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.

WARNINGS Severe Hypersensitivity Reactions Severe hypersensitivity reactions, including wheezing, rash, and pruritis, have been reported with administration of Sucraid.

Sucraid contains papain, which is associated with hypersensitivity reactions (see DESCRIPTION).

A pediatric patient in the clinical trials experienced a hypersensitivity reaction of severe wheezing that required hospitalization.

Postmarketing cases of cutaneous hypersensitivity reactions have also been reported.

Instruct patients or caregivers to stop Sucraid and seek medical attention if symptoms suggestive of a hypersensitivity reaction occur.

Sucraid is contraindicated in patients who have had a known hypersensitivity reaction (see CONTRAINDICATIONS).

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).