Trastuzumab


Concise Prescribing Info
Indications/Uses
Listed in Dosage.
Dosage/Direction for Use
Adult : IV Metastatic breast cancer As monotherapy or in combination therapy: Initial: 4 mg/kg over 90 min followed by 2 mg/kg 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. Adjuvant treatment of HER2-positive early carcinoma of breast; Neoadjuvant treatment of early stage HER2-positive carcinoma of breast For treatment after chemotherapy, radiotherapy or surgery. Initial: 4 mg/kg over 90 min followed by 2 mg/kg over 30 min wkly for 1 yr or until disease recurrence, whichever occurs 1st. Alternatively, initial dose of 8 mg/kg over 90 min followed by 6 mg/kg over 30-90 min at 3-wkly interval for 1 yr or until disease recurrence, whichever occurs 1st. Gastric cancer For metastatic: Initial: 8 mg/kg over 90 min followed by 6 mg/kg over 30-90 min at 3-wkly interval until progression of disease. All doses to be given via IV infusion.
Dosage Details
Intravenous
Adjuvant treatment of HER2-positive early carcinoma of breast, Neoadjuvant treatment of early stage HER2-positive carcinoma of breast
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 infusion over 30-90 min at 3-wkly interval for 1 yr or until disease recurrence, whichever occurs 1st.

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.

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.
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.
MonitoringParameters
Monitor cardiac function prior and during treatment.
Drug Interactions
May increase cardiotoxicity of antineoplastic agents. May increase neutropenic effect of immunosuppressants. May increase serum level w/ paclitaxel.
Action
Description: 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.
Pharmacokinetics:
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
Store between 2-8°C.
ATC Classification
L01XC03 - trastuzumab ; Belongs to the class of monoclonal antibodies, other antineoplastic agents. Used in the treatment of cancer.
References
Anon. Trastuzumab. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/11/2014.

Buckingham R (ed). Trastuzumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/11/2014.

Herceptin (Genentech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed/. Accessed 05/11/2014.

Herceptin. U.S. FDA. https://www.fda.gov/. Accessed 05/11/2014.

Joint Formulary Committee. Trastuzumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/11/2014.

McEvoy GK, Snow EK, Miller J et al (eds). Trastuzumab. AHFS Drug Information (AHFS DI) [online]. American Society of Health-System Pharmacists (ASHP). https://www.medicinescomplete.com. Accessed 05/11/2014.

Disclaimer: This information is independently developed by MIMS 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 MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS 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 © 2020 MIMS. All rights reserved. Powered by MIMS.com
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