NORD Registered
 

Sucraid™ (sacrosidase) oral solution is an enzyme replacement therapy for use in the treatment of Congenital Sucrase-Isomaltase Deficiency (CSID) developed initially by Orphan Medical, Inc.   CSID is a condition where your body lacks the enzymes needed to properly break down and absorb sucrose (table sugar) and isomaltase (a type of starch) from the intestines. 

Sucraid™ can help improve the breakdown and absorption of sucrose (table sugar) from the intestine and can help relieve the symptoms of CSID.  Sucraid™ may also possibly improve growth in young children and make it easier to sleep by relieving gastrointestinal symptoms.

Sucraid™ does not contain the enzyme needed to break down and absorb isomaltase ( a type of starch) from the intestine.  Your doctor should be consulted to determine if starch intake needs to be restricted. 

For more information on Sucraid™ you can contact www.ivpcare.com or call 800-424-9002.

In May of 2003, Orphan Medical sold Sucraid™ to QOL Medical and enclosed a letter from QOL Medical that highlighted the following information:

• QOL Medical has selected ivpcare as the exclusive provider of comprehensive specialty pharmacy services for Sucraid™.  ivpcare will be your one-stop resource for obtaining your medication, beginning in May 2003.  
  
• Ivpcare provides complimentary insurance benefits investigation, and free, confidential delivery directly to your home or office.  ivpcare's pharmacists are available 24/7 to answer dosage administration and medication questions when you call 800-424-9002.  To place an order, please have your physician call 800-424-9002 or have your physician fax your prescription to 800-874-9179.  
  

• Ivpcare and QOL Medical will be contacting all current Sucraid™ providers to inform them of their new resource for Sucraid™.  Ivpcare looks forward to speaking with you soon.  The Sucraid™ Customer Service Team can be reached at 800-424-9002 for any questions regarding the transfer of your Sucraid™ prescription. 

Frequently Asked Questions about Sucraid provided by QOL Medical

Clinical Pharmacology;

SucraidŽ Description: Chemical Name: B,D fructofuranoside fractohydrolase

SucraidŽ(sacrosidase) oral solution is an enzyme replacement therapy for the treatment of the genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID). SucraidŽ is a pale yellow, clear solution with a pleasant, sweet taste.

The active ingredient is sacrosidase [enzyme derived from bakers yeast (saccharomyces cerevisiae)]. SucraidŽ also contains 50% glycerol in an aqueous solution, with no expected toxicity at recommended SucraidŽ dose levels.

The solution is fully soluble with water, milk and infant formula. DO NOT HEAT SOLUTIONS CONTAINING SucraidŽ. Do not put SucraidŽ in warm or hot liquids. DO NOT MIX WITH SUGARY DRINKS SUCH AS FRUIT JUICES.


Does SucraidŽ contain isomaltase?
SucraidŽ does not contain isomaltase.


Does SucraidŽ contain gluten?
SucraidŽ does not contain gluten.

Is a support group available?
Yes. A parent support group is available. Visit www.csidinfo.com

Mechanism of Action
SucraidŽ facilitates breakdown and absorption of sucrose (table sugar) from the intestine and can help relieve the gastrointestinal symptoms of CSID.

SucraidŽ does not break down starch. Therefore, you may need to restrict the amount of starch in your diet. Your doctor will tell you if you should restrict the amount of starch in your diet.

What causes CSID?
It is a genetic, inheritable disease the consequences of which interfere with the enzyme transport mechanism. Sucrase is a naturally-occurring enzyme that is produced in the brush-border of the small intestine, primarily in the distal duodenum and jejunum. Sucrase hydrolyzes sucrose, a disaccharide, into its component monosaccharides, glucose and fructose. Congenital sucrase-isomaltase deficiency (CSID) is a rare, chronic, autosomal recessive, phenotypically heterogenous disease with very variable enzyme activity. CSID is usually characterized by a complete or almost complete lack of endogenous sucrase activity, a very marked reduction in isomaltase activity, a moderate decrease in maltase activity and normal lactase levels.


What are the symptoms of CSID?
Symptoms may include some or all of the following: excessive gas, bloating, abdominal cramps, watery diarrhea, nausea, vomiting, and failure to thrive.

Sucrase is naturally produced in the brush border of the small intestine. Sucrase hydrolyzes the disaccharide sucrose into its component monosaccharides, glucose and fructose. In the absence of endogenous human sucrase, sucrose is not metabolized. This may lead to an osmotic retention of water, which causes loose stools. Unabsorbed sucrose in the colon is fermented by bacterial flora to produce increased amounts of hydrogen, methane and water. As a consequence, excessive gas, bloating, abdominal cramps, nausea and vomiting may occur.

Chronic malabsorption of disaccharides may result in malnutrition. Undiagnosed/untreated CSID patients often fail to thrive and fall behind in their expected growth and development.


How do you diagnose CSID?
CSID is difficult to diagnose. The definitive test for diagnosis of CSID is measurement of intestinal disaccharidases following small bowel biopsy.

Less invasive diagnoses are: A positive breath hydrogen test following an oral challenge with sucrose and a negative breath hydrogen test following oral challenge with lactose along with a stool pH of less than 6 provides an acceptable diagnosis of CSID.

Alternatively, because of the difficulty in diagnosing CSID a physician may prescribe a short therapeutic trial in patients suspected of having sucrase deficiency. Therapeutic trial supplies may be ordered by physicians by calling 1-800-424-9002


Are there any other treatments available for CSID?
There are no other FDA approved treatments for CSID. Historically the only way to manage CSID was to eat a restricted diet containing very little sucrose. In clinical trials, patients still suffered symptoms of watery diarrhea, abdominal pain and cramps even when on a fully restricted diet.


Clinical Studies
A two phase (dose-response preceded by a breath hydrogen phase), double blind, multi-site, crossover trial was conducted in 28 patients (aged 4 months to 11.5 years) with confirmed CSID, as published in, Treem WR, Mc Adams L, Stanford L, Kastoff G, Justinich C, Hyams J. Sacrosidase Therapy for Congenital Sucrase-Isomaltase Deficiency. Journal of Pediatric Gastroenterology and Nutrition 1999; 28(2):137-142.

Dose did not vary with age or sucrose intake;
Dose-response relationship was shown between the two higher and the two lower doses;
The two higher doses of sacrosidase were associated with significantly fewer total stools and higher proportions of patients having lower total symptom scores, the primary efficacy endpoints;
Higher doses of sacrosidase were associated with a significantly greater number of hard and formed stools as well as with fewer watery and soft stools, the secondary efficacy endpoints; and
Analysis of the overall symptomatic response as a function of age indicated that in CSID patients up to 3 years of age, 86% became asymptomatic. In patients over 3 years of age, 77% became asymptomatic. Thus, the therapeutic response did not differ significantly according to age.
Off-label Uses
The effects of SucraidŽ have not been evaluated in patients with secondary (acquired) disaccharidase deficiencies.



Do I need to restrict my diet and watch my carbohydrate intake?
Patients in the clinical trial consumed a normal diet consisting of 2g/kg sucrose (table sugar) and 5 g/kg carbohydrates. It is generally recommended to avoid adding starch immediately back into the diet and to gradually introduce sucrose. Once a patient is well maintained on their normal sucrose diet (over approximately 2 weeks), starhc van be added back into the diet and symptoms monitored. Because CSID has many phenotypes, a small number of patients migh need to remain starch-free.


What precautions should be discussed with my physician before starting SucraidŽ therapy?

Tell your doctor if you are allergic to, have ever had a reaction to, or have ever had difficulty taking yeast, yeast products, or glyercin (glycerol).
Tell your doctor if you have diabetes. With SucraidŽ, sucrose (table sugar) can be absorbed from your diet and your blood glucose levels may change. Your doctor will tell you if your diet or diabetes medicines need to be changed.

Drug Interactions
Neither drug-drug nor drug-food interactions are expected or have been reported with the use of SucraidŽ. However, SucraidŽ should not be reconstituted or consumed with fruit juice, since it's acidity may reduce the enzyme activity.



Are there any tests available to determine if a patient is allergic to SucraidŽ?
The patient may be tested for hypersensitivity to SucraidŽ through skin abrasion testing. The patient should discuss this with the primary care physician or allergist.


How do you treat an overdose?
No incidents of overdose have been reported. Glycerin, a component of SucraidŽ, is an osmotic laxative; so dehydration may occur if too much SucraidŽ is ingested. If an overdose should occur, adequate hydration should be maintained.

Dosing Instructions

1 mL (one full measuring scoop or 22 drops) per meal or snack for patients up to 15 kg in body weight. 2 mL (two full measuring scoops or 44 drops) per meal or snack for patient over 15 kg in body weight. It is suggested that half of the dose be taken before the meal and the other half be taken half way through the meal.

Can I put SucraidŽ in other drinks such as water or milk?

SucraidŽ is completely soluble in water, milk, and infant formula. Beverages containing SucraidŽ should be consumed cold or at room temperature. Heating beverages containing SucraidŽ, or adding SucraidŽ to hot beverages, will likely decrease the potency. SucraidŽ should not be reconstituted or consumed with fruit juice, since its acidity may reduce the enzyme activity. KEEP SucraidŽ REFRIGERATED

Stability

How long will SucraidŽ be stable once it is put into another liquid such as water or baby formula?
We recommend preparation immediately prior to the meal or snack, with half of the dosage taken before the meal or snack and the remainder of the dosage half way through.

We just received a new shipment of SucraidŽ and it was not refrigerated right away. Is it still good?
SucraidŽ is an enzyme product and needs to be maintained at refrigerated conditions. However, brief exposure to ambient room temperature should not affect the potency. If you have concerns, please call 1-800-424-9002
 

Food and Drug Sucraid Information:

FAQ  |  Instructions  |  Glossary  |  Contact Us  |  CDER Home    Drug Details Drug Name(s) SUCRAID (Brand Name Drug) FDA Application No. (NDA) 020772 Active Ingredient(s) SACROSIDASE Company QOL MEDCL Original Approval or Tentative Approval Date April 9, 1998 Chemical Type 1  New molecular entity (NME)   Review Classification P  Priority review drug O Orphan drug There are no Therapeutic Equivalents Label Information Approval History, Letters, Reviews, and Related Documents Consumer Information Sheet   Products on Application (NDA) #020772     Click on a column header to re-sort the table: Drug Name Active Ingredients Strength Dosage Form/Route Marketing Status RLD TE Code SUCRAID  SACROSIDASE  8,500 IU/ML  SOLUTION; ORAL  Prescription  Yes  None