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Dosing and Administration
Herceptin should be administered for a total of 52 weeks using one of the regimens listed below:
TCH Regimen1
AC-->TH Regimen1
Herceptin Monotherapy Regimen
In this regimen, Herceptin is administered as a single agent once every three weeks, beginning after the completion of surgery and chemotherapy with or without radiotherapy. Hormonal therapy may be given concurrently with Herceptin.
Dosage Calculation1
The recommended dosages of Herceptin are based on patient body weight. To determine the correct number of milligrams of Herceptin needed for a given patient:
Reconstitution1
- Reconstitution with 20 mL of the supplied BacteriostaticWater for Injection (BWFI), USP, containing 1.1% benzyl alcohol as a preservative, yields a multidose solution containing 21 mg/mL trastuzumab at a pH of approximately 6
- Keep the multidose solution refrigerated at 2ºC-8ºC (36ºF-46ºF).When reconstituted with BWFI, the multidose solution may be used for 28 days when stored at 2ºC-8ºC (36ºF-46ºF). DO NOT FREEZE OR SHAKE RECONSTITUTED SOLUTION
- If the patient has known sensitivity to benzyl alcohol, Herceptin must be reconstituted with SterileWater for Injection (SWFI) (see DOSING AND ADMINISTRATION in accompanying full Prescribing Information)
HERCEPTIN THAT HAS BEEN RECONSTITUTED WITH SWFI MUST BE USED IMMEDIATELY AND ANY UNUSED PORTION DISCARDED. USE OF OTHER RECONSTITUTION DILUENTS SHOULD BE AVOIDED.
- Add calculated amount of reconstituted Herceptin solution to 250 mL of 0.9% Sodium Chloride Injection, USP. DO NOT USE DEXTROSE (5%) SOLUTION
Additional Administration Information1
- Herceptin may be given in an outpatient setting
- DO NOT ADMINISTER AS AN IV PUSH OR BOLUS
- DO NOT MIX HERCEPTIN WITH OTHER DRUGS
- During the first infusion with Herceptin, a symptom complex most commonly consisting of chills and/or fever was observed in about 40%of patients in clinical trials
- The symptoms were usually mild to moderate in severity and were treated with acetaminophen, diphenhydramine, and meperidine (with or without reduction in the rate of Herceptin infusion)