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IMPORTANT SAFETY INFORMATION:

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Important Safety Information for Sucraid® (sacrosidase) Oral Solution

  • Do not prescribe Sucraid® to patients known to be hypersensitive to yeast, yeast products, papain, or glycerin (glycerol).
  • Sucraid® may cause a serious allergic reaction. Patients should stop taking Sucraid® and get emergency help immediately if any of the following side effects occur: difficulty breathing, wheezing, or swelling of the face. Care should be taken when administering initial doses of Sucraid® to observe any signs of acute hypersensitivity reaction.
  • Although Sucraid® provides replacement therapy for the deficient sucrase, it does not provide specific replacement therapy for the deficient isomaltase.
  • Adverse reactions as a result of taking Sucraid® may include worse abdominal pain, vomiting, nausea, diarrhea, constipation, difficulty sleeping, headache, nervousness, and dehydration.
  • Before prescribing Sucraid® to diabetic patients, the physician should consider that Sucraid® will enable sucrose hydrolysis and the absorption of those hydrolysis products, glucose and fructose.
  • The effects of Sucraid® have not been evaluated in patients with secondary (acquired) disaccharidase deficiency.
  • DO NOT HEAT SOLUTIONS CONTAINING SUCRAID®. Do not put Sucraid® in warm or hot fluids. Do not reconstitute or consume Sucraid® with fruit juice since the acidity of the juice may reduce the enzyme activity of Sucraid®. Half of the reconstituted Sucraid® should be taken at the beginning of the meal or snack and the other half during the meal or snack.
  • Sucraid® should be refrigerated at 36°F-46°F (2°C-8°C) and should be protected from heat and light; single-use containers can be removed from refrigeration and stored at 59°F-77°F (15°C-25°C) for up to 3 days (72 hours). Refer to Instructions for Use for full information on how to take Sucraid®.

Indication

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.

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IMPORTANT SAFETY INFORMATION:

Prevalence

How Common is Congenital Sucrase-Isomaltase Deficiency?

The prevalence of CSID in other North American and European populations has been estimated at approximately 1 in 500 to 1 in 2,000 among non-Hispanic whites.1

The Estimated Prevalence of CSID in Various Populations

In past clinical studies, the prevalence of a CSID diagnosis, based on results from disaccharidase assays of intestinal tissue samples, was found to be relatively high in certain demographic groups:2

  • 2% to 10% in indigenous Greenlanders
  • 3% to 7% in indigenous people of Canada
  • 3% in Alaskans of native ancestry

The prevalence of CSID in other North American and European populations has been estimated to be lower than in these groups, approximately 1 in 500 to 1 in 2,000 among non-Hispanic whites. This translates to a prevalence of approximately 0.05% to 0.2%. The prevalence is thought to be even lower in African-Americans and whites of Hispanic descent.1

It is possible that a significant proportion of children and adults affected with CSID are not being tested for CSID, and therefore are not being properly diagnosed or adequately treated. Because the gastrointestinal (GI) symptoms associated with CSID are similar to many other GI disorders, such as irritable bowel syndrome (IBS) or toddler’s diarrhea, some researchers believe that many of those who are diagnosed with IBS may actually have undiagnosed CSID.

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Important Safety Information for Sucraid® (sacrosidase) Oral Solution

  • Do not prescribe Sucraid® to patients known to be hypersensitive to yeast, yeast products, papain, or glycerin (glycerol).
  • Sucraid® may cause a serious allergic reaction. Patients should stop taking Sucraid® and get emergency help immediately if any of the following side effects occur: difficulty breathing, wheezing, or swelling of the face. Care should be taken when administering initial doses of Sucraid® to observe any signs of acute hypersensitivity reaction.
  • Although Sucraid® provides replacement therapy for the deficient sucrase, it does not provide specific replacement therapy for the deficient isomaltase.
  • Adverse reactions as a result of taking Sucraid® may include worse abdominal pain, vomiting, nausea, diarrhea, constipation, difficulty sleeping, headache, nervousness, and dehydration.
  • Before prescribing Sucraid® to diabetic patients, the physician should consider that Sucraid® will enable sucrose hydrolysis and the absorption of those hydrolysis products, glucose and fructose.
  • The effects of Sucraid® have not been evaluated in patients with secondary (acquired) disaccharidase deficiency.
  • DO NOT HEAT SOLUTIONS CONTAINING SUCRAID®. Do not put Sucraid® in warm or hot fluids. Do not reconstitute or consume Sucraid® with fruit juice since the acidity of the juice may reduce the enzyme activity of Sucraid®. Half of the reconstituted Sucraid® should be taken at the beginning of the meal or snack and the other half during the meal or snack.
  • Sucraid® should be refrigerated at 36°F-46°F (2°C-8°C) and should be protected from heat and light; single-use containers can be removed from refrigeration and stored at 59°F-77°F (15°C-25°C) for up to 3 days (72 hours). Refer to Instructions for Use for full information on how to take Sucraid®.

Indication

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.