t, patients should fully understand the risks and benefits of GATTEX. Ensure that all patients receive the Medication Guide prior to initiating GATTEX therapy.
Acceleration of Neoplastic Growth
Advise patients with active gastrointestinal malignancy (GI tract, hepatobiliary, pancreatic), that GATTEX therapy should be discontinued. In patients with active non-gastrointestinal malignancy, the clinical decision to continue GATTEX should be discussed with patients and be made based on risk-benefit considerations. [see Clinical Pharmacology (12.1) and Nonclinical Toxicology (13.1)]
Colorectal polyps.
Advise patients that 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.
Advise patients that they 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
Advise patients to tell their physician if they experience any signs or symptoms suggestive of intestinal obstruction. If obstruction is present, the physician may temporarily discontinue GATTEX. [see Warnings and Precautions (5.2)]
Gallbladder and Bile Duct Disease
Advise patients that laboratory assessments should be done before and then every 6 months while on GATTEX to monitor gallbladder and biliary function. If clinically significant change occurs, further eva luation (i.e., imaging studies or other) may be necessary. Advise patients to report to their physician all signs and symptoms suggestive of cholecystitis, cholangitis, or cholelithiasis while on GATTEX. [see Warnings and Precautions (5.3)]
Pancreatic Disease
Advise patients that laboratory assessments should be done before and then every 6 months while on GATTEX. If clinically significant change occurs, further eva luation (i.e., imaging studies or other) may be necessary. Advise patients to report to their physician all signs and symptoms suggestive of pancreatic disease while on GATTEX. [see Warnings and Precautions (5.3)]
Cardiovascular Disease
Advise patients with cardiovascular disease to report to their physician any signs of fluid overload or cardiac decompensation while on GATTEX. [see Warnings and Precautions (5.4)]
Risks Resulting from Increased Absorption of Concomitant Oral Medication
Instruct patients to report to all of their physicians any concomitant oral medications that they are taking in order to assess any potential for increased absorption during GATTEX treatment of those oral medications requiring titration or with a narrow therapeutic index. [see Warnings and Precautions (5.5)]
Instructions
Inform patients that GATTEX should not be administered intravenously or intramuscularly. The drug should be used for subcutaneous injection within 3 hours after reconstitution. Advise patients that subcutaneous administration has been associated with injection site reactions, but if they experience a severe reaction i |
