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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.

IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION:

Taking Sucraid®

Dosage and Administration

Please follow the dosing instructions for Sucraid® carefully.

Sucraid® is Supplied in Bottles and Single-Use Containers

  • Sucraid® is available in 118-mL bottles and 2-mL single-use containers

Dosing Instructions for Sucraid® Bottles:

  • 1 mL (8,500 IU; one full measuring scoop; use the white plastic scoop provided in your box of Sucraid®) per meal or snack for infants, toddlers, and small children weighing up to 33 lb (15 kg)
  • 2 mL (17,000 IU, 2 full measuring scoops) per meal or snack for adults and children over 33 lb (15 kg) in body weight

Each Sucraid® dose should be diluted in 4 ounces of water, milk, or infant formula. Sucraid® can be measured with the white, plastic, 1-mL measuring scoop that is provided.

Dosing Instructions for Sucraid® Single-Use Containers:

The contents of the Sucraid® 2-ml single-use container should be diluted in 4 ounces of water, milk, or infant formula. Patients should consume:

  • all of the mixed solution dose per meal or snack for patients over 33 lb (15 kg) in body weight
  • half of the mixed solution dose per meal or snack for patients 33 lb (15 kg) and less

It is recommended that approximately half the dosage be taken at the beginning of each meal or snack and the remainder of the dosage taken during the meal or snack. Sucraid® acts on the food you eat while it is in your gastrointestinal (GI) tract. Therefore, it is important that Sucraid® be taken when you are eating.

If you still have some symptoms after starting therapy with Sucraid®, your doctor may recommend avoiding starchy foods for several weeks and then gradually adding back foods containing starch while monitoring your GI symptoms.

Please refer to the Prescribing Information and Instructions for Use for full dosing instructions.

Sucraid® Single-Use Container

Figure 1. Sucraid® single-use container (pictured). Also available in bottle form.

Administration, Storage, and Shelf Life of Sucraid® Bottles

The following should be noted with regards to administration, storage, and shelf life of Sucraid®:

  • Sucraid® is a substitute for the missing sucrase enzyme, so it must be taken with every meal or snack to work. Half of each dose should be taken before a meal and the other half during a meal
  • The beverage or infant formula used to dilute Sucraid® should be served cold or at room temperature. Do not heat beverages containing Sucraid®, or add Sucraid® to hot beverages, as the heated fluid could decrease the potency of the enzyme
  • For patients 33 lb (15 kg) and less using the Sucraid® 2-ml single-use container, the second half of the mixed solution should be refrigerated and discarded if not used within 24 hours
  • Sucraid® should be refrigerated at 36°F to 46°F (2°C to 8°C) and protected from heat and light
  • Sucraid® should not be consumed with fruit juices, as the acidity may impair enzyme activity
  • Sucraid® should not be taken directly from the bottle or measuring scoop without first diluting in water, milk, or infant formula
  • Discard bottles of Sucraid® four weeks after first opening, because, as with all proteins, there is the potential for bacterial growth

Traveling with Sucraid® Bottles

Sucraid® should be kept refrigerated at 36°F to 46°F (2°C to 8°C) and should be protected from heat and light. For this reason, traveling with Sucraid® can be difficult. Parents and caregivers of patients with Congenital Sucrase-Isomaltase Deficiency (CSID) have used a variety of techniques to facilitate travel with Sucraid®.

Common travel ideas for transporting a Sucraid® bottle are:

  • A cooler with reusable ice gel packs or ice blocks (the bottle should be wrapped in an insulated lunchbox or protective compartment so Sucraid® will not freeze completely if using dry ice)
  • Insulated lunchboxes with reusable ice gel packs or ice blocks
  • Medical coolers
  • A wide-mouthed thermos-type bottle, packed with ice
  • Insulated bags intended for baby bottles
  • Insulated bags with coolant inside that allows the entire bag to be frozen before inserting the Sucraid® bottle

Discover the Convenience of Sucraid® Single-Use Containers

  • An on-the-go option is Sucraid® single-use containers
  • Small enough to fit in your pocket
  • Sucraid® 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).

Dosing Instructions for Sucraid® single-use containers

  • No measuring required
  • Just twist, squeeze, and mix

Letter of Medical Necessity for Sucraid® Bottles

Traveling by plane with Sucraid® can also prove to be challenging. The U.S. Transportation Security Administration (TSA) permits “prescription liquid medications and other liquids needed by persons with disabilities and medical conditions. This includes all prescription and over-the-counter medications. This also includes gels or frozen liquids needed to cool disability- or medically-related items used by persons with disabilities or medical conditions.” Sucraid® can go through the X-ray machine as part of the security process without the scan affecting the ability of Sucraid® to continue working.

People have found that the burden of traveling with Sucraid® is reduced when a physician provides them with a Letter of Medical Necessity. The Letter of Medical Necessity should include the following information:

      • Patient’s name
      • Patient’s date of birth
      • Patient’s diagnosis of CSID
      • Patient’s need for therapy with Sucraid®
      • The need for Sucraid® to be refrigerated/maintained at 36°F to 46°F (2°C to 8°C)
      • The need for any ice gel packs or ice blocks to be kept with the Sucraid® at all times

Traveling with Sucraid® poses some unique challenges. For longer trips, it is advised to find out if your destination has a refrigerator available.

Please click this link to access a sample Letter of Medical Necessity to use during travel, which patients can bring to their healthcare provider for his/her signature.

Learn How You Can Get Sucraid® from Our Specialty Pharmacy

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.