Trastuzumab


Full Generic Medicine Info
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.
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.
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.
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.
CIMS Class
Targeted Cancer Therapy
ATC Classification
L01FD01 - trastuzumab ; Belongs to the class of HER2 (Human Epidermal Growth Factor Receptor 2) inhibitors. Used in the treatment of cancer.
Disclaimer: This information is independently developed by CIMS based on trastuzumab from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to CIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, CIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2024 CIMS. All rights reserved. Powered by CIMSAsia.com
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