PANCREASE MT

). 2 Geriatrics It is recommended that enzyme doses, expressed as lipase units/kg/meal, be decreased in older patients since they weigh more but tend to ingest less fat per kilogram (see 4 DOSAGE AND ADMINISTRATION) 2 CONTRAINDICATIONS Pancrease MT is contraindicated in: • patients who have known hypersensitivity to porcine protein, pancreatic enzymes, or any excipients (see

1 Adverse Reaction Overview The most common adverse reactions are abdominal discomfort, constipation and dermatitis. Other gastrointestinal reactions are less common and include abnormal stool and diarrhea. Nausea and vomiting have been reported, but these are not common.

With high doses, perianal irritation and inflammation have been reported (see 7 WARNINGS AND PRECAUTIONS). At extremely high doses, hyperuricosuria and hyperuricemia have been reported. Allergic or hypersensitivity reactions of the skin have been reported (see 7 WARNINGS AND PRECAUTIONS, General).

5 Post-Market Adverse Reactions The following adverse reactions have been reported during post-marketing experience (Table ).

The frequencies are provided according to the following convention:

Very common  1/10 Common  1/100 and < 1/10 Uncommon  1/1,000 and < 1/100 Rare  1/10,000 and < 1/1000 Very rare < 1/10,000 Table 2: Adverse Drug Reactions Identified During Post-Marketing Experience with Pancrease MT by Frequency Category Estimated from Spontaneous Reporting Rates Gastrointestinal Disorders Very rare Abdominal distention, abdominal pain, diarrhea, intestinal obstruction*, nausea, vomiting Skin and Subcutaneous Tissue Disorders Very rare Rash * Mainly cases of fibrosing colonopathy in pediatric subjects with cystic fibrosis (see 7 WARNINGS AND PRECAUTIONS).

). Usually, half the mealtime dose is given with a snack. The total daily dose should reflect approximately three meals and two snacks per day. Instruct the patient to take the medication immediately and not store it to be taken later.

2 Recommended Dose and Dosage Adjustment If doses greater than 2,500 lipase units/kg/meal (4,000 lipase units/g fat/day) are required to control malabsorption, further investigation is warranted to rule out other causes of malabsorption.

Doses greater than 2,500 units/kg/meal should be used with caution and only if they are documented to be effective by 3-day fecal fat studies. Doses greater than 6,000 lipase units/kg/meal have been associated with colonic strictures, particularly in children with cystic fibrosis less than 12 years of age.

Patients currently on higher doses than 6,000 lipase units/kg/meal should be re-evaluated and the dosage either immediately decreased or titrated downward to the lowest effective clinical dose as assessed by 3-day fecal fat excretion (see 7 WARNINGS AND PRECAUTIONS, Gastrointestinal).

Pancrease MT (pancrelipase) Page 6 of 18 Infants (up to 12 months):

Fat Consumption Scheme • 2,000-4,000 USP lipase units per 120 mL of formula or per breast-feeding. 5 grams of fat per 120 mL standard cow’s milk-based formula). Higher doses are used in infants because, on average, infants ingest 5 grams of fat per kilogram of body weight per day, whereas adults tend to ingest about 2 grams of fat per kilogram per day.

Contents of the capsule should not be mixed directly into formula or breast milk as this may diminish efficacy.

Children (over 12 months) and Adults:

Weight-based Scheme • Less than 4 years: Begin with 1,000 USP lipase units/kg/meal to a maximum of 2,500 lipase units/kg/meal. • Over 4 years and Adults: Begin with 500 USP lipase units/kg/meal to a maximum of 2,500 lipase units/kg/meal.

Pancrease MT is contraindicated in: • patients who have known hypersensitivity to porcine protein, pancreatic enzymes, or any excipients (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). • patients experiencing an episode of acute pancreatitis or the acute exacerbation of chronic pancreatitis excipients (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING).