Imagine—a life so narrow.

Children aged 1 year and older with short bowel syndrome (SBS) may require long-term Parenteral Support (PN/IV)1*

What if you could reduce PS* in your pediatric SBS patients’ lives with GATTEX®?

The primary endpoint was a reduction in PS volume of at least 20% from baseline to the end of treatment.1

*Parenteral support (PS) is parenteral nutrition/intravenous fluids (PN/IV).

GATTEX may mean less weekly PS volume in your SBS patients’ lives1

GATTEX was studied in a range of pediatric patients with SBS in a 24-week pivotal study1,2

Intent-to-treat population

Demographics GATTEX 0.05 mg/kg/day
(n=26)
Mean age, years (SD) 6 (4)
1-11 years (%) 24 (92)
12-16 years (%) 2 (8)
17-<18 years (%) 0
Male, n (%) 19 (73)
Primary cause of SBS, n (%)
Gastroschisis 14 (54)
Midgut volvulus 6 (23)
Necrotizing enterocolitis 3 (12)
Intestinal atresia 1 (4)
Hirschsprung’s disease 1 (4)
Other 1 (4)
Baseline Characteristics GATTEX 0.05 mg/kg/day
(n=26)
Mean remaining small intestine length, cm (SD) 47 (28)
Stoma, n (%) 5 (19)
Jejunostomy, (%) 80
Patients with remaining colon, n (%) 25 (96)
Colon in continuity, (%) 88
Mean actual PS volume, mL/kg/day (SD) 60 (29)
Mean PS infusion time, days/week (SD) 7 (1)
Mean PS infusion time, hours/day (SD) 11 (3)

SD=standard deviation.

Reductions in weekly PS volume

Study design1,2

24-week, multicenter study of GATTEX in pediatric patients aged 1 through 17 years with SBS who were dependent on PS (N=59). Patients chose to receive either GATTEX or SOC. Patients in the GATTEX arm were randomized to 0.025 mg/kg/day or 0.05 mg/kg/day.

Patients had SBS resulting from major intestinal resection and were dependent on PS that required PN/IV support that provided at least 30% of caloric and/or fluid/electrolyte needs for at least 3 months prior to screening.

PS requirement at baseline in the 24-week study:

  • Stable PN/IV support (defined as inability to significantly reduce PN/IV support [ie, 10% or less change in PN/IV or advance in feeds]) for at least 3 months prior to and during screening as assessed by the investigator

The primary endpoint was a reduction in PS volume of at least 20% from baseline to the end of treatment. Additional endpoints included: enteral autonomy, mean change in baseline PS infusion days/week at Week 24, and reduction in infusion hours/day.

The recommended dose of GATTEX is 0.05 mg/kg once daily.


A majority of pediatric patients with SBS reduced PS volume requirements with GATTEX1

In the intent-to-treat population based on patient diary information:

Image of 69% (18/26) graphic

of GATTEX-treated patients* achieved at least a 20% reduction from baseline in PS volume at Week 24

*GATTEX 0.05 mg/kg/day dose group.
Weight-normalized reduction.


Pediatric patients achieved time off of daily PS with GATTEX

Mean reduction in hours/day on PS at Week 241,3*

Image of Reduction PS icon
3 hours/day

Standard deviation (±3.8).
*GATTEX 0.05 mg/kg/day dose group.
11 hours/day mean baseline PS infusion time for GATTEX study group.


Percentage of patients with >1 days/week off of PS1

Image of 38% (10/26) graphic

of GATTEX-treated* patients achieved a reduction in PS infusion of ≥1 day/week at Week 24

*GATTEX 0.05 mg/kg/day dose group.


Patients who fully weaned off of PS by Week 241

Image of Weaned icon
3 patients*

3 out of 26 (12%)

*GATTEX 0.05 mg/kg/day dose group.

In 2 clinical trials, 41 pediatric patients were treated with GATTEX 0.05 mg/kg/day1

Overall, the safety profile of GATTEX in pediatric patients aged 1 year to less than 17 years was similar to that in adults.

Of the 41 patients, there was: 1 infant (1 year to less than 2 years), 37 children (2 years to less than 12 years) and 3 adolescents (12 years to less than 17 years).

In the long-term extension studies with mean exposure of 41 weeks, no new safety signals were identified.

Most common adverse reactions in adult patients with SBS
(≥5% in the GATTEX group and greater than the placebo group)
Placebo (N=59)
(%)
GATTEX 0.05 mg/kg/day
(N=77)
(%)
Abdominal pain1 22 30
Nausea 20 23
Upper respiratory tract infection2 12 21
Abdominal distension 2 20
Injection site reaction3 12 13
Vomiting 10 12
Fluid overload4 7 12
Hypersensitivity5 7 10
Flatulence 7 9
Decreased appetite 3 7
Influenza6 2 7
Skin hemorrhage7 2 5
Cough 0 5
Sleep disturbances8 0 5

1 Includes: Abdominal pain, upper abdominal pain, lower abdominal pain

2 Includes: Upper respiratory tract infection, nasopharyngitis, pharyngitis, sinusitis, laryngitis, rhinitis, viral upper respiratory tract infection

3 Includes: Injection site hematoma, injection site erythema, injection site pain, injection site swelling, injection site hemorrhage, injection site discoloration, injection site reaction, injection site rash

4 Includes: Fluid overload, peripheral edema, edema, generalized edema, fluid retention and jugular vein distension

5 Includes: Erythema, rash, dermatitis allergic, pruritus, rash macular, drug eruption, eyelid edema, flushing

6 Includes: Influenza, influenza-like illness

7 Includes: Hematoma, abdominal wall hematoma, post procedural hematoma, umbilical hematoma, blood blister

8 Includes: Insomnia (3 patients) and hypersomnia (1 patient)

Among the 53 patients with a stoma in the placebo-controlled studies (Study 1 and Study 3), the percentage of patients with gastrointestinal stoma complication was 42% (13/31) for patients receiving GATTEX 0.05 mg/kg/day and 14% (3/22) for patients receiving placebo.

GATTEX offers individualized, weight-based dosing1

The recommended dose in patients 1 year of age and older is 0.05 mg/kg once daily

  • Use of the GATTEX 5 mg kit is not recommended in pediatric patients weighing less than 10 kg
  • The recommended dosage in adult and pediatric patients with moderate and severe renal impairment and end‑stage renal disease (estimated glomerular filtration rate (eGFR) less than 60 mL/min/1.73 m2) is 0.025 mg/kg once daily

GATTEX is a once-daily subcutaneous injection

  • GATTEX is for caregiver administration. Self-administration in pediatric patients has not been tested
  • Caregiver should alternate sites between 1 of the 4 quadrants of the abdomen, or into alternating thighs or alternating arms
  • Full preparation and injection instructions can be found in the GATTEX Instructions for Use
Image of GATTEX training kit
GATTEX is available in a 5 mg vial
Image of GATTEX training kit

Do you have a pediatric SBS patient aged 1 year or older who is dependent on PS?

Getting Started

Image of child actor portrayal of GATTEX patient

Not actual patient

Indication:
GATTEX® (teduglutide) for injection is indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support.

Important Safety Information:

Warnings and Precautions:
GATTEX has been associated with acceleration of neoplastic growth, intestinal obstruction, biliary and pancreatic disease, fluid imbalance and fluid overload, and increased absorption of concomitant oral medication. Click here for additional Important Safety Information.

Click here for additional Important Safety Information.

Indication

GATTEX® (teduglutide) for injection is indicated for the treatment of adults and pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who are dependent on parenteral support.

Important Safety Information

Warnings and Precautions

Acceleration of neoplastic growth

Colorectal polyps were identified during clinical trials. There is a risk for acceleration of neoplastic growth. In adults, within 6 months prior to starting treatment with GATTEX, colonoscopy of the entire colon with removal of polyps should be performed and follow-up colonoscopy (or alternate imaging) is recommended at the end of 1 year of GATTEX. Subsequent colonoscopies should be performed every 5 years or more often as needed.

In children and adolescents, perform fecal occult blood testing prior to initiating treatment with GATTEX. Colonoscopy/sigmoidoscopy is required if there is unexplained blood in the stool. Perform subsequent fecal occult blood testing annually in children and adolescents while they are receiving GATTEX. Colonoscopy/sigmoidoscopy is recommended for all children and adolescents after 1 year of treatment, every 5 years thereafter while on continuous treatment with GATTEX, and if they have new or unexplained gastrointestinal bleeding.

In case of intestinal malignancy (GI tract, hepatobiliary, pancreatic), discontinue GATTEX. The clinical decision to continue GATTEX in patients with non-gastrointestinal malignancy should be made based on benefit-risk considerations.

Intestinal obstruction

Intestinal obstruction has been reported in clinical trials and postmarketing. In patients who develop intestinal or stomal obstruction, GATTEX should be temporarily discontinued pending further clinical evaluation and management.

Biliary and pancreatic disease

Cholecystitis, cholangitis, cholelithiasis, and pancreatitis have been reported in clinical trials and postmarketing. Laboratory assessment (bilirubin, alkaline phosphatase, lipase, amylase) should be obtained within 6 months prior to starting GATTEX. Subsequent laboratory tests should be done every 6 months or more often as needed. If clinically meaningful changes are seen, further evaluation is recommended including imaging, and continued treatment with GATTEX should be reassessed.

Fluid imbalance and fluid overload

Fluid overload and congestive heart failure have been observed in clinical trials. If fluid overload occurs, especially in patients with underlying cardiovascular disease, parenteral support should be adjusted and GATTEX treatment reassessed. If significant cardiac deterioration develops while on GATTEX, continued GATTEX treatment should be reassessed.

Discontinuation of treatment with GATTEX may also result in fluid and electrolyte imbalance. Fluid and electrolyte status should be monitored in patients who discontinue treatment with GATTEX.

Increased absorption of concomitant oral medication

In clinical trials, one patient receiving prazepam concomitantly with GATTEX experienced dramatic deterioration in mental status progressing to coma during first week of GATTEX therapy. Patients receiving concomitant oral drugs requiring titration or with a narrow therapeutic index should be monitored for adverse reactions due to potential increased absorption of the concomitant drug. The concomitant drug may require a reduction in dosage.

Adverse Reactions

The most common adverse reactions (≥ 10%) with GATTEX are abdominal pain, nausea, upper respiratory tract infection, abdominal distension, injection site reaction, vomiting, fluid overload, and hypersensitivity.

Use in Specific Populations

Breastfeeding is not recommended during treatment with GATTEX.

Please click here for full Prescribing Information.

References:
  1. GATTEX (teduglutide) for injection [package insert]. Lexington, MA: Shire-NPS Pharmaceuticals, Inc; 2019.
  2. Data on file, Takeda Pharmaceuticals, Inc.
  3. Study NCT02682381. clinicaltrials.gov/​ct2/​show/​study/​NCT02682381. Accessed August 8, 2019.