GATTEX FOR
CHILDREN WITH SBS
Penelope, GATTEX patientwith her mom, Kelsey
GATTEX® (teduglutide) is a prescription medicine used in adults and children 1 year of age and older with short bowel syndrome (SBS) who are dependent on parenteral support (PS)
The science behind GATTEX
GATTEX works like a natural GLP-2.
In a study of adults, GATTEX was proven to help the remaining intestine absorb more fluid.*†
Increased absorption of fluid by the intestines by ~750 to 1000 mL/day
Increased
villus height
increased depth
between villi
The image above is for illustrative purpose only.
The ability of GATTEX to improve the amount of fluid absorbed by the intestines was studied in 17 adults with SBS. Participants in the study received GATTEX for 21 days. All the participants in this study knew they were taking GATTEX. They each took daily doses of either 0.03, 0.10, or 0.15 mg/kg by injection (0.6 to 3 times the recommended dose). The recommended dose is 0.05 mg/kg/day. The injections were administered under the skin in the stomach area (abdomen). All of the doses studied, except for the 0.03 mg/kg once-daily dose, resulted in enhanced absorption of fluid by the intestines—approximately 750 to 1000 mL per day—and increased the surface area of the intestines.
The ability of GATTEX to improve intestinal absorption in children has not been investigated.
Understanding How GATTEX Works
Watch this video to gain a better understanding of short bowel syndrome and the GATTEX mechanism of action.
Gattex is the first and only medicine that works like the
glp-2 the body normally makes on its own
See the results of the clinical trials in patients on PS
GATTEX (teduglutide) Pediatric Clinical Trial
GATTEX was evaluated in a clinical study
STUDY DESIGN: In a 6-month study, 59 children aged 1 through 17 chose whether to receive GATTEX or standard of care (SOC).‡ Children who were treated with GATTEX were subsequently randomized in a double-blind manner to receive either 0.025 mg/kg/day (n=24) or 0.05 mg/kg/day (n=26), while 9 children received SOC. Randomization to the GATTEX groups was stratified by age. All children were dependent on PS prior to the study. The goal was to see if children treated with GATTEX achieved a reduction in weekly PS volume of at least 20% from baseline. The study also evaluated safety.
‡In this clinical trial, SOC primarily referred to parenteral nutrition, and for many patients, it also included enteral nutrition.
Patient baseline characteristics:
| Demographics |
People treated with GATTEX 0.05 mg/kg/day |
|---|---|
| Age | |
| 1-11 years | 92% |
| 12-17 years | 8% |
| Male | 73% |
| Primary causes of SBS | |
| Gastroschisis | 54% |
| Midgut volvulus | 23% |
| Necrotizing enterocolitis | 12% |
| Intestinal atresia | 4% |
| Hirschsprung’s disease | 4% |
| Baseline characteristics | |
| Mean remaining small intestine length | 47% |
| Mean PS infusion volumes | 60 mL/kg/day |
| Mean PS infusion time | 7 days/week |
Most children needed less volume of parenteral support (PS) with GATTEX
In a clinical study, children treated with GATTEX reduced parenteral support (PS) volume over time§
At 6 months with GATTEX
More than half
69% (18/26)
reduced their weekly
volume of PS by 20% or
more
from baseline‖
42% average
reduction
(-23/mL/kg/day) in daily
PS volume from baseline
Results are based on participant diary data.
Results are presented for the 0.05 mg/kg/day dosage, which is the recommended dosage of GATTEX.
Baseline average PS volume was 60 mL/kg/day.
In a clinical study, GATTEX helped children achieve less time and fewer days on parenteral support (PS) each week¶
At 6 months with GATTEX
38% (10/26) achieved
at least 1 day off
or more off of PS#
3 fewer hours
on average,
of PS per day**
¶ Results are presented for the 0.05 mg/kg/day dosage, which is the recommended dosage of GATTEX.
# 7 days/week average baseline PS requirement for GATTEX 0.05 mg/kg/day dosage group.
** 11 hours/day average baseline PS requirement for GATTEX 0.05 mg/kg/day dosage group.
See the details on GATTEX clinical trials for children.
Freedom from parenteral support (PS) may be possible
Some children taking GATTEX achieved complete freedom from parenteral support (PS) after 6 months of treatment.‡
12% of children
(3/26) no longer needed PS
Not all children will fully wean off of PS.
‡Results are presented for the 0.05 mg/kg/day dosage, which is the recommended dosage of GATTEX.
See the details on GATTEX clinical trials for children.
It may take time for GATTEX to work
The time it takes for a reduction in weekly PS volume can vary.
For the majority of children, GATTEX started to work within 6 months. For some children, it may
take longer,
or they may not respond at all.
Common Side Effects of GATTEX
In clinical studies of adults, the most common (≥10%) side effects were:
- Stomach area (abdomen) pain or swelling
- Nausea
- Cold or flu symptoms
- Skin reaction where the injection was given
- Vomiting
- Swelling of the hands or feet
- Allergic reactions
Work with your child's doctor to understand treatment expectations and check with them if your child is experiencing any side effects. Have your child continue taking GATTEX as long as their doctor recommends.
The safety of GATTEX has been studied in 41 children with short bowel syndrome (SBS) across 2 clinical studies‖‖
The side effects seen in children and adolescents (aged 1 to 17 years) were similar to those seen in adults. Be sure to talk to your or your child’s doctor about any side effects that are bothersome or that do not go away.
‖‖This includes pediatric patients from an additional 3-month study that was conducted with GATTEX.
GATTEX HAS BEEN APPROVED FOR USE IN CHILDREN SINCE 2019
I had no expectations...
but we kept going...
Penelope’s now free from PS
KELSEY,
mother of Penelope,
GATTEX patient
After 6 months of treatment, 3 out of 26 children treated
with GATTEX no longer needed PS.
Individual results may vary.
“I had no expectations... but we kept going... Penelope’s now free from PS”
KELSEY,
MOTHER OF PENELOPE, GATTEX PATIENT
After 6 months of treatment, 3 out of 26 children treated with GATTEX no longer needed PS.
Individual results may vary
Things to keep in mind during your child’s treatment journey
Track your child’s experiences and keep detailed notes that can be used in conversations with the doctor.
Check in with the doctor and talk openly about what your child is experiencing.
Take GATTEX as recommended by your child's doctor.
Everyone with sbs is unique. Experiences with gattex will be, too.
Considering GATTEX?
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