Prescribing Information Important Safety Information
Treatment

Sucraid® (sacrosidase) Oral Solution

The treatment of the sucrase deficiency associated with Congenital Sucrase-Isomaltase Deficiency (CSID) consists of lifelong adherence to a strict sucrose-free diet. It is also sometimes necessary for some of you with CSID to adhere to a starch-free or low-starch diet when a sucrose-free diet does not provide adequate relief of gastrointestinal symptoms.

However, given the sucrose content of Western diets, your compliance with a sucrose-free diet is, at best, difficult. For both these reasons, those with CSID often experience continued chronic gastrointestinal symptoms despite attempts to restrict their diet. At the same time, some struggle to maintain their body weight.

Sucraid® (sacrosidase) Oral Solution is a sucrase enzyme replacement therapy that breaks down sucrose into glucose and fructose, allowing these simple sugars to be absorbed by the small intestine into the bloodstream.

Enzyme replacement therapy with Sucraid® offers a pharmacologic alternative to strict sucrose-free diets. Sucraid® is an effective option for the management of CSID symptoms. The medication may reduce or eliminate both the need for sucrose dietary restrictions and the symptoms of CSID associated with sucrase deficiency in the majority of treated individuals.

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What Does Sucraid® Do?

CSID is a genetic disorder that occurs due to the absence or low levels of sucrase, the enzyme that plays a role in the body’s breakdown of sucrose (table sugar). Enzyme replacement therapy with Sucraid® acts as a substitute for the missing sucrase and can reduce or eliminate the symptoms of CSID when taken as directed.

Although Sucraid® provides replacement therapy for deficient sucrase, it does not provide specific replacement therapy for deficient isomaltase. Therefore, restricting starch in the diet may still be necessary to help reduce gastrointestinal symptoms as much as possible in individuals with CSID. The need for dietary starch restriction for those using Sucraid® should be evaluated under the care of a physician and a registered dietitian.

How Do I Get Access to Sucraid®?

Sucraid® is a prescription enzyme replacement medication that is available through a specialty pharmacy. Ask your physician if Sucraid® would be appropriate for you or your child. If insurance issues make it difficult to access Sucraid®, support programs are available.

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IMPORTANT SAFETY INFORMATION:

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Important Safety Information for Sucraid® (sacrosidase) Oral Solution

  • Tell your doctor if you are allergic to, have ever had a reaction to, or have ever had difficulty taking yeast, yeast products, papain, or glycerin (glycerol).
  • Sucraid® may cause a serious allergic reaction. If you notice any swelling or have difficulty breathing, get emergency help right away.
  • Sucraid® does not break down some sugars that come from the digestion of starch. You may need to restrict the amount of starch in your diet. Your doctor will tell you if you should restrict starch in your diet.
  • Tell your doctor if you have diabetes, as your blood glucose levels may change if you begin taking Sucraid®. Your doctor will tell you if your diet or diabetes medicines need to be changed.
  • Some patients treated with Sucraid® may have worse abdominal pain, vomiting, nausea, or diarrhea. Constipation, difficulty sleeping, headache, nervousness, and dehydration have also occurred in patients treated with Sucraid®. Check with your doctor if you notice these or other side effects.
  • Sucraid® has not been tested to see if it works in patients with secondary (acquired) sucrase deficiency.
  • NEVER HEAT SUCRAID® OR PUT IT IN WARM OR HOT BEVERAGES OR INFANT FORMULA. Do not mix Sucraid® with fruit juice or take it with fruit juice. Take Sucraid® as prescribed by your doctor. Normally, half of the dose of Sucraid® is taken just before a meal or snack and the other half is taken 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.

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.