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GATTEX For Adult Patients
With
Short Bowel Syndrome
(SBS)

GATTEX® (teduglutide) is the first FDA-approved analog of naturally occurring GLP-2 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

GATTEX Mechanism of Action

How GATTEX works

GATTEX amino chain

Half-life of GATTEX in patients with SBS1,2

~1.3 HOURS

(AGE: >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 amino chain

GLP-2=glucagon-like peptide-2

GATTEX (teduglutide) enhanced intestinal absorption in adult patients with short bowel syndrome (SBS)1,3

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 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.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

Understanding the GATTEX
Mechanism of Action

Share the video below with your patients to see how GATTEX works.

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

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)†

  • 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

6-month study1,5

Study design

Screening period

(1 to 7 days)

Optimization period

(0 to 8 weeks)

Stabilization period

(4 to 8 weeks)

Enrolled in STEPS

GATTEX

n=43
(0.05 mg/kg/day)

Placebo

n=43

Completed STEPS

GATTEX

n=39
(0.05 mg/kg/day)

Placebo

n=39

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‡

  • 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)

24-month extension study1,6

Study design

Enrolled in STEPS-2

GATTEX/GATTEX

n=37
(0.05 mg/kg/day)

Placebo/GATTEX

n=39
(0.05 mg/kg/day)

Not treated in STEPS/GATTEX

n=12
(0.05 mg/kg/day)

Completed STEPS-2

GATTEX/GATTEX

n=30 (0.05 mg/kg/day);
Duration on GATTEX=30 months

Placebo/GATTEX

n=29 (0.05 mg/kg/day);
Duration on GATTEX=24 months

Not treated in STEPS/GATTEX

n=6 (0.05 mg/kg/day);
Duration on GATTEX=24 months

†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

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

Intestinal Resection Baseline Characteristics1,7

Patients had varying types of intestinal resection1,7

  • 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:

  • 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, dosing, time to response, and weaning PS.

Adult patients achieved significant reductions in parenteral support (PS) volume with GATTEX1*

2X more patients treated with GATTEX achieved ≥20% reduction in weekly PS volume vs placebo

At 6 months in STEPS study:

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

(P=0.002)

100%

After 30 months, even more patients treated with GATTEX saw the same reduction

Who completed 30 months in STEPS and STEPS-2 studies:

93%
(28/30)
of patients treated with GATTEX achieved ≥20% reduction in weekly PS volume

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

Average weekly PS volume reduction

STEPS: At 6 months (P<0.001)1§

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 1 2 . 4 0 1 2 3 4 5 7 8 9 12 15 18 2 1 2 4 27 10 15 5 0 Pla c e b o ( n=3 9 ) G A TTE X / G A TTE X ( n=3 0 ) M E A N PS V O L UME (L / W E E K ) S TEPS S TEPS - 2 MONTHS 30 6 1 1 . 1 10 . 9 1 1.3 1 1 . 7 1 2 .2 1 2 . 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 1 0 .5 1 1.5

-66%

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

“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 ≥1 day off of PS per week

At 6 months in STEPS study*†:

GATTEX
54% (21/39)
Placebo
23% (9/39)

100%

Who completed 30 months in STEPS and STEPS-2 studies:

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

1 out of 3 adult patients achieved complete freedom from parenteral support (PS)1

Percentage of patients who achieved complete freedom from PS

Who completed 30 months in STEPS and STEPS-2 studies††:

33%
(10/30)
of patients treated with GATTEX weaned off PS completely

Of the 10 patients who achieved complete freedom from PS6:

3 of 10
  • Had resection due to inflammatory bowel disease
  • Did not have colon-in-continuity
7 of 10
  • Had resection due to vascular and other causes
  • Had colon-in-continuity
  • The average duration of treatment to achieve complete freedom from PS was ~20 months (range: ~7 to ~30 months)7
  • No patients completely weaned off of PS in STEPS
  • Not all patients treated with 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.

Peggy, GATTEX Patient

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

Peggy,
GATTEX Patient

How long does it take GATTEX to work?

Time to response for adults 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 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 (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 an ileocecal valve (0%)

Late responders (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 an ileocecal valve (28.6%)

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.

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.

Characteristics of early vs late responders8

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.

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 reactions1
(≥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.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 adult patients receiving GATTEX

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
Colonoscopy1 Examination of the entire colon with removal of 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
Colonoscopy after 1 year of GATTEX* and at least every 5 years1
Examination of the entire colon with removal of 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

*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.

GATTEX Dosing & Administration1

Weight-based Dosing

  • The recommended dosage of GATTEX in 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

Calculation of weight-based 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)

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

To get your appropriate patients started on GATTEX, begin with these steps.

Betsy, GATTEX Patient

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

Betsy,
GATTEX Patient

Weaning parenteral support (PS) while on GATTEX

Once you have decided GATTEX is appropriate for your patient with SBS, it's important to understand the weaning process. Below you will find information on weaning parenteral support (PS), which ranges from IV hydration to total parenteral nutrition (TPN), for patients with SBS. Not every patient will be able to wean completely off of PS. However, reducing the volume or number of days on PS may help patients reach their treatment goals.1

PS is lifesaving for patients with SBS9

When patients achieve and maintain nutrition/hydration goals with an optimal amount of PS (in conjunction with diet and antidiarrheals), there may be some hesitation to change therapy. However, once patients are optimized and stabilized on their individualized plan, they should begin reducing their dependence on PS.9,10

Weaning parenteral support (PS) is a multistep process9,10

Preparation

  • Establish treatment goals for PS reductions, symptom management, and diet/lifestyle modifications
  • Educate patients about their condition and why it’s important to reduce or eliminate PS
  • Inform patients on the importance of their diet, signs of dehydration, and how oral rehydration solutions (ORS) can help
  • Identify and coordinate with a multidisciplinary team (MDT)

Optimization

  • Monitor hydration and nutrition status when adjusting PS and oral fluid intake
  • Optimize medications used to treat SBS symptoms (ie, antidiarrheal, antisecretory, and pain management)
  • Customize diet and use of ORS according to patient characteristics

PS modification and patient monitoring

  • Once patient is optimized, begin reduction of PS volume or frequency (hours or days off)
  • Monitor hydration and nutrition status at regular intervals
  • Adjust medications for SBS symptoms if needed
  • Monitor for electrolyte, nutrient, and vitamin deficiencies, as well as renal function
  • Ensure the patient is increasing oral fluid intake with ORS

Ongoing monitoring

  • Continue to monitor electrolytes as well as mineral and vitamin supplements at regular intervals, as needed
  • Monitor renal function
  • Reassess and establish new goals, as needed
  • Observe patient compliance with diet, ORS, and supplements
  • Monitor weight

Prepare a personalized parenteral support (PS) weaning plan with your patients

Develop the weaning plan based on patient characteristics as well as patients’ treatment goals10

Patients with short bowel syndrome (SBS) differ in age and pathophysiology as well as in duration of parenteral support (PS) and nutritional status. These and other factors can impact weaning success.9,11

Patient characteristics that can positively impact a PS weaning plan9,12

Characteristic Influence on weaning success
Length of
remnant bowel Length of remnant bowel is important and can increase chances of weaning success but ultimately function of bowel is the primary factor
Presence of a colon Allows PS weaning by facilitating fluid and energy absorption
Presence of ileum/ileocecal valve Slows small bowel transit time and may reduce reflux of colonic bacteria into the small intestine
Sufficient bowel adaptation Increases absorption and extends intestinal transit time
Absence of underlying pathology/
disease Patients free of underlying conditions (i.e. Crohn’s disease, radiation enteritis, carcinoma) generally experience more complete PS weaning
Compliance Patient compliance with all therapies (diet, oral rehydration solutions [ORS], antidiarrheal, other medications) can impact weaning success

Include a multidisciplinary team in the
parenteral support (PS) weaning plan

A multidisciplinary team (MDT) can help
ensure a successful weaning process10,13,14

Multidisciplinary care improves outcomes in weaning parenteral support (PS), facilitating enteral autonomy, and reducing complications. To establish an MDT, the first step is to start with a single dedicated physician who will drive the development of the team. This physician will connect with specialists needed to help support the patient. The size of the team may vary, depending on the circumstances. Start by adding a few specialists at a time who can contribute to the success of the patient’s weaning goals.10,13-15

Leading physician*

Assembles team and oversees treatment
strategy

Consulting physicians

(e.g. gastroenterologist (GI), surgeon,
nephrologist, infectious disease doctor)

Home care company

Provides infusion support

Pharmacist

Collaborates with care team on medications
and PS

Specialty pharmacy

Provides PS and GATTEX

Dietitian

Monitors nutrition and hydration

Nurse (PS/Ostomy)

Helps educate patients on PS infusions
and stoma care

Primary care physician

Manages overall health and medical plan

Social worker

Assists patients with challenges and connects
them with the appropriate resources

*While a gastroenterologist is often the leading physician, other physicians could serve in this role as well.

A stepwise, personalized weaning plan should accommodate the patient’s unique needs9,10

Depending on patient characteristics, eliminating PS requirements may not be possible — but patients may still achieve meaningful reductions in parenteral support (PS)
volume and time, with fewer hours/days on PS9,10,16

Clearly defined care protocols should be established for situations such as dehydration or nutritional instability that may require IV fluids or vitamin/mineral/electrolyte supplements and diet adjustment

Patients should have a good understanding of who is part of their multidisciplinary team, their contact information, and how each of them will help during the weaning process10,13-15

Patients need to remain consistent with all therapies (modified diet, ORS, medications, vitamin/mineral/electrolyte supplements, and use of PS and adherence to PS reductions as directed)

Water is not recommended for most patients with SBS.17

Homemade Oral Rehydration Solution

1 quart of ready to drink Gatorade® G2 Low Calorie*

1/2 teaspoon salt

Directions: Add salt to ready to drink Gatorade G2 and shake well.

Note: Potassium levels in this recipe are well below the recommended amount for an ORS

*Gatorade® is a registered trademark of PepsiCo.

Optimization prepares the patient for successful parenteral support (PS) weaning

Optimizing hydration and nutrition prepares the patient for parenteral support (PS) reduction9,10

Patients should be nutritionally stable (ie, meet dry weight, steady calorie and protein intake from all sources) and well hydrated before they begin to wean PS. Therefore, it is recommended that steps be taken to optimize diet, oral fluid intake, and antidiarrheal/antisecretory/pain management medications before starting the weaning process to avoid dehydration and malnutrition.

  • Daily fluid goal (targeting urine output >1 L/day) must be met to ensure adequate hydration
  • Blood and urine samples can be used to evaluate hydration and nutrition

Other measures to consider when optimizing patients for PS weaning

  • Daily caloric intake and weight should be steady before attempting PS weaning
  • Patient should be clinically stable (ie, meet adequate electrolyte levels, fluid status and weight goal) before starting the weaning process

In the STEPS and STEPS-2 studies, PS/IV support was optimized and stabilized prior to randomization1

  • For ≤8 weeks prior to randomization, investigators optimized the PN/IV volume of all patients
  • Optimization was followed by a 4–8 week period of fluid stabilization

Parenteral support (PS) modifications and patient monitoring

In STEPS and STEPS-2 studies, once a patient was optimized and stable, parenteral support (PS) infusions were slowly reduced over time.5,6 Gradual reductions minimize the risk of dehydration and increase the likelihood of weaning success.10

Reductions in PS are often made in one of the following ways9,10:

  • Total infusion volume per week
  • Infusion volume per day
  • Number of infusion days per week
  • Number of infusion hours per day

STEPS and STEPS-2 relied on urine output, but alternative approaches are available9,15

Nutrition-focused physical assessment

Stool output

Oral intake

Electrolyte and micronutrient levels

Body weight

Evaluating weaning in terms of intake, output, and other clinical measures

The overall approach for weaning PS may consider9,10:

  • A patient’s intake (oral, enteral and parenteral support)
  • A patient’s outputs (stool, urine, ostomy, etc.)
  • Regular body weight monitoring
  • Hydration tracked through urine output
  • Lab testing to confirm nutritional needs are met

Discussing the weaning PS process with your patients can help guide an appropriate approach

Monitoring hydration and nutritional stability during and after parenteral support (PS)

After your patient has achieved their PS weaning goal, long-term monitoring of hydration and nutrition status is recommended10

Monitor electrolytes, trace elements, vitamins and minerals

Antidiarrheal medications should be continued and adjusted based on stool volume (stoma), frequency and consistency

Monitor weight for nutritional status

Adequate energy and fluid intake and sustained hydration should be reinforced
at each visit9,10

Ongoing monitoring

Parameters monitored in STEPS study7,18

(Evaluated every 1-4 weeks)

  • Glucose, BUN, creatinine, electrolytes, calcium, magnesium, phosphorous
  • CBC with differential
  • Total bilirubin, direct bilirubin, AP, AST, ALT
  • PTT, PT, INR
  • Triglyceride level
  • Serum proteins (total protein and albumin)
  • Cholesterol
  • GGT
  • LDH
  • Complete urinalysis

Additional parameters to consider monitoring in clinical practice18

Included in ASPEN Consensus Recommendations for monitoring during parenteral nutrition

  • Iron indices
  • Zinc, selenium, manganese, copper, chromium
  • Vitamin A, 25-OH vitamin D, vitamin E
  • Vitamin B12 and folate
  • Carnitine
  • TSH
Fat-soluble vitamins and micronutrients

If a patient cannot maintain adequate hydration or nutrition status after full PS weaning, PS should be restarted

Abbreviations: ALT, alanine aminotransferase; AP, alkaline phosphatase; AST, aspartate aminotransferase; BUN, blood urea nitrogen; CBC, complete blood count; GGT, gamma-glutamyl transferase; INR, international normalized ratio; LDH, lactate dehydrogenase; PN, parenteral nutrition; PT, prothrombin time; PTT, partial thromboplastin time; TSH, thyroid-stimulating hormone.

Eliminating PS requirements is the ultimate goal for all patients with SBS, however reducing the hours per day or days per week on PS can provide substantial benefits.16

More About Weaning PS

Initiate PS Weaning for your appropriate patients with this comprehensive guide

DOWNLOAD PS
WEANING BROCHURE

  1. GATTEX (teduglutide) for injection [package insert]. Cambridge, MA: Takeda Pharmaceuticals U.S.A., Inc.
  2. Tappenden KA et al. J Clin Gastroenterol. 2013;47(7):602-607.
  3. Jeppesen PB et al. Gut. 2005;54(9):1224-1231.
  4. Tavares W et al. Am J Physiol Endocrinol Metab. 2000;278(1):E134-E139.
  5. Jeppesen PB et. al. Gastroenterology. 2012;143(6):1473-1481.e3.
  6. Schwartz LK et al. Clin Transl Gastroenterol. 2016;7:e142. doi:10.1038/ctg.2015.69.
  7. Data on file, Takeda Pharmaceuticals, Inc.
  8. Joly F et al. Poster presented at: United European Gastroenterology Week; October 15-19, 2016; Vienna, Austria. Poster P1619.
  9. DiBaise JK, Matarese LE, Messing B, Steiger E. J Clin Gastroenterol. 2006;40(Suppl 2):S94-S98.
  10. Ukleja A. Gastroenterol Clin North Am. 2019;48(4):525-550.
  11. Hofstetter S et al. Curr Med Res Opin. 2013;29(5):495-504.
  12. Parrish CR. A Patient’s Guide to Managing a Short Bowel. 5th ed. Carol Rees Parrish, MS, RD; 2021
  13. Stanger JD, Oliveira C, Blackmore C, Avitzur Y, Wales PW. J Pediatr Surg. 2013;48(5):983-992.
  14. Matarese LE, Jeppesen PB, O’Keefe SJD. JPEN J Parenter Enteral Nutr. 2014;38(1Suppl):60S-64S.
  15. August D, Teitelbaum D, Albina J, et al. JPEN J Parenter Enteral Nutr. 2002;26(1Suppl):1SA-138SA.
  16. Kelly DG, Tappenden KA, Winkler MF. JPEN J Parenter Enteral Nutr. 2014;38(4):427-437.
  17. Oral Rehydration Solution (ORS) Recipes. oley.org. Accessed September 2021. https://cdn.ymaws.com/oley.org/resource/resmgr/ors_recipes/ORS_recipes_handout.pdf. Updated January 2017.
  18. Worthington P, Balint J, Bechtold M, et al. JPEN J Parenter Enteral Nutr. 2017;41(3):324-377.
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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 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
Intestinal polyps were identified during clinical trials. Postmarketing cases of colorectal, gastric, and small intestinal (duodenum, ileum, and jejunum) polyps have been reported. There is a risk for acceleration of neoplastic growth. In adults, within 6 months prior to starting treatment with GATTEX, perform colonoscopy and an upper gastrointestinal (GI) endoscopy with removal of polyps. A follow-up colonoscopy and upper GI endoscopy (or alternate imaging) is recommended at the end of 1 year of GATTEX. Subsequent colonoscopies and upper GI endoscopies (or alternate imaging) should be performed every 5 years or more often as needed. If a polyp is found, adherence to current polyp follow-up guidelines is recommended.

In pediatric patients, perform fecal occult blood testing within 6 months prior to initiating treatment with GATTEX. If there is new or unexplained blood in the stool, perform colonoscopy/sigmoidoscopy and an upper GI endoscopy. Perform subsequent fecal occult blood testing annually in pediatric patients while they are receiving GATTEX, followed by colonoscopy/sigmoidoscopy and an upper GI endoscopy if there is new or unexplained blood in the stool. Colonoscopy/sigmoidoscopy is recommended for all pediatric patients after 1 year of treatment and at least every 5 years thereafter while on continuous treatment with GATTEX. Consider upper GI endoscopy (or alternate imaging) during treatment with GATTEX.

In adult and pediatric patients who develop active gastrointestinal 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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