Generic Name and Formulations:
Trastuzumab 440mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free.
Company:
Genentech, Inc.
HER2-overexpressing metastatic breast cancer as a single agent in patients who have received one or more chemotherapy regimens; or in combination with paclitaxel in patients who have not received chemotherapy. Adjuvant treatment in HER2-overexpressing, node-positive or node-negative breast cancer (as a single agent following multi-modality anthracycline based therapy; in combination with doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; or in combination with docetaxel and carboplatin).
Give as IV infusion. Initially 4mg/kg over 90 minutes, followed by 2mg/kg over 30 minutes weekly; administer until tumor progression. Adjuvant treatment (administer trastuzumab weekly for 52 weeks); In combination therapy: with doxorubicin and cyclophosphamide, followed by either paclitaxel or docetaxel; or with docetaxel/carboplatin: initially 4mg/kg over 90 minutes, followed by 2mg/kg over 30 minutes once weekly for the 1st 12 weeks (concurrently w. paclitaxel or docetaxel) or 1st 18 weeks (concurrently w. docetaxel/carboplatin). One week after the last trastuzumab weekly dose, give trastuzumab 6mg/kg over 30–90 minutes every 3 weeks. Following multi-modality anthracycline based therapy: initially 8mg/kg over 90 minutes, then 6mg/kg over 30–90 minutes every 3 weeks. Infusion reactions or cardiomyopathy: see literature.
Not recommended.
Human epidermal growth factor receptor (HER2) inhibitor.
Increased risk of cardiomyopathy. Conduct cardiac assessment (eg, history, physical exam, LVEF) at baseline, every 3 months during and after therapy; repeat LVEF at 4 week intervals if dose is withheld due to significant left ventricular cardiac dysfunction. Interrupt therapy if dyspnea or significant hypotension occurs; consider discontinuing permanently if severe infusion reactions, CHF, pulmonary toxicity, or significant left ventricular myocardial dysfunction develops. Symptomatic intrinsic lung disease. Extensive tumor involvement of the lungs. Test for HER2 protein overexpression and HER2 gene amplification using FDA-approved tests for specific tumor type (breast or gastric/gastroesophageal adenocarcinoma). Elderly. Pregnancy (Cat.D); use adequate contraception during and at least 6 months after therapy. Nursing mothers: not recommended.
Increased cardiomyopathy with anthracycline-containing chemotherapy. Increased toxicity with other myelosuppressives. Potentiated by paclitaxel.
Fever, GI upset, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, myalgia, thrombosis/embolism; severe infusion reactions, febrile neutropenia/exacerbation of chemotherapy-induced neutropenia, pulmonary toxicity (eg, interstitial pneumonitis), cardiomyopathy (eg, left ventricular myocardial dysfunction); pregnant women (2nd & 3rd trimesters): possible oligohydramnios (monitor).
Enroll pregnant women with breast cancer who are using trastuzumab in the Cancer and Childbirth Registry (800) 690-6720.
Testing considerations: HER2 protein overexpression
Vial—1 (w. diluent)
HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, in combination with cisplatin and capecitabine or 5-fluorouracil, in patients who have not received prior treatment.
Give as IV infusion. Initially 8mg/kg over 90 minutes, followed by 6mg/kg over 30–90 minutes every 3 weeks until disease progression. Infusion reactions or cardiomyopathy: see literature.
Not recommended.
Human epidermal growth factor receptor (HER2) inhibitor.
Increased risk of cardiomyopathy. Conduct cardiac assessment (eg, history, physical exam, LVEF) at baseline, every 3 months during and after therapy; repeat LVEF at 4 week intervals if dose is withheld due to significant left ventricular cardiac dysfunction. Interrupt therapy if dyspnea or significant hypotension occurs; consider discontinuing permanently if severe infusion reactions, CHF, pulmonary toxicity, or significant left ventricular myocardial dysfunction develops. Symptomatic intrinsic lung disease. Extensive tumor involvement of the lungs. Test for HER2 protein overexpression and HER2 gene amplification using FDA-approved tests for specific tumor type (breast or gastric/gastroesophageal adenocarcinoma). Elderly. Pregnancy (Cat.D); use adequate contraception during and at least 6 months after therapy. Nursing mothers: not recommended.
Increased cardiomyopathy with anthracycline-containing chemotherapy. Increased toxicity with other myelosuppressives. Potentiated by paclitaxel.
Fever, GI upset, infections, stomatitis, weight loss, upper respiratory tract infections, thrombocytopenia, mucosal inflammation, nasopharyngitis, dysgeusia, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, myalgia, thrombosis/embolism; severe infusion reactions, febrile neutropenia/exacerbation of chemotherapy-induced neutropenia, pulmonary toxicity (eg, interstitial pneumonitis), cardiomyopathy (eg, left ventricular myocardial dysfunction); pregnant women (2nd & 3rd trimesters): possible oligohydramnios (monitor).
Testing considerations: HER2 protein overexpression
Vial—1 (w. diluent)