Sucraid

Generic Name: Sacrosidase
Class: Enzymes
ATC Class: A16AB06
VA Class: GA500
Chemical Name: Saccharomyces cerevisiae clone F14 protein moiety reduced
CAS Number: 85897-35-4

Warning(s)

REMS:

FDA approved a REMS for sacrosidase to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().

Introduction

Synthetic form of sucrase; derived from Saccharomyces cerevisiae.1 2 3

Uses for Sucraid

Congenital Sucrase-Isomaltase Deficiency

Oral replacement therapy for the genetic sucrase deficiency that is part of congenital sucrase-isomaltase deficiency (CSID)1 2 3 (designated an orphan drug by FDA for this use).b

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May be used as a short (e.g., 1-week) therapeutic trial to assess response in patients suspected of having CSID when the diagnosis is in doubt.1 2

Sucraid Dosage and Administration

Administration

Oral Administration

Administer orally with each meal or snack.1 2 3 4

Use measuring scoop or dropper dispensing tip provided by manufacturer for measurement of the dose.1 2 3 4

Dose must be diluted with 60–120 mL of water, milk, or infant formula prior to administration.1 2 4 Do not dilute or consume with fruit juice.1 2 4 (See Compatibility under Stability.)

Do not warm or heat diluents before or after addition of sacrosidase; decreased potency likely with heat.1 2 4 Administer cold or at room temperature.1 2 4

Administration with food and/or milk appears to diminish the degradation of the enzyme by intragastric pepsin.2 (See Elimination under Pharmacokinetics.)

Administer half of each dose at the beginning of each meal or snack, and the other half at the end of meal or snack.1 2 3 4

Dosage

Dosage expressed in international units (IU, units).1 2 Each mL of sacrosidase contains 8500 units of the enzyme.1 2

Pediatric Patients

Congenital Sucrase-Isomaltase Deficiency
Oral

For patients weighing ≤15 kg: 8500 units (1 mL using the measuring scoop provided or 22 drops from the Sucraid container tip) with each meal or snack.1 2 3 4

For patients weighing >15 kg: 17,000 units (2 mL using the measuring scoop provided or 44 drops from the Sucraid container tip) with each meal or snack.1 2 3 4

Adults

Congenital Sucrase-Isomaltase Deficiency
Oral

17,000 units (2 mL using the measuring scoop provided or 44 drops from the Sucraid container tip) with each meal or snack.1 2 3 4

Special Populations

No special population dosage recommendations at this time.c

Cautions for Sucraid

Contraindications

  • Known hypersensitivity to yeast, yeast products, or glycerin (glycerol).1 2

Warnings/Precautions

Sensitivity Reactions

Hypersensitivity Reactions

Serious hypersensitivity reactions (i.e., severe wheezing) reported 90 minutes after administration of a second dose.1 2 3

Administer initial doses near a facility where adequate treatment for acute hypersensitivity reactions can be obtained.1 2 4 Alternatively, perform skin testing to assess presence of hypersensitivity to sacrosidase.1 3

If hypersensitivity reaction occurs, discontinue immediately and institute appropriate therapy as indicated (e.g., epinephrine, corticosteroids, maintenance of an adequate airway, oxygen).1 3

General Precautions

Dietary Restriction of Starch

Sacrosidase does not provide replacement for isomaltase deficiency; restriction of dietary starch may be necessary to achieve greatest reduction in symptoms.1 2 4 Evaluate each patient treated to determine need for restriction of dietary starch.1 2

Acquired Disaccharidase Deficiencies

Not evaluated in patients with secondary (acquired) disaccharidase deficiencies.1 2

Diabetes Mellitus

Sacrosidase allows absorption of glucose and fructose (products of sucrose hydrolysis); careful consideration recommended in dietary planning in patients with diabetes mellitus.1 2

Specific Populations

Pregnancy

Category C.1 2

Lactation

Not distributed into milk; sacrosidase not absorbed intact into systemic circulation.2

Pediatric Use

Safety and efficacy established in pediatric patients; sacrosidase has been used in patients ≥5 months of age.3

Common Adverse Effects

Abdominal pain, vomiting, constipation, diarrhea, nausea, dehydration, headache, insomnia, nervousness.1 2 3 4

Sucraid Pharmacokinetics

Absorption

Bioavailability

Not absorbed intact into systemic circulation.2

Elimination

Metabolism

Undergoes degradation to simple amino acids by pepsin produced by the GI mucosa; resultant amino acids and peptides are absorbed into systemic circulation as nutrients.1 2

Stability

Storage

Oral

Solution Concentrate

2–8°C; protect from heat and light.4 a Discard 4 weeks after opening.1 2

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Oral

Solution Compatibility

May be diluted with water, milk, or infant formula.1 4 a

Do not dilute or consume with fruit juice; acidity may reduce enzyme activity.1 2 4

Actions

  • Replaces the deficient endogenous enzyme (sucrase) in patients with CSID.1 2 3

  • Hydrolyzes sucrose into glucose and fructose.1

Advice to Patients

  • Importance of notifying clinician immediately if swelling of the face, difficulty breathing, wheezing, or other manifestations of an allergic reaction are experienced.1 2 4

  • Importance of storing sacrosidase oral solution in a refrigerator, protecting the bottle from heat and light,4 and discarding 4 weeks after first opening the bottle.1 2

  • Importance of taking sacrosidase as prescribed with each meal or snack.1 2 3 4

  • Importance of rinsing the measuring cup with water after each use because of potential for bacterial growth.1 2

  • Importance of not diluting or consuming sacrosidase oral solution with fruit juice because of possible reduction in enzyme activity caused by juice acidity.1 2 4

  • Importance of not diluting sacrosidase oral solution in warm or hot beverages or heated infant formula because of possible heat-related reduction in enzyme activity.1 2 4

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of patients informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as concomitant illnesses, especially diabetes mellitus.a

  • Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Sacrosidase

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

For solution, concentrate

8500 units/mL

Sucraid

QOL

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions October 27, 2011. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Orphan Medical, Inc. Sucraid (sacrosidase) oral solution prescribing information. Minnetonka, MN; 1998 Apr.

2. Orphan Medical, Inc. Product monograph on Sucraid (sacrosidase) oral solution. Minnetonka, MN; 1998.

3. Treem WR, McAdams L, Stanford L et al. Sacrosidase therapy for congenital sucrase-isomaltase deficiency. J Pediatr Gastroenterol Nutr. 1999; 28:137`42. (IDIS 422478) [IDIS 422478] [PubMed 9932843]

4. Orphan Medical, Inc. Sucraid (sacrosidase) oral solution patient information. Minnetonka, MN; 1998 Apr.

a. QOL Medical, LLC. Sucraid (sarcrosidase) oral solution product information. In: Package Insert. From the DailyMed website (). Last revised 2006 Jun. Accessed 2007 Sept 28.

b. Food and Drug Administration. Cumulative list of orphan drugs designated and/or approved. Rockville, MD; 2007, Oct 3. From FDA web site (http: / / www.fda.gov / ForIndustry / DevelopingProductsforRareDiseasesConditions / HowtoapplyforOrphanProductDesignation / default.htm).

c. AHFS drug information 2007. McEvoy GK, ed. Sacrosidase. Bethesda, MD: American Society of Health-System Pharmacists; 2007:2741-2.

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