Sacrosidase

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.

Sucraid is contraindicated in patients known to be hypersensitive to yeast, yeast products, glycerin (glycerol), or papain (see 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).

Increased Blood Glucose Concentrations in Patients with Diabetes Mellitus Sucraid enables the products of sucrose hydrolysis, glucose and fructose, to be absorbed and may increase blood glucose concentrations. Monitor blood glucose concentrations and adjust the diet accordingly for patients with diabetes mellitus. Dietary Starch Restriction Sucraid does not replace isomaltase. Therefore, patients may still experience symptoms of CSID while taking Sucraid. Consider dietary starch restriction in addition to Sucraid, especially in patients in whom symptoms are not adequately controlled by Sucraid. Information for Patients See Patient Package Insert and the Instructions for Use. 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). Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term studies in animals with Sucraid have not been performed to evaluate the carcinogenic potential. Studies to evaluate the effect of Sucraid on fertility or its mutagenic potential have not been performed. Pregnancy Teratogenic Effects Animal reproduction studies have not been conducted with Sucraid. Sucraid is not expected to cause fetal harm when administered to a pregnant woman or to affect reproductive capacity. Sucraid should be given to a pregnant woman only if clearly needed. Nursing Mothers The Sucraid enzyme is broken down in the stomach and intestines, and the component amino acids and peptides are then absorbed as nutrients. Pediatric Use The safety and effectiveness of Sucraid for the treatment of sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID), have been established in pediatric patients aged 5 months and older. Use of Sucraid for this indication is supported by evidence from adequate and well-controlled studies in pediatric patients (see CLINICAL STUDIES and ADVERSE REACTIONS). Geriatric Use Clinical trials of Sucraid did not include patients 65 years of age and older to determine if they respond differently from younger adult patients.

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).

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).

Teratogenic Effects Animal reproduction studies have not been conducted with Sucraid. Sucraid is not expected to cause fetal harm when administered to a pregnant woman or to affect reproductive capacity. Sucraid should be given to a pregnant woman only if clearly needed.

The Sucraid enzyme is broken down in the stomach and intestines, and the component amino acids and peptides are then absorbed as nutrients.

The safety and effectiveness of Sucraid for the treatment of sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID), have been established in pediatric patients aged 5 months and older. Use of Sucraid for this indication is supported by evidence from adequate and well-controlled studies in pediatric patients (see CLINICAL STUDIES and ADVERSE REACTIONS).

Clinical trials of Sucraid did not include patients 65 years of age and older to determine if they respond differently from younger adult patients.