Half-life of GATTEX in patients with SBS1,2
~42 Minutes
(AGE: 1-11 YEARS)
~60 MInutes
(AGE: 12-17 YEARS)
The information in the site you are about to see is intended for US healthcare professionals only. Visit Patient Site.
Penelope, GATTEX Patient
with her mom, kelsey
Half-life of GATTEX in patients with SBS1,2
~42 Minutes
(AGE: 1-11 YEARS)
~60 MInutes
(AGE: 12-17 YEARS)
Half-life of naturally occurring GLP-2 is ~7 minutes1,2
The amino acid sequence of naturally occurring GLP-2 and GATTEX are nearly identical, except for a single amino acid substitution—alanine replaced with glycine.1-4
GLP-2=glucagon-like peptide-2
Increased
Villus Height
Increased
Crypt Depth
Not an actual biopsy. Image is for illustrative purposes only and does not represent results from the study.
GATTEX enhanced gastrointestinal fluid (wet weight) absorption in adults by approximately 750–1000 mL/day1
The ability of GATTEX to improve intestinal absorption in children has not been investigated.
The ability of GATTEX (teduglutide) to improve intestinal absorption was studied in 17 adult subjects with SBS (n=2-3 per dose group) using daily doses of 0.03, 0.1, or 0.15 mg/kg (doses ranging from 0.6 to 3 times the recommended dose) in a 21-day, open-label, multicenter, dose-ranging study. Fourteen of 17 patients were dependent on PS. All subcutaneous (abdomen) doses studied, except 0.03 mg/kg once daily, resulted in enhanced gastrointestinal fluid (wet weight) absorption of approximately 750 to 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] <60 mL/min/1.73 m2) is 0.025 mg/kg once daily.1
Share the video below with your patients to see how GATTEX works.
In the pivotal Phase 3, 6-month, multicenter, clinical study of GATTEX in pediatric patients aged 1 through 17 years with short bowel syndrome (SBS) who were dependent on parenteral support (PS) (N=59)1,5,6:
Screening period
Caregivers chose for patients to receive either GATTEX (n=50) or SOC (n=9)
Enrolled and completed
study: 6 months
GATTEX + SOC
n=24GATTEX + SOC
n=26SOC only
n=9Follow-up period:
4 weeks
SOC only
INTENT-TO-TREAT POPULATION1,5 | GATTEX 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 (%) | |
Gastroschisis | 14 (84) |
Midgut volvulus | 6 (23) |
Necrotizing enterocolitis | 3 (12) |
Intestinal atresia | 1 (4) |
Hirschsprung’s disease | 1 (4) |
Other | 1 (4) |
BASELINE CHARACTERISTICS | |
Mean remaining small intestine length, cm (SD) | 47 (28) |
Stoma, n (%) Jejunostomy | 5 (18) 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 with GATTEX, safety profile, and dosing.
“As Penelope's mother, watching us reduce days of PS to get us where we are now has been the most rewarding experience in our SBS journey to date. She now sleeps line-free, and we have a lot more time together as a family.”
Percentage of patients who achieved ≥20% reduction in weekly parenteral support (PS) volume from baseline
PS volume requirements were reduced by 23 mL/kg/day (±18), which was a 42% (±29) reduction from baseline§
Patients who achieved time off of PS
Number of patients who achieved complete freedom from PS††‡‡
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§§ | 22 | 30 |
Nausea | 20 | 23 |
Upper respiratory tract infection¶¶ | 12 | 21 |
Abdominal distension | 2 | 20 |
Injection site reaction|| || | 12 | 13 |
Vomiting | 10 | 12 |
Fluid overload## | 7 | 12 |
Hypersensitivity*** | 7 | 10 |
Flatulence | 7 | 9 |
Decreased appetite | 3 | 7 |
Influenza†† | 2 | 7 |
Skin hemorrhage‡‡‡ | 2 | 5 |
Cough | 0 | 5 |
Sleep disturbances§§§ | 0 | 5 |
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).
Ongoing | Every 6 months |
After 1 year of GATTEX¶¶¶ |
Every year |
At least every 5 years |
||
---|---|---|---|---|---|---|
Fecal occult blood test1 |
Examine for unexplained blood in stool |
|
||||
Colonoscopy/ Sigmoidoscopy1¶¶¶ |
Assess for colorectal polyps |
|
|
|||
Laboratory assessments1 | Bilirubin |
|
||||
Alkaline phosphatase |
|
|||||
Lipase |
|
|||||
Amylase |
|
|||||
Clinical evaluations1 |
Signs and symptoms of intestinal obstruction |
|
||||
Signs and symptoms of fluid imbalance and fluid overload |
|
|||||
Increased absorption of concomitant oral medication(s) |
|
|||||
Observation of other adverse events |
|
Fecal occult blood test every year1 |
---|
Examine for unexplained blood in stool |
Colonoscopy/Sigmoidoscopy after 1 year of GATTEX and every 5 years thereafter 1¶¶¶ |
Assess for colorectal polyps |
Laboratory assessments every 6 months1 |
Bilirubin |
Alkaline phosphatase |
Lipase |
Amylase |
Ongoing Clinical Evaluations1 |
Signs and symptoms of intestinal obstruction |
Signs and symptoms of fluid imbalance and fluid overload |
Increased absorption of concomitant oral medication(s) |
Observation of other adverse events |
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.
patient weight (kg)
patient weight (kg)
Multiply by 0.05 OR
0.025 per above
Divide by 200 (0.05 dose)
OR 400 (0.025 dose)
patient dose (mg/day)
volume (mL/day)
Kevin | 7 years
History of illness
Kevin’s experience starting GATTEX
Kevin’s experience weaning with GATTEX
*Reductions followed by safety evaluation after 1 week, including 48-hour urine collection and clinical evaluation: signs and symptoms of dehydration, weight changes, review of recorded oral fluid intake, blood samples (hematocrit, creatinine, blood urea nitrogen), and urine sodium.
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.
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 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.