Over dosage with SUCRAID has not been reported.
Patients known to be hypersensitive to yeast, yeast products, glycerin (glycerol), or papain.
Adverse experiences with SUCRAID in clinical trials were generally minor and were frequently associated with the underlying disease.
In clinical studies of up to 54 months duration, physicians treated a total of 52 patients with SUCRAID. The adverse experiences and respective number of patients reporting each event (in parenthesis) were as follows: abdominal pain (4), vomiting (3), nausea (2), diarrhea (2), constipation (2), insomnia (1) headache (1) nervousness (1) and dehydration (1).
Note: diarrhea and abdominal pain can be a part of the clinical presentation of the genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID).
One asthmatic child experienced a serious hypersensitivity reaction (wheezing) probably related to sacrosidase (see WARNINGS). The event resulted in withdrawal of the patient from the trial but resolved with no sequelae.
SUCRAID (sacrosidase) oral solution is indicated as oral replacement therapy of the genetically determined sucrase deficiency, which is part of congenital sucraseisomaltase deficiency. (CSID)
Animal reproduction studies have not been conducted with SUCRAID. SUCRAID is not expected to cause fetal harm when administered to a pregnant woman or to affect reproductive capacity. SUCRAID should be given to a pregnant woman only if clearly needed.
SUCRAID is available in 118 mL (4 fluid ounces) translucent plastic bottles, packaged two bottles per box. Each mL of solution contains 8,500 International Units (I.U.) of sacrosidase. A 1 mL measuring scoop is provided with each bottle. A full measuring scoop is 1 mL.
Store in a refrigerator at 2°- 8° C (36°- 46°F). Product is sterile until opened. Discard four weeks after first opening due to the potential for bacterial growth.
Protect from heat and light.
Distributed by: QOL Medial, LLC, Vero Beach, FL 32963. Revised: 06/12
Severe wheezing, 90 minutes after a second dose of sacrosidase, necessitated admission into the ICU for a 4-year old boy. The wheezing was probably caused by sacrosidase. He had asthma and was being treated with steroids. A skin test for sacrosidase was positive. Other serious events have not been linked to SUCRAID.
PRECAUTIONSCare should be taken to administer initial doses of SUCRAID near (within a few minutes' travel) a facility where acute hypersensitivity reactions can be adequately treated. Alternatively, the patient may be tested for hypersensitivity to SUCRAID through skin abrasion testing. Should symptoms of hypersensitivity appear, discontinue medication and initiate symptomatic and supportive therapy.
Skin testing as a rechallenge has been used to verify hypersensitivity in one asthmatic child who displayed wheezing after oral sacrosidase.
GeneralAlthough SUCRAID provides replacement therapy for the deficient sucrase, it does not provide specific replacement therapy for the deficient isomaltase. Therefore, restricting starch in the diet may still be necessary to reduce symptoms as much as possible. The need for dietary starch restriction for patients using SUCRAID should be evaluated in each patient.
It may sometimes be clinically inappropriate, difficult or inconvenient to perform a small bowel biopsy or breath hydrogen test to make a definitive diagnosis of CSID. If the diagnosis is in doubt, it may be warranted to conduct a short therapeutic trial (e.g. one week) with SUCRAID to assess response in a patient suspected of sucrase deficiency.
The effects of SUCRAID have not been evaluated in patients with secondary (acquired) disaccharidase deficiencies.
Information For PatientsSee Patient Package Insert. Patients should be instructed to discard bottles of SUCRAID 4 weeks after opening due to the potential for bacterial growth. For the same reason, patients should be advised to rinse the measuring scoop with water after each use.
SUCRAID is fully soluble with water, milk and infant formula, but it is important to note that this product is sensitive to heat. SUCRAID should not be reconstituted or consumed with fruit juice, since its acidity may reduce the enzyme activity.
Use in diabeticsThe use of SUCRAID will enable the products of sucrose hydrolysis - glucose and fructose to be absorbed. This fact must be carefully considered in planning the diet of diabetic CSID patients using SUCRAID.
Laboratory testsThe definitive test for diagnosis of CSID is the measurement of intestinal disaccharidases following small bowel biopsy. Other tests used alone may be inaccurate: for example, the breath hydrogen test (high incidence of false-negatives) or oral sucrose tolerance test (high incidence of false positives). Differential urinary disaccharide testing has been reported to show good agreement with small intestinal biopsy for diagnosis of CSID.
Carcinogenesis, mutagenesis, impairment of fertilityLong-term studies in animals with SUCRAID have not been performed to evaluate the carcinogenic potential. Studies to evaluate the effect of SUCRAID on fertility or its mutogenic potential have not been performed.
Pregnancy Teratogenic effects - Pregnancy Category CAnimal reproduction studies have not been conducted with SUCRAID. SUCRAID is not expected to cause fetal harm when administered to a pregnant woman or to affect reproductive capacity. SUCRAID should be given to a pregnant woman only if clearly needed.
Nursing mothersThe SUCRAID enzyme is broken down in the stomach and intestines and the component amino acids and peptides are then absorbed as nutrients.
Pediatric useSUCRAID has been used in patients as young as 5 months of age. Evidence in one controlled trial in primarily pediatric patients shows that SUCRAID is safe and effective for the treatment of the genetically acquired sucrase deficiency, which is part of CSID.
The recommended dosage is 1 or 2 mL (8,500 to 17,000 I.U.) or 1 or 2 full measuring scoops (each full measuring scoop equals 1mL; 28 drops from the SUCRAID container tip equals 1mL) taken orally with each meal or snack diluted with 2 to 4 ounces of water, milk or infant formula. The beverage or infant formula should be served cold or at room temperature. The beverage or infant formula should not be warmed or heated before or after addition of SUCRAID because heating is likely to decrease potency. SUCRAID should not be reconstituted or consumed with fruit juice since its acidity may reduce the enzyme activity.
It is recommended that approximately half of the dosage be taken at the beginning of the meal or snack and the remainder be taken during the meal or snack.
The recommended dosage is as follows:
1 mL (8,500 I.U.) (one full measuring scoop or 28 drops) per meal or snack for patients up to 15 kg in body weight.
2mL (17,000 I.U.) (two full measuring scoops or 56 drops) per meal or snack for patients over 15 kg in body weight.
Dosage may be measured with the 1 mL measuring scoop (provided) or by drop count method (1mL equals 28 drops from the SUCRAID container tip).
Adverse experiences with SUCRAID in clinical trials were generally minor and were frequently associated with the underlying disease.
In clinical studies of up to 54 months duration, physicians treated a total of 52 patients with SUCRAID. The adverse experiences and respective number of patients reporting each event (in parenthesis) were as follows: abdominal pain (4), vomiting (3), nausea (2), diarrhea (2), constipation (2), insomnia (1) headache (1) nervousness (1) and dehydration (1).
Note: diarrhea and abdominal pain can be a part of the clinical presentation of the genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID).
One asthmatic child experienced a serious hypersensitivity reaction (wheezing) probably related to sacrosidase (see WARNINGS). The event resulted in withdrawal of the patient from the trial but resolved with no sequelae.
DRUG INTERACTIONSNeither drug-drug nor drug-food interactions are expected or have been reported with the use of SUCRAID. However, SUCRAID should not be reconstituted or consumed with fruit juice, since its acidity may reduce the enzyme activity.
