It is a HER2/neu receptor antagonist indicated for: ? the treatment of HER2 overexpressing breast cancer . ? the treatment of HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma
The HER2 (or c-erbB2) proto-oncogene encodes a transmembrane receptor protein of 185 kDa, which is structurally related to the epidermal growth factor receptor. Trastuzumab has been shown, in both in vitro assays and in animals, to inhibit the proliferation of human tumor cells that overexpress HER2. Trastuzumab is a mediator of antibody-dependent cellular cytotoxicity (ADCC). In vitro, Trastuzumab-mediated ADCC has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2.
For intravenous (IV) infusion only. Do not administer as an IV push or bolus (5.2). Adjuvant Treatment of HER2-Overexpressing Breast Cancer Administer at either: ? Initial dose of 4 mg/kg over 90 minute IV infusion,then 2 mg/kg over 30 minute IV infusion weekly for 52 weeks,or ? Initial dose of 8 mg/kg over 90 minutes IV infusion,then 6 mg/kg over 30?90 minutes IV infusion every three weeks for 52 weeks. Metastatic HER2-Overexpressing Breast Cancer . ? Initial dose of 4 mg/kg as a 90 minute IV infusion followed by subsequent weekly doses of 2 mg/kg as 30 minute IV infusions. Metastatic HER2-overexpressing Gastric Cancer . ? Initial dose of 8 mg/kg over 90 minutes IV infusion,followed by 6 mg/kg over 30 to 90 minutes IV infusion every 3 weeks.
Patients who receive anthracycline after stopping Trastuzumab may be at increased risk of cardiac dysfunction because of Trastuzumab’s long washout period based on population PK analysis. If possible, physicians should avoid anthracycline-based therapy for up to 7 months after stopping Trastuzumab. If anthracyclines are used, the patient’s cardiac function should be monitored carefully.
Adjuvant Breast Cancer ? Most common side effects (?5%) are headache,diarrhea,nausea,and chills. Metastatic Breast Cancer ? Most common side effectss (> 10%) are fever,chills,headache, infection,congestive heart failure,insomnia,cough,and rash. Metastatic Gastric Cancer ? Most common side effects (?10%) are neutropenia,diarrhea,fatigue, anemia,stomatitis,weight loss,upper respiratory tract infections,fever, thrombocytopenia,mucosal inflammation,nasopharyngitis,and dysgeusia.
Nursing Mothers: Discontinue nursing or discontinue It.Pregnancy Category D. There is positive evidence of human foetal risk,but the benefits from use in pregnant women may be acceptable despite the risk (e.g.,if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).
There is no experience with overdosage in human clinical trials. Single doses higher than 8 mg/kg
have not been tested
Store the vial in original carton at 2°-8°C. Protect from light. Keep out of the reach of children. Store reconstituted Trastuzumab in the refrigerator at 2°C to 8°C, discard unused Trastuzumab after 28 days. If Trastuzumab is reconstituted with SWFI without preservative, use immediately and discard any unused portion. Do not freeze. The solution of Trastuzumab for infusion diluted in 0.9% Sodium Chloride Injection, USP, should be stored at 2°C to 8°C for no more than 24 hours prior to use. Do not freeze.
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