er a one-vial kit or a 30-vial kit. The one-vial kit is pre-assembled and ready to be used. The 30-vial kit is to be assembled by a pharmacist with the following two cartons:
Carton of Drug Vials (NDC 68875-0101-2):
Thirty single-use vials of drug (NDC 68875-0101-1)
Carton of Ancillary Supplies:
Thirty disposable prefilled syringes containing diluent (0.5 mL Sterile Water for Injection USP) for reconstitution
Thirty separate needles (22G x 1½ in) to attach to the syringes for reconstitution
Thirty sterile disposable 1-mL syringes with needle (26G x 5/8 in)
Sixty alcohol swabs
The pharmacist in a dispensing pharmacy will assemble a 30-vial kit by transferring the trays containing 30 vials from a Carton of Drug Vials into a Carton of Ancillary Supplies. The final patient kits should contain the items listed as follows:
30-vial kit (NDC 68875-0102-1):
Thirty single-use vials of drug (NDC 68875-0101-1)
Thirty disposable prefilled syringes containing 0.5 mL Sterile Water for Injection USP for reconstitution, with 30 separate needles (22G x 1½ in) to attach to the syringes
Thirty sterile disposable 1-mL syringes with needle (26G x 5/8 in) for dosing
Sixty alcohol swabs
One-vial kit (NDC 68875-0103-1):
One single-use vial of drug (NDC 68875-0101-1)
One disposable prefilled syringe containing 0.5 mL Sterile Water for Injection USP for reconstitution, with a separate needle (22G x 1½ in) to attach to the syringe
One sterile disposable 1-mL syringe with needle (26G x 5/8 in) for dosing
Four alcohol swabs
Reconstitution with 0.5 mL of preservative-free Sterile Water for Injection, provided in a prefilled syringe, is required prior to subcutaneous administration of the drug. Reconstituted GATTEX is a sterile, clear, colorless to light straw-colored 10 mg/mL solution, which should be free from particulates. Upon reconstitution with the 0.5 mL Sterile Water for Injection provided in the prefilled syringe, a maximum of 0.38 mL of the reconstituted solution which contains 3.8 mg of teduglutide can be withdrawn from the vial for dosing.
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.
Patient Counseling Information
See FDA-approved patient labeling (Medication Guide and Instructions for Use).
General Counseling Information – Prior to treatmen |
