Sacrosidase

INDICATIONS AND USAGE Sucraid ® (sacrosidase) Oral Solution is indicated for the treatment of sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID), in adult and pediatric patients 5 months of age and older.

DOSAGE AND ADMINISTRATION Important Administration Information Administer Sucraid with each meal or snack. Mix Sucraid with cold or room temperature water, milk or infant formula prior to administration. Administration of Sucraid in liquids other than water, milk, or infant formula has not been studied and is not recommended. Do not mix or consume Sucraid with fruit juice. Do not warm or heat the water, milk, or infant formula before or after addition of Sucraid. Administer half of the dose at the beginning of the meal or snack and the other half of the dose during the meal or snack. Recommended Dosage The recommended dosage is: Patients weighing 15 kg and less: 8,500 International Units (1 mL) administered orally with each meal or snack. Patients weighing more than 15 kg: 17,000 International Units (2 mL) administered orally with each meal or snack. Preparation and Administration Instructions for Patients Weighing 15 kg or Less Multiple-Dose Bottle: Using the measuring scoop provided, add 1 scoop of Sucraid (1 mL) to 60 mL of cold or room temperature water, milk, or infant formula. Stir to mix well. Administer half of the mixed Sucraid solution (30 mL) at the beginning of the meal or snack and the other half of the mixed solution (30 mL) during the meal or snack. Do not save any of the mixed Sucraid solution for later use. Rinse the measuring scoop with water. Single-Use Container: Empty the entire contents of the single-use container (2 mL) in 120 mL of cold or room temperature water, milk, or infant formula. Stir to mix well. Divide the mixed Sucraid solution into two separate 60 mL portions. The first portion (60 mL) is for immediate use. • Administer half of the first portion (30 mL) of the mixed Sucraid solution at the beginning of the meal or snack and the other half of the first portion (30 mL) of the mixed Sucraid solution during the meal or snack. Store the second portion of the mixed Sucraid solution (60 mL) at 2°C to 8°C (36°F to 46°F) for up to 24 hours for administration with the next meal or snack. • Discard the mixed Sucraid solution if not used within 24 hours. Preparation and Administration Instructions for Patients Weighing More than 15 kg Multiple-Dose Bottle: Using the measuring scoop provided, add 2 scoops of Sucraid (2 mL) to 120 mL of cold or room temperature water, milk, or infant formula. Stir to mix well. Administer half of the mixed Sucraid solution (60 mL) at the beginning of the meal or snack and the other half of the mixed Sucraid solution (60 mL) during the meal or snack. Do not save any of the mixed Sucraid solution for later use. Rinse the measuring scoop with water. Single-Use Container: Empty the entire contents of the single-use container (2 mL) in 120 mL of cold or room temperature water, milk, or infant formula. Stir to mix well. Administer half of the mixed Sucraid solution (60 mL) at the beginning of the meal or snack and the other half of the mixed solution during the meal or snack (60 mL). Do not save any of the mixed Sucraid solution for later use.

ADVERSE REACTIONS The following adverse reactions associated with the use of sacrosidase were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. In clinical studies of up to 54 months duration, a total of 52 patients were treated with Sucraid. The reported adverse reactions (number of patients) were as follows: abdominal pain (4), vomiting (3), nausea (2), diarrhea (2), constipation (2), insomnia (1), headache (1), nervousness (1), and dehydration (1). Hypersensitivity reactions (wheezing, rash, and pruritis) have been reported (see WARNINGS).

Drug Interactions Fruit Juice The acidity in fruit juice may reduce the enzyme activity in Sucraid. Administration of Sucraid with liquids other than water, milk, or infant formula has not been studied and is not recommended (see DOSAGE AND ADMINISTRATION, Administration Instructions).