IMPORTANT SAFETY INFORMATION:

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).

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.

  • For individuals who weigh 33 lb (15 kg) or less, Sucraid® is dispensed in 118-mL translucent plastic bottles, packaged with two bottles per box
  • Each mL of solution contains 8,500 international units (IU) of sacrosidase
  • A 1-mL measuring scoop is provided with each bottle
  • For individuals who weigh more than 33 lb (15 kg), Sucraid® is dispensed in 2-mL single-use containers packaged in a foil pouch
  • Each foil pouch includes five single-use containers
  • Single-use containers are stable for up to three days at room temperature, 59ºF to 77ºF (15ºC to 25ºC)

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.

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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Important Safety Information for Sucraid® (sacrosidase) Oral Solution

  • 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.
  • Do not use Sucraid® with patients known to be hypersensitive to yeast, yeast products, papain, or glycerin (glycerol).
  • 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.

Indication

Sucraid®(sacrosidase) Oral Solution is an enzyme replacement therapy for the treatment of genetically determined sucrase deficiency, which is part of Congenital Sucrase-Isomaltase Deficiency (CSID).