GATTEX IN ADULTS

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

LYNDA,
GATTEX PATIENT

PEGGY,
GATTEX PATIENT

How GATTEX works

GATTEX amino chain graphic

The half-life of naturally occurring GLP-2 is ~7 minutes. The half-life of GATTEX is ~1.3 hours in adult patients.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.1-4

GLP-2 amino chain graphic

GATTEX enhanced intestinal absorption in patients with short bowel syndrome (SBS)3

IN ADULTS, RESULTS SHOWED THAT GATTEX HAD THE ABILITY TO INCREASE INTESTINAL ABSORPTION1,3*

INCREA SED C R Y PT DEPTH INCREA SED VILLUS HEIGHT No t an actual biop s y . Image is f or illu s t r a ti v e pur p os e s only a n d do e s n o t r ep r e sent actual r e sults f r om t h e s tud y .

GATTEX enhanced gastrointestinal fluid (wet weight) absorption by approximately 750-1000 mL/day1

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

Study Design

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The ability of GATTEX 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 parenteral support (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.

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.

Lynda GATTEX patient

My surgeon had heard about GATTEX, and he explained that this drug might help me reduce the amount of volume and days on total parenteral nutrition (TPN).”

-Lynda,
GATTEX PATIENT

Study Design

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Pivotal Phase 3 study: STEPS

STEPS was a 6-month, randomized, double-blind, placebo-controlled study of adult patients with short bowel syndrome (SBS) (n=43, GATTEX; n=43, placebo)

6 months icon
  • The primary endpoint was defined as a patient achieving a ≥20% reduction in weekly parenteral support (PS) volume from baseline (immediately before randomization) to Weeks 20 and 24
  • Efficacy analysis was performed by comparing the intent-to-treat population in the treatment group and placebo group, respectively1,5
    • PS volume adjustments (up to a 30% decrease) and clinical assessments were made at Weeks 2, 4, 8, 12, 20, and 241

Extension study: STEPS-2

STEPS-2 was a 24-month, open-label extension study measuring long-term response (n=37, GATTEX/GATTEX; n=39, placebo/GATTEX; n=12, not treated/GATTEX)1,6‡

24 months icon
  • Of the patients who completed STEPS, 97% (76/78) elected to enroll in STEPS-26
  • All patients received GATTEX in STEPS-26
  • Clinical response in STEPS-2 was defined as a ≥20% reduction in weekly PS volume from baseline (start of GATTEX treatment ) to the last visit6
  • Efficacy analysis was calculated in patients who completed 24 months of treatment with GATTEX in the placebo/GATTEX subgroup, and 30 months of treatment with GATTEX in the GATTEX/GATTEX subgroup6
  • Of the 88 patients enrolled in STEPS-26:
    • 65 (74%) completed the study (n=30/37, GATTEX/GATTEX; n=29/39, placebo/GATTEX; n=6/12, not treated/GATTEX)
After randomization of the intent-to-treat population (N=86), 4 patients in the GATTEX arm and 4 patients in the placebo arm discontinued treatment, leaving 78 evaluable patients.5
Patients who completed fluid optimization and stabilization but were not randomized in the initial 6-month, placebo-controlled study because of full study enrollment were eligible for direct enrollment into STEPS-2.6

GATTEX was studied in a range of adult patients5

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Patient Baseline Characteristics in STEPS1,5,7

AVERAGE RANGE
AGE 50 years 18-82 years
ESTIMATED SMALL BOWEL LENGTH 77.3 cm 5-343 cm
LENGTH OF TIME ON PS 6 years 1-26 years
PRESCRIBED DAYS PER WEEK ON PS 5.73 days 3-7 days
INFUSION VOLUME 13 L/week 0.9-35 L/week

 

STUDY PATIENTS HAD VARYING TYPES OF INTESTINAL RESECTION1,7
unequal icon
  • 44% (37/85) of patients did not have colon in continuity
    — An average of 37% of the colons in these patients had been removed
  • 54% (13/24) of patients with an intact distal/terminal ileum had an ileocecal valve
  • Stoma (most commonly jejunostomy and ileostomy) was present in 45% (38/85) of patients

 

THE MOST COMMON REASONS FOR INTESTINAL RESECTION INCLUDED1
intestinal resection icon
  • Vascular disease: 34% (29/85)
  • Crohn’s disease: 21% (18/85)
  • Other: 21% (18/85)

 

See how to get your appropriate patients started or keep reading to explore results with GATTEX, safety profile and dosing and time to response.

 

GATTEX reduced weekly parenteral support (PS) volume for the majority of patients1

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

STEPS: AT 6 MONTHS (P=0.002)1

GATTEX
63%
(27/43)
Placebo
30%
(13/43)
100%

STEPS + STEPS-2: WHO COMPLETED 30 MONTHS1

GATTEX/GATTEX
93%
(28/30)
100%

The primary endpoint in STEPS was defined as a patient achieving a ≥20% reduction in weekly PS volume from baseline (immediately before randomization) to Weeks 20 and 24. Clinical response in STEPS-2 was defined as a ≥20% reduction in weekly PS volume from baseline (start of GATTEX treatment) to the last visit.1,6


GATTEX reduced average weekly parenteral support (PS) volume over time5,6

Average weekly PS volume reduction

 

STEPS: AT 6 MONTHS (P<0.001)

Patients who received GATTEX achieved an average reduction of 4.4 L/week.
Patients who received placebo achieved an average reduction of 2.3 L/week.||

STEPS + STEPS-2: WHO COMPLETED 30 MONTHS5,6

After 30 months, patients treated with GATTEX (n=30) achieved a mean reduction in PS volume of 7.55 L/week, which represented a 66% reduction from baseline.




13.2 12.4 0 1 2 3 4 5 7 8 9 12 15 18 2 1 24 27 10 15 5 0 Plac e b o (n=39) GATTEX/GATTEX(n=30) MEANPS V OLUME (L/WEEK ) STEPS STEPS-2 MONTHS 30 6 1 1 .1 10.9 1 1.3 1 1 .7 12.2 12.7 8.0 7.8 4.9 7.1 6.7 6.8 7.2 6.9 5.9 5.8 5.2 4.8 8.9 9.6 10.5 1 1.5

 

66% REDUCTION IN PS VOLUME AFTER 30 MONTHS OF TREATMENT WITH GATTEX1

§
In STEPS, mean reduction in PS volume was a selected secondary endpoint.
From a pretreatment baseline of 12.9 L/week (n=43).
||
From a pretreatment baseline of 13.2 L/week (n=43).
Kat GATTEX patient traveling

With the help of GATTEX, my doctor was able to cut my weekly PS. I’m now infusing fewer liters of PS a week.”

-Kat,
GATTEX PATIENT

GATTEX reduced the amount of time patients spent on parenteral support (PS)1,5

Percentage of patients who achieved time off of PS

STEPS: AT 6 MONTHS1,5#**

54%(21/39)

OF PATIENTS TREATED WITH GATTEX

ACHIEVED ≥1 DAY OFF OF PS PER WEEK

vs 23% (9/39) who received placebo.

STEPS + STEPS-2: WHO COMPLETED 30 MONTHS1

70%(21/30)

OF PATIENTS TREATED WITH GATTEX

ACHIEVED ≥1 DAY OFF OF PS PER WEEK

60%(18/30)

OF PATIENTS TREATED WITH GATTEX

ACHIEVED ≥3 DAYS OFF OF PS PER WEEK

#
After randomization of the intent-to-treat population (N=86), 4 patients in the GATTEX arm and 4 patients in the placebo arm discontinued treatment, resulting in 78 evaluable patients in the 6-month study.5
**
In STEPS, reduction in days off of PS was a selected exploratory endpoint.7
Peggy GATTEX patient walking on beach

Now, I spend my days off PS engaged in pastimes like being with friends, traveling, and engaging in volunteer activities.”

-Peggy,
GATTEX PATIENT

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

Percentage of patients who achieved complete freedom from PS

STEPS + STEPS-2: WHO COMPLETED 30 MONTHS1

33%(10/30)

OF PATIENTS TREATED WITH GATTEX WEANED OFF PS COMPLETELY††

Snake
3/10 PATIENTS6
  • Had resection due to inflammatory bowel disease
  • Did not have colon-in-continuity
7/10 PATIENTS6
  • Had resection due to vascular and other causes
  • Had colon-in-continuity
  • The average duration of treatment to achieve complete freedom from PS in patients from the GATTEX/GATTEX subgroup was ~20 months (range: ~7 to ~30 months)7
  • No patients fully weaned off of PS in STEPS
  • Not all patients who take GATTEX will fully wean off of PS or experience weekly PS volume reduction
††
During the study, patients were maintained on GATTEX after weaning off of PS. Prior to GATTEX, these 10 patients required 3.5-13.4 L/week of PS for 1.2-15.5 years. The timing of the complete wean ranged from 7 to 30 months (mean ~20 months).1
Betsy GATTEX patient walking

Over time with GATTEX, my doctors started slowly reducing my PS. A year later, my PS had been stopped altogether.”

-Betsy,
GATTEX PATIENT

GATTEX has a demonstrated safety profile1

Adverse reactions that were more frequently reported in ≥5% of adult patients with short bowel syndrome (SBS) who were treated with GATTEX than in those who received placebo in 2 placebo-controlled studies.1

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
  • If patients have a stoma, advise them that, while they may experience abdominal pain and swelling of their stoma, especially when starting treatment with GATTEX, if they experience symptoms of intestinal obstruction, they should contact their physician.1
  • 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 received GATTEX 0.05 mg/kg/day and 14% (3/22) for patients who received placebo.
 
 
‡‡
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 adult patients receiving GATTEX

6 months icon

Within 6 months prior to starting GATTEX treatment1:

  • Perform a colonoscopy of the entire colon with removal of polyps1
  • Obtain baseline laboratory assessments (bilirubin, alkaline phosphatase, lipase, and amylase)1
Ongoing Every 6 months After 1 year of Gattex§§§ At least every 5 years
Colonoscopy after 1 year of GATTEX and at least every 5 years 1††††1 Examination of the entire colon with removal of polyps     X X
Laboratory Assessments every 6 months1 Bilirubin   X    
Alkaline phosphatase   X    
Lipase   X    
Amylase   X    
Ongoing Clinical Evaluations1 Signs and symptoms of intestinal obstruction X      
Signs and symptoms of fluid imbalance and fluid overload X      
Increased absorption of concomitant medication(s) X      
Observation of other adverse events X      

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

§§§
Follow-up colonoscopy (or alternate imaging) is recommended at the end of 1 year of treatment with GATTEX.1

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

Dosing & Administration1

Weight-based Dosing

  • The recommended dosage of GATTEX for adults is 0.05 mg/kg once daily by subcutaneous injection
  • For adult patients with moderate and severe renal impairment and end-stage renal disease (estimated glomerular filtration rate less than 60 mL/min/1.73 m2), the recommended dosage is 0.025 mg/kg once daily
  • For patients with a dose that is more than 3.8 mg/day, two 30-vial kits are recommended

Patient-administered Subcutaneous Injection

  • GATTEX is administered by subcutaneous injection once daily
    – Not for intravenous (IV) or intramuscular (IM) injection
  • Patients 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
  • GATTEX is supplied in a single-dose vial
  • GATTEX should be administered within 3 hours after reconstitution

Time to response for patients on GATTEX may vary

Bowel anatomy may impact time to response

Post hoc analysis8

A Takeda-sponsored post hoc analysis of STEPS and STEPS-2 identified factors that may be associated with mean time to sustain parenteral support (PS) reduction.

 

To evaluate factors associated with sustained PS volume reduction and early vs late response, a Takeda-sponsored post hoc analysis was conducted of patients with short bowel syndrome (SBS) who were treated with GATTEX in the STEPS study (n=43) and who then continued treatment with GATTEX for up to 24 months in the extension study, STEPS-2.¶¶¶

EARLY RESPONDERS
  • Patients who completed STEPS with a PS volume reduction of ≥20% from baseline at both Week-20 and Week-24 visits during STEPS
LATE RESPONDERS
  • Patients who completed STEPS-2
  • Patients who had a PS volume reduction of ≥20% from baseline at any 2 consecutive visits during the extension study or at both the Week-24 visit in STEPS and the Month-1 visit in STEPS-2
  • PS volume reduction was defined as 2 consecutive visits with a PS volume reduction of ≥20%
  • Time to sustained PS volume reduction was defined as the period between the baseline visit for STEPS and the second consecutive visit at which PS volume reduction was ≥20%

A Kaplan-Meier analysis was conducted for time to sustained PS volume reduction; a multivariable Cox proportional hazards model was used for predictors of sustained PS volume reduction. Time to sustained PS volume reduction was described for early and late responders. Patient characteristics were described and compared between early vs late responders using chi-square tests for categorical variables and Wilcoxon rank sum tests for continuous variables.

Characteristics of early vs late responders

POST HOC ANALYSIS7
CHARACTERISTICS EARLY RESPONDERS
(n=27)
LATE RESPONDERS
(n=7)
P VALUE
Baseline demographics
Age (years), mean (SD) 51.6 (13.3) 52.4 (10.2) 0.966
Male, n (%) 14 (51.9) 3 (42.9) 0.672
White, n (%) 26 (96.3) 7 (100.0) 0.605
BMI (kg/m2), mean (SD) 22.3 (3.3) 22.3 (3.9) 0.881
Baseline PS characteristics, mean (SD)
Composite fluid balance (L/week) 17.3 (11.7) 18.3 (15.0) 0.966
Actual baseline PS volume (L/week) 13.5 (7.7) 12.7 (9.8) 0.639
Time since start on PS dependence (years) 7.4 (6.4) 3.5 (3.0) 0.287
Actual number of days of PS per week 5.8 (1.5) 5.4 (1.8) 0.537
Concomitant medications
Narcotics, n (%) 10 (37.0) 3 (42.9) 1.000
Baseline SBS characteristics
Cause of major intestinal resection, n (%)
Crohn’s disease 7 (25.9) 1 (14.3) 1.000
Vascular disease 8 (29.6)) 4 (57.1) 0.211
Injury 2 (7.4) 1 (14.3) 0.511
Volvulus 3 (11.1) - 1.000
Cancer 1 (3.7) - 1.000
Other 6 (22.2) 1 (14.3) 1.000
Presence of stoma, n (%) 15 (55.6) 2 (28.6) 0.203
Type of stoma, n (%)      
Jejunostomy 10 (37.0) - 0.078
Ileostomy 3 (11.1) - 1.000
Colostomy 2 (7.4) 2 (28.6) 0.180
Missing or not available 12 (44.4) 5 (71.4) 0.398
Colon-in-continuity, n (%) 14 (51.9) 7 (100.0) 0.020|| || ||
Percentage of colon remaining, mean (SD) 24.6 (26.1) 57.1 (19.8) 0.016|| || ||
Estimated remaining small intestine length (cm), n (%)      
<60 cm 11 (40.7) 3 (42.9) 1.000
≥60 cm 14 (51.9) 3 (42.9) 1.000
Missing 2 (7.4) 1 (14.3) 0.511
Presence of distal/terminal ileum, n (%) 5 (18.5) 3 (42.9) 0.176
Presence of ileocecal valve, n (%) 0 (0.0) 2 (28.6) 0.004|| || ||
Time since last small bowel resection (years), mean (SD) 5.8 (5.1) 3.9 (2.7) 0.639

Adapted from Joly et al, 2016, United European Gastroenterology Week.

¶¶¶
This is a post hoc analysis of patients who completed STEPS and STEPS-2. Please note that efficacy in STEPS was based on the intent-to-treat population, while efficacy in STEPS-2 was based on study completers. Further randomized, controlled clinical studies are necessary to corroborate these findings.8-10
|| || ||
P<0.05.
EARLY RESPONDERS TO TREATMENT (n=27)

3.6
Months
(1.1 SD)

  • Lower percentage had colon in continuity (51.9%)
  • Patients had a lower mean percentage of colon remaining (24.6%)
  • Fewer patients had ileocecal valve (0%)
LATE RESPONDERS TO TREATMENT (n=7)

10.0
Months
(6.1 SD)

  • Higher percentage had colon in continuity (100%)
  • Patients had a higher mean percentage of colon remaining (57.1%)
  • More patients had ileocecal valve (28.6%)

Study limitations: This study was limited by the relatively small sample size, which may not have sufficient statistical power to identify factors associated with response. This study was also limited by the heterogeneity within the group of patients who had SBS with intestinal failure. The population consisted of patients who were subject to specific inclusion and exclusion criteria. Thus, the results may have limited generalizability.

 

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.

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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.

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