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Important Safety Information
Prescribing Information
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What is Sucraid®?

Sucraid® is the only FDA-approved enzyme replacement therapy 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®
4-Day Trial

See if Sucraid® is right for your patients diagnosed with sucrase deficiency caused by Congenital Sucrase-Isomaltase Deficiency (CSID).

Sucraid® 4-Day Trial

Figure 1. How Sucraid® is dispensed

Sucraid® is an enzyme replacement therapy that facilitates the breakdown of sucrose (sugar) into monosaccharides for absorption by the small intestine. It has been shown to help alleviate the gastrointestinal (GI) symptoms associated with sucrase deficiency caused by CSID, and, as a result, patients can maintain a more normal diet that includes sucrose-containing foods.

Sucraid® is provided as a liquid to be mixed in cold or room temperature water, milk, or infant formula with each dose taken partly before and then during meals or snacks. Please refer to the Prescribing Information and Instructions for Use for full dosing instructions.

How does Sucraid® work?

Figure 2. Role of Sucraid® in the metabolism of sucrose and absorption of its metabolic byproducts glucose and fructose across small intestine microvilli

Sucraid® has been shown in clinical trials to be effective in the treatment of patients with sucrase deficiency caused by CSID. The active ingredient in Sucraid® is sacrosidase, a sucrase enzyme replacement that catalyzes the hydrolysis of sucrose into glucose and fructose, thereby facilitating absorption from the small intestine into the bloodstream. Sacrosidase is a potent and robust enzyme; on a per milliliter basis, sacrosidase is approximately 100-fold more potent than endogenous sucrase.1 It has been shown to be stable when stored at 4°C.2

Although Sucraid® provides replacement therapy for deficient sucrase, it does not provide specific replacement therapy for deficient isomaltase.3 Therefore, Sucraid® does not metabolize dietary starches (for example, potato, bread, or pasta) and restricting starch in the diet may still be necessary to minimize symptoms in patients with sucrase deficiency caused by CSID who are starch intolerant. When starting therapy with Sucraid®, patients who still have symptoms are advised to restrict dietary starch for two weeks and then gradually reintroduce starch while monitoring for gastrointestinal symptoms. Keeping a dietary diary for the first few weeks of therapy is also recommended.

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References
    1. Treem WR, McAdams L, Stanford L, Kastoff G, Justinich C, Hyams J. Sacrosidase therapy for Congenital Sucrase-Isomaltase Deficiency. J Pediatr Gatroenterol Nutr. 1999;28(2):137-142. doi:10.1097/00005176-199902000-00008
    2. Treem WR, Ahsan N, Sullivan B, et al. Evaluation of liquid yeast-derived sucrase enzyme replacement in patients with sucrase-isomaltase deficiency. Gatroenterology. 1993;105(4):1061-1068. doi:10.1016/0016-5085(93)90950-h
    3. Sucraid® [package insert]. Vero Beach, FL: QOL Medical, LLC; 2024.
Important Safety Information for Sucraid® (sacrosidase) Oral Solution
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.

Contraindication

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

Warnings, Precautions, and Additional Important Safety Information
  • Severe Hypersensitivity Reactions
    Severe hypersensitivity reactions, including wheezing, difficulty breathing, rash, pruritis, and swelling of the face, lips, mouth, or tongue have been reported with administration of Sucraid®. Sucraid® contains papain, which is associated with hypersensitivity reactions.
  • Increased Blood Glucose Concentration 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®.
  • Adverse reactions as a result of taking Sucraid® may include worse abdominal pain, vomiting, nausea, diarrhea, constipation, difficulty sleeping, headache, nervousness, and dehydration.
  • 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®.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

IMPORTANT SAFETY INFORMATION:

Important Safety Information for Sucraid® (sacrosidase) Oral Solution

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.

Contraindication

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

Warnings, Precautions, and Additional Important Safety Information

  • Severe Hypersensitivity Reactions
    Severe hypersensitivity reactions, including wheezing, difficulty breathing, rash, pruritis, and swelling of the face, lips, mouth, or tongue have been reported with administration of Sucraid®. Sucraid® contains papain, which is associated with hypersensitivity reactions.
  • Increased Blood Glucose Concentration 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®.
  • Adverse reactions as a result of taking Sucraid® may include worse abdominal pain, vomiting, nausea, diarrhea, constipation, difficulty sleeping, headache, nervousness, and dehydration.
  • 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®.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

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