ted solution which contains 3.8 mg of teduglutide can be withdrawn from the vial for dosing.
16.2 Storage and Handling
Prior to Dispensing: Store refrigerated at 2°C to 8°C (36°F to 46°F) for Cartons of Drug Vials and the One-vial kits. Do not freeze. Do not use beyond the expiration date on the label. Store at room temperature up to 25°C (77°F) for the Cartons of Ancillary Supplies.
Instruction for the Pharmacist:
Prior to Dispensing: Store at 2°C to 8°C (36°F to 46°F) for Cartons of Drug Vials and the One-vial kits. Do not freeze.
Dispensing Instructions: Dispense with a 90-day "use by" dating and specify "Store at room temperature up to 25°C (77°F). Do not freeze." Dispense Medication Guide to each patient.
Reconstituted GATTEX is a sterile, clear, colorless to light straw-colored solution, which should be free from particulates. The drug should be completely dissolved before the solution is withdrawn from the vial. Do not shake or freeze the reconstituted solution. If the product remains undissolved after the second attempt, do not use. GATTEX does not contain any preservatives and is for single-use only. Any unused portion should be discarded. The product should be used within 3 hrs after reconstitution.
17 PATIENT COUNSELING INFORMATION
See FDA-approved patient labeling (Medication Guide and Instructions for Use).
General Counseling Information – Prior to treatment, patients should fully understand the risks and benefits of GATTEX. Ensure that all patients receive the Medication Guide prior to initiating GATTEX therapy.
17.1 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)]
17.2 Intestinal ObstructionAdvise patients to tell their physician if they experience any signs or symptoms suggestive of intestinal obstruction. If obstruction is present, the physician should temporarily discontinue GATTEX. [see Warnings and Precautions (5.2)]
17.3 Gallbladder and Bile Duct DiseaseAdvise 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 an |
