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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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Treatment

What are the Options for Treating CSID?

For patients with Congenital Sucrase-Isomaltase Deficiency (CSID) who present with gastrointestinal symptoms that warrant intervention, three major treatment options exist:

  • Severe diet restriction

  • Sucraid®

  • Sucraid® with moderate diet restriction

In This Section

Before Sucraid® was available, treatment of CSID consisted of lifelong adherence to a strict sucrose-free diet. However, given the high sucrose content of Western diets, patient compliance with a sucrose-free diet is challenging. Patient noncompliance is often accompanied by chronic gastrointestinal (GI) symptoms and a low body mass index (BMI) that falls below an age-adjusted growth curve.1-3 In a clinical trial observing the response to a restricted diet, up to 75% of patients remained symptomatic, mostly due to noncompliance with the diet.4

Enzyme replacement therapy with Sucraid® offers a pharmacologic alternative to sucrose-free diets. Sucraid® is an effective option for the management of sucrase deficiency and reduces or eliminates the need for dietary restrictions of sucrose and the symptoms associated with CSID in the majority of patients. In a long-term clinical trial, 81% of patients with CSID managed by Sucraid® became asymptomatic, defined as symptom-free for at least 7 of the 10 treatment days.4 Note that Sucraid® does not provide specific replacement therapy for deficient isomaltase.5 Therefore, restricting starch in the diet may still be necessary in order to minimize symptoms. The need for dietary starch restriction in patients using Sucraid® should be evaluated on a patient-by-patient basis.

Treatment Percent of CSID Patients Treated With Sucraid® Became Asymptomatic

Figure 1. In a long-term clinical trial, 81% of study subjects with CSID who were treated with Sucraid® became asymptomatic, defined as symptom-free for at least 7 of the 10 treatment days.4

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References
  1. Treem WR. Congenital Sucrase-Isomaltase Deficiency. J Pediatr Gastroenterol Nutr. 1995;21(1):1-14. doi:10.1097/00005176-199507000-00001
  2. Gudmand-Høyer E. Sucrose malabsorption in children: a report of thirty-one Greenlanders. J Pediatr Gastroenterol Nutr. 1985;4(6):873-877. doi:10.1097/00005176-198512000-00005
  3. Gudmand-Høyer E, Krasilnikoff PA, Skovbjerg H. Sucrose-isomaltose malabsorption. Adv Nutr Res. 1984;6:233-269. doi:10.1007/978-1-4613-2801-8_9
  4. Treem WR. Clinical aspects and treatment of Congenital Sucrase-Isomaltase Deficiency. J Pediatr Gastroenterol Nutr. 2012;55(suppl 2):S7-S13. doi:10.1097/00005176-199902000-00008
  5. Sucraid® [package insert]. Vero Beach, FL: QOL Medical, LLC; 2023.

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.