Monograph Details
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Neoplasms
> Monoclonal antibodies
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HERCEPTIN |
| Manufacturer |
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Genentech, Inc. |
| Legal Classification |
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Rx
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| Pharmacological Class |
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Human epidermal growth factor receptor (HER2) inhibitor. |
| Generic Name |
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Trastuzumab 440mg/vial; lyophilized pwd for IV infusion after reconstitution and dilution; preservative-free. |
| Indications |
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HER2-expressing 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-expressing, 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). |
| Children |
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Not recommended. |
| Adults |
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Give as IV infusion. Metastatic breast cancer: 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 30–60 minutes every 3 weeks. Following multi-modality anthracycline based therapy: initially 8mg/kg over 90 minutes, then 6mg/kg over 30 minutes every 3 weeks. Infusion reactions or cardiomyopathy: see literature. |
| Precautions |
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Test for HER2 protein overexpression. 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. Monitor cardiac function at baseline, every 3 months during and after therapy. Elderly. Pregnancy (Cat.D); use adequate contraception during and at least 6 months after therapy. Nursing mothers: not recommended. |
| Interactions |
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Increased toxicity with other myelosuppressives. Potentiated by paclitaxel. |
| Adverse Reactions |
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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). |
| Extra Text |
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Note: Enroll pregnant women with breast cancer who are using trastuzumab in the Cancer and Childbirth Registry (800) 690-6720. |
| How Supplied |
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Vial—1 (w. diluent) |
| Additional Resources |
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• Related Prescribing Note |
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