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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.

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IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION:

About Sucraid®

Sucraid® Is an Effective Treatment for CSID

Three clinical trials have evaluated the therapeutic benefits of sacrosidase (the generic name for Sucraid®).

In This Section
Clinical Trial 1

The first study used the sucrose hydrogen breath test to measure the activity of sacrosidase in study participants diagnosed with Congenital Sucrase-Isomaltase Deficiency (CSID).

The therapeutic benefit of the replacement enzyme was measured by the hydrogen breath test, which measures the activity of the sucrase enzyme. This study also measured the ability of four different doses of the replacement enzyme sacrosidase to relieve GI symptoms associated with CSID. The study included 14 patients, average age of 7.6 years, who were diagnosed with CSID. When they were given sacrosidase, results from the sucrose hydrogen breath test indicated a highly significant improvement in their ability to digest the sucrose. Among the four doses tested, the higher doses of sacrosidase resulted in greater relief of GI symptoms. The researchers concluded that sacrosidase is an effective and well-tolerated treatment for sucrase deficiency associated with CSID.1

Clinical Trial 2

In the second clinical trial, the researchers also used the hydrogen breath test to measure the activity of sacrosidase, taken by the study participants diagnosed with CSID.

The relief of GI symptoms was also measured after treatment with four different doses of sacrosidase. There were 28 study participants, average age 4 years, who were diagnosed with CSID. This study also used the sucrose hydrogen breath test, and found that sacrosidase significantly improved sucrose digestion. The frequency and severity of GI symptoms were greatly diminished with sacrosidase. 81% of the participants were free of GI symptoms during treatment with sacrosidase, defined as being symptom-free for at least 7 of the 10 treatment days. The researchers concluded that treatment with sacrosidase would allow consumption of a more normal diet in patients with CSID.2

Clinical Trial 3

The third clinical trial was conducted over a period of several years in 32 participants diagnosed with CSID and treated with Sucraid®.

The researchers again found therapy with Sucraid® to be well-tolerated and effective in reducing the GI symptoms of sucrase deficiency associated with CSID. Study participants in this long-term study spanned a broad range of ages. While taking Sucraid®, the study participants consumed a normal, sucrose-containing diet and experienced fewer GI symptoms than before therapy with Sucraid®.3

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References
  1. Treem WR, Ahsan N, Sullivan B, et al. Evaluation of liquid yeast-derived sucrase enzyme replacement in patients with sucrase-isomaltase deficiency. Gastroenterology. 1993;105(4):1061-1068. doi:10.1016/0016-5085(93)90950-h
  2. Treem WR, McAdams L, Stanford L, Kastoff G, Justinich C, Hyams J. Sacrosidase therapy for Congenital Sucrase-Isomaltase Deficiency. J Pediatr Gastroenterol Nutr. 1999;28(2):137-142. doi:10.1097/00005176-199902000-00008
  3. QOL Medical, LLC. Open-label, long-term study of sucrase enzyme therapy for Congenital Sucrase-Isomaltase Deficiency. Data on file, OMC-SUC-3. 1997.

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.