Safety Information


Trastuzumab is to be prescribed by a Registered Medical Practitioner only. Consult your local Registered Medical Practitioner before any usage.

Indications and Usage

  • For the treatment of adult patients with HER2 positive Early Breast Cancer (EBC)

    • following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable).
    • following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.
    • in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin.
    • in combination with neoadjuvant chemotherapy followed by adjuvant trastuzumab therapy, for locally advanced (including inflammatory) disease or tumours > 2 cm in diameter.
  • For the treatment of adult patients with HER2 positive metastatic breast cancer (MBC)

    • as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.
    • in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.
    • in combination with 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 patients with hormone-receptor positive MBC, not previously treated with trastuzumab.
  • For the treatment of adult patients with Metastatic Gastric Cancer (MGC)

    • in combination with capecitabine or 5-fluorouracil and cisplatin for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastroesophageal junction who have not received prior anti-cancer treatment for their metastatic disease.HERVYCTA® should only be used in patients with MGC whose tumours have HER2 overexpression as defined by IHC 2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result.

Possible Serious Side Effects with Hervycta®

Like all medications, few patients on this medication may experience few side effects. Some of these may be serious leading to hospitalization. Your treating doctor may decide to stop therapy in case of intolerance to side effects.

Important side effects with Hervycta® treatment are as follows:

  • Heart Problems

    Patients treated with trastuzumab are at increased risk for developing congestive heart failure or reduced heart function—with or without symptoms. 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. These may be moderate to severe in intensity and could be associated with death. In addition, caution should be exercised in treating patients with increased cardiac risk, e.g. hypertension, documented coronary artery disease, congestive heart failure, left ventricular ejection fraction of less than 55%, or older age group.

    Monitoring of heart problems before, during, and after treatment with Hervycta® should be done by the treating doctor.

  • Infusion‐related reactions (IRRs) and hypersensitivity reactions

    During treatment with trastuzumab, chills, fever and other flu like symptoms may occur. These are very common and may affect more than 1 in 10 people. Other symptoms are: feeling sick (nausea), vomiting, pain, increased muscle tension and shaking, headache, dizziness, breathing difficulties, wheezing, high or low blood pressure, heart rhythm disturbances (palpitations, heart fluttering or irregular heart beat), swelling of the face and lips, rash and feeling tired. Some of these symptoms can be serious and may lead to death of the patient.

    You should be under the observation of a healthcare professional during the drug administration, for six hours after the start of the first administration. On very rare occasions, patients have experienced the onset of infusion symptoms and pulmonary symptoms more than six hours after the start of the trastuzumab infusion. Patients should be warned of the possibility of such a late onset and should be instructed to contact their physician if these symptoms occur.

  • Severe pulmonary events

    Important pulmonary side effects include: Interstitial lung disease including lung infiltrates, acute respiratory distress syndrome, pneumonia, pneumonitis, pleural effusion, respiratory distress, acute pulmonary edema and respiratory insufficiency. These events have occasionally been fatal.

  • Haematotoxicity

    Febrile neutropenia, leukopenia, anaemia, thrombocytopenia and neutropenia occurred very commonly. The frequency of occurrence of hypoprothrombinemia is not known. The risk of neutropenia may be slightly increased when trastuzumab is administered with docetaxel following anthracycline therapy.

  • Side Effects on Pregnancy

    Hervycta® therapy may adversely affect the health of unborn baby resulting in death or birth defects. You should use effective contraception during treatment with Hervycta® and for at least 7 months after treatment has ended.In case of exposure to Hervycta® during pregnancy or within 7 months of becoming pregnant, consult your doctor immediately.

  • Other very commonly seen side effects of trastuzumab (may affect more than 1 in 10 people)

    • infections
    • diarrhoea
    • constipation
    • heartburn (dyspepsia)
    • weakness
    • skin rashes
    • chest pain
    • abdominal pain
    • joint pain
    • low counts of red blood cells and white blood cells (which help fight infection) sometimes with fever
    • bruising
    • numbness or tingling of the fingers and toes
    • redness, swelling or sores in your mouth and/or throat
    • cough
    • vomiting
    • muscle pain
    • conjunctivitis
    • watery eyes
    • nose bleeds
    • runny nose
    • hair loss
    • tremor
    • hot flush
    • dizziness
    • nail disorders
    • weight loss
    • loss of appetite
    • inability to sleep (insomnia)
    • altered taste
    • low platelet count
    • pain, swelling, redness or tingling of
    • hands and/or feet
    • breathlessness
    • headache
    • nausea

    For a full list of reported side effects, please see the Prescribing Information.


HERVYCTA® is contraindicated in the following conditions:

Appropriate usage

HER2 testing is mandatory prior to initiation of therapy (Detection of HER2 protein overexpression is necessary for selection of patients appropriate for HERVYCTA® therapy because these are the only patients studied and for whom benefit has been shown in clinical trials). There is no relevant use of trastuzumab in the paediatric population. Trastuzumab should be avoided during pregnancy unless the potential benefit for the mother outweighs the potential risk to the foetus. There is no information regarding the presence of trastuzumab in human milk, and the potential for harm to the baby is unknown. However human IgG is secreted into human milk, hence breastfeeding should be avoided during trastuzumab therapy and 7 months after the last dose. Fertility data is not available for trastuzumab. Trastuzumab has no or negligible influence on the ability to drive or use machines. However, patients experiencing infusion-related symptoms should be advised not to drive and use machines until symptoms subside. For more information, please see full Prescribing Information for HERVYCTA®.


There is no experience with over dosage in human clinical trials. Single doses of up to 960 mg of trastuzumab subcutaneous formulation have been administered with no reported untoward effects.


Do not dilute with glucose solutions since these cause aggregation of the protein.

For more information, please refer to the full Prescribing Information for HERVYCTA®.You should contact your doctor immediately if you have any of the side effects mentioned above.

You are encouraged to report side effects to



  1. HERVYCTA® (Trastuzumab) Prescribing information, Dr. Reddy’s.