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Transcript
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
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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.
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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.
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