GNH USA

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.

Trastuzumab

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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?+
The active ingredient in Herwenda is trastuzumab, a monoclonic antibody that targets the HER2 receptor.
For which cancers is Herwenda indicated in the European Union?+
Herwenda is indicated for HER2‑positive breast cancer and HER2‑positive gastric or gastro‑esophageal junction adenocarcinoma.
How is Herwenda administered to patients?+
Herwenda is given by intravenous infusion under the supervision of a qualified healthcare professional.
Can Herwenda be used together with chemotherapy?+
Yes, Herwenda is commonly combined with chemotherapy agents, such as taxanes, to enhance treatment efficacy in HER2‑positive cancers.
What cardiac monitoring is recommended during Herwenda therapy?+
Baseline and periodic evaluation of left ventricular ejection fraction by echocardiogram or MUGA scan is recommended to detect potential cardiac dysfunction.
What are common infusion‑related side effects of Herwenda?+
Common infusion‑related reactions include fever, chills, nausea, fatigue, headache, and mild skin rash.
Is Herwenda safe for use during pregnancy?+
Herwenda is generally avoided during pregnancy and breastfeeding unless the potential benefits outweigh the risks, as safety data are limited.
What should be done if a patient experiences a severe allergic reaction to Herwenda?+
Infusion should be stopped immediately, and appropriate emergency measures, such as administration of epinephrine and antihistamines, should be initiated.
Are there any known drug interactions with Herwenda?+
Herwenda should not be used concurrently with anthracyclines due to increased cardiotoxicity risk, and live vaccines should be avoided during treatment.
What is the mechanism by which trastuzumab exerts its antitumor effect?+
Trastuzumab binds to the extracellular domain of HER2, blocks receptor dimerization, inhibits downstream signaling, and induces antibody‑dependent cellular cytotoxicity.
How often are cardiac function tests performed while on Herwenda?+
Cardiac assessments are typically performed before treatment initiation and then every three months, or more frequently if clinically indicated.
Can Herwenda be used as a single agent without chemotherapy?+
Herwenda can be used as monotherapy in certain clinical scenarios, but it is often more effective when combined with chemotherapy or other HER2‑targeted agents.
Information provided on this page is for educational use by procurement and clinical professionals. Always consult a licensed healthcare provider for medical advice and prescribing decisions. GNH USA supplies this product subject to applicable regulatory and licensing requirements.

Product details

Drug
Trastuzumab
Route
Intravenous Use
Manufacturer
Sandoz Gmbh
Origin
EU

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