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    Active Ingredient
    Trastuzumab 150, 420 mg

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    Metastatic breast cancer
    Weekly schedule: 
    The recommended initial loading dose of Trastuzumab is 4 mg/kg body weight. The recommended weekly maintenance dose of Trastuzumab  is 2 mg/kg body weight, beginning one week after the loading dose.
    Administration in combination with paclitaxel or docetaxel: In the pivotal trials (H0648g, M77001), paclitaxel or docetaxel was administered the day following the first dose of trastuzumab (for dose, see the prescribing information of paclitaxel or docetaxel) and immediately after the subsequent doses of trastuzumab if the preceding dose of trastuzumab was well tolerated.
    Administration in combination with an aromatase inhibitor: In the pivotal trial (BO16216) trastuzumab and anastrozole were administered from day 1. There were no restrictions on the relative timing of trastuzumab and anastrozole at administration (for dose, see the prescribing information of anastrozole or other aromatase inhibitors).
    Early breast cancer
    Three-weekly and weekly schedule: As a three-weekly regimen the recommended initial loading dose of Trastuzumab is 8 mg/kg body weight. The recommended maintenance dose of Trastuzumab at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
    As a weekly regimen (initial loading dose of 4 mg/kg followed by 2 mg/kg every week) concomitantly with paclitaxel following chemotherapy with doxorubicin and cyclophosphamide.
    For chemotherapy combination dosing. See prescribing information for full details.
    Metastatic gastric cancer
    Three-weekly schedule: The recommended initial loading dose is 8 mg/kg body weight. The recommended maintenance dose at three-weekly intervals is 6 mg/kg body weight, beginning three weeks after the loading dose.
    Breast cancer and gastric cancer
    Duration of treatment: Patients with MBC or MGC should be treated with Trastuzumab until progression of disease. Patients with EBC should be treated with Trastuzumab for 1 year or until disease recurrence, whichever occurs first, extending treatment in EBC beyond one year is not recommended.
    Dose reduction: No reductions in the dose of trastuzumab were made during clinical trials. Patients may continue therapy during periods of reversible, chemotherapy-induced myelosuppression but they should be monitored carefully for complications of neutropenia during this time. Refer to the prescribing information of paclitaxel, docetaxel or aromatase inhibitor for information on dose reduction or delays.
    If left ventricular ejection fraction (LVEF) percentage drops ≥ 10 points from baseline AND to below 50%, treatment should be suspended and a repeat LVEF assessment performed within approximately 3 weeks. If LVEF has not improved, or has declined further, or if symptomatic congestive heart failure (CHF) has developed, discontinuation of Trastuzumab should be strongly considered, unless the benefits for the individual patient are deemed to outweigh the risks. All such patients should be referred for assessment by a cardiologist and followed up.
    Missed doses: If the patient has missed a dose of Trastuzumab by one week or less, then the usual maintenance dose (weekly regimen: 2 mg/kg; three-weekly regimen: 6 mg/kg) should be administered as soon as possible. Do not wait until the next planned cycle. Subsequent maintenance doses should be administered 7 days or 21 days later according to the weekly or three-weekly schedules, respectively.
    If the patient has missed a dose of Trastuzumab by more than one week, a re-loading dose of Trastuzumab should be administered over approximately 90 minutes (weekly regimen: 4 mg/kg; three-weekly regimen: 8 mg/kg) as soon as possible. Subsequent Trastuzumab maintenance doses (weekly regimen: 2 mg/kg; three-weekly regimen 6 mg/kg respectively) should be administered 7 days or 21 days later according to the weekly or three-weekly schedules respectively.
    Special populations: Dedicated pharmacokinetic studies in the elderly and those with renal or hepatic impairment have not been carried out. In a population pharmacokinetic analysis, age and renal impairment were not shown to affect trastuzumab disposition.
    Pediatric population: There is no relevant use of trastuzumab in the pediatric population.
    Method of administration: Trastuzumab is for intravenous use only. The loading dose should be administered as a 90-minute intravenous infusion. Do not administer as an intravenous push or bolus. Trastuzumab intravenous infusion should be administered by a healthcare provider prepared to manage anaphylaxis and an emergency kit should be available. Patients should be observed for at least six hours after the start of the first infusion and for two hours after the start of the subsequent infusions for symptoms like fever and chills or other infusion-related symptoms. Interruption or slowing the rate of the infusion may help control such symptoms. The infusion may be resumed when symptoms abate.
    If the initial loading dose was well tolerated, the subsequent doses can be administered as a 30-minute infusion.
    See prescribing information for full details.


    Metastatic breast cancer (MBC): Treatment of patients with metastatic breast cancer who have tumors that overexpress HER2;
    As a single agent, for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease.
    In combination with Paclitaxel or Docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.
    In combination with an aromatase inhibitor for the treatment of postmenopausal patient with hormone-receptor positive metastatic breast cancer.
    Early breast cancer (EBC): Trastuzumab is indicated to treat patients with HER2 positive early breast cancer following surgery and chemotherapy (neoadjuvant or adjuvant) either alone or in combination with chemotherapy excluding anthracyclines.
    This drug should only be used in patients whose tumors have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
    HER2 Metastatic gastric cancer (MGC): Trastuzumab in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of patients with HER2-positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
    Trastuzumab should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC 2+ and a confirmatory FISH+ result, or IHC 3+, as determined by an accurate and validated assay.


    Hypersensitivity to trastuzumab, murine proteins, or to any of the excipients.
    Severe dyspnea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.  

    Special Precautions

    Traceability: In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded.
    HER2 testing must be performed in a specialized laboratory which can ensure adequate validation of the testing procedures.
    Currently no data from clinical trials are available on re-treatment of patients with previous exposure to trastuzumab in the adjuvant setting.
    Cardiac dysfunction
    General considerations: Patients treated with Trastuzumab are at increased risk for developing CHF (New York Heart Association [NYHA] Class II-IV) or asymptomatic cardiac dysfunction. These events have been observed in patients receiving trastuzumab therapy alone or in combination with paclitaxel or docetaxel, particularly following anthracycline (doxorubicin or epirubicin) containing chemotherapy.
    Metastatic breast cancer: Trastuzumab and anthracyclines should not be given concurrently in combination in the MBC setting.
    Patients with MBC who have previously received anthracyclines are also at risk of cardiac dysfunction with Trastuzumab treatment, although the risk is lower than with concurrent use of Trastuzumab and anthracyclines.
    Early breast cancer: For patients with EBC, cardiac assessments, as performed at baseline, should be repeated every 3 months during treatment and every 6 months following discontinuation of treatment until 24 months from the last administration of Trastuzumab. In patients who receive anthracycline-containing chemotherapy further monitoring is recommended, and should occur yearly up to 5 years from the last administration of Trastuzumab, or longer if a continuous decrease of LVEF is observed.
    Patients with history of myocardial infarction (MI), angina pectoris requiring medical treatment, history of or existing CHF (NYHA Class II–IV), LVEF of < 55%, other cardiomyopathy, cardiac arrhythmia requiring medical treatment, clinically significant cardiac valvular disease, poorly controlled hypertension (hypertension controlled by standard medical treatment eligible), and hemodynamic effective pericardial effusion were excluded from adjuvant and neoadjuvant EBC pivotal trials with trastuzumab and therefore treatment cannot be recommended in such patients.
    Adjuvant treatment: Trastuzumab and anthracyclines should not be given concurrently in combination in the adjuvant treatment setting.
    Neoadjuvant-adjuvant treatment: In patients with EBC eligible for neoadjuvant-adjuvant treatment, Trastuzumab should be used concurrently with anthracyclines only in chemotherapy-naive patients and only with low-dose anthracycline regimens i.e. maximum cumulative doses: of doxorubicin 180 mg/m² or epirubicin 360 mg/m².
    If patients have been treated concurrently with a full course of low-dose anthracyclines and Trastuzumab in the neoadjuvant setting, no additional cytotoxic chemotherapy should be given after surgery. In other situations, the decision on the need for additional cytotoxic chemotherapy is determined based on individual factors.
    Infusion-related reactions (IRRs) and hypersensitivity: Serious IRRs to trastuzumab infusion including dyspnea, hypotension, wheezing, hypertension, bronchospasm, supraventricular tachyarrhythmia, reduced oxygen saturation, anaphylaxis, respiratory distress, urticaria and angioedema have been reported. Pre-medication may be used to reduce risk of occurrence of these events. The majority of these events occur during or within 2.5 hours of the start of the first infusion. Should an infusion reaction occur the infusion should be discontinued or the rate of infusion slowed and the patient should be monitored until resolution of all observed symptoms. These symptoms can be treated with an analgesic/antipyretic such as meperidine or paracetamol, or an antihistamine such as diphenhydramine.
    See prescribing information for full details.

    Side Effects

    Most common: Infection, Nasopharyngitis, Neutropenic sepsis, Cystitis, Herpes zoster, Influenza, Sinusitis, Skin infection, Rhinitis, Upper respiratory tract infection, Urinary tract infection ,Pharyngitis, Tremor, Dizziness, Headache, Paresthesia, Dysgeusia, Peripheral neuropathy, Hypertonia, Somnolence, hypotension, hypertension, Cardiac flutter, Ejection fraction decreased, Cardiac failure (congestive) , Cardiomyopathy, arrhythmia, Dyspnea , Cough, Epistaxis , Rhinorrhea, Pneumonia, Asthma, Lung disorder  , Pleural effusion, Hepatocellular injury, Hepatitis , Liver tenderness, Jaundice.
    See prescribing information for full details.

    Drug interactions

    No formal drug interaction studies have been performed. Clinically significant interactions between trastuzumab and the concomitant medicinal products used in clinical trials have not been observed.
    See prescribing information for full details.

    Pregnancy and Lactation

    Pregnancy: Women of childbearing potential should be advised to use effective contraception during treatment with trastuzumab and for 7 months after treatment has concluded.
    LactationIt is not known whether trastuzumab is secreted in human milk.
    See prescribing information for full details.


    There is no experience with overdose in human clinical trials. Single doses of trastuzumab alone greater than 10 mg/kg have not been administered in the clinical trials; a maintenance dose of 10 mg/kg q3w following a loading dose of 8 mg/kg has been studied in a clinical trial with metastatic gastric cancer patients. Doses up to this level were well tolerated.

    Important notes

    Storage: Store in a refrigerator (2°C – 8°C). Do not freeze the reconstituted solution. Store in the original package in order to protect from light.
    Compatibility: No incompatibilities between trastuzumab and polyvinylchloride, polyethylene or polypropylene bags have been observed.
    Effects on ability to drive and use machines
    Trastuzumab has a minor influence on the ability to drive or use machines. Dizziness and somnolence may occur during treatment with trastuzumab. Patients experiencing infusion-related symptoms should be advised not to drive and use machines until
    symptoms abate.
    See prescribing information for full details.

    Amgen Europe B.V., Breda, Netherlands.
    Licence holder