Gattex Side Effects

6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Acceleration of Neoplastic Growth [see Warnings and Precautions ( 5.1 )] Intestinal Obstruction [see Warnings and Precautions ( 5.2 )] Biliary and Pancreatic Disease [see Warnings and Precautions ( 5.3 )] Fluid Imbalance and Fluid Overload [see Warnings and Precautions ( 5.4 )] Most common adverse reactions (≥10%) are: abdominal pain, nausea, upper respiratory tract infection, abdominal distension, injection site reaction, vomiting, fluid overload, and hypersensitivity.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals U.S.A., Inc.

at 1-877-TAKEDA-7 (1-877-825-3327) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical Trials Experience Adults Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice.

The rates of adverse reactions in 136 adult patients with SBS participating in two randomized, placebo-controlled, 24-week, double-blind clinical studies (Study 1 and Study 3) are summarized in Table 1 .

Only those reactions with a rate of at least 5% in the GATTEX group, and greater than placebo group, are summarized in Table 1 .

Table 1: Common Adverse Reactions Reported at a rate of at least 5% in the GATTEX group, and greater than the placebo group.

in Adult Patients with SBS in Placebo-Controlled Studies: Studies 1 and 3 Adverse Reaction Placebo (N=59) (%) GATTEX 0.05 mg/kg Once Daily (N=77) (%) Abdominal pain Includes: Abdominal pain, upper abdominal pain, lower abdominal pain 22 30 Nausea 20 23 Upper respiratory tract infection Includes: Upper respiratory tract infection, nasopharyngitis, pharyngitis, sinusitis, laryngitis, rhinitis, viral upper respiratory tract infection 12 21 Abdominal distension 2 20 Injection site reaction 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 12 13 Vomiting 10 12 Fluid Overload Includes: Fluid overload, peripheral edema, edema, generalized edema, fluid retention and jugular vein distension 7 12 Hypersensitivity Includes: Erythema, rash, dermatitis allergic, pruritus, rash macular, drug eruption, eyelid edema, flushing 7 10 Flatulence 7 9 Decreased appetite 3 7 Influenza Includes: Influenza, influenza-like illness 2 7 Skin hemorrhage Includes: Hematoma, abdominal wall hematoma, post procedural hematoma, umbilical hematoma, blood blister 2 5 Cough 0 5 Sleep disturbances Includes: Insomnia (3 patients) and hypersomnia (1 patient) 0 5 Adverse Reactions in the Subset of Patients with a Stoma Among the 53 patients with a stoma in the placebo-controlled studies (Study 1 and Study 3), the percentage of patients with gastrointestinal stoma complication was 42% (13/31) for patients receiving GATTEX 0.05 mg/kg/day and 14% (3/22) for patients receiving placebo.

Pediatric Patients 1 Year to Less Than 17 Years of Age In two clinical studies of 24-week and 12-week duration, 41 pediatric patients aged 1 year to less than 17 years were treated with GATTEX 0.05 mg/kg/day [see Use in Specific Populations ( 8.4 ), Clinical Studies ( 14.2 )] .

Overall, the safety profile of GATTEX was similar to that in adults.