Prescribing Information Important Safety Information
Treatment

Infant Formulas

Infant Formulas

Breast milk is recommended for infants with Congenital Sucrase-Isomaltase Deficiency (CSID). An infant with CSID who is exclusively breastfed does not display symptoms until food or medication containing sucrose or starch is introduced. Unfortunately, there are circumstances in which feeding with breast milk is not a feasible option. In these circumstances, you need to know which infant formula is safe for an infant with CSID.

Many parents and caregivers may change the infant’s formula several times before they find one that does not cause gastrointestinal symptoms. It is important to continue to find the formula that works best, because a lack of growth when using traditional formula may result in an infant being diagnosed with failure to thrive. A registered dietitian or pediatric gastroenterologist may help with formula choices.

Some infants with CSID are able to tolerate traditional infant formulas. Options considered CSID-friendly (as of 2015) include Enfamil® Infant and Similac® Advance. Most infants with CSID should be able to tolerate formulas with lactose as the carbohydrate source. These formulas are the most economical and easiest to obtain.

Unfortunately, not all infants with CSID can tolerate traditional infant formulas due to gastrointestinal symptoms and weight loss. Some traditional and specialty infant formulas use sucrose or starches as their carbohydrate source and may produce gastrointestinal symptoms in an infant with CSID. For this reason, two specialty formulas have been shown to be successful for those infants with CSID who do not tolerate traditional formulas: 3232A by Mead Johnson™ and RCF® No Added Carbohydrate Soy Infant Formula Base with Iron. All formula changes should be conducted under the advice of a physician or a registered dietitian.

3232A by Mead Johnson

This formula is a protein hydrosylate powder that has to be mixed with an appropriate carbohydrate before consumption. This formula is indicated for use with infants with disaccharidase deficiencies or other disorders of carbohydrate malabsorption. Because 3232A is not nutritionally complete by itself, it is mixed with dextrose powder. Infants with CSID can tolerate dextrose. If 3232A formula is used long-term, additional essential fatty acid supplementation should be considered. Infants on 3232A formula should be closely monitored by a physician and a registered dietitian. It should be noted that 3232A formula does contain tapioca starch. For those who cannot tolerate starch, 3232A may not be tolerated.

RCF No Added Carbohydrate Soy Infant Formula Base with Iron

This formula is indicated for use with infants who are unable to tolerate the carbohydrates found in traditional infant formulas. This product has no added carbohydrate, so appropriate carbohydrates must be added, usually in the form of dextrose powder. This formula uses soy protein isolate to avoid symptoms of cow’s milk protein allergy or sensitivity. Infants on RCF should be closely monitored by a physician and a registered dietitian.

Due to the high cost of these alternative infant formulas, some insurance companies or the WIC (Women, Infant, and Children program) may pay for them. Your physician may help you draft a letter of medical necessity to the insurance company, in the hope of obtaining coverage for the cost of the formula. The letter of medical necessity should include the following information:

  • Patient’s name
  • Patient’s date of birth
  • Patient’s diagnosis of CSID
  • Current body weight
  • Current body length/height
  • Other relevant information, such as infant formulas that have been tried and not tolerated
    Request for insurance coverage or reimbursement for specialty infant formula

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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.