harmacology (12.1) and Nonclinical Toxicology (13.1)]
Colorectal Polyps
Colorectal polyps were identified during the clinical trials. Colonoscopy of the entire colon with removal of polyps should be done within 6 months prior to starting treatment with GATTEX. A follow-up colonoscopy (or alternate imaging) is recommended at the end of 1 year of GATTEX. Subsequent colonoscopies should be done every 5 years or more often as needed. If a polyp is found, adherence to current polyp follow-up guidelines is recommended. In case of diagnosis of colorectal cancer, GATTEX therapy should be discontinued. [see Adverse Reactions (6.1)]
Small Bowel Neoplasia
Based on benign tumor findings in the rat carcinogenicity study, patients should be monitored clinically for small bowel neoplasia. If a benign neoplasm is found, it should be removed. In case of small bowel cancer, GATTEX therapy should be discontinued. [see Nonclinical Toxicology (13.1)]
Intestinal Obstruction
Intestinal obstruction has been reported in clinical trials. In patients who develop intestinal or stomal obstruction, GATTEX should be temporarily discontinued while the patient is clinically managed. GATTEX may be restarted when the obstructive presentation resolves, if clinically indicated. [see Adverse Reactions (6.1)]
Biliary and Pancreatic Disease
Gallbladder and Biliary Tract Disease
Cholecystitis, cholangitis, and cholelithiasis, have been reported in clinical studies. For identification of the onset or worsening of gallbladder/biliary disease, patients should undergo laboratory assessment of bilirubin and alkaline phosphatase within 6 months prior to starting GATTEX, and at least every 6 months while on GATTEX; or more frequently if needed. If clinically meaningful changes are seen, further eva luation including imaging of the gallbladder and/or biliary tract is recommended; and the need for continued GATTEX treatment should be reassessed. [see Adverse Reactions (6.1)]
Pancreatic Disease
Pancreatitis has been reported in clinical studies. For identification of onset or worsening of pancreatic disease, patients should undergo laboratory assessment of lipase and amylase within 6 months prior to starting GATTEX, and at least every 6 months while on GATTEX; or more frequently if needed. If clinically meaningful changes are seen, further eva luation such as imaging of the pancreas is recommended; and the need for continued GATTEX treatment should be reassessed. [see Adverse Reactions (6.1) and Nonclinical Toxicology (13.1)]
Fluid Overload
Fluid overload and congestive heart failure have been observed in clinical trials, which were felt to be related to enhanced fluid absorption associated with GATTEX. If fluid overload occurs, parenteral support should be adjusted and GATTEX treatment should be reassessed, especially in patients with underlying cardiovascular disease. If significant cardiac deterioration develops while on GATTEX, the need for continued GATTEX treatment should be reassessed. [see Adverse Reactions (6.1) ]
Increased Absorption of Concomitant Oral Medication
Altered mental status in association with GATTEX has been observed in patients on benzodiazepines in clinical trials. Patients on concomitant oral drugs (e.g., benzodiazepines, phenothiazines) requiring titration or with a narrow therapeutic index may require dose adjustment while on GATTEX. [see Adverse Reactions (6.2)]
Adverse Reactions
Clinical Trials |
