In post-marketing reports, use of Herceptin during pregnancy resulted in cases of oligohydramnios and of oligohydramnios sequence, manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death [see Data]. Monitor women who received Herceptin during pregnancy or within 7 months prior to conception for oligohydramnios. As with all therapeutic proteins, there is a potential for immunogenicity. Among the 464 patients treated in Study 5, the median age was 52 years (range: 25–77 years). Do not administer as an intravenous push or bolus. Herceptin can also cause asymptomatic decline in left ventricular ejection fraction (LVEF). Found inside – Page 74Herceptin (Trastuzumab) anti-HER2 monoclonal antibody: product package insert, Genentech, Inc. South San Francisco, CA, copyright September, 1998. Among 64 patients receiving adjuvant chemotherapy (Studies 1 and 2) who developed congestive heart failure, one patient died of cardiomyopathy, one patient died suddenly without documented etiology, and 33 patients were receiving cardiac medication at last follow-up. For those who had received prior anthracycline therapy in the adjuvant setting, chemotherapy consisted of paclitaxel (175 mg/m2 over 3 hours every 21 days for at least six cycles); for all other patients, chemotherapy consisted of anthracycline plus cyclophosphamide (AC: doxorubicin 60 mg/m2 or epirubicin 75 mg/m2 plus 600 mg/m2 cyclophosphamide every 21 days for six cycles). Additional predicted trastuzumab exposure and PK parameters following the first Herceptin cycle and at steady state exposure are described in Tables 7 and 8, respectively. In Study 7 (metastatic gastric cancer), of the 294 patients treated with Herceptin, 108 (37%) were 65 years of age or older, while 13 (4.4%) were 75 and over. Found inside – Page 87Roche, Inc. Herceptin package insert. http://www. medsafe.govt.nz/profs/datasheet/h/Herceptininf.pdf. Accessed 3 April 2014. Hoffmann-La Roche. Found insideAnd throughout there are the stories of the heroic women with advanced breast cancer who volunteered for the trials, risking what time they had left on an unproven treatment. In Study 7 (metastatic gastric cancer) on the Herceptin-containing arm as compared to the chemotherapy alone arm the incidence of renal impairment was 18% compared to 14.5%. All patients were either HER2 gene amplified (FISH+) or HER2 overexpressing (IHC 3+). Complete responses were observed only in patients with disease limited to skin and lymph nodes. Prior to resumption of Herceptin infusion, the majority of patients who experienced a severe infusion reaction were pre-medicated with antihistamines and/or corticosteroids. The average trastuzumab exposure following the first cycle and at steady state as well as the time to steady state was higher in breast cancer patients compared to MGC patients at the same dosage; however, the reason for this exposure difference is unknown. Providers should consider additional monitoring and/or treatment as clinically indicated. Warnings. Found inside – Page 505Endocrinology 2004; 145 5439–5447 Genentech Inc., Herceptin [package insert]. South San Francisco CA: Genentech Inc, October 2010. • Patient convenience. Trastuzumab is a humanized IgG1 kappa monoclonal antibody that selectively binds with high affinity to the extracellular domain of the human epidermal growth factor receptor 2 protein, HER2. recommend that ado-trastuzumab emtansine be considered as subsequent therapy. N Engl J Med 2001;344:783-792. Subsequent Herceptin maintenance doses (weekly schedule: 2 mg/kg; three-weekly schedule 6 mg/kg) should be administered 7 days or 21 days later according to the weekly or three-weekly schedules, respectively. Only patients with 2+ or 3+ positive tumors were eligible (about 33% of those screened). 27. Herceptin® will be administered at a dose of 2 mg/kg IV according to the Herceptin® package insert. Trazimera . 14.2 Metastatic Breast Cancer. Herceptin is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma who have not received prior treatment for metastatic disease. tnacity Breast Cancer (Recurrent or Metastatic) Treatment Regimens Clinical Trials: The NCCN recommends cancer patient participation in clinical trials as the gold standard for treatment. Although the average trastuzumab exposure was higher following the first cycle in breast cancer patients receiving the three-weekly schedule compared to the weekly schedule of Herceptin, the average steady-state exposure was essentially the same at both dosages. In Study 4, the incidence of NCI-CTC Grade 3/4 cardiac ischemia/infarction was higher in the Herceptin containing regimens (AC-TH: 0.3% (3/1068) and TCH: 0.2% (2/1056)) as compared to none in AC-T. Infusion reactions consist of a symptom complex characterized by fever and chills, and on occasion included nausea, vomiting, pain (in some cases at tumor sites), headache, dizziness, dyspnea, hypotension, rash, and asthenia [see Adverse Reactions (6.1)]. Chemotherapy was administered for six 21-day cycles. The safety and efficacy of Herceptin in treatment of women with metastatic breast cancer were studied in a randomized, controlled clinical trial in combination with chemotherapy (Study 5, n = 469 patients) and an open-label, single agent clinical trial (Study 6, n = 222 patients). Found inside – Page 509Endocrinology 2004; 145 543945447 Genentech Inc., Herceptin [package insert]. South San Francisco CA: Genentech Inc, October 2010. Do not wait until the next planned cycle. Herceptin administration can result in sub-clinical and clinical cardiac failure. Results. Herceptin can cause left ventricular cardiac dysfunction, arrhythmias, hypertension, disabling cardiac failure, cardiomyopathy, and cardiac death. gb-pl-herceptin-clean-210615-150mg-sol-inf PACKAGE LEAFLET: INFORMATION FOR THE USER Herceptin 150 mg powder for concentrate for solution for infusion Trastuzumab Read all of this leaflet carefully before you start using this medicine because it contains important information for you. Referenced with permission from the NCCN Drugs & Biologics Compendium (NCCN . A newer form of Herceptin, Herceptin Hylecta (chemical name: trastuzumab and hyaluronidase-oysk), can be given as an injection. Accessed May 2020. Administer 840 mg loading dose, 420 mg for subsequent cycles; Herceptin dosing: 8 mg/kg loading dose, 6 mg/kg for subsequent cycles. HER2 IQFISH pharmDx™ Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients. For these reasons, comparison of the incidence of antibodies to Herceptin with the incidence of antibodies to other products may be misleading. For early breast cancer, treatment is given for a year or until the . How long does Herceptin stay in your body? Complications included volume overload and congestive heart failure. The data summarized in Table 3 below, from Study 3, reflect exposure to Herceptin in 1678 patients; the median treatment duration was 51 weeks and median number of infusions was 18. Herceptin Hylecta is a . Found insideGenentech Inc. Herceptin (trastuzumab) [package insert]. South San Francisco, CA. November 2018. Genentech Inc. Herceptin Hylecta (trastuzumab and ... This patient did not experience an allergic reaction. Herceptin is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative (ER/PR negative or with one high risk feature [see Clinical Studies ()]) breast cancer. Understanding that you have malignancy could be extremely devastating and leave you seeking solutions from everywhere. If Herceptin is administered during pregnancy, or if a patient becomes pregnant while receiving Herceptin or within 7 months following the last dose of Herceptin, health care providers and patients should immediately report Herceptin exposure to Genentech at 1-888-835-2555. Of 222 patients enrolled, 66% had received prior adjuvant chemotherapy, 68% had received two prior chemotherapy regimens for metastatic disease, and 25% had received prior myeloablative treatment with hematopoietic rescue. Patients with ER+ and/or PR+ tumors received hormonal therapy. HERCEPTIN (trastuzumab) kit HERCEPTIN (trastuzumab) injection, powder, lyophilized, for solution. Here are, If you are focused on building muscle, you have to buckle lower and get started off. Data in Table 4 are based on Studies 5 and 6. Patients with a history of CHF, myocardial infarction, Grade 3 or 4 cardiac arrhythmia, angina requiring medication, clinically significant valvular heart disease, poorly controlled hypertension (diastolic > 100 mm Hg), any T4 or N2, or known N3 or M1 breast cancer were not eligible. Figure 2 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. Herceptin use can result in serious and fatal pulmonary toxicity. There is a 4–6 fold increase in the incidence of symptomatic myocardial dysfunction among patients receiving Herceptin as a single agent or in combination therapy compared with those not receiving Herceptin. Is used to prevent bronchospasm, hypoxia, dyspnea, pulmonary infiltrates, pleural effusions, non-cardiogenic pulmonary,!, as it contains no preservative and is intended for single-dose use, containing 21 mg/mL trastuzumab the to! 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