Prescribing Information Important Safety Information
About CSID

How Do I Interpret Disaccharid­ase Biopsy Results?

It may be beneficial for you to keep a copy of your or your child’s disaccharidases small bowel biopsy results. You can ask your doctor or the medical records department of your child’s medical practice for a copy.

Classic disaccharidases small bowel biopsy results associated with congenital sucrase-isomaltase deficiency (CSID) are as follows:1

Decreased (usually absent) sucrase activity
Decreased-to-normal isomaltase (palatinase) activity
Reduced maltase activity
Decreased-to-normal lactase activity

Your or your child’s levels of enzyme activity may differ from the list above, since there are individual differences in the severity of CSID and the degree to which each individual has problems digesting starches. Almost all those with CSID have decreased sucrase activity, even if such sucrase activity is not entirely absent.2

Some individuals with CSID can tolerate typical amounts of starches in their diet. These individuals would most likely have normal levels of maltase and isomaltase (palatinase) activity. Some with CSID tolerate no dietary starches at all. These individuals would probably show low levels of maltase and isomaltase (palatinase) activity.1

Knowing the level of lactase activity is also valuable, because dairy foods can be an important source of dietary calories for those with CSID who are not lactose intolerant. Some individuals with CSID have normal levels of lactase activity, while others are deficient in the lactase enzyme.3

Abnormal Disaccharidase Levels

Knowing disaccharidase levels of activity can help in developing the best diet for each individual’s unique situation. Note that the chart below shows ranges for abnormal laboratory values in the United States only.4 Consult your individual lab report for what is considered abnormal for the particular lab that conducted your disaccharidase testing.

Sucrase

Abnormal range is less than 25 U*

Maltase

Abnormal range is less than 100 U*

Isomaltase (Palatinase)

Abnormal range is less than 5 U*

Lactase

Abnormal range is less than 15 U*
*U, units; activity level may be reported as μM/min/g
References
  1. Treem WR. Congenital sucrase-isomaltase deficiency. J Pediatr Gastroenterol Nutr. 1995;21(1):1-14. doi:10.1097/00005176-199507000-00001
  2. Smith H, Romero B, Flood E, Boney A. The patient journey to diagnosis and treatment of congenital sucrase-isomaltase deficiency. Qual Life Res. 2021;30(8):2329-38. doi:10.1007/s11136-021-02819-z
  3. Treem WR. Clinical aspects and treatment of congenital sucrase-isomaltase deficiency. J Pediatr Gastroenterol Nutr. 2012;55(suppl 2):S7-13. doi:10.1097/01.mpg.0000421401.57633.90
  4. Hackenmuller SA, Grenache DG. Reference intervals for intestinal disaccharidase activities determined from a non-reference population. J Appl Lab Med. 2016;1(2):172-80. doi:10.1373/jalm.2016.020388

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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.