12-day treatment phase on the same individually-titrated dose of ULTRESA. The mean daily dose of ULTRESA during the treatment phase was 6,846 lipase units per kilogram body weight per day. All patients consumed a high-fat diet (2 grams of fat per kilogram of body weight per day) during both the washout phase and the treatment phase.
The mean coefficient of fat absorption (CFA) was determined during the washout phase (no treatment) and during the ULTRESA treatment phase. Mean CFA was 35% during the washout phase and was 83% during the ULTRESA treatment phase.
15 REFERENCES1 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.
4 Smyth RL, Ashby D, O’Hea U, et al. Fibrosing colonopathy in cystic fibrosis: results of a case-control study. Lancet. 1995; 346: 1247-1251.
5 FitzSimmons SC, Burkhart GA, Borowitz DS, et al. High-dose pancreatic-enzyme supplements and fibrosing colonopathy in children with cystic fibrosis. New England Journal of Medicine. 1997; 336: 1283-1289.
16 HOW SUPPLIED/STORAGE AND HANDLINGULTRESA 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 and Handling
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. Th
