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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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About Sucraid®

What is Sucraid®?

Sucraid® is the only FDA-approved enzyme replacement therapy indicated for the treatment of genetically determined sucrase deficiency, which is a part of Congenital Sucrase-Isomaltase Deficiency (CSID).

In This Section

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 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.

Sucraid® Single Use Container

Figure 1. How Sucraid® is dispensed

How Does Sucraid® Work?

Sucraid® has been shown in clinical trials to be effective in the treatment of patients with 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 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.

Sucraid® and the metabolism of sucrose

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

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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

  • 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.