NDC 67871-111 Sucraid

Sacrosidase

NDC Product Information

Sucraid with NDC 67871-111 is a a human prescription drug product labeled by Qol Medical, Llc. The generic name of Sucraid is sacrosidase. The product's dosage form is solution and is administered via oral form.

Labeler Name: Qol Medical, Llc

Dosage Form: Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Sucraid Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • SACROSIDASE 8500 [iU]/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • GLYCERIN (UNII: PDC6A3C0OX)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Oral - Administration to or by way of the mouth.
  • Oral - Administration to or by way of the mouth.

Pharmacological Class(es)

What is a Pharmacological Class?
These are the reported pharmacological class categories corresponding to the SubstanceNames listed above.

  • Sucrose-specific Enzyme - [EPC] (Established Pharmacologic Class)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Qol Medical, Llc
Labeler Code: 67871
FDA Application Number: BLA020772 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: BLA - A product marketed under an approved Biologic License Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 04-09-1998 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2021 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA’s requests for correction to deficient or non-compliant submissions. Values = ‘Y’ or ‘N’.

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Sucraid Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Sucraid® (sacrosidase) Oral Solution is an enzyme replacement therapy for the treatment of genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID).

Chemistry

Sucraid is a pale yellow to colorless, clear solution with a pleasant sweet taste. Each milliliter (mL) of Sucraid contains 8,500 International Units (I.U.) of the enzyme sacrosidase, the active ingredient. The chemical name of this enzyme is ß,D-fructofuranoside fructohydrolase. The enzyme is derived from baker’s yeast (Saccharomyces cerevisiae).It has been reported that the primary amino acid structure of this protein consists of 513 amino acids with an apparent molecular weight of 100,000 g/mole for the glycosylated monomer (range 66,000-116,000 g/mole). Reports also suggest that the protein exists in solution as a monomer, dimer, tetramer, and octomer ranging from 100,000 g/mole to 800,000 g/mole. It has an isoelectric point (pI) of 4.5.Sucraid may contain small amounts of papain. Papain is known to cause allergic reactions in some people. Papain is a protein-cleaving enzyme that is introduced in the manufacturing process to digest the cell wall of the yeast and may not be completely removed during subsequent process steps.Sucraid contains sacrosidase in a vehicle comprised of glycerol (50% wt/wt), water, and citric acid to maintain the pH at 4.0 to 4.7. Glycerol (glycerin) in the amount consumed in the recommended doses of Sucraid has no expected toxicity.This enzyme preparation is fully soluble with water, milk, and infant formula. DO NOT HEAT SOLUTIONS CONTAINING SUCRAID. Do not put Sucraid in warm or hot liquids.

Clinical Pharmacology

Congenital sucrase-isomaltase deficiency (CSID) is a chronic, autosomal recessive, inherited, phenotypically heterogeneous 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.Sucrase is naturally produced in the brush border of the small intestine, primarily the distal duodenum and jejunum. Sucrase hydrolyzes the disaccharide sucrose into its component monosaccharides, glucose and fructose. Isomaltase breaks down disaccharides from starch into simple sugars. Sucraid does not contain isomaltase.In the absence of endogenous human sucrase, as in CSID, sucrose is not metabolized. Unhydrolyzed sucrose and starch are not absorbed from the intestine and their presence in the intestinal lumen may lead to osmotic retention of water. This may result in 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 curves. Previously, the treatment of CSID has required the continual use of a strict sucrose-free diet.CSID is often difficult to diagnose. Approximately 4% to 10% of pediatric patients with chronic diarrhea of unknown origin have CSID. Measurement of expired breath hydrogen under controlled conditions following a sucrose challenge (a measurement of excess hydrogen excreted in exhalation) in CSID patients has shown levels as great as 6 times that in normal subjects.A generally accepted clinical definition of CSID is a condition characterized by the following: stool pH <6, an increase in breath hydrogen of > 10 ppm when challenged with sucrose after fasting and a negative lactose breath test. However, because of the difficulties in diagnosing CSID, it may be warranted to conduct a short therapeutic trial (e.g., one week) to assess response in patients suspected of having CSID.

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. During the dose response phase, the patients were challenged with an ordinary sucrose-containing diet while receiving each of four doses of sacrosidase: full strength (9000 I.U./mL) and three dilutions (1:10 [900 I.U./mL], 1:100 [90 I.U./mL], and 1:1000 [9 I.U./mL]) in random order for a period of 10 days. Patients who weighed no more than 15 kg received 1 mL per meal; those weighing more than 15 kg received 2 mL per meal. The dose did not vary with age or sucrose intake. A 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 end-points. In addition, 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 end-points.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.A second study of similar design and execution as the first used 4 different dilutions of sacrosidase: 1:100 (90 I.U./mL), 1:1000 (9 I.U./mL), 1:10,000 (0.9 I.U./mL), and 1:100,000 (0.09 I.U./mL). There were inconsistent results with regards to the primary efficacy parameters.In both trials, however, patients showed a marked decrease in breath hydrogen output when they received sacrosidase in comparison to placebo.

Indications And Usage

Sucraid® (sacrosidase) Oral Solution is indicated as oral replacement therapy of the genetically determined sucrase deficiency, which is part of congenital sucrase-isomaltase deficiency (CSID).

Contraindications

Patients known to be hypersensitive to yeast, yeast products,
glycerin (glycerol), or papain.

Warnings

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.

Precautions

Care should be taken to administer initial doses of Sucraid near (within a few minutes of 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.

General

Although 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 Patients

See 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 Diabetics

The 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 Tests

The 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.

Drug Interactions

Neither 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.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

Long-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 mutagenic potential have not been performed.

Pregnancy

Teratogenic effects. Pregnancy Category C. 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.

Nursing Mothers

The Sucraid enzyme is broken down in the stomach and intestines,
and the component amino acids and peptides are then absorbed as nutrients.

Pediatric Use

Sucraid 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.

Adverse Reactions

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 (seeWarnings). The event resulted in withdrawal of the patient from the trial but resolved with no sequelae.

Overdosage

Overdosage with Sucraid has not been reported.

Dosage And Administration

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 1 mL; 28 drops from the Sucraid container tip equals 1 mL) taken orally with each meal or snack diluted with 2 to 4 ounces (60 to 120 mL) 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.2 mL (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 (1 mL equals 28 drops from the Sucraid container tip).

How Supplied

Sucraid® (sacrosidase) Oral Solution 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.Rx only.Distributed by:QOL Medical, LLCVero Beach, FL 32963To order, or for any questions, call 1-866-469-3773www.sucraid.netNDC# 67871-111-04

Sucraid® (Sacrosidase) Oral Solution

Please read this leaflet carefully before you take Sucraid® (sacrosidase) Oral Solution or give Sucraid to a child. Please do not throw away this leaflet. You may need to read it again at a later date. This leaflet does not contain all the information on Sucraid. For further information or advice, ask your doctor or pharmacist.

Before Taking Sucraid

WARNING: Sucraid may cause a serious allergic reaction. If you
notice any swelling or have difficulty breathing, get emergency help right away.
Before taking your first and second doses, be sure that there are health
professionals nearby (within a few minutes of travel) just in case there is an
allergic reaction.

Information About Your Medicine

The name of your medicine is Sucraid (sacrosidase) Oral Solution.
It can be obtained only with a prescription from your doctor.

The Purpose Of Your Medicine:

Sucraid is an enzyme replacement therapy for the treatment of the
genetically determined sucrase deficiency, which is part of congenital
sucrase-isomaltase deficiency (CSID). CSID is a condition where your body lacks
the enzymes needed to break down and absorb sucrose (table sugar) and other
sugars from starch.The symptoms of CSID often include frequent watery diarrhea, abdominal pain,
bloating, and gas. In many cases, the symptoms of CSID are similar to other
medical problems. Only your doctor can make a definite diagnosis of CSID. Sucraid can help improve the breakdown and absorption of sucrose (table
sugar) from the intestine and can help relieve the gastrointestinal symptoms of
CSID.Sucraid does not break down some sugars resulting from the digestion of
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.

Discuss The Following Important Information With Your Doctor Before You Begin To Take Sucraid:

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).Tell your doctor if you have diabetes. With Sucraid, 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.

Side Effects To Watch For:

Some patients may have worse abdominal pain, vomiting, nausea, or
diarrhea. Constipation, difficulty sleeping, headache, nervousness, and
dehydration have also occurred. Other side effects may also occur. If you notice
these or any other side effects during treatment with Sucraid, check with your
doctor.Stop taking Sucraid and get emergency help immediately if any of the
following side effects occur: difficulty breathing, wheezing, or swelling of the
face.

How To Take Your Medicine:

Each bottle of Sucraid is supplied with a plastic screw cap which covers a dropper dispensing tip. Remove the outer cap and measure out the required dose. Reseal the bottle after each use by replacing and twisting the cap until tight.Write down the date the sealed bottle is first opened in the space provided on the bottle label. Always throw away the bottle four weeks after first opening it because Sucraid contains no preservatives. For the same reason, you should rinse the measuring scoop with water after each time you finish using it.To get the full benefits of this medicine, it is very important to take Sucraid as your doctor has prescribed. The usual dosage is 1 to 2 milliliters (mL) with each meal or snack: 1mL = 1 full measuring scoop (28 drops from the bottle tip) and 2 mL = 2 full measuring scoops (56 drops from the bottle tip).Measure your dose with the measuring scoop provided (see Figure 1). Do not use a kitchen teaspoon or other measuring device since it will not measure an accurate dose.Figure 1. Measure dose with measuring scoop.Mix your dose in 2 to 4 ounces of water, milk, or infant formula (see Figure 2). Sucraid should not be dissolved in or taken with fruit juice.NEVER HEAT SUCRAID OR PUT IT IN WARM OR HOT BEVERAGES OR INFANT FORMULA. Heating Sucraid causes it to lose its effectiveness. The beverage or infant formula should be taken cold or at room temperature.Figure 2. Mix dose in beverage or infant formula.It is recommended that approximately half of your dosage be taken at the beginning of each meal or snack and the remainder of your dosage be taken during the meal or snack.

Storing Your Medicine:

Sucraid is available in 4 fluid ounce (118 mL) see-through plastic bottles, packaged two bottles per box. A 1 mL measuring scoop is provided with each bottle. Always store Sucraid in a refrigerator at 36°F - 46°F (2°C - 8°C). Protect Sucraid from heat and light.If your bottle of Sucraid has expired (the expiration date is printed on the bottle label), throw it away.Keep this medicine in a safe place in your refrigerator where children cannot reach it.QOL Medical, LLCVero Beach, FL 32963www.sucraid.netFor questions call 1-866-469-3773Rev 03/17Part No. 0110

Package Label

Carton Panel, Front:

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