Europe — EMA
Herzuma
Herzuma (trastuzumab) is an EU‑approved monoclonal antibody for HER2‑positive breast and gastric cancers. Mechanism, uses, safety and FAQs.
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What is Trastuzumab?
Herzuma is a prescription monoclonal antibody whose active ingredient is trastuzumab, supplied as a sterile solution for injection. It is marketed in the European Union and is classified as an antineoplastic agent. The product is administered intravenously and targets HER2‑positive cancers. As a biosimilar of reference trastuzumab, Herzuma is used for HER2‑positive breast and gastric cancers after specialist evaluation.
What is Trastuzumab used for?
Herzuma is prescribed for patients whose tumors overexpress the human epidermal growth factor receptor 2 (HER2). The drug is used in both early and advanced disease settings across several cancer types. - HER2‑positive metastatic breast cancer, in combination with chemotherapy. - HER2‑positive early breast cancer, as adjuvant or neoadjuvant therapy. - HER2‑positive gastric or gastro‑esophageal junction adenocarcinoma, together with chemotherapy. - HER2‑positive locally advanced or unresectable breast cancer, when surgery is not feasible. - HER2‑positive disease in patients who have completed prior trastuzumab‑containing regimens, as per clinical guidance.
What are the side effects of Trastuzumab?
Adverse reactions to Herzuma vary in frequency and severity, reflecting its immunologic and vascular effects. Common: - Infusion‑related reactions such as fever, chills, flushing, or hypotension. - Nausea, vomiting, or mild gastrointestinal upset including abdominal discomfort. - Fatigue, headache, dizziness, or mild skin rash at the injection site. Serious: - Cardiac dysfunction, including reduced left ventricular ejection fraction or congestive heart failure. - Severe hypersensitivity or anaphylactic reactions, potentially requiring emergency treatment. - Thromboembolic events such as deep‑vein thrombosis, pulmonary embolism, or arterial occlusion.
What precautions apply to Trastuzumab?
Before initiating Herzuma, clinicians should evaluate several patient‑specific factors to minimize risk and ensure appropriate monitoring. - Assess baseline cardiac function with echocardiography or MUGA scan, and repeat periodically. - Review history of hypersensitivity reactions to monoclonal antibodies or trastuzumab‑containing products. - Evaluate hepatic and renal function, adjusting treatment if significant impairment is present. - Monitor for signs of infusion‑related reactions during and after each administration. - Use caution in patients with uncontrolled hypertension or active infections. - Discuss contraception and potential fetal risks, as safety in pregnancy has not been established.
What does Trastuzumab interact with?
Herzuma may interact with other medicines that affect cardiac function, immune response, or drug clearance. Avoid: - Concurrent use of anthracyclines (e.g., doxorubicin) due to increased risk of cardiotoxicity. - Live vaccines during treatment, because immune suppression may reduce vaccine efficacy and increase infection risk. Use with caution: - Chemotherapeutic agents that also cause myelosuppression, requiring close blood count monitoring. - Medications that prolong QT interval, as cardiac monitoring is already indicated. - Hormonal therapies (e.g., tamoxifen) that may have additive cardiac effects.
Frequently asked questions
What type of medication is Herzuma?+
Which cancers are approved for treatment with Herzuma in the EU?+
How does trastuzumab target HER2‑positive tumors?+
Is cardiac monitoring required when using Herzuma?+
Can Herzuma be given together with chemotherapy?+
What are the most common side effects of Herzuma?+
What serious adverse reactions should patients be aware of?+
Should patients receive live vaccines while on Herzuma?+
Is Herzuma safe to use during pregnancy?+
What laboratory tests are recommended before starting Herzuma?+
Can trastuzumab cause interactions with anthracycline chemotherapy?+
How is Herzuma administered?+
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