JoJo
09-23-2004, 04:21 AM
Excerpt from www.herceptin.com:
DOSAGE AND ADMINISTRATION Usual Dose The recommended initial loading dose is 4 mg/kg Trastuzumab administered as a 90-minute infusion. The recommended weekly maintenance dose is 2 mg/kg Trastuzumab and can be administered as a 30-minute infusion if the initial loading dose was well tolerated. HERCEPTIN may be administered in an outpatient setting. HERCEPTIN is to be diluted in saline for IV infusion. DO NOT ADMINISTER AS AN IV PUSH OR BOLUS.
Preparation for Administration The diluent provided has been formulated to maintain the stability and sterility of HERCEPTIN for up to 28 days. Other diluents have not been shown to contain effective preservatives for HERCEPTIN. Each vial of HERCEPTIN should be reconstituted with 20 mL of BWFI, USP, 1.1% benzyl alcohol preserved, as supplied, to yield a multi-dose solution containing 21 mg/mL Trastuzumab. Immediately upon reconstitution with BWFI, the vial of HERCEPTIN must be labeled in the area marked "Do not use after:" with the future date that is 28 days from the date of reconstitution.
If the patient has known hypersensitivity to benzyl alcohol, HERCEPTIN must be reconstituted with Sterile Water for Injection (see PRECAUTIONS). HERCEPTIN WHICH HAS BEEN RECONSTITUTED WITH SWFI MUST BE USED IMMEDIATELY AND ANY UNUSED PORTION DISCARDED. USE OF OTHER RECONSTITUTION DILUENTS SHOULD BE AVOIDED.
Shaking the reconstituted HERCEPTIN or causing excessive foaming during the addition of diluent may result in problems with dissolution and the amount of HERCEPTIN that can be withdrawn from the vial.
DOSAGE AND ADMINISTRATION Usual Dose The recommended initial loading dose is 4 mg/kg Trastuzumab administered as a 90-minute infusion. The recommended weekly maintenance dose is 2 mg/kg Trastuzumab and can be administered as a 30-minute infusion if the initial loading dose was well tolerated. HERCEPTIN may be administered in an outpatient setting. HERCEPTIN is to be diluted in saline for IV infusion. DO NOT ADMINISTER AS AN IV PUSH OR BOLUS.
Preparation for Administration The diluent provided has been formulated to maintain the stability and sterility of HERCEPTIN for up to 28 days. Other diluents have not been shown to contain effective preservatives for HERCEPTIN. Each vial of HERCEPTIN should be reconstituted with 20 mL of BWFI, USP, 1.1% benzyl alcohol preserved, as supplied, to yield a multi-dose solution containing 21 mg/mL Trastuzumab. Immediately upon reconstitution with BWFI, the vial of HERCEPTIN must be labeled in the area marked "Do not use after:" with the future date that is 28 days from the date of reconstitution.
If the patient has known hypersensitivity to benzyl alcohol, HERCEPTIN must be reconstituted with Sterile Water for Injection (see PRECAUTIONS). HERCEPTIN WHICH HAS BEEN RECONSTITUTED WITH SWFI MUST BE USED IMMEDIATELY AND ANY UNUSED PORTION DISCARDED. USE OF OTHER RECONSTITUTION DILUENTS SHOULD BE AVOIDED.
Shaking the reconstituted HERCEPTIN or causing excessive foaming during the addition of diluent may result in problems with dissolution and the amount of HERCEPTIN that can be withdrawn from the vial.