Herceptin Lawsuit

Herceptin Lawsuit

              Herceptin is a trastuzumab Intravenous Infusion Initial and is used for the treatment of adjuvant breast cancer and metastatic breast cancer.

              For adjuvant breast cancer Herceptin is used to treat HER2 over expressing node positive or node negative breast cancer either as a part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and naclitaxel or docetaxel; with docetaxel and carboplatin; or as a single agent following multi-modality anthracycline based therapy.

              For Metastatic breast cancer Herceptin is used in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer or as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease.

              For adjuvant treatment of breast cancer, during and following paclitaxel, docetaxel, or docetaxel/carboplatin, the initial dose should be 4mg/kg as an intravenous infusion over 90 minutes then at 2 mg/kg as an intravenous infusion over 30 minutes weekly during chemotherapy for the first 12 weeks for paclitaxel or docetaxel or 18 weeks for docetaxel and carboplatin. There should be a total of 52 weeks of Herceptin therapy. One week after the last weekly dose of the drug, administer Herceptin at 6 mg/kg as an intravenous infusion over 30-60 minutes every three weeks.

              For adjuvant treatment of breast cancer, as a single agent within three weeks following completion of multi-modality, anthracycline-based chemotherapy regimens, the initial dose should be 8mg/kg as an intravenous infusion over 90 minutes and subsequent doses at 6 mg/kg as an intravenous infusion over 30 minutes every three weeks.

              For metastatic treatment of breast cancer Herceptin should be administered, alone or with paclitaxel, as a 90 minute intravenous infusion at an initial dose of 4mg/kg followed by a subsequent once weekly doses of 2 mg/kg as 30 minute intravenous infusions until disease shows progress.

              Herceptin is provided containing 440mg trastuzumab as lyophilized sterile powder in a multi-use vial under vacuum. Contained in each carton are one vial of Herceptin and one 20mL vial of Bacteriostatic Water for injection. The Bacteriostatic Water(BWIF) contains 1.1% benzyl alcohol as a preservative.

              Herceptin vials are stable at 36-46°F prior to reconstitution and should not be used beyond the displayed expiration date. Once reconstituted with BWIF, a vial of Herceptin is stable for 28 days and should be refridgerated at 36-46°F. Any remaining multi-dose reconstituted solution should be discarded after 28 days. Herceptin vails should be stored at 36-46°F for no more than 24 hours prior to use if the solution of Herceptin for infusion is diluted in polyvinylchloride or polyethylene bags containing 0.9% Sodium Chloride Injection.

              Herceptin is a mediator of antibody-dependent cellular cytotoxicity (ADCC) and has been shown to be preferentially exerted on HER2 overexpressing cancer cells compared with cancer cells that do not overexpress HER2.

              Reproductive toxicology studies that have been conducted in cynomolgus monkeys at doses up to 25 times the weekly recommended human dose of 2 mg/kg Herceptin have revealed no evidence of impaired fertility or harm to the fetus.

              Some of the most common side effects and adverse reactions associated with Herceptin include:

Fever
Nausea
Vomiting
infusion reactions
diarrhea
infections
increased cough
headache
fatigue
dyspnea
rash
neutropenia
anemia
myalgia
             

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