GATTEX Has a Demonstrated Safety Profile in Adult Patients1

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 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 Adult Patients Receiving GATTEX

Within 6 months prior to starting GATTEX treatment1:

  • Perform a colonoscopy and an upper gastrointestinal (GI) endoscopy with removal of polyps1
  • Obtain baseline laboratory assessments (bilirubin, alkaline phosphatase, lipase, and amylase)1
Monitoring timeline Ongoing/As needed Every 6 months After 1 year of GATTEX At least every 5 years
Colonoscopy and upper GI endoscopy (or alternate imaging)*
  • 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

*Follow-up colonoscopy and upper GI endoscopy (or alternate imaging) is recommended at the end of 1 year of treatment with GATTEX. If no polyp is found, subsequent colonoscopies and upper GI endoscopies (or alternate imaging) should be done no less frequently than every 5 years. If a polyp is found, adherence to current polyp follow-up guidelines is recommended.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