Europe — EMA
Herwenda
Herwenda trastuzumab is an EU‑approved IV monoclonal antibody for HER2‑positive breast and gastric cancers. Learn uses, mechanism, side effects, and precautions.
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What is Trastuzumab?
Herwenda is a trastuzumab‑containing intravenous medication, supplied in a defined strength and dosage form, approved for prescription use in the European Union. It is a monoclonal antibody that targets the HER2 receptor and is classified as an antineoplastic agent. The product is indicated for HER2‑positive cancers and is typically used in combination with chemotherapy or as part of a targeted therapy regimen in clinical practice.
What is Trastuzumab used for?
Herwenda is prescribed for patients whose tumors overexpress the human epidermal growth factor receptor 2 (HER2). It is used as part of a treatment plan that may include chemotherapy, surgery, or radiation.
- HER2‑positive breast cancer (early‑stage or metastatic) - HER2‑positive gastric or gastro‑esophageal junction adenocarcinoma - Adjuvant therapy following surgical resection of HER2‑positive breast cancer - Neoadjuvant therapy to shrink HER2‑positive tumors before surgery - Combination regimens with taxane‑based chemotherapy in metastatic disease
What are the side effects of Trastuzumab?
Adverse reactions to Herwenda are reported across clinical studies and may vary in frequency and severity. The frequency of each event depends on patient factors and treatment duration.
Common: - Infusion‑related reactions (fever, chills, nausea) - Fatigue or asthenia - Diarrhea or abdominal discomfort - Rash or mild skin irritation - Headache - Upper respiratory symptoms - Elevated liver enzymes
Serious: - Cardiac dysfunction, including decreased left ventricular ejection fraction - Severe hypersensitivity reactions such as anaphylaxis - Thromboembolic events (deep vein thrombosis, pulmonary embolism) - Interstitial lung disease - Hepatotoxicity
What precautions apply to Trastuzumab?
Before initiating Herwenda, clinicians should evaluate patient history and monitor specific parameters throughout therapy.
- Baseline and periodic assessment of cardiac function (e.g., echocardiogram) - Review of prior infusion reactions or hypersensitivity to monoclonal antibodies - Caution in patients with pre‑existing cardiac disease or reduced ejection fraction - Monitor liver function tests during treatment - Avoid use in pregnant or breastfeeding women unless benefits outweigh risks - Adjust therapy in patients with severe renal impairment if applicable
What does Trastuzumab interact with?
Herwenda may interact with other agents that affect cardiac function or immune response.
Avoid: - Concurrent use with anthracyclines (e.g., doxorubicin) due to increased cardiotoxicity risk - Live vaccines during treatment because of immunosuppression
Use with caution: - Other HER2‑targeted therapies (pertuzumab, lapatinib) as combined cardiotoxic potential - Medications that prolong QT interval - Concomitant chemotherapy agents that may exacerbate infusion reactions - Steroids that may mask early signs of hypersensitivity
Frequently asked questions
What is the active ingredient in Herwenda?+
For which cancers is Herwenda indicated in the European Union?+
How is Herwenda administered to patients?+
Can Herwenda be used together with chemotherapy?+
What cardiac monitoring is recommended during Herwenda therapy?+
What are common infusion‑related side effects of Herwenda?+
Is Herwenda safe for use during pregnancy?+
What should be done if a patient experiences a severe allergic reaction to Herwenda?+
Are there any known drug interactions with Herwenda?+
What is the mechanism by which trastuzumab exerts its antitumor effect?+
How often are cardiac function tests performed while on Herwenda?+
Can Herwenda be used as a single agent without chemotherapy?+
Product details
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