the book of elecare and elecare - abbott...

The book of EleCare®

and EleCare® Jr

©2011 Abbott Laboratories Inc. 77078/MAy 2011LITHO IN USA

AvAilAbility

Nutritionally Complete

Clinically Documented Success • Clinically shown to support the growth of exclusively formula-

fed infants.2

• Shown to be effective in maintaining growth of children with cow’s milk protein allergy when used as a primary source of calories.3

• Infants receiving EleCare showed decreased symptoms associated with protein-sensitive colitis after receiving EleCare for 42 days.14

Reliable tolerance for even your toughest patients • Hypoallergenic3—virtually eliminating the potential for an

allergic reaction to the formula in multiple-food-allergic children.

• 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.

EleCare DHA/ARA Infant 55251 70074-0535-11

EleCare Jr Unflavored 1 yr. + 55253 70074-0552-54

EleCare Jr Vanilla 1 yr. + 56585 70074-0565-86

REIMBURSEMENT INFORMATION: EleCare and EleCare Jr may be considered for coverage by WIC®† (Women, Infants and Children) or Medicaid if specific criteria are met.

ELECARE AND ELECARE JR ARE EASILy ACCESSIbLE TO pATIENTS:Order onlineVisit the Abbott Store at www.abbottstore.com.Order by phone1-800-FORMULA (800-367-6852)

Ask a pharmacist about placing a special order.

REIMBURSEMENT HELP LINE (800) 558-7677 Contact Help Line for any questions or resources related to reimbursement.

Use Under Medical sUpervision.

SpECIFICALLy DESIgNED FOR INFANTS

NUTRITIONALLy COMPLETE

SpECIFICALLy DESIgNED FOR CHILDREN OVER 1 yEAR OF AgE

IntroducingEleCare Jr

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.

Flavor Age List No. NDC Format Code*

† 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.

EleCare and EleCare Jr can help give your patient’s story a happy ending.

SpECIFICALLy DESIgNED FOR INFANTS SpECIFICALLy DESIgNED FOR CHILDREN OVER 1 yEAR OF AgE




* Abbott 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.

Severe 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.

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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






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• Clinically shown to be hypoallergenic.3

• 33% of fat blend as MCTs—an easily digested and well absorbed fat source.

• DHA and ARA,† special nutrients found in breast milk to help support brain and eye development.

• 100% free amino acids as the protein source.

• Nutritionally complete.

• For tube or oral feeding.

Designed to address a wide range of nutritional needs.

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.

*These studies were conducted with a previous formulation of EleCare Unflavored without DHA/ARA.

†DHA/ARA only available in EleCare Infant Formula.

The nutrition of EleCare and EleCare Jr is an ongoing gift, something Jack and his friends keep growing with.

EleCare Jr caloric distribution

Protein Equivalent: 15% of calories4 100% free L-amino acids

Fat: 43% of calories 33% MCTs 39% high-oleic safflower oil 28% soy oil

Carbohydrate: 42% of calories 100% corn syrup solids

EleCare caloric distribution

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

Carbohydrate: 43% of calories 100% corn syrup solids

product Features Details benefits

EleCare

Osmolality at 20 Cal/fl oz

Standard Infant Formula Mixing

DHA/ARA

growth*

350 mOsm/kg water.

When reconstituted at 20 Cal/fl oz, EleCare mixes like a standard formula—1 scoop of powder to 2 fl oz of water.

0.15% fatty acids as DHA0.40% fatty acids as ARA

Shown to support normal growth of infants exclusively fed EleCare from birth to 4 months of age. 2

Osmolality at standard dilution is close to the osmolality of human milk (260–300).1

Consistent with standard infant formulas. Less risk of dilution errors.

Nutrients found in breast milk to help support brain and eye development.

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

EleCare Jr

Iron Status* Iron status of multiple-food-allergic children significantly improved after 4 months of EleCare feeding.3

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 43%

carbohydrates

42% fat

15% protein4

42% carbohydrates

43% fat

15% protein4

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EleCare and EleCare Jr are for the dietary management of:

• Severe food allergies • Malabsorption • Eosinophilic GI disorders • Protein maldigestion • Short bowel syndrome • GI tract impairment







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*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.

*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.

Mixing guide

Desired Caloric Density

(Cal/fl oz)

Water*(fl oz)

powder†

(unpacked level scoop)

Approx yield‡

(fl oz)

20 2 1 (9.4 g) 2

12 6 (56.4 g) 13

24 12 (112.8 g) 27

85 1 can (400 g) 95

22 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

24 8 5 (47 g) 9

16 10 (94 g) 18

24 15 (141 g) 27

69 1 can (400 g) 79

26 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

27 7 5 (47 g) 8

14 10 (94 g) 16

28 20 (188 g) 33

60 1 can (400 g) 70

Mixing guide

Recipe Size

Caloric DensityFor Children

(Cal/fl oz)

Water*(fl oz)

powder†

(unpacked level scoop)

Approx yield‡

(fl oz)

Small 30 54 scoops

(38 g)6

Medium 30 1512 scoops

(114 g)18

Large 30 2520 scoops

(190 g)30

Whole Can 30 541 can

(400 g)64

After Jack was an infant, childhood was next. Mom made sure EleCare and EleCare Jr stayed in the mix.

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).

3. Add powder; return dry scoop to can.

4. Cap bottle; shake well; attach nipple.

5. Once feeding begins, use within 1 hour or discard.

Mixing Instructions for EleCare® JrMixing instructions for children over 1 year of age.

to prepare EleCare Jr:1. Wash your hands, surfaces

and utensils.

2. pour desired amount of water into clean container (see Mixing guide).

3. Add powder; return dry scoop to can.

4. Cap container; shake well.

5. Once feeding begins, use within 1 hour or discard.

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Nutrient per 100†

Cal20

(Cal/fl oz)22

(Cal/fl oz)24

(Cal/fl oz)26

(Cal/fl oz)27

(Cal/fl oz)28

(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

vITAMINS

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

MINERALS

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

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

To young Jack’s physician, recommending EleCare was about composition.

Estimated Nutrient Composition of EleCare PER LITER

*Estimated Potential Renal Solute Load = [(Protein (g) x 5.7) + mOsm (Na+K+Cl+P)] †5 fl oz prepared as directed.

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Nutrient per 100grams of powder

30(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

vITAMINS

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

Niacin, mcg 7,878 17,040

Folic Acid (Folacin), mcg 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

MINERALS

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

The young boy’s mom wanted to know, just what was in EleCare Jr that would help Jack grow?

PER LITER

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*Estimated Potential Renal Solute Load = [(Protein (g) x 5.7) + mOsm (Na+K+Cl+P)]

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Estimated Nutrient Composition of EleCare Jr

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Magical beans may have their place, but clinical data is a more solid base.


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Relevant Clinical Summaries*

gROWTH & TOLERANCE

INFANTSborschel 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.

• 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).

• Weight and weight gain were the same in both groups and serum albumin concentrations at 112 days of age were similar between groups.

• 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 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.

• Eighteen subjects (ages 6 months to 17 years) with eosinophilic gastroenteritis and/or multiple food allergies were followed on EleCare.

• 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, retinol-binding 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.

• 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.

Relevant Clinical Summaries*

TOLERANCE

INFANTSVanderhoof 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.

• Forty-three infants < 6 months of age with documented protein sensitive colitis (pSC) were fed EleCare at 20 kcal/fl oz for 42 days.

• 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.

• 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.

CHRONIC dIARRHEA

INFANTSAntonson 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.

• 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).

• 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.

Results demonstrated that EleCare was suitable for use in the nutritional management of infants with chronic diarrhea of multiple etiologies.

CHILDRENSaavedra 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.

• 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%).

• 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.


How EleCare® and EleCare® Jr can helpEleCare 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.

• 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

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.

EleCare and Elecare Jr play a significant role in:• 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

Allergies and intolerance Jack could not evade, so the benefits of EleCare and EleCare Jr were carefully weighed.

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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.

SymptomsSymptoms of food allergies may include atopic dermatitis, urticaria (hives), abdominal pain, diarrhea with blood and mucus in the stool, nausea and severe vomiting.

SymptomsSymptoms of EoE may include abdominal pain, diarrhea, nausea, severe vomiting, difficulty swallowing and at times obstruction.6,8

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How EleCare® and EleCare® Jr can help with short bowel syndromeInfants 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.

EleCare and EleCare Jr have 33% of fat blend as medium-chain triglycerides (MCts), which:

• Do not require bile acids for absorption.

• 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:

• The number of stools decreased11

• Adequate growth resulted11

Early establishment of an amino acid-based enteral feeding may promote intestinal adaptation and improved feeding tolerance.12

How EleCare and EleCare Jr can help with FpIESFpIES 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 are clinically shown to be hypoallergenic3 and well tolerated2,3 :

• Complete nutrition for patients who cannot tolerate intact or hydrolyzed protein.

• Supported by strict manufacturing standards and ELISA (Enzyme-Linked Immunosorbent Assay) testing.

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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 SyndromeShort 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

SymptomsSymptoms include weight loss, malabsorption of fluids, and malabsorption of micro- and macro-nutrients (especially fat malabsorption).10

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 food-allergic reaction are cow’s milk and soybeans.

SymptomsFpIES 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

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Accessibility and ReimbursementEleCare® 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.

For detailed information, visit www.EleCare.com or call the Reimbursement Help Line at 1-800-558-7677.

Golden egg production was virtually nil, but Jack’s family had options to help cover the bill.

*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.

patient Assistance programIf 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 ChecklistAdvise patients to follow these tips when working with insurance providers:

Stay up-to-date. patients should obtain a written copy of their policy. They should ensure that claim information is complete and follows their insurance company’s guidelines.

Don’t give up. Don’t settle for an automated answer; patients should ask to speak to a Nurse Case Manager at their insurance company.

Do the homework. Some states require insurance companies to reimburse amino acid-based elemental formulas, like EleCare or EleCare Jr.

Ask about their insurance company’s appeal process. They should document every conversation and 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.

Use all available resources. If patients have a Health Spending Account or Flexible Spending Account, they should check to see if EleCare or EleCare Jr is eligible.

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OrderingThere 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.

Jack’s friend Goldilocks couldn’t eat hot cereal. Her physician said, “For delicious ideas, read this online material.”

Our tale featured giants and magic beans, now discover what all those little numbers mean.

References1. 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.

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Web ResourcesFood Allergies

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

Short Bowel SyndromeNational Digestive Diseases Information Clearinghouse http://digestive.niddk.nih.gov/ddiseases/pubs/shortbowel/






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