Dosage/Direction for Use
Intravenous Metastatic breast cancer Adult: As monotherapy or combination therapy (w/ an aromatase inhibitor or taxane): Initially, 4 mg/kg via infusion over 90 min followed by 2 mg/kg via infusion over 30 min at wkly interval until progression of disease. As trastuzumab emtansine: 3.6 mg/kg as infusion 3 wkly (21-day cycle). Admin initial dose for 90 min. Subsequent doses may be administered as 30 min infusions. Reconstitution: Reconstitute w/ 20 mL of bacteriostatic sterile water for inj into a soln containing 21 mg/mL of trastuzumab. Swirl gently; do not shake. Dilute further prior to admin w/ appropriate vol of reconstituted trastuzumab soln in 250 mL of NaCl 0.9% inj. Incompatibility: Incompatible w/ dextrose 5% in water. Intravenous Early breast cancer Adult: For treatment after chemotherapy, radiotherapy or surgery. Initially, 4 mg/kg via infusion over 90 min followed by 2 mg/kg via infusion over 30 min wkly for 1 yr or until disease recurrence, whichever occurs 1st. Alternatively, initial dose of 8 mg/kg via infusion over 90 min followed by 6 mg/kg via IV infusion over 30-90 min at 3-wkly interval for 1 yr or until disease recurrence, whichever occurs 1st. Reconstitution: Reconstitute w/ 20 mL of bacteriostatic sterile water for inj into a soln containing 21 mg/mL of trastuzumab. Swirl gently; do not shake. Dilute further prior to admin w/ appropriate vol of reconstituted trastuzumab soln in 250 mL of NaCl 0.9% inj. Incompatibility: Incompatible w/ dextrose 5% in water. Intravenous Gastric cancer Adult: For metastatic: Initially, 8 mg/kg via infusion over 90 min followed by 6 mg/kg via infusion over 30-90 min at 3-wkly interval until progression of disease. Reconstitution: Reconstitute w/ 20 mL of bacteriostatic sterile water for inj into a soln containing 21 mg/mL of trastuzumab. Swirl gently; do not shake. Dilute further prior to admin w/ appropriate vol of reconstituted trastuzumab soln in 250 mL of NaCl 0.9% inj. Incompatibility: Incompatible w/ dextrose 5% in water. |
Contraindications
Severe dyspnoea at rest.
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Special Precautions
Patient w/ pre-existing CV and pulmonary disease; extensive pulmonary tumour involvement. Pregnancy and lactation. Monitoring Parameters Monitor cardiac function prior and during treatment.
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Adverse Reactions
Fever, headache, fatigue, nausea, vomiting, diarrhoea, infections, increased cough, dyspnoea, rash, neutropenia, anaemia, and myalgia; cardiac dysfunction, CHF.
Potentially Fatal: Hypersensitivity and infusion reaction (e.g. anaphylaxis, angioedema), febrile neutropenia, exacerbation of chemotherapy-induced neutropenia, cardiomyopathy, pulmonary toxicity (e.g. pneumonitis, resp failure, pulmonary infiltrates), acute resp distress syndrome. |
Drug Interactions
May increase cardiotoxicity of antineoplastic agents. May increase neutropenic effect of immunosuppressants. May increase serum level w/ paclitaxel.
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Action
Trastuzumab and trastuzumab emtansine (also known as ado-trastuzumab emtansine) is a recombinant humanised monoclonal antibody that has action directed against a cell surface protein produced by the human epidermal growth factor receptor 2 (HER2). It inhibits proliferation of tumour cells that overexpress HER2 protein.
Distribution: Volume of distribution: 44 mL/kg (as trastuzumab); 3.13 L (as trastuzumab emtansine). Metabolism: As trastuzumab emtansine: Undergoes deconjugation and catabolism through proteolysis in cellular lysosomes. Excretion: Elimination half-life: 6 days (wkly dosing); 16 days (3 wkly regimen); approx 4 days (as trastuzumab emtansine). Elimination may involve clearance of IgG through the reticuloendothelial system. |
Storage
Intravenous: Store between 2-8°C.
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CIMS Class
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ATC Classification
L01FD01 - trastuzumab ; Belongs to the class of HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors. Used in the treatment of cancer.
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