Europe — EMA
Herceptin
Herceptin (trastuzumab) is a subcutaneous monoclonal antibody for HER2‑positive breast and gastric cancers; see uses, mechanism, side effects and precautions.
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What is Trastuzumab?
Herceptin is a prescription monoclonal antibody whose active ingredient is trastuzumab, provided as a subcutaneous injection (strength not specified) for use in the European Union. It belongs to the antineoplastic class and functions as a HER2 receptor antagonist. The product is indicated for HER2‑positive cancers and is administered by a healthcare professional, often in combination with chemotherapy or other targeted therapies as part of a treatment regimen.
What is Trastuzumab used for?
Herceptin is used in clinical practice for several HER2‑positive malignancies, where it targets the HER2 receptor to improve outcomes.
- Treatment of HER2‑positive metastatic breast cancer, often with chemotherapy. - Adjuvant therapy for HER2‑positive early‑stage breast cancer after surgery. - Management of HER2‑positive gastric or gastroesophageal adenocarcinoma. - Combined with taxane‑based chemotherapy in advanced disease settings. - Neoadjuvant use before surgery to increase pathological response rates. - Maintenance therapy following initial response in metastatic HER2‑positive disease. - Combined with pertuzumab to provide dual HER2 blockade in selected regimens.
What are the side effects of Trastuzumab?
Herceptin may cause a range of adverse reactions, which are generally categorized as common or serious.
Common: - Infusion‑related reactions such as fever, chills, flushing, or nausea during or shortly after administration. - Fatigue or generalized weakness that may affect daily activities. - Diarrhea or abdominal discomfort, sometimes with mild cramping. - Rash or mild skin irritation at the injection site, often presenting as redness or itching.
Serious: - Cardiac dysfunction, including reduced left ventricular ejection fraction, which may cause shortness of breath or edema. - Severe allergic reactions (anaphylaxis) with respiratory distress, hypotension, or urticaria requiring immediate medical attention. - Thrombocytopenia or neutropenia leading to increased risk of bleeding or infection, possibly necessitating treatment interruption.
What precautions apply to Trastuzumab?
When prescribing Herceptin, clinicians should consider several precautions to minimize risks and ensure safe use.
- Assess baseline cardiac function (e.g., left ventricular ejection fraction) before initiating therapy. - Monitor cardiac function periodically during treatment, especially in patients with prior heart disease. - Evaluate for pregnancy and advise appropriate contraception, as safety in pregnancy is not established. - Screen for active infections, including hepatitis B, before starting therapy. - Use caution in patients with known hypersensitivity to trastuzumab or any component of the formulation. - Adjust or discontinue treatment if severe adverse reactions or significant laboratory abnormalities occur.
What does Trastuzumab interact with?
Herceptin may interact with other medicines, and certain combinations should be avoided or used with caution.
Avoid: - Concurrent use with other HER2‑targeted monoclonal antibodies not studied, due to potential additive toxicity. - Live vaccines during treatment, because immunosuppression may reduce vaccine efficacy and increase infection risk.
Use with caution: - Anthracycline chemotherapy (e.g., doxorubicin) given sequentially, as combined cardiotoxicity may be increased. - Cardiotoxic agents such as trastuzumab‑emtansine or pertuzumab, requiring close cardiac monitoring. - Medications that prolong QT interval, which may exacerbate cardiac effects. - Hormonal therapies (e.g., tamoxifen) may have overlapping metabolic pathways; monitor for potential interactions.
Frequently asked questions
What type of medication is Herceptin and how is it administered?+
Which cancers are approved for treatment with Herceptin in the EU?+
How does trastuzumab target cancer cells?+
What are the most common side effects of Herceptin?+
What serious cardiac risks are associated with Herceptin?+
Should patients be screened for heart function before starting Herceptin?+
Can Herceptin be used during pregnancy?+
Are live vaccines safe for patients receiving Herceptin?+
What drug combinations increase the risk of cardiotoxicity with Herceptin?+
How is Herceptin monitored for safety during treatment?+
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