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Ultresa

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Ultresa

INDICATIONS

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

DOSAGE AND ADMINISTRATION

ULTRESA is not interchangeable with other pancrelipase products.

ULTRESA is orally administered. Therapy should be initiated at the lowest recommended dose and gradually increased. The dosage of ULTRESA should be individualized based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet as described in the Limitations on Dosing below [see DOSAGE AND ADMINISTRATION and WARNINGS AND PRECAUTIONS].

Administration

Children and Adults

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

For patients who are unable to swallow intact capsules, the capsules may be carefully opened and the contents sprinkled on a small amount of applesauce, yogurt and other acidic soft food with a pH of 4.5 or less at room temperature.

The ULTRESA-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 to avoid mucosal irritation.

Any unused portion of capsule contents should be discarded, and not used for subsequent dosing. The remaining exposed contents may lose potency and become less effective.

Dosage

Dosage recommendations for pancreatic enzyme replacement therapy were published following the Cystic Fibrosis Foundation Consensus Conferences.1,2,3 ULTRESA 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.

Children Older than 12 Months and Younger than 4 Years and Weight 14 kg or Greater

Children older than 12 months and younger than 4 years, weighing under 14 kg should not be dosed with this product because capsule dosage strengths cannot adequately provide dosing for these children.

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 Weight 28 kg or Greater and Adults

Children 4 years and older, weighing under 28 kg should not be dosed with this product because capsule dosage strengths cannot adequately provide dosing for these children.

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 ULTRESA dose for an individualized full meal should be given with each snack. The total daily dosage 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 stricture, indicative of fibrosing colonopathy, in children 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.

Use of ULTRESA in children is limited by the available capsule dosage strengths and their ability to provide the recommended dose based on age and weight. Attempting to divide the capsule contents in small fractions to deliver small doses of lipase is not recommended.

HOW SUPPLIED

Dosage Forms And Strengths

The active ingredient in ULTRESA evaluated in clinical trials is lipase. ULTRESA is dosed by lipase units. Other active ingredients include protease and amylase.

ULTRESA is available in 3 color coded delayed-release capsule strengths. Each ULTRESA delayed-release capsule strength contains the specified amounts of lipase, protease, and amylase as follows:

  • 13,800 USP units of lipase; 27,600 USP units of protease; 27,600 USP units of amylase delayed-release capsules have a white cap printed with “13800UL” and yellow body printed with “AXCA” in black.
  • 20,700 USP units of lipase; 41,400 USP units of protease; 41,400 USP units of amylase delayed-release capsules have a gray cap printed with “20700UL” and white body printed with “AXCA” in black.
  • 23,000 USP units of lipase; 46,000 USP units of protease; 46,000 USP units of amylase delayed-release capsules have a light gray cap printed with “23000UL” and yellow body printed with “AXCA” in black.

Storage And Handling

ULTRESA Delayed-Released Capsules

13,800 USP units of lipase; 27,600 USP units of protease; 27,600 USP units of amylase

Each ULTRESA capsule is available as a two-piece gelatin capsule with a white cap printed with “13800UL” and a yellow body printed with “AXCA” that contains light brown, bright, homogeneous mini-tablets of delayed-release pancrelipase supplied in bottles of:

100 capsules (NDC 58914-003-10)

ULTRESA Delayed-Released Capsules

20,700 USP units of lipase; 41,400 USP units of protease; 41,400 USP units of amylase

Each ULTRESA capsule is available as a two-piece gelatin capsule with a gray cap printed with “20700UL” and a white body printed with “AXCA” that contains light brown, bright, homogeneous mini-tablets of delayed-release pancrelipase supplied in bottles of:

100 capsules (NDC 58914-019-10)

ULTRESA Delayed-Released Capsules

23,000 USP units of lipase; 46,000 USP units of protease; 46,000 USP units of amylase

Each ULTRESA capsule is available as a two-piece gelatin capsule with a light gray cap printed with “23000UL” and a yellow body printed with “AXCA” that contains light brown, bright, homogeneous mini-tablets of delayed-release pancrelipase supplied in bottles of:

100 capsules (NDC 58914-005-10)
500 capsules (NDC 58914-005-50)

Storage

Avoid excessive heat. ULTRESA capsules should be stored in a dry place in the original container. Store at room temperature 20-25°C (68-77°F). After opening, keep the container tightly closed between uses to protect from moisture.

ULTRESA is dispensed in bottles containing a desiccant. The desiccant packet should not be eaten or thrown away. The desiccant packet will protect the product from moisture.

Do not crush ULTRESA delayed-release capsule 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.

Marketed by: Aptalis Pharma US, Inc 22 Inverness Center Parkway Birmingham, AL 35242 USA. Manufactured by: Aptalis Pharma S.r.L. Pessano, Italy 20060. Revised: March 2012

Last reviewed on RxList: 3/12/2012
This monograph has been modified to include the generic and brand name in many instances.

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