GATTEX IN PEDIATRICS ≥1 YEAR

GATTEX is the first and only FDA-approved GLP-2 analog for patients with short bowel syndrome (SBS) who are dependent on parenteral support (PS)1

ACTOR PORTRAYAL

How GATTEX works

GATTEX amino chain graphic

The half-life of native GLP-2 is ~7 minutes; in adult patients with SBS, the half-life of GATTEX is 1.3 hours.1,2

The amino acid sequence of native GLP-2 and GATTEX are nearly identical, except for a single amino acid substitution—alanine replaced with glycine. This substitution results in decreased degradation by dipeptidyl 22% peptidase-IV (DPP-IV) and an extended half-life.1,3-5

GLP-2 amino chain graphic

GATTEX enhanced intestinal absorption in patients with SBS4

IN ADULTS, RESULTS SHOWED THAT GATTEX HAD THE ABILITY TO INCREASE INTESTINAL ABSORPTION1,4*

GATTEX increased villus height and crypt depth illustration

GATTEX enhanced gastrointestinal fluid (wet weight) absorption by approximately 750-1000 mL/day.1

*
The ability of GATTEX to improve intestinal absorption in children has not been investigated.

Study Design

Close Open

In a 3-week, Phase 2, open-label, multicenter, dose-ranging study of adult patients with SBS, GATTEX increased the absorptive capacity of the intestine.1

Seventeen patients with SBS (n=2-3 per dosage group) were given daily doses of GATTEX 0.03, 0.10, or 0.15 mg/kg (doses ranged from 0.6 to 3 times the recommended dose).1

All subcutaneous (abdomen) dosages studied, except 0.03 mg/kg/day, resulted in enhanced gastrointestinal fluid (wet weight) absorption of approximately 750-1000 mL/day and increased villus height and crypt depth of the intestinal mucosa.1

The recommended dosage of GATTEX for both adult and pediatric patients is 0.05 mg/kg once daily by subcutaneous injection. 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.

Boy on trampoline with father

Actor Portrayal

Study Design

Close Open

Pivotal study of GATTEX in pediatric patients

6 months icon

In the pivotal Phase 3, 6-month, multicenter, clinical trial of GATTEX in pediatric patients aged 1 through 17 years with SBS who were dependent on PS (N=59)1,6,7:

  • Patients chose to receive either GATTEX (n=50) or standard of care (SOC) (n=9)
    • Patients in the GATTEX arm were randomized to 0.025 mg/kg/day (n=24) or 0.05 mg/kg/day (n=26)
  • Patients had SBS resulting from major intestinal resection and were dependent on PS that provided ≥30% of caloric and/or fluid/electrolyte needs for ≥3 months prior to screening
  • PS requirements at baseline in the 6-month study:
    • Stable PS support (defined as the inability to significantly reduce PS support [ie, 10% or less change in PS or advance in feeds]) for ≥3 months prior to and during screening as assessed by the investigator
    • PS and specialized enteral nutrition were recorded in intake diaries by the child’s parent or guardian
  • The primary endpoint was a reduction in PS volume of ≥20% from baseline to the end of treatment. Additional endpoints included reduction in PS volume from baseline and infusion hours/day, mean change in baseline PS infusion days/week at Week 24, and enteral autonomy

Patient Baseline Characteristics

Close Open

GATTEX was studied in a range of pediatric patients1,6

Patient baseline characteristics

INTENT-TO-TREAT POPULATION1,6GATTEX 0.05 mg/kg/day
(n=26)
DEMOGRAPHICS
Mean age, years (standard deviation [SD])6 (4)
1-11 years (%)24 (92)
12-16 years (%)2 (8)
17-<18 years (%)0
Male, n(%)19 (73)
PRIMARY CAUSES OF SBS, n (%)
Gastroschisis14 (64)
Midgut volvulus6 (23)
Necrotizing enterocolitis3 (12)
Intestinal atresia1 (4)
Hirschsprung's disease1 (4)
Other1 (4)
BASELINE CHARACTERISTICS
Mean remaining small intestine length, cm (SD)47 (28)
Stoma, n (%)
  Jejunostomy
5 (19)
4 (80)
Patients with remaining colon, n (%)
  Colon-In-continuity
25 (96)
22 (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)

 

See how to get your appropriate patients started, or keep reading to explore results, safety, and dosing.

kid on bike with father holding handlebars

Actor Portrayal

GATTEX reduced weekly PS volume for the majority of patients1,6

Reduction in PS VOLUME requirements1,6

Percentage of pediatric patients who achieved a ≥20% reduction in weekly PS volume from baseline

69%(18/26)

of patients treated with GATTEX achieved a

≥20% reduction IN PS VolUME FROM BASELINE AT 6 MONTHS1,6‡§¶


GATTEX reduced mean weekly PS volume over time1,6||

mean weekly PS volume over time for pediatrics patients chart

mother carrying child in arms

Actor Portrayal

GATTEX reduced the amount of time patients spent on PS1,6

Time off of PS1,6

time off of PS calendar icon

PEDIATRIC PATIENTS WHO ACHIEVED TIME OFF OF PS

AT 6 MONTHS¶|| 3 HOURS/DAY
(±3.8 hours/day)

Patients treated with GATTEX achieved a mean

REDUCTION IN TIME ON PS OF 3 HOURS/DAY6#

38% (10/26)

of patients treated with GATTEX spent

1 FEWER DAYS PER WEEK ON PS1,6**

Primary efficacy endpoint.
Results based on patient diary data from the intent-to-treat population.
§
Weight-normalized reduction.
GATTEX 0.05 mg/kg/day dosage group.
||
Key secondary efficacy endpoint.
#
11 hours/day mean baseline PS infusion time.
**
7 days/week mean PS infusion time.

GATTEX helped some patients achieve complete freedom from parenteral support (PS)1,6

Complete freedom from PS

freedom from PS icon

NUMBER OF PEDIATRIC PATIENTS WHO ACHIEVED COMPLETE FREEDOM FROM PS††‡‡

AT 6 MONTHS 3 PATIENTS
(3/26,12%)

Patients treated with GATTEX were able to

WEAN OFF PS COMPLETELY1,6

††
GATTEX 0.05 mg/kg/day dosage group.
‡‡
Key secondary efficacy endpoint.

GATTEX has a demonstrated safety profile1

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

  • Overall, the safety profile of GATTEX for pediatric patients aged 1 to <17 years was similar to that for adults1
  • The 41 patients included 1 infant (1 to <2 years), 37 children (2 to <12 years), and 3 adolescents (12 to <17 years)1
  • In the long-term extension studies with a mean exposure of 41 weeks, no new safety signals were identified1
MOST COMMON ADVERSE REACTIONS IN ADULTS1
(≥5% in the GATTEX group and greater than in the placebo group)
Placebo
(n=59)
(%)
GATTEX 0.05 mg/kg/day
(n=77)
(%)
Abdominal pain§§2230
Nausea2023
Upper respiratory tract infection¶¶1221
Abdominal distension220
Injection site reaction || ||1213
Vomiting1012
Fluid overload ##712
Hypersensitivity ***710
Flatulence79
Decreased appetite37
Influenza ††27
Skin hemorrhage ‡‡‡25
Cough05
Sleep disturbances §§§05

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

 
 
§§
Includes: Abdominal pain, upper abdominal pain, lower abdominal pain.
¶¶
Includes: Upper respiratory tract infection, nasopharyngitis, pharyngitis, sinusitis, laryngitis, rhinitis, viral upper respiratory tract infection.
|| ||
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.
##
Includes: Fluid overload, peripheral edema, edema, generalized edema, fluid retention, and jugular vein distension.
***
Includes: Erythema, rash, dermatitis allergic, pruritus, rash macular, drug eruption, eyelid edema, flushing.
††
Includes: Influenza, influenza-like illness.
‡‡‡
Includes: Hematoma, abdominal wall hematoma, post-procedural hematoma, umbilical hematoma, blood blister.
§§§
Includes: Insomnia (3 patients) and hypersomnia (1 patient).

Monitoring timeline for pediatric patients receiving GATTEX

6 months icon

Within 6 months prior to starting treat GATTEX treatment1:

  • Perform fecal occult blood testing; if there is unexplained blood in the stool, perform colonoscopy/sigmoidoscopy1
  • Obtain baseline laboratory assessments (bilirubin, alkaline phosphatase, lipase, and amylase)1
OngoingEvery 6 monthsAfter 1 year of GattexEvery yearAt least every 5 years
Fecal occult blood test every year1Examine for unexplained blood in stool   X 
Colonoscopy / Sigmoidoscopy after 1 year of GATTEX and every 5 years thereafter1¶¶¶Assess for colorectal polyps  X X
Laboratory Assessments every 6 months1Bilirubin X   
Alkaline phosphatase X   
Lipase X   
Amylase X   
Ongoing Clinical Evaluations1Signs and symptoms of intestinal obstructionX    
Signs and symptoms of fluid imbalance and fluid overloadX    
Increased absorption of concomitant medication(s)X    
Observation of other adverse eventsX    

Discontinuation of treatment with GATTEX may result in fluid and electrolyte imbalance. Fluid and electrolyte status should be monitored in patients who discontinue treatment with GATTEX.1

¶¶¶
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.1

See how to get your appropriate patients started, or keep reading for information on dosing and the time to response.

Dosing & Administration1

The recommended dosage in pediatric patients 1 year of age and older is 0.05 mg/kg once daily by subcutaneous injection

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

 

GATTEX should always be administered by a caregiver

  • Full preparation and injection instructions can be found in the GATTEX Instructions for Use
  • Self-administration in pediatric patients has not been tested
  • Caregivers should inject GATTEX into 1 of the 4 quadrants of the abdomen, either thigh, or either arm. They should use a different injection site each time

Getting Started

Steps to getting your appropriate patients started on GATTEX

 

Learn More

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 or Información de prescripción en español.

Close Close Open

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.

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 or Información de prescripción en español.

Are you a healthcare professional?

The information in the site you are about to see is intended for US healthcare professionals only. Click OK if you are a US healthcare professional.

OK Cancel

You are now leaving GATTEXHCP.COM

By clicking CONTINUE, you will leave GATTEXHCP.COM. To stay on GATTEXHCP.COM, select CANCEL

CANCEL Continue