WHAT ARE THE SIDE EFFECTS OF GATTEX® (teduglutide)?
Possible GATTEX Side Effects
GATTEX may cause side effects in adults, adolescents, and children. If you have any questions about side effects, whether before or during treatment, talk to your or your child’s care team.
Common side effects associated with GATTEX
GATTEX may cause serious side effects including making abnormal cells grow faster, polyps in the intestines, blockage of the bowel (intestines), swelling (inflammation) or blockage of your gallbladder or pancreas, and fluid overload.
In clinical studies of adults, the most common (≥10%) side effects of GATTEX were:
- stomach area (abdomen) pain or swelling
- nausea
- cold or flu symptoms
- skin reaction where the injection was given
- vomiting
- swelling of the hands or feet
- allergic reactions
Common side effects* in adult patients with SBS in 2 clinical studies
GATTEX
(77 people)
Placebo
(59 people)
If you experience any side effects, check in with your doctor. Continue taking GATTEX as long as your doctor recommends and work together to understand treatment expectations.
* Reported at a rate of at least 5% in the GATTEX group, and greater than the placebo group.
1 Includes: Abdominal pain, upper abdominal pain, lower abdominal pain
2 Includes: Upper respiratory tract infection, nasopharyngitis, pharyngitis, sinusitis, laryngitis, rhinitis, viral upper respiratory tract infection
3 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
4 Includes: Fluid overload, peripheral edema, edema, generalized edema, fluid retention and jugular vein distension
5 Includes: Erythema, rash, dermatitis allergic, pruritus, rash macular, drug eruption, eyelid edema, flushing
6 Includes: Influenza, influenza-like illness
7 Includes: Hematoma, abdominal wall hematoma, post procedural hematoma, umbilical hematoma, blood blister
8 Includes: Insomnia (3 patients) and hypersomnia (1 patient)
Common side effects in children and adolescents
The safety of GATTEX has been studied in 41 children with short bowel syndrome (SBS) across 2 clinical studies.* The side effects seen in children and adolescents (aged 1 to 17 years) were similar to those seen in adults.
* This includes pediatric patients from a 3-month study that was conducted with GATTEX.