|FDA Approved For:
|HERCEPTIN as a single agent is indicated for the treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have received one or more chemotherapy regimens for their metastatic disease. HERCEPTIN in combination with paclitaxel is indicated for treatment of patients with metastatic breast cancer whose tumors overexpress the HER2 protein and who have not received chemotherapy for their metastatic disease. HERCEPTIN should only be used in patients whose tumors have HER2 protein overexpression. (See CLINICAL STUDIES: HER2 protein overexpression for information regarding HER2 protein testing and the relationship between the degree of overexpression and the treatment effect.)
|The safety and effectiveness of HERCEPTIN in pediatric patients have not been established.
|HERCEPTIN has not been tested for its carcinogenic potential.
|No evidence of mutagenic activity was observed in Ames tests using six different test strains of bacteria, with and without metabolic activation, at concentrations of up to 5000 ?g/mL Trastuzumab. Human peripheral blood lymphocytes treated i nv i t r o at concentrations of up to 5000 g/plate Trastuzumab, with and without metabolic activation, revealed no evidence of mutagenic potential. In an i nv i v o mutagenic assay (the micronucleus assay), no evidence of chromosomal damage to mouse bone marrow cells was observed following bolus intravenous doses of up to 118 mg/kg Trastuzumab.
|Manufacturer and/or Distributor:
A total of 958 patients have received HERCEPTIN alone or in combination with chemotherapy. Data in the table below are based on the experience with the recommended dosing regimen for HERCEPTIN in the randomized controlled clinical trial in 234 patients who received HERCEPTIN in combination with chemotherapy and four open-label studies of HERCEPTIN as a single agent in 352 patients at doses of 10–500 mg administered weekly. Cardiac Failure/Dysfunction: For a description of cardiac toxicities, see WARNINGS. Anemia and Leukopenia: An increased incidence of anemia and leukopenia was observed in the treatment group receiving HERCEPTIN and chemotherapy, especially in the HERCEPTIN and ACsubgroup, compared with the treatment group receiving chemotherapy alone. The majority of these cytopenic events were mild or moderate in intensity, reversible, and none resulted in discontinuation of therapy with HERCEPTIN. Hematologic toxicity is infrequent following the administration of HERCEPTIN as a single agent, with an incidence of Grade III toxicities for WBC, platelets, hemoglobin all<1%. No Grade IV toxicities were observed. Diarrhea : Of patients treated with HERCEPTIN as a single agent, 25% experienced diarrhea. An increased incidence of diarrhea, primarily mild to moderate in severity, was observed in patients receiving HERCEPTIN in combination with chemotherapy. Infection: An increased incidence of infections, primarily mild upper respiratory infections of minor clinical significance or catheter infections, was observed in patients receiving HERCEPTIN in combination with chemotherapy. Infusion-Associated Symptoms: During the first infusion with HERCEPTIN, a symptom complex most commonly consisting of chills and/or fever was observed in about 40% of patients. 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). HERCEPTIN discontinuation was infrequent. Other signs and/or symptoms may include nausea, vomiting, pain (in some cases at tumor sites), rigors, headache, dizziness, dyspnea, hypotension, rash, and asthenia. The symptoms occurred infrequently with subsequent HERCEPTIN infusions. Table 4 Other serious adverse events The following other serious adverse events occurred in at least one of the 958 patients treated with HERCEPTIN (Trastuzumab): Body as a Whole: cellulitis, anaphylactoid reaction, ascites, hydrocephalus, radiation injury, deafness, amblyopia Cardiovascular: vascular thrombosis, pericardial effusion, heart arrest, hypotension, syncope, hemorrhage, shock arrhythmia Digestive : hepatic failure, gastroenteritis, hematemesis, ileus, intestinal obstruction, colitis, esophageal ulcer, stomatitis, pancreatitis, hepatitis Endocrine: hypothyroidism Hematological: pancytopenia, acute leukemia, coagulation disorder, lymphangitis Metabolic : hypercalcemia, hypomagnesemia, hyponatremia, hypoglycemia, growth retardation, weight loss Musculoskeletal: pathological fractures, bone necrosis, myopathy Nervous: convulsion, ataxia, confusion, manic reaction Respiratory: apnea, pneumothorax, asthma, hypoxia, laryngitis Skin: herpes zoster, skin ulceration Urogenital : hydronephrosis, kidney failure, cervical cancer, hematuria, hemorrhagic cystitis, pyelonephritis )More Information