| Composition: Trastuzumab 150mg.
Reconstituted solution contains 21mg/ml. Presentation: Powder for concentrate for solution for infusion. Storage and stability: Store at 2-8C. Do not freeze reconstituted solution. Action: Recombinant humanised IgG1 monoclonal antibody against human epidermal growth factor receptor 2 (HER2). Indications: Treatment of patients with metastatic breast cancer whose tumours overexpress HER2: as monotherapy for the treatment of patients who have received at least two chemotherapy regimens for metastatic disease, including 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 unsuitable for these treatments. Also in combination with paclitaxel for the treatment of patients who have not received chemotherapy for metastatic disease and for whom an anthracycline is not suitable. Trastuzumab should only be used in patients whose tumours have HER2 overexpression at a 3+ level (staining intensity score) as determined by immunohistochemistry (see SPC). Contraindications: Hypersensitivity to active substance, murine proteins or any excipients. Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy. Dosage and administration: HER2 testing must be performed prior to initiation. For monotherapy and in combination with paclitaxel, loading dose, 4mg/kg body weight. Subsequent doses, 2mg/kg body weight weekly, beginning one week after loading dose. Administer as a 90-minute intravenous infusion. Patients should be observed for infusion related symptoms (see SPC) for at least six hours after the start of the first infusion and for two hours after the start of subsequent infusions. If initial loading dose was well tolerated, subsequent doses can be administered as a 30-minute infusion. See SPC for reconstitution, use and handling. Do not administer as intravenous push or bolus. Trastuzumab should be administered until progression of disease. Paclitaxel may be administered on the day following the first dose of trastuzumab or immediately after subsequent doses, if the preceding dose of trastuzumab was well tolerated. Paediatric patients (under 18 years of age), safety and efficacy not established. Pregnancy, avoid unless potential benefit for mother outweighs potential risk to foetus. Lactation, potential harm to infant unknown. Women should not breastfeed during treatment and for six months after the last dose. Overdosage: No experience. Precautions: Use of trastuzumab and anthracyclines in combination has been associated with a high risk of cardiotoxicity. They should not be used currently in combination except in a "well-controlled" trial setting with cardiac monitoring. Caution should be taken in treating patients with symptomatic heart failure, a history of hypertension, or documented coronary artery disease. Baseline cardiac assessment should be undertaken and cardiac function monitored during treatment. Patients experiencing infusion-related symptoms should be advised not to drive or operate machinery until symptoms abate. Drug interactions: Studies have not been performed in humans. Risk of interactions cannot be excluded. Side effects: The most common adverse effects are infusion- related symptoms, such as chills and fever, usually following the first infusion of trastuzumab. In trials, adverse effects (greater than 10 per cent) included abdominal pain, asthenia, chest pain, chills, fever, headache, pain, diarrhoea, nausea, vomiting, arthralgia, myalgia, rash. See SPC for other adverse effects. Net price: 1 vial (150mg in 15ml) £407.40. Supplier: Roche Products, 40 Broadwater Road, Welwyn Garden City, Hertfordshire AL7 3AY. Tel 01707 367882, fax 01707 366803. Legal class: POM. |
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