GATTEX® Pediatric Safety Data for HCPs

GATTEX Has a Demonstrated Safety Profile in Pediatric Patients¹

In 2 clinical studies, 41 pediatric patients were treated with GATTEX 0.05 mg/kg/day

Overall, the safety profile of GATTEX in pediatric patients ≥1 year was similar to that in adults¹
The 41 patients included 1 infant (1 year to less than 2 years), 37 children (2 years to less than 12 years), and 3 adolescents (12 years to less than 17 years)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 adults (%)¹

Most common adverse reactions in adults (%)¹ (≥5% in the GATTEX 0.05 mg/kg/day group, and greater than in the placebo group)	Placebo (n=59)	GATTEX (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 physician¹
Among the 53 patients with stoma in the placebo-controlled studies, 42% (13/31) of patients with gastrointestinal stoma complication received GATTEX 0.05 mg/kg/day and 14% (3/22) received placebo¹

* 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, 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

Within 6 months prior to starting GATTEX treatment¹:

Perform fecal occult blood testing; if there is unexplained blood in the stool, perform colonoscopy/sigmoidoscopy and an upper GI endoscopy¹
Obtain baseline laboratory assessments (bilirubin, alkaline phosphatase, lipase, and amylase)¹

Monitoring timeline	Ongoing/ as needed	Every 6 months	After 1 year of GATTEX*	Every year	At least every 5 years
Fecal occult blood test Examine for unexplained blood in stool
Colonoscopy/Sigmoidoscopy^†† Assess for intestinal polyps
Upper GI endoscopy^‡‡ Assess for intestinal polyps
Laboratory assessments Bilirubin Alkaline phosphatase Lipase Amylase
Clinical evaluations Signs and symptoms of intestinal obstruction Signs and symptoms of fluid imbalance and fluid overload Increased absorption of concomitant medication(s) Observation of other adverse events

††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

‡‡Consider upper GI endoscopy (or alternate other imaging) during treatment with GATTEX. If there is new or unexplained blood in the stool, perform colonoscopy/sigmoidoscopy and an upper GI endoscopy.¹

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

See how to help get pediatric patients started on GATTEX here

Pediatric Study MOA

Connect With Us

Connect to the latest GATTEX information by speaking one-on-one with a Rep or signing up
to receive GATTEX resources to help deliver more information to your patients with SBS.

Get in Touch

Get In Touch

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.

Reference: 1. GATTEX (teduglutide) for injection [package insert]. Cambridge, MA: Takeda Pharmaceuticals U.S.A., Inc.