ULTRESA Rx

Indications for ULTRESA:

Treatment of exocrine pancreatic insufficiency due to cystic fibrosis, or other conditions.

Adults and Children:

Start at the lowest recommended dose and increase gradually. Individualize based on clinical symptoms, the degree of steatorrhea present, and the fat content of the diet. Swallow whole; do not crush or chew caps. May mix contents with applesauce or other acidic soft food (pH≤ 4.5); swallow mixture immediately, follow with water or juice; take with meals; do not let any drug remain in mouth. ≤12mos: 4000 lipase units per 120mL of formula or per breastfeeding; give prior to each feeding, do not mix directly. >12mos–<4yrs: initially 1000 lipase units/kg per meal. ≥4yrs: initially 500 lipase units/kg per meal. Max (>12mos): 2500 lipase units/kg per meal (or ≤10000 lipase units/kg/day), or <4000 lipase units/g fat ingested/day. See full labeling.

Warnings/Precautions:

Not interchangeable with other pancrelipase products. Fibrosing colonopathy (with high doses); risk of stricture formation (monitor). Pork allergy. Potential viral transmission. Gout. Renal impairment. Hyperuricemia. Contents irritating to oral mucosa. Pregnancy (Cat.C). Nursing mothers.

Pharmacological Class:

Pancreatic enzymes (porcine).

Adverse Reactions:

Headache, pharyngolaryngeal pain, epistaxis; allergic reactions.

Generic Availability:

NO

How Supplied:

Caps—100