prior to each feeding, using a dosage of 2,000 to 4,000 lipase units per 120 mL of formula or per breast-feeding. Contents of the capsule may be sprinkled on small amounts of acidic soft food with a pH of 4.5 or less (e.g., applesauce) and given to the infant within 15 minutes. Contents of the capsule may also be administered directly to the mouth. Administration should be followed by breast milk or formula. Contents of the capsule should not be mixed directly into formula or breast milk as this may diminish efficacy. Care should be taken to ensure that PANCREAZE is not crushed or chewed or retained in the mouth, to avoid irritation of the oral mucosa.

Children and Adults

PANCREAZE should be taken during meals or snacks, with sufficient fluid. PANCREAZE capsules and capsule contents should not be crushed or chewed. Capsules should be swallowed whole.

For patients who are unable to swallow intact capsules, the capsules may be carefully opened and the contents sprinkled on small amounts of acidic soft food with a pH of 4.5 or less (e.g., applesauce). The PANCREAZE-soft food mixture should be swallowed immediately without crushing or chewing, and followed with water or juice to ensure complete ingestion. Care should be taken to ensure that no drug is retained in the mouth.

HOW SUPPLIED

Dosage Forms And Strengths

The active ingredient in PANCREAZE evaluated in clinical trials is lipase. PANCREAZE is dosed by lipase units.

PANCREAZE is available in 4 color coded capsule strengths.

Other active ingredients include protease and amylase. Each PANCREAZE capsule strength contains the specified amounts of lipase, protease, and amylase as follows:

  • 4,200 USP units of lipase; 10,000 USP units of protease; 17,500 USP units of amylase capsules have a yellow opaque body and clear cap, printed with “McNEIL” and “MT 4”
  • 10,500 USP units of lipase; 25,000 USP units of protease; 43,750 USP units of amylase capsules have a pink opaque body and clear cap, printed with “McNEIL” and “MT 10”
  • 16,800 USP units of lipase; 40,000 USP units of protease; 70,000 USP units of amylase capsules have a salmon opaque body and clear cap, printed with “McNEIL” and “MT 16”
  • 21,000 USP units of lipase; 37,000 USP units of protease; 61,000 USP units of amylase capsules have a white opaque body and cap, printed with “McNEIL” and “MT 20”
PANCREAZE (pancrelipase) Delayed-Release Capsules

4,200 USP units of lipase; 10,000 USP units of protease; 17,500 USP units of amylase.

PANCREAZE (pancrelipase) is supplied as hard gelatin capsules with a yellow opaque body and clear cap imprinted with “McNEIL” and “MT 4” and packaged in bottles of 100-(NDC 50458-341-60).

PANCREAZE (pancrelipase) Delayed-Release Capsules

10,500 USP units of lipase; 25,000 USP units of protease; 43,750 USP units of amylase.

PANCREAZE (pancrelipase) is supplied as hard gelatin capsules with a pink opaque body and clear cap imprinted with “McNEIL” and “MT 10” and packaged in bottles of 100-(NDC 50458-342-60).

PANCREAZE (pancrelipase) Delayed-Release Capsules

16,800 USP units of lipase; 40,000 USP units of protease; 70,000 USP units of amylase.

PANCREAZE (pancrelipase) is supplied as hard gelatin capsules with a salmon opaque body and clear cap imprinted with “McNEIL” and “MT 16” and packaged in bottles of 100-(NDC 50458-343-60).

PANCREAZE (pancrelipase) Delayed-Release Capsules

21,000 USP units of lipase; 37,000 USP units of protease; 61,000 USP units of amylase.

PANCREAZE (pancrelipase) is supplied as hard gelatin capsules with a white opaque body and cap imprinted with “McNEIL” and “MT 20” and packaged in bottles of 100-(NDC 50458-346-60).

Storage And Handling

Avoid heat. PANCREAZE hard gelatin capsules should be stored in a dry place in the original container. After opening, KEEP THE CONTAINER TIGHTLY CLOSED between uses to PROTECT FROM MOISTURE. Do not store above 25°C (77°F).

The PANCREAZE 4,200 USP units of lipase and PANCREAZE 21,000 USP units of lipase bottles contain a desiccant canister. DO NOT eat or throw away the canister (desiccant) in your medicine bottle. This canister will protect your medicine from moisture.

Keep out of reach of children.

DO NOT CRUSH PANCREAZE delayed-release capsules or the capsule contents.

REFERENCES

1.Borowitz DS, Grand RJ, Durie PR, et al. Use of pancreatic enzyme supplements for patients with cystic fibrosis in the context of fibrosing colonopathy. Journal of Pediatrics. 1995; 127: 681-684.

2.Borowitz DS, Baker RD, Stallings V. Consensus report on nutrition for pediatric patients with cystic fibrosis. Journal of Pediatric Gastroenterology Nutrition. 2002 Sep; 35: 246-259.

3.Stallings VA, Start LJ, Robinson KA, et al. Evidence-based practice recommendations for nutrition-related management of children and adults with cystic fibrosis and pancreatic insufficiency: results of a systematic review. Journal of the American Dietetic Association. 2008; 108: 832-839.

Product of Germany : Finished Product Manufactured by: Nordmark Arzneimittel GmbH & Co. KG 25436 Uetersen, Germany. Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560. Issued: November 2013

Last reviewed on RxList: 6/9/2014
This monograph has been modified to include the generic and brand name in many instances.

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