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  • Herceptin IV
    / Roche

    Active Ingredient
    Trastuzumab 440 mg/ml

    Status in Israel

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft


    1 x 440 mg

    partial basket chart 35510 8343

    Related information


    HER2 testing is mandatory prior to initiation of therapy. Treatment should only be initiated by a physician experienced in the administration of cytotoxic chemotherapy, and should be administered by healthcare professional only.
    In order to prevent medication errors it is important to check the vial labels to ensure that the drug being prepared and administered is trastuzumab and not trastuzumab emtansine.
    Metastatic breast cancer: Weekly schedule. The recommended initial loading dose is 4 mg/kg body weight. The recommended weekly maintenance dose 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 of paclitaxel or docetaxel, see the prescribing information full details) and immediately after the subsequent doses of Herceptin if the preceding dose 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 the drugs at administration (for dose of anastrozole or other aromatase inhibitors, see the prescribing information for full details).
    Early breast cancer: Three-weekly and weekly schedule. As a three-weekly regimen 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. 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.
    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.
    See prescribing information for full details.
    Breast cancer and gastric cancer: Duration of treatment. Patients with MBC or MGC should be treated until progression of disease. Patients with EBC should be treated 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 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) drops ≥ 10 ejection fraction (EF) 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 declined further, or symptomatic congestive heart failure (CHF) has developed, discontinuation 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 misses a dose by one week or less, then the usual maintenance dose (weekly regimen: 2 mg/kg; three-weekly regimen: 6 mg/kg) should be given as soon as possible. Do not wait until the next planned cycle. Subsequent maintenance doses (weekly regimen: 2 mg/ kg; three-weekly regimen: 6 mg/kg respectively) should then be given according to the previous schedule. If the patient misses a dose by more than one week, a re-loading dose should be given over approximately 90 minutes (weekly regimen: 4 mg/kg; three-weekly regimen: 8 mg/kg). Subsequent maintenance doses (weekly regimen: 2 mg/kg; three-weekly regimen 6 mg/kg respectively) should then be given (weekly regimen: every week; three-weekly regimen every 3 weeks) from that point.
    Special Populations: Dedicated pharmacokinetic studies in older people 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.
    Paediatric population: There is no relevant use in the paediatric population.
    Method of administration: Loading dose should be administered as a 90-minute intravenous infusion. Do not administer as an intravenous push or bolus. Intravenous infusion should be administered by a health-care 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.


    Metastatic Breast Cancer (MBC): Herceptin is indicated for the treatment of patients with metastatic breast cancer who have tumours that overexpress HER2;
    1. As a single agent, for the treatment of those patients who have received one or more chemotherapy regimens for their metastatic disease.
    2. In combination with Paclitaxel or Docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.
    3. In combination with an aromatase inhibitor for the treatment of postmenopausal patient with hormone-receptor positive metastatic breast cancer.
    Early Breast Cancer (EBC): Herceptin 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
    Herceptin should only be used in patients whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
    HER2 Metastatic Gastric Cancer (MGC): Herceptin 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 gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease.
    Herceptin should only be used in patients with metastatic gastric cancer whose tumours have HER2 overexpression as defined by IHC2+ 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 dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy.

    Special Precautions

    In order to improve traceability of biological medicinal products, the trade name of the administered product should be clearly recorded (or stated) in the patient file.
    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 in the adjuvant setting.
    See prescribing information for full details.

    Side Effects

    The most common side effects are: Asthenia, Chest pain, Chills, Fatigue, Influenza-like symptoms, Infusion related reaction, Pain , Pyrexia, Mucosal inflammation, Arthralgia , Muscle tightness , Myalgia , Erythema , Rash , Swelling face , Alopecia , Nail disorder , Diarrhoea , Vomiting , Nausea , Lip swelling, Abdominal pain, Dyspepsia, Constipation, Wheezing, Cough, Dyspnoea, Epistaxis, Rhinorrhoea, Hot flush, Blood pressure decreased, Blood pressure increased, Heart beat irregular, Palpitation, Cardiac flutter, Ejection fraction decreased, Conjunctivitis, Lacrimation increased, Tremor, Dizziness, Headache, Febrile neutropenia, Anaemia, Neutropenia, White blood cell count decreased/leukopenia, Infection.
    See prescribing information for full details.

    Drug interactions

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

    Pregnancy and Lactation

    Pregnancy: Reproduction studies have been conducted in cynomolgus monkeys at doses up to 25 times that of the weekly human maintenance dose of 2 mg/kg and have revealed no evidence of impaired fertility or harm to the foetus. Placental transfer of trastuzumab during the early (days 20–50 of gestation) and late (days 120–150 of gestation) foetal development period was observed. It is not known whether it can affect reproductive capacity. As animal reproduction studies are not always predictive of human response, the treatment should be avoided during pregnancy unless the potential benefit for the mother outweighs the potential risk to the fetus.
    Lactation: A study conducted in lactating cynomolgus monkeys at doses 25 times that of the weekly human maintenance dose of 2 mg/kg demonstrated that trastuzumab is secreted in the milk. The presence of trastuzumab in the serum of infant monkeys was not associated with any adverse effects on their growth or development from birth to 1 month of age. It is not known whether trastuzumab is secreted in human milk. As human IgG1 is secreted into human milk, and the potential for harm to the infant is unknown, women should not breast-feed during therapy and for 7 months after the last dose.
    See prescribing information for full details.


    There is no experience with overdose in human clinical trials. Single doses alone greater than 10 mg/kg have not been administered in the clinical trials. Doses up to this level were well tolerated.
    See prescribing information for full details.

    Important notes

    Incompatibilities: This medicinal product must not be mixed or diluted with other medicinal products except bacteriostatic water for injection, or water for injection. Use of other reconstitution solvents should be avoided.
    Do not dilute with glucose solutions since these cause aggregation of the protein.
    Special precautions for storage:  Store vials at a refrigerator 2°C–8°C.
    A vial reconstituted with Bacteriostatic Water for Injection, as supplied, is stable for 28 days when stored refrigerated at 2°C–8°C.
    The reconstituted solution contains preservative and is therefore suitable for multiple uses. Any remaining reconstituted solution should be discarded after 28 days. If Water for Injection without preservative is used, the reconstituted solution should be used immediately and any unused portion discarded.
    Use of other solvents for the reconstitution should be avoided.
    Do not freeze the reconstituted solution. Solutions for infusion are stable in polyvinylchloride, polyethylene or polypropylene bags containing 0.9% sodium chloride at 2°C–8°C for 24 hours. Diluted drug solution has been shown to be physically and chemically stable for up to 24 hours at temperatures up to 30°C. However, since diluted drug solution contains effectively no preservative, the reconstituted and diluted solution should be stored refrigerated at 2°C-8°C. From a microbiological point of view, infusion solution should be used immediately. The product is not intended to be stored after dilution unless the dilution has taken place under controlled and validated aseptic conditions.
    See prescribing information for full details.

    Hoffmann La Roche, Switzerland