The book of EleCare® and EleCare® Jr
Transcription
The book of EleCare® and EleCare® Jr
E Availability leCare and EleCare Jr can help give your patient’s story a happy ending. EleCare® DHA/ARA (for infants) EleCare® Jr is available in Unflavored and Vanilla. Powder: 14.1 oz (400 g) cans (measuring scoop enclosed); 6/case For oral or tube feeding. Nutritionally Complete Clinically Documented Success Flavor Age List No. NDC Format Code* EleCare DHA/ARA • Shown to be effective in maintaining growth of children with cow’s milk protein allergy when used as a primary source of calories.3 Reliable tolerance for even your toughest patients • Hypoallergenic —virtually eliminating the potential for an allergic reaction to the formula in multiple-food-allergic children. ® ® • Clinically shown to support the growth of exclusively formulafed infants.2 • Infants receiving EleCare showed decreased symptoms associated with protein-sensitive colitis after receiving EleCare for 42 days.14 The book of EleCare and EleCare Jr Infant 55251 70074-0535-11 EleCare Jr Unflavored 1 yr. + 55253 70074-0552-54 EleCare Jr Vanilla 56585 70074-0565-86 1 yr. + EleCare and elecare jr are easily accessible to patients: Introducing EleCare Jr Order online Visit the Abbott Store at www.abbottstore.com. Order by phone 1-800-Formula (800-367-6852) Ask a pharmacist about placing a special order. nutritionally Complete 3 • 33% of fat blend as medium-chain triglycerides (MCTs)— an easily digested and absorbed fat source. • Clinically shown to be well tolerated.2 • For multiple conditions for infants and children of all ages. REIMBURSEMENT HELP LINE (800) 558-7677 Contact Help Line for any questions or resources related to reimbursement. specifically designed for infants REIMBURSEMENT INFORMATION: EleCare and EleCare Jr may be considered for coverage by WIC®† (Women, Infants and Children) or Medicaid if specific criteria are met. Introducing EleCare Jr nutritionally Complete specifically designed for infants specifically designed for children over 1 year of age Use under Medical Supervision. WIC is a registered trademark of the US Department of Agriculture and an abbreviation for the special supplemental nutrition program for Women, Infants, and Children. † ©2011 Abbott Laboratories Inc. 77078/May 2011 LITHO IN USA *A bbott Nutrition does not represent NDC format codes to be actual National Drug Codes (NDCs). NDC format codes are product codes adjusted to standard industry practice to meet the format requirements of pharmacy and health insurance computer systems. specifically designed for children over 1 year of age Use under Medical Supervision. S evere food allergies and GI disorders feel giant to kids like Jack, but our amino acid–based formulas can help them stay on their growth track. Table of Contents EleCare® and EleCare® Jr Advantages......... 4 Mixing Instructions....................................... 6 EleCare Nutrient Composition...................... 8 EleCare Jr Nutrient Composition................ 10 Clinical Summaries.................................... 12 Food Allergies............................................ 14 GI Disorders.............................................. 16 Accessibility............................................... 18 Resources................................................. 20 References................................................ 21 Availability.................................... Back Cover Introducing EleCare Jr nutritionally Complete specifically designed for infants specifically designed for children over 1 year of age Use under Medical Supervision. 3 Elecare and Elecare Jr Advantages T he nutrition of EleCare and EleCare Jr is an ongoing gift, something Jack and his friends keep growing with. Designed to address a wide range of nutritional needs. • Clinically shown to be hypoallergenic.3 EleCare® is designed to meet the nutritional needs of infants and EleCare® Jr is designed to meet the nutritional needs of children 1–13 years of age who cannot tolerate intact or hydrolyzed protein. It’s not just a progression— it’s progressive nutrition. • 33% of fat blend as MCTs—an easily digested and well absorbed fat source. EleCare and EleCare Jr are for the dietary management of: • Severe food allergies • Eosinophilic GI disorders • Short bowel syndrome Product • Malabsorption • Protein maldigestion • GI tract impairment Features Osmolality at 20 Cal/fl oz EleCare Details 350 mOsm/kg water. Osmolality at standard dilution is close to the osmolality of human milk (260–300).1 When reconstituted at 20 Cal/fl oz, EleCare mixes like a standard formula—1 scoop of powder to 2 fl oz of water. Consistent with standard infant formulas. Less risk of dilution errors. DHA/ARA 0.15% fatty acids as DHA 0.40% fatty acids as ARA Nutrients found in breast milk to help support brain and eye development. Growth* Shown to support normal growth of infants exclusively fed EleCare from birth to 4 months of age. 2 A study of 213 infants demonstrated normal growth of healthy term infants exclusively fed EleCare from birth to 4 months of age. The study included the first 2 months of life, when nutrient requirements of infants are greatest.2 Iron status of multiple-food-allergic children significantly improved after 4 months of EleCare feeding.3 • Nutritionally complete. • For tube or oral feeding. Benefits Standard Infant Formula Mixing Iron Status* EleCare Jr • DHA and ARA,† special nutrients found in breast milk to help support brain and eye development. • 100% free amino acids as the protein source. EleCare caloric distribution EleCare Jr caloric distribution Protein Equivalent: 15% of calories4 100% free L-amino acids Protein Equivalent: 15% of calories4 100% free L-amino acids Fat: 42% of calories 33% MCTs 38% high-oleic safflower oil 28% soy oil 0.15% fatty acids as DHA 0.40% fatty acids as ARA Fat: 43% of calories 33% MCTs 39% high-oleic safflower oil 28% soy oil Carbohydrate: 42% of calories 100% corn syrup solids Carbohydrate: 43% of calories 100% corn syrup solids Iron status of multiple-food-allergic children, 89% on Neocate® or Neocate® 1+ at study entry, significantly improved after 4 months of EleCare as a primary source of nutrition.3 42% 43% carbohydrates carbohydrates 43% 42% 15% 15% nutritionally Complete † 4 fat fat *These studies were conducted with a previous formulation of EleCare Unflavored without DHA/ARA. protein4 nutritionally Complete specifically designed for infants specifically designed for children over 1 year of age Use under Medical Supervision. Use under Medical Supervision. protein4 DHA/ARA only available in EleCare Infant Formula. 5 A Mixing Instructions for EleCare® DHA/ARA Mixing instructions for infants. To prepare EleCare: 1. Wash your hands, surfaces and utensils. 2. Pour desired amount of water into clean bottle (see Mixing Guide). Mixing Guide Desired Caloric Density Powder† (fl oz) (unpacked level scoop) Approx Yield‡ (fl oz) (Cal/fl oz) 20 22 3. Add powder; return dry scoop to can. 24 4. Cap bottle; shake well; attach nipple. 5. Once feeding begins, use within 1 hour or discard. Water* 26 27 2 1 (9.4 g) 2 12 6 (56.4 g) 13 24 12 (112.8 g) 27 85 1 can (400 g) 95 3.5 2 (18.8 g) 4 10.5 6 (56.4 g) 12 21 12 (112.8 g) 24 76 1 can (400 g) 86 8 5 (47 g) 9 16 10 (94 g) 18 24 15 (141 g) 27 69 1 can (400 g) 79 1.5 1 (9.4 g) 2 9 6 (56.4 g) 10 27 18 (169.2 g) 31 63 1 can (400 g) 73 7 5 (47 g) 8 14 10 (94 g) 16 28 20 (188 g) 33 60 1 can (400 g) 70 Mixing instructions for children over 1 year of age. To prepare EleCare Jr: 1. W ash your hands, surfaces and utensils. 2. Pour desired amount of water into clean container (see Mixing Guide). Mixing Guide Recipe Size Caloric Density Water* Powder† Approx (fl oz) (unpacked Yield‡ level scoop) For Children (Cal/fl oz) Small 30 5 Medium 30 15 Large 30 25 Whole Can 30 54 (fl oz) 4 scoops5 (38 g) 12 scoops (114 g) 20 scoops (190 g) 1 can (400 g) 6 18 30 64 3. A dd powder; return dry scoop to can. 4. Cap container; shake well. 5. O nce feeding begins, use within 1 hour or discard. nutritionally Complete nutritionally Complete specifically designed for infants specifically designed for children over 1 year of age Use under Medical Supervision. Use under Medical Supervision. *For most accurate results, water should be measured in a liquid-measuring instrument with ¼ ounce measuring capabilities. ¼ ounce = 7.5 mL. † 1 scoop = approximately 9.4 grams. “Scoop” refers to enclosed scoop. For most accurate results, EleCare DHA/ARA powder should be weighed on a scale that reads in grams. ‡ Yields are rounded to nearest whole number after calculations. 6 Mixing Instructions for EleCare® Jr Mixing Instructions fter Jack was an infant, childhood was next. Mom made sure EleCare and EleCare Jr stayed in the mix. *For most accurate results, water should be measured in a liquid-measuring instrument with ¼ ounce measuring capabilities. ¼ ounce = 7.5 mL. † 1 scoop = approximately 9.5 grams. “Scoop” refers to enclosed scoop. For most accurate results, EleCare Jr powder should be weighed on a scale that reads in grams. ‡ Yields are rounded to nearest whole number after calculations. 7 Per Liter Estimated Nutrient Composition of EleCare T Per 100† 20 22 24 26 27 28 Cal (Cal/fl oz) (Cal/fl oz) (Cal/fl oz) (Cal/fl oz) (Cal/fl oz) (Cal/fl oz) Energy, Cal 100 676 744 812 880 913 947 Protein Equivalent, g 3.1 21.0 23.1 25.2 27.3 28.3 29.4 Fat, g 4.8 32.5 35.7 39.0 42.2 43.8 45.5 Linoleic Acid, mg 840 5,683 6,252 6,820 7,389 7,673 7,958 Carbohydrate, g 10.7 72.4 79.6 86.9 94.1 97.7 101.4 Vitamin A, IU 273 1,847 2,032 2,217 2,401 2,494 2,586 Vitamin D, IU 60 406 447 487 528 548 568 Vitamin E, IU 2.1 14.2 15.6 17.1 18.5 19.2 19.9 Vitamin K, mcg 13 88.0 96.8 105.6 114.4 118.8 123.2 Thiamin (Vitamin B1), mcg 210 1,421 1,563 1,705 1,847 1,918 1,989 Riboflavin (Vitamin B2), mcg 105 710 781 853 924 959 995 Vitamin B6, mcg 84.2 570 627 684 741 769 798 Vitamin B12, mcg 0.4 2.7 3.0 3.2 3.5 3.7 3.8 Niacin, mcg 1,680 11,366 12,503 13,641 14,778 15,347 15,915 Folic Acid (Folacin), mcg 29.5 200 220 240 259 269 279 Pantothenic Acid, mcg 421 2,848 3,133 3,418 3,703 3,846 3,988 Biotin, mcg 4.2 28.4 31.3 34.1 36.9 38.4 39.8 Vitamin C (Ascorbic Acid), mg 9 61 67 73 79 82 85 Choline, mg 15 101 112 122 132 137 142 Inositol, mg 5.1 35 38 41 45 47 48 Calcium, mg 116 785 863 942 1,020 1,060 1,099 Phosphorus, mg 84.2 570 627 684 741 769 798 Magnesium, mg 8.4 56.8 62.5 68.2 73.9 76.7 79.6 Iron, mg 1.8 12.2 13.4 14.6 15.8 16.4 17.1 Zinc, mg 1.15 7.8 8.6 9.3 10.1 10.5 10.9 Manganese, mcg 84 568 625 682 739 767 796 Copper, mcg 126 852 938 1,023 1,108 1,151 1,194 Iodine, mcg 8.9 60 66 72 78 81 84 Nutrient o young Jack’s physician, recommending EleCare was about composition. specifically designed for infants Use under Medical Supervision. Elecare Nutrient Composition nutritionally Complete Vitamins Minerals Sodium, mg (mEq) 45 (2.0) 304 (13.2) 335 (14.6) 365 (15.9) 396 (17.2) 411 (17.9) 426 (18.5) Potassium, mg (mEq) 150 (3.9) 1,015 (26) 1,116 (28.6) 1,218 (31.2) 1,319 (33.8) 1,370 (35.0) 1,421 (36.3) Chloride, mg (mEq) 60 (1.7) 406 (11.5) 447 (12.6) 487 (13.8) 528 (14.9) 548 (15.5) 568 (16.1) Selenium, mcg 2.6 17.6 19.4 21.1 22.9 23.8 24.6 Chromium, mcg 2.3 15.6 17.1 18.7 20.2 21.0 21.8 Molybdenum, mcg 2.5 17.1 18.8 20.5 22.2 23.1 23.9 Osmolality (mOsm/kg water) — 350 390 430 475 490 518 Potential Renal Solute Load (mOsm/L)* — 189 208 227 246 255 264 *Estimated Potential Renal Solute Load = [(Protein (g) x 5.7) + mOsm (Na+K+Cl+P)] † 5 fl oz prepared as directed. 8 9 Per Liter Estimated Nutrient Composition of EleCare Jr T Per 100 30 grams of powder (Cal/fl oz) Energy, Cal 469 1,014 Protein Equivalent, g 14.3 31 Fat, g 22.7 49.1 Linoleic Acid, mg 3,939 8,520 Carbohydrate, g 49.3 106.7 Vitamin A, IU 1,280 2,769 Vitamin D, IU 281 608 Vitamin E, IU 9.71 21 Vitamin K, mcg 60 130 Thiamin (Vitamin B1), mcg 985 2,130 Riboflavin (Vitamin B2), mcg 495 1,070 Vitamin B6, mcg 393 850 Vitamin B12, mcg 2.0 4.3 7,878 17,040 139 300 Pantothenic Acid, mcg 1,974 4,270 Biotin, mcg 19.9 43 Vitamin C (Ascorbic Acid), mg 42.5 92 Choline, mg 140 303 Inositol, mg 23.6 51 Nutrient he young boy’s mom wanted to know, just what was in EleCare Jr that would help Jack grow? Vitamins nutritionally Complete specifically designed for children over 1 year of age Minerals Use under Medical Supervision. Calcium, mg 543 1,174 Phosphorus, mg 395 854 Magnesium, mg 74 160 Iron, mg 8.3 18 Zinc, mg 5.4 11.7 Manganese, mcg 601 1,300 Copper, mcg 601 1,300 Iodine, mcg 41.6 90 Sodium, mg (mEq) 212 (9.2) 459 (20.0) Potassium, mg (mEq) 706 (18.0) 1,526 (39.0) Chloride, mg (mEq) 281 (7.9) 608 (17.0) Selenium, mcg 12.5 27 Chromium, mcg 10.9 23.5 Molybdenum, mcg 12.3 26.5 Osmolality (mOsm/kg water) — 590 Potential Renal Solute Load (mOsm/L)* — 280 Elecare Jr Nutrient Composition Niacin, mcg Folic Acid (Folacin), mcg *Estimated Potential Renal Solute Load = [(Protein (g) x 5.7) + mOsm (Na+K+Cl+P)] 10 11 M Relevant Clinical Summaries* agical beans may have their place, but clinical data is a more solid base. Tolerance • Forty-three infants < 6 months of age with documented protein sensitive colitis (PSC) were fed EleCare at 20 kcal/fl oz for 42 days. INFANTS Relevant Clinical Summaries* Growth & Tolerance • Two hundred thirteen infants were followed from 0-9 days to 112 days of age and randomized to EleCare® (Abbott Nutrition, Columbus, OH) or Nutramigen® (Mead Johnson Nutritionals, Evansville, IN). Infants Borschel MW, Ziegler EE, Wedig RF, Oliver JS, Williams TA: Growth of healthy term infants fed a free amino acid-based medical food. J Pediatr Gastroenterol Nutr 2001;33(3):393A. • Weight and weight gain were the same in both groups and serum albumin concentrations at 112 days of age were similar between groups. • Eighteen subjects (ages 6 months to 17 years) with eosinophilic gastroenteritis and/or multiple food allergies were followed on EleCare. Chronic Diarrhea • Twenty-two infants with chronic diarrhea of multiple etiologies, mean age at entry 3.3 ± 0.3 months, received EleCare for 80 days (≥ 50% of energy requirements). INFANTS Antonson DL, Murray ND, Oliva-Hemker MM, et al: Nutritional management of infants with chronic diarrhea fed a free amino acid-based medical food. J Pediatr Gastroenterol Nutr 2002;35:443. • Mean weight for age improved significantly from -0.47 ± 0.21 at Study Day 1 compared to -0.19 ± 0.10 at study completion. Mean rank stool consistencies were 2.07 ± 0.13 during baseline vs. 2.72 ± 0.16 at study completion and the mean number of stools per day was 3.5 ± 0.5 at baseline vs. 1.5 ± 0.2 at study completion. • At Study Day 1, 63% of subjects had mild to severe complaints of nausea, abdominal pain or decreased physical activity compared to 4% at study completion. Eighty-one percent of subjects had mild to severe complaints of emesis or diarrhea at Study Day 1 compared to 0% at study completion. CLINICAL SUMMARIES Sicherer SH, Noone SA, Koerner CB, Christie L, Burks WA, Sampson HA: Hypoallergenicity and efficacy of an amino acid-based formula in children with cow’s milk and multiple food hypersensitivities. J Pediatr 2001;138(5):688-693. • Growth and biochemistries were assessed at entry and after four months. No significant changes in weight or height NCHS Z-scores from entry were found and no significant changes in serum albumin, transthyretin, retinolbinding protein, serum urea nitrogen, retinol, α-tocopherol, γ-tocopherol, or ß-carotene were observed. Significant increases in hemoglobin (+0.8 g/dL, P=0.008), hematocrit (+2.6%, P=0.005), and serum ferritin (+10.6 ng/mL, P=0.005) were observed. •The number of daily stools decreased from 2.1 ± 0.2 at Study Day 1 to 1.1 ± 0.1 at Study Day 43. Mean rank stool consistency decreased from 2.5 ± 0.1 at Study Day 1 to 2.4 ± 0.2 at Study Day 43 (Scale, 1=watery, 2=loose/ mushy, 3=soft, 4=formed, 5=hard). Results of the study showed diminished symptoms associated with PSC were observed in infants receiving EleCare for 42 days. • Number of stools per day were significantly different at 14 and 28 days of age (P<0.0001) between Nutramigen and EleCare, 2-3.5 and 1.5-2.0 respectively. Mean rank stool consistency was 2.8 on Nutramigen and 2.3-2.5 on EleCare (Scale, 1=watery, 2=loose/mushy, 3=soft, 4=formed, 5=hard) at 14 and 28 days. Results confirm that infants fed EleCare had similar growth, tolerance and protein status when compared to infants fed a casein hydrolysate-based formula. Infants and Children Vanderhoof JA, Antonson DL, Murray ND, et al: Evaluation of a free amino acid-based medical food (EleCare®) in infants with protein sensitive colitis. J Pediatr Gastroenterol Nutr 2001;33(3):394A. • A physician-rated symptom score (PRSS) to assess formula tolerance and symptoms of PSC was performed at Study Day 1 and exit. Ten symptoms were rated on a scale of 0=none to 3=severe. Significant decreases in PRSS at Study Day 1 and exit were observed, 9.1 ± 0.5 and 4.8 ± 0.5, respectively. Results demonstrated that EleCare was suitable for use in the nutritional management of infants with chronic diarrhea of multiple etiologies. • Eighteen clinically stable children, 1.2-9.6 years (median 6.2 years) of age, with chronic diarrhea of multiple etiologies, received EleCare for three months (≥ 50% of energy requirements). Primary diagnoses included short bowel syndrome (68%), irritable bowel syndrome (11%), allergic enteropathy (11%), and protein malabsorption (11%). • There was no significant change in stool number or consistency over the 4-month period. The study concluded that EleCare was effective in maintaining normal growth for children with cow’s milk allergy and multiple food allergies. Children Saavedra JM, Mattis LE, Chao C, Borschel MW, Kerzner B, Hummer KA: Use of an amino acid (AA)-based formula for the management of chronic diarrhea in children. Pediatr Res 2000;47:168A. • Mean weight Z-scores increased (P=0.026) from -0.91 ± 0.18 at Study Day 1 vs. -0.59 ± 0.20 at Study Day 84. There were no significant changes in blood biochemistries or mean rank stool consistency (MRSC); however MRSC increased from 1.5 ± 1.0 at baseline vs. 1.7 ± 0.2 at Study Day 84. • The mean number of stools per day decreased from 5.5 + 1.0 at baseline vs. 4.9 + 1.0 at Study Day 84. At entry, 72% of the subjects had complaints of intolerance (nausea, pain, change in activity) compared to 17% at exit. Five children were receiving parenteral nutrition (PN) at entry (32% of total calories). After three months, PN contributed to 23% of total calories and three of the five children tolerated an increase in enteral intake. Results support the use of EleCare for children with chronic diarrhea, particularly those with short bowel syndrome. *These studies were conducted with a previous formulation of EleCare Unflavored without DHA/ARA. 12 *These studies were conducted with a previous formulation of EleCare Unflavored without DHA/ARA. 13 A llergies and intolerance Jack could not evade, so the benefits of EleCare and EleCare Jr were carefully weighed. Severe Food Allergies Food allergies are adverse immune responses to specific food proteins (as opposed to carbohydrates or fats). They can be immunoglobulin E (IgE)-mediated, non-IgE-mediated, or a combination of both. Approximately 90% of allergic reactions are caused by eight foods5: milk, eggs, peanuts, tree nuts, fish, soy, wheat and shellfish. Four out of every 100 children in the US have food allergy.5 Cow’s Milk Allergy (CMA) Studies indicate that approximately 2.5% of infants develop CMA within the first year of life.3 Infants with IgE-mediated CMA can generally tolerate soy protein,3 but in those with non-IgE-mediated CMA, infants frequently react to soy protein.6,7 For this reason, nutritional management with a hypoallergenic amino-acid formula could be beneficial if trial with a protein hydrolysate formula does not work for these patients. Eosinophilic Gastroenteropathies Eosinophilic esophagitis (EoE) is the most common and difficult type of eosinophilic gastroenteropathy to manage, characterized by inflammation of the esophagus due to abnormally high levels of eosinophils (white blood cells) in that area of the GI tract.6 Other types of eosinophilic gastroenteropathies include eosinophilic gastroenteritis and eosinophilic colitis. These diseases are associated with eosinophils and inflammation at different locations along the GI tract. Symptoms Symptoms of EoE may include abdominal pain, diarrhea, nausea, severe vomiting, difficulty swallowing and at times obstruction.6,8 Symptoms Symptoms of food allergies may include atopic dermatitis, urticaria (hives), abdominal pain, diarrhea with blood and mucus in the stool, nausea and severe vomiting. How EleCare® and EleCare® Jr can help • Elimination diets to help manage non-IgE-mediated food allergies when gastrointestinal symptoms are present.8 • Facilitating intestinal adaptation and further identification of offending allergens as food is reintroduced.8 Food Allergies EleCare and EleCare Jr are made of 100% free amino acids as the protein source to virtually eliminate the potential for an allergic reaction to the formula in multiple-food-allergic children. EleCare and Elecare Jr play a significant role in: • Clinically shown to be hypoallergenic3 and well tolerated.2,3 • Dietary management for severe food protein allergies. • Supported by strict manufacturing standards and ELISA (Enzyme-Linked Immunosorbent Assay) testing. • For those who cannot tolerate milk, soy or protein hydrolysate formulas. EleCare and EleCare Jr have been shown to maintain growth in infants2 as well as children with cow’s milk allergy and multiple food protein allergies.3 14 15 GI Disorders Malabsorption Malabsorption can occur in patients who are unable to absorb sufficient protein, fat, carbohydrate, or nutrients from an infant formula or a normal diet. The causes of malabsorption can vary greatly, from food allergies such as cow’s milk or soy protein allergy, to other gastrointestinal disorders such as pancreatic insufficiency, liver disease or short bowel syndrome. Short Bowel Syndrome Short bowel syndrome refers to a series of various GI symptoms occurring with congenital or acquired reduction in gastrointestinal absorptive surface. Leading causes of short bowel syndrome in children are intestinal volvulus, intestinal atresia, necrotizing enterocolitis, abdominal wall defects or trauma.9 Food-Protein-Induced Enterocolitis Syndrome Food-protein-induced enterocolitis syndrome, or FPIES, is a non-IgE-mediated immune reaction to one or more specific foods that occurs in both the large and small intestines. The most common dietary proteins responsible for this foodallergic reaction are cow’s milk and soybeans. Symptoms Symptoms Symptoms include weight loss, malabsorption of fluids, and malabsorption of micro- and macro-nutrients (especially fat malabsorption).10 FPIES is commonly characterized by severe vomiting, blood in the stools, and diarrhea, which generally begin to appear in the first month of life in association with failure to thrive.13 How EleCare® and EleCare® Jr can help with short bowel syndrome How EleCare and EleCare Jr can help with FPIES Infants and children with short bowel syndrome tend to develop an allergic response.10 EleCare is hypoallergenic and made of 100% free amino acids as the protein source to virtually eliminate the potential for an allergic reaction to the formula in multiple-food-allergic children. FPIES symptoms rapidly subside after the causal protein(s) is removed from the diet, which can be accomplished by switching to a hypoallergenic amino acid-based formula, such as EleCare or EleCare Jr. EleCare and EleCare Jr have 33% of fat blend as medium-chain triglycerides (MCTs), which: • Complete nutrition for patients who cannot tolerate intact or hydrolyzed protein. • Do not require bile acids for absorption. • Supported by strict manufacturing standards and ELISA (Enzyme-Linked Immunosorbent Assay) testing. EleCare and EleCare Jr are clinically shown to be hypoallergenic3 and well tolerated2,3 : • Provide an easily digested and well-absorbed fat source. • Benefit patients with fat malabsorption and short bowel syndrome. When EleCare was used with children who had chronic diarrhea, mostly due to short bowel syndrome, the results were favorable: •T he number of stools decreased11 • Adequate growth resulted11 GI Disorders Early establishment of an amino acid-based enteral feeding may promote intestinal adaptation and improved feeding tolerance.12 16 17 G olden egg production was virtually nil, but Jack’s family had options to help cover the bill. Accessibility and Reimbursement EleCare and EleCare Jr may be considered for coverage by WIC®* (Women, Infants and Children) or Medicaid if your patient meets specific medical criteria and has a physician’s prescription. For private insurance, patients must contact their plan’s Nurse Case Manager directly. ® ® WIC: Most programs consider EleCare or EleCare Jr to be a Special Formula or Exception Formula. This designation requires a physician’s prescription documenting why, medically, the formula is needed. Medicaid: Many states will consider coverage of EleCare or EleCare Jr for children who require a feeding tube or for oral use when specific medical criteria are met. Coverage is determined on a case-by-case basis. Private Insurance: Many plans will consider coverage of EleCare or EleCare Jr for children who require a feeding tube or for oral use when specific medical-necessity criteria are met. Patients can contact their plan directly and request to speak to a Nurse Case Manager. Be Prepared: Some insurance plans may require a letter from a physician that explains why EleCare or EleCare Jr is medically necessary. Abbott Nutrition provides a template letter that outlines medical benefits and features of EleCare and EleCare Jr for you and your patients. The letter includes product billing codes that may be needed when submitting a claim. You can obtain this letter from the EleCare web site or the Help Line below. Ordering There are three easy ways for your patients to order EleCare or EleCare Jr: Order online and have EleCare or EleCare Jr delivered to the home. Visit the Abbott Store at www. abbottstore.com and click on Child Nutrition/EleCare. Order by phone and have EleCare or EleCare Jr delivered to the home: 800-FORMULA (800-367-6852). Ask a pharmacist about placing a special order. Patient Assistance Program If a patient’s insurance does not cover EleCare or EleCare Jr and they cannot afford it, they may still qualify for help. Further information on alternative government and private assistance programs is available at the Partnership for Prescription Assistance web site (www.pparx.org). This site contains information on 475 assistance programs, with downloadable applications and web tools to help your patients find the right program. The Partnership can also be reached toll free at 1-888-477-2669. The Reimbursement Checklist Advise patients to follow these tips when working with insurance providers: tay up-to-date. Patients should obtain a written copy of their policy. They should ensure that claim S information is complete and follows their insurance company’s guidelines. on’t give up. Don’t settle for an automated answer; patients should ask to speak to a Nurse Case D Manager at their insurance company. o the homework. Some states require insurance companies to reimburse amino acid-based elemental D formulas, like EleCare or EleCare Jr. sk about their insurance company’s appeal process. They should document every conversation and A retain all pieces of communication. Submit invoices. If patients have coverage and purchase EleCare or EleCare Jr directly from Abbott, they should make sure to request an invoice and submit it for reimbursement. se all available resources. If patients have a Health Spending Account or Flexible Spending Account, U they should check to see if EleCare or EleCare Jr is eligible. *WIC is a registered trademark of the U.S. Department of Agriculture and abbreviation for the special supplemental nutrition program for Women, Infants and Children. 18 19 Accessibility For detailed information, visit www.EleCare.com or call the Reimbursement Help Line at 1-800-558-7677. J ack’s friend Goldilocks couldn’t eat hot cereal. Her physician said, “For delicious ideas, read this online material.” O ur tale featured giants and magic beans, now discover what all those little numbers mean. Web Resources References Food Allergies 1. Kleinman RE, Ed. Pediatric Nutrition Handbook. 5th Ed. Elk Grove Village, IL. American Academy of Pediatrics; 2004:938. 2. Borschel MW, Ziegler EE, Wedig RT, et al: Growth of healthy term infants fed a free amino acid-based medical food. J Pediatr Gastroenterol Nutr 2001;33(3)393A. 3. Sicherer SH, Noone SA, Koerner CB, et al: Hypoallergenicity and efficacy of an amino acid-based formula in children with cow’s milk and multiple food hypersensitivities. J Pediatr 2001;138:688-693. 4. May ME, Hill JO: Energy content of diets of variable amino acid composition. Am J Clin Nutr 1990;52:770-777. 5. Branum AM, Lukacs SL: Food allergy among US children: Trends in prevalence and hospitalizations. NCHS data brief, No. 10. Hyattsville, MD: National Center for Health Statistics. 2008. Centers for Disease Control and Prevention, National Center for Health Statistics web site. http://www.cdc.gov/nchs/data/databriefs/db10.pdf. Accessed May 3, 2011. 6. Sicherer SH: Clinical aspects of gastrointestinal food allergy in childhood. Pediatrics 2003;111(6)(Suppl 2):1609-1616. 7. Burks AW, Casteel HB, Fiedorek SC, Williams LW, Pumphrey CL: Prospective oral food challenge study of two soybean isolates in patients with possible milk or soy protein enterocolitis. Pediatr Allergy Immunol 1994;5:40-45. 8. Mofidi S: Food Allergies. In: Life Cycle Nutrition: An Evidence-Based Approach. Edelstein S, Sharlin J, eds: Sudbury, Mass: Jones and Bartlett Publishers; 2009:247-266. 9. Sigalet DL: Short bowel syndrome in infants and children: an overview. Semin Pediatr Surg 2001;10:49-55. 10. Corkins MR, Scolapino J: Diarrhea. The A.S.P.E.N. Nutrition Support Practice Manual. 2nd ed. Russell Merritt, Editor. (2005). Silver Spring, MD: The American Society for Parenteral and Enteral Nutrition. 203-210. 11. Saavedra JM, Mattis LE, Chao C, Borschel MW, Kerzner B, Hummer KA. Use of an amino acid (AA)-based formula for the management of chronic diarrhea in children. Pediatr Res 2000;47:168A. 12. Bines J, Francis D, Hill D: Reducing parenteral requirement in children with short bowel syndrome: Impact of an amino acid based complete infant formula. J Pediatr Gastroenterol Nutr 1998;26:123-128. 13. Sicherer SH: Food protein-induced enterocolitis syndrome: case presentations and management lessons. J Allergy Clin Immunol 2005;115:149-156. 14. Vanderhoof JA, Antonson DL, Murray ND, et al: Evaluation of a free amino acid-based medical food (EleCare®) in infants with protein sensitive colitis. J Pediatr Gastroenterol Nutr 2001;33(3):394A. Kids with Food Allergies www.kidswithfoodallergies.org American Academy of Allergy, Asthma and Immunology www.aaaai.org Food Allergy and Anaphylaxis Network (FAAN) www.foodallergy.org American College of Allergy, Asthma and Immunology www.acaai.org Eosinophilic Gastrointestinal Disorders (EGIDs) The American Partnership for Eosinophilic Disorders www.apfed.org/egid.htm Food Allergy and Anaphylaxis Network: Eosinophilic Esophagitis Page www.foodallergy.org/page/eosinophilic-esophagitis1 Kids with Food Allergies www.kidswithfoodallergies.org CURED Foundation www.curedfoundation.org Abbott Nutrition Reimbursement Information: Short Bowel Syndrome www.abbottnutrition.com/reimbursement or call 800-558-7677 National Digestive Diseases Information Clearinghouse http://digestive.niddk.nih.gov/ddiseases/pubs/shortbowel/ Introducing EleCare Jr nutritionally Complete specifically designed for infants specifically designed for children over 1 year of age Use under Medical Supervision. 20 21