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| Drug class description : | Monoclonal antibodies (antineoplastic agents). |
| Generic Name : | Trastuzumab |
| Drug description : | White to pale yellow lyophilised powder. |
| Presentation : | Powder for concentrate for solution for infusion, trastuzumab 150mg per vial. Reconstituted solution contains trastuzumab 21mg/mL. |
| Indications : | Treatment of patients with metastatic breast cancer whose tumours overexpress HER2: (a) as monotherapy for treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy unless patients are unsuitable for these treatments (b) in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. |
| Adult Dosage : | Recommended initial loading dose, 4mg/kg body weight; subsequent doses, 2mg/kg body weight once a week beginning one week after the loading dose. Refer to Summary of Product Characteristics. |
| Child Dosage : | Not recommended. |
| Contra Indications : | Known hypersensitivity to trastuzumab, murine proteins or to any of the excipients. Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy. Lactation - women should not breast feed during therapy or for six months after last dose. |
| Special Precautions : | HER2 testing is mandatory prior to initiation of Herceptin therapy. Therapy should be initiated only by a physician experienced in the administration of cytotoxic chemotherapy. Herceptin and anthracyclines should not be used currently in combination except in a well- controlled clinical trial setting with cardiac monitoring. Risk of infusion reactions - refer to Summary of Product Characteristics. Symptomatic heart failure, history of hypertension, documented coronary artery disease. Patients should undergo a baseline cardiac assessment. Pregnancy - avoid unless potential benefit for mother outweighs risk to foetus. |
| Interactions : | Drug interaction studies have not been performed with Herceptin in humans. |
| Adverse Reactions : | Most commonly (>10% patients), abdominal pain, asthenia, chest pain, chills, fever, headache, pain, diarrhoea, nausea, vomiting, arthralgia, myalgia, rash. Less commonly (>1% and <10% patients), flu syndrome, back pain, infection, neck pain, malaise, allergic reaction, mastitis, weight loss, hypotension, heart failure, cardiomyopathy, palpitation, anorexia, constipation, dyspepsia, liver tenderness, dry mouth, leucopenia, ecchymosis, peripheral oedema, oedema, bone pain, leg cramps, arthritis, anxiety, depression, dizziness, insomnia, paraesthesia, somnolence, hypertonia, neuropathy, tremor, asthma, cough increased, dyspnoea, epistaxis, lung disorders, pharyngitis, rhinitis, sinusitis, urinary tract infection, pruritus, sweating, nail disorder, dry skin, alopecia, acne, maculopapular rash, taste perversion. Infusion-related symptoms, allergic-like and hypersensitivity reactions, serious pulmonary events, cardiac toxicity, hepatic toxicity. Refer to Summary of Product Characteristics. |
| Manufacturer : | Roche |
| Drug Availability : | (POM) |
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