IntravenousHER2-overexpressing metastatic breast cancerAdult: As monotherapy in patients who have received ≥1 chemotherapy regimens, in combination with paclitaxel or docetaxel in patients who have not received chemotherapy, or in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive cases: Weekly schedule: Initially, 4 mg/kg, followed after 1 week by a maintenance dose of 2 mg/kg given at weekly intervals. Alternative dosing recommendation: 3-weekly schedule: Initially, 8 mg/kg, followed after 3 weeks by a maintenance dose of 6 mg/kg once every 3 weeks. Continue until disease progression. Doses are given initially via IV infusion over 90 minutes; if tolerated, subsequent doses may be given via IV infusion over 30 minutes. Missed dose: If missed dose is ≤1 week, give usual maintenance dose (weekly regimen: 2 mg/kg or 3-weekly regimen: 6 mg/kg) as soon as possible; do not wait until the next planned cycle. Subsequent maintenance doses must be given 7 days or 21 days later based on the weekly or 3-weekly schedules, respectively. If missed dose is >1 week, a re-loading dose (weekly regimen: 4 mg/kg or 3-weekly regimen: 8 mg/kg) must be given (over 90 minutes) as soon as possible. Subsequent maintenance doses (weekly regimen: 2 mg/kg or 3-weekly regimen: 6 mg/kg) must be given 7 days or 21 days later based on the weekly or 3-weekly schedules, respectively. Dose interruption or discontinuation may be required according to individual safety or tolerability. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
IntravenousHER2-positive early breast cancerAdult: In combination with adjuvant chemotherapy (consisting of docetaxel and carboplatin) or neoadjuvant chemotherapy followed by adjuvant trastuzumab for locally advanced breast cancer or tumours >2 cm in diameter; following surgery, chemotherapy (adjuvant or neoadjuvant) and radiotherapy (if applicable); following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel: Weekly schedule: Initially, 4 mg/kg, followed after 1 week by a maintenance dose of 2 mg/kg given at weekly intervals. Alternative dosing recommendation: 3-weekly schedule: Initially, 8 mg/kg, followed after 3 weeks by a maintenance dose of 6 mg/kg once every 3 weeks. Continue treatment for 1 year or until recurrence of disease occurs. Doses are given initially via IV infusion over 90 minutes; if tolerated, subsequent doses may be given via IV infusion over 30 minutes. Missed dose: If missed dose is ≤1 week, give usual maintenance dose (weekly regimen: 2 mg/kg or 3-weekly regimen: 6 mg/kg) as soon as possible; do not wait until the next planned cycle. Subsequent maintenance doses must be given 7 days or 21 days later based on the weekly or 3-weekly schedules, respectively. If missed dose is >1 week, a re-loading dose (weekly regimen: 4 mg/kg or 3-weekly regimen: 8 mg/kg) must be given (over 90 minutes) as soon as possible. Subsequent maintenance doses (weekly regimen: 2 mg/kg or 3-weekly regimen: 6 mg/kg) must be given 7 days or 21 days later based on the weekly or 3-weekly schedules, respectively. Dose interruption or discontinuation may be required according to individual safety or tolerability. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
IntravenousHER2-positive metastatic gastric adenocarcinoma, HER2-positive metastatic gastrooesophageal junction adenocarcinomaAdult: In combination with 5-fluorouracil or capecitabine and cisplatin for patients who have not received prior anti-cancer therapy: 3-weekly schedule: Initially, 8 mg/kg, followed after 3 weeks by a maintenance dose of 6 mg/kg once every 3 weeks. Continue until disease progression. Doses are given initially via IV infusion over 90 minutes; if tolerated, subsequent doses may be given via IV infusion over 30 minutes. Missed dose: If missed dose is ≤1 week, give the usual maintenance dose (3-weekly schedule: 6 mg/kg) as soon as possible; do not wait until the next planned cycle. Subsequent maintenance doses must be given 21 days later based on the 3-weekly schedule. If missed dose is >1 week, a re-loading dose (3-weekly regimen: 8 mg/kg) must be given (over 90 minutes) as soon as possible. Subsequent maintenance doses (3-weekly regimen: 6 mg/kg) must be given 21 days later based on the 3-weekly schedule. Dose interruption or discontinuation may be required according to individual safety or tolerability. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
SubcutaneousHER2-positive early breast cancerAdult: In combination with adjuvant chemotherapy (consisting of docetaxel and carboplatin) or neoadjuvant chemotherapy followed by adjuvant trastuzumab for locally advanced breast cancer or tumours >2 cm in diameter; following surgery, chemotherapy (adjuvant or neoadjuvant) and radiotherapy (if applicable); following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel: 600 mg once every 3 weeks via SC inj over 2-5 minutes. Continue treatment for 1 year or until disease recurrence. Missed dose: Administer the missed dose as soon as possible; interval between consecutive doses must not be <3 weeks. Dose interruption or discontinuation may be required according to individual safety or tolerability. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
SubcutaneousHER2-overexpressing metastatic breast cancerAdult: As monotherapy in patients who have received ≥1 chemotherapy regimens, in combination with paclitaxel or docetaxel in patients who have not received chemotherapy, or in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive cases not previously treated with trastuzumab: 600 mg once every 3 weeks via SC inj over 2-5 minutes. Continue until disease progression. Missed dose: Administer the missed dose as soon as possible; interval between consecutive doses must not be <3 weeks. Dose interruption or discontinuation may be required according to individual safety or tolerability. Treatment recommendations may vary among countries and between individual products (refer to specific product guidelines).
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Intravenous:
Powder for solution for infusion: Reconstitute each vial labelled as 50 mg with 7.2 mL of sterile water for inj, each vial labelled as 60 mg with 3 mL sterile water for inj, and each vial labelled as 440 mg with 20 mL of bacteriostatic water for inj. Gently swirl the vial to dissolve. Do not shake. Allow the vials to stand undisturbed for approx 5 minutes. Withdraw the appropriate dose and volume from the vial, then dilute with 250 mL NaCl 0.9% solution. Gently invert the bag to mix. Avoid foaming. Instructions for reconstitution may vary among countries and between individual products (refer to specific product guidelines).
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Incompatible with glucose solution (e.g. dextrose 5% in water).
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Hypersensitivity. Severe dyspnoea at rest.
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Patient with increased cardiac risk (e.g. CHF, documented CAD, LVEF of <55%, diastolic dysfunction, hypertension), extensive pulmonary tumour involvement, pre-existing pulmonary disease (e.g. pneumonitis). Ensure that the appropriate drug is being given prior to administration; trastuzumab is not interchangeable with other products containing trastuzumab emtansine, trastuzumab deruxtecan, and other preparations that contain trastuzumab in combination with other agents. Verify if the correct formulation (IV or SC) is being given to the patient; trastuzumab IV formulation is not interchangeable with the SC formulation. Pregnancy. Discontinue breastfeeding during therapy and for 7 months after the last dose.
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Significant: Arrhythmias, hypertension, mural thrombus formation, stroke. Rarely, nephrotic syndrome with evidence of glomerulopathy.
Blood and lymphatic system disorders: Neutropenic sepsis, febrile neutropenia, anaemia, leucopenia, thrombocytopenia.
Cardiac disorders: Cardiac flutter, supraventricular tachyarrhythmia, palpitation.
Eye disorders: Conjunctivitis, dry eye, increased lacrimation.
Gastrointestinal disorders: Constipation, abdominal pain, diarrhoea, dyspepsia, dry mouth, stomatitis, haemorrhoids, dysgeusia.
General disorders and administration site conditions: Asthenia, chest pain, fatigue, influenza-like symptoms, peripheral oedema, mucosal inflammation, malaise, oedema.
Hepatobiliary disorders: Liver tenderness, hepatitis, hepatocellular injury.
Infections and infestations: Infection, influenza.
Injury, poisoning and procedural complications: Contusion.
Investigations: Decreased weight, increased blood pressure.
Metabolism and nutrition disorders: Anorexia.
Musculoskeletal and connective tissue disorders: Arthralgia, muscle tightness, myalgia, arthritis, back pain, bone pain, neck pain, muscle spasms, pain in extremity.
Nervous system disorders: Tremor, somnolence, paraesthesia, peripheral neuropathy, hypertonia.
Psychiatric disorders: Insomnia, anxiety, depression.
Renal and urinary disorders: Cystitis, UTI, renal disorder.
Reproductive system and breast disorders: Mastitis.
Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, sinusitis, rhinitis, pharyngitis, URTI, cough, epistaxis, rhinorrhoea, asthma, lung disorder.
Skin and subcutaneous tissue disorders: Erythema, pruritus, swelling face, alopecia, nail disorder, palmar-plantar erythrodysaesthesia syndrome, acne, dry skin, ecchymosis, onychoclasis, dermatitis, hyperhidrosis.
Vascular disorders: Hot flush, vasodilatation.
Potentially Fatal: CHF, asymptomatic cardiac dysfunction, severe pulmonary toxicity (e.g. pulmonary infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, respiratory distress, pleural effusion, acute pulmonary oedema, respiratory insufficiency), infusion-related reactions (e.g. fever, chills, nausea, vomiting, pain, headache, dizziness, dyspnoea, rash) or hypersensitivity reactions.
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IV/SC: Z (Risk of oligohydramnios resulting in neonatal complications. If unavoidable, closely monitor the amniotic fluid status.)
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Women of childbearing potential must use effective birth control methods during treatment and for 7 months after the last dose. Discontinue breastfeeding during therapy and for 7 months after the last dose. This drug may cause dizziness and somnolence, if affected, do not drive or operate machinery.
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Verify pregnancy status prior to treatment initiation. Establish HER2 status before treatment initiation. Perform standard cardiac function test (e.g. ECG or multiple gated acquisition scanning) before treatment initiation and at least every 3 months during treatment. Assess for signs and symptoms of infusion-related reactions during and after every administration; cardiac dysfunction (e.g. heart failure) and pulmonary toxicity.
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May increase exposure of 1 doxorubicin metabolite (7-deoxy-13 dihydro-doxorubicinone [D7D]). Increased risk of cardiotoxicity with anthracyclines or cyclophosphamide.
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Description: Overview: Trastuzumab is a recombinant humanised IgG1 monoclonal antibody antineoplastic agent. Mechanism of Action: Trastuzumab is directed against a cell surface protein produced by human epidermal growth factor receptor 2 (HER2) gene. It binds with high affinity and specificity to the extracellular domain of HER2, thereby inhibiting ligand-independent HER2 signalling and preventing proteolytic cleavage of the extracellular domain (key activation mechanism of HER2). This action inhibits the proliferation of tumour cells that overexpress HER2 protein. Pharmacodynamics: The exposure-response relationship and pharmacodynamic profile of trastuzumab are not yet fully established. In vitro studies demonstrate that trastuzumab-mediated antibody-dependent cellular cytotoxicity (ADCC) prefers cancer cells that overexpress HER2 compared with those without HER2 overexpression.
Effects of trastuzumab on ECG endpoints were evaluated in patients with HER2-positive solid tumours; trastuzumab had no clinically significant effect on the QT interval, and there was no evident correlation between serum trastuzumab levels and changes in QT interval duration. Pharmacokinetics: Absorption: Bioavailability: Approx 77%. Time to peak plasma concentration: Approx 3 days (SC). Excretion: Elimination half-life: Approx 28 days (metastatic breast cancer); approx 12 days (early breast cancer).
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Intravenous:
Powder for solution for infusion: Store between 2-8°C. Reconstituted solution: Store between 2-8°C for up to 24 hours (if diluent is sterile water for inj) or up to 28 days (if diluent is bacteriostatic water for inj). Diluted solution for IV infusion: Store between 2-8°C for up to 24 hours. Do not freeze.
Subcutaneous:
Solution for inj: Store between 2-8°C. Do not freeze. Protect from light. After removal from the refrigerator, use within 6 hours and store below 30°C.
This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration, and disposal. Storage recommendations may vary among countries and between individual products (refer to specific product guidelines).
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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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Brayfield A, Cadart C (eds). Trastuzumab. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/09/2025. Herceptin 150 mg Powder for Concentrate for Solution for Infusion (Roche Products Ltd). MHRA. https://products.mhra.gov.uk. Accessed 09/09/2025. Herceptin 600 mg Solution for Injection in Vial (Roche Products Ltd). MHRA. https://products.mhra.gov.uk. Accessed 09/09/2025. Herceptin 600 mg/5 mL Solution for Injection (Roche [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 09/09/2025. Herceptin Vial 440 mg Powder for Concentrate (Roche [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 09/09/2025. Joint Formulary Committee. Trastuzumab. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/09/2025. Roche Products (New Zealand) Limited. Herceptin 150 mg and 440 mg Powder for Concentrate for Solution for Infusion data sheet 8 October 2024. Medsafe. http://www.medsafe.govt.nz. Accessed 09/09/2025. Roche Products (New Zealand) Limited. Herceptin SC 600 mg/5 mL data sheet 26 August 2024. Medsafe. http://www.medsafe.govt.nz. Accessed 09/09/2025. Trastuzumab. Gold Standard Drug Database in ClinicalKey [online]. Elsevier Inc. https://www.clinicalkey.com. Accessed 09/09/2025. Trastuzumab. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 09/09/2025. Trastuzumab. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 09/09/2025. Trazimera Injection, Powder, Lyophilized, for Solution (Pfizer Laboratories Div Pfizer Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/09/2025. Zercepac 60 mg Powder for Concentrate for Solution for Infusion (Accord Healthcare Limited). MHRA. https://products.mhra.gov.uk. Accessed 24/09/2025.
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