Trastuzumab: Indication, Dosage, Side Effect, Precaution

Generic Medicine Info Patient Medicine Information

This information is not country-specific. Please refer to the Myanmar prescribing information.

Generic Medicine Info

Indications and Dosage

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.

Pregnancy Category (US FDA)

IV/SC: Z (Risk of oligohydramnios resulting in neonatal complications. If unavoidable, closely monitor the amniotic fluid status.)

Monitoring Parameters

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.

MIMS 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.

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.

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