Sucraid® | Travel Tips & Best Practices for Patients [PDF]

The letter of medical necessity should include the following information: Patient's name; Patient's date of birth; Patie

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HOW TO ORDER | PATIENT SUPPORT Important Safety Information | Prescribing Information | Visit our Healthcare Professional site

About GSID

About Sucraid®

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Ordering

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Go to... About Sucraid® Benefits Taking Sucraid®

Taking Sucraid®

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ABOUT GSID

Dosage and Administration Please follow the dosing instructions for Sucraid® (sacrosidase) Oral Solution carefully. 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 (33.07 lbs.) 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 (33.07 lbs.) in body weight. Dosage should be diluted in 2 to 4 ounces of water, milk or infant formula, and 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). The following should be noted in regard to administration, storage and expiration of Sucraid®: It is suggested that half of each dose be taken before the meal and the other half be taken during the meal. The beverage or infant formula 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. Sucraid® should be refrigerated at 36°F-46°F (2°C-8°C) and should be protected from heat and light. Sucraid® should not be reconstituted or consumed with fruit juices as the acidity may reduce the enzyme activity. Discard bottles of Sucraid® four weeks after first opening due to the potential for bacterial growth. Your doctor may recommend avoiding starch for two weeks and then gradually adding starch back into the diet while monitoring symptoms.

Traveling with Sucraid® Sucraid® should be refrigerated at 36°F-46°F (2°C-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 Genetic Sucrase-Isomaltase Deficiency have used a variety of techniques to 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

Letter of Medical Necessity Traveling by plane with Sucraid® can also prove to be challenging. The United States Transportation Security Administration 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 any efficacy concerns.

Genetic Sucrase-Isomaltase Deficiency (GSID), also known as Congenital Sucrase-Isomaltase Deficiency (CSID), is a disorder that causes a reduction of the enzyme activity needed to break down and absorb table sugar (sucrose) and other sugars from starch.

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SYMPTOMS Infants, children and adults can suffer from Genetic Sucrase-Isomaltase Deficiency. Symptoms include chronic, watery diarrhea, gas, bloating and abdominal pain.

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DIAGNOSIS Genetic Sucrase-Isomaltase Deficiency (GSID) can be diagnosed by abnormal results from a disaccharidase activity test or a brief Sucraid® therapeutic trial. A sucrose intolerance hydrogen breath test or genetic testing may aid in the diagnosis of GSID.

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SUCRAID® Sucraid® (sacrosidase) Oral Solution is the only FDA-approved enzyme replacement therapy that facilitates breakdown of sucrose (sugar) into simpler forms for absorption from the intestine into the blood. Sucraid® is usually taken with each meal or snack, mixed into 2-4 ounces of water, milk or infant formula.

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See Important Safety Information below.

People have found that the burden of traveling with Sucraid® is reduced when a physician drafts 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 Genetic Sucrase-Isomaltase Deficiency/Congenital Sucrase-Isomaltase Deficiency Patient’s need for Sucraid® The need for Sucraid® to be refrigerated/maintained at 36°F-46°F (2°C-8°C) The need for any ice gel packs or ice blocks to be kept with the Sucraid® at all times Please click this link to access a sample letter that patients can bring to their healthcare provider for signature, and then use during their travel. Letter of Medical Necessity Traveling with Sucraid® poses some unique challenges. For longer trips, it is advised to find out if your destination has a refrigerator available.

Indication 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).

IMPORTANT SAFETY INFORMATION FOR SUCRAID® (SACROSIDASE) ORAL SOLUTION 1. Sucraid® may cause a serious allergic reaction. If you notice any swelling or have difficulty breathing, get emergency help right away. 2. 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. 3. 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). 4. 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. 5. Some patients may have worse abdominal pain, vomiting, nausea or diarrhea. Constipation, difficulty sleeping, headache, nervousness and dehydration have also occurred. Check with your doctor if you notice these or other side effects. 6. Sucraid® has not been tested to see if it works in patients with secondary (acquired) sucrase deficiency. 7. 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 before a meal or snack and the other half is taken during the meal or snack. 8. Sucraid® should be refrigerated at 36°F-46°F (2°C-8°C) and should be protected from heat and light.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800FDA-1088. Sucraid® is available by prescription only. The information on this website should not take the place of talking with your doctor or healthcare professional. If you have any questions about your condition, or if you would like more information about Sucraid®, talk to your doctor or healthcare professional and see the full Prescribing Information. expand

INFORMATION ADDRESS 3405 Ocean Drive Vero Beach, FL 32963 Get Directions PHONE EMAIL 1-800-705-1962 [email protected]

IMPORTANT SAFETY INFORMATION FOR SUCRAID® (SACROSIDASE) ORAL SOLUTION 1. Sucraid® may cause a serious allergic reaction. If you notice any swelling or have difficulty breathing, get emergency help right away. 2. 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. 3. 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). 4. 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. 5. Some patients may have worse abdominal pain, vomiting, nausea or diarrhea. Constipation, difficulty sleeping, headache, nervousness and dehydration have also occurred. Check with your doctor if you notice these or other side effects. 6. Sucraid® has not been tested to see if it works in patients with secondary (acquired) sucrase deficiency. 7. 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 before a meal or snack and the other half is taken during the meal or snack. 8. Sucraid® should be refrigerated at 36°F-46°F (2°C-8°C) and should be protected from heat and light.

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. Sucraid® is available by prescription only. The information on this website should not take the place of talking with your doctor or healthcare professional. If you have any questions about your condition, or if you would like more information about Sucraid®, talk to your doctor or healthcare professional and see the full Prescribing Information. minimize IMPORTANT SAFETY INFORMATION FOR SUCRAID® (SACROSIDASE) ORAL SOLUTION 1. Sucraid® may cause a serious allergic reaction. If you notice any swelling or have difficulty breathing, get emergency help right away. 2. 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. 3. 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). 4. 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. 5. Some patients may have worse abdominal pain, vomiting, nausea or diarrhea. Constipation, difficulty sleeping, headache, nervousness and dehydration have also occurred. Check with your doctor if you notice these or other side effects. 6. Sucraid® has not been tested to see if it works in patients with secondary (acquired) sucrase deficiency. 7. 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 before a meal or snack and the other half is taken during the meal or snack. 8. Sucraid® should be refrigerated at 36°F-46°F (2°C-8°C) and should be protected from heat and light.

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. Sucraid® is available by prescription only. The information on this website should not take the place of talking with your doctor or healthcare professional. If you have any questions about your condition, or if you would like more information about Sucraid®, talk to your doctor or healthcare professional and see the full Prescribing Information.

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