Finished product reference
Trastuzumab Deruxtecan
Injection, Powder, for Solution · Parenteral · 100 mg
- List code
- 53090
- Pharmacologic class
- Antineoplastic; HER2-directed antibody–drug conjugate (topoisomerase I inhibitor payload)
What it is and how it works
Trastuzumab deruxtecan consists of a humanised anti-HER2 IgG1 antibody linked by a cleavable tetrapeptide linker to deruxtecan, a topoisomerase I inhibitor. After binding to HER2 and internalisation, the linker is cleaved and the membrane-permeable payload causes DNA damage and apoptosis in target cells and neighbouring tumour cells (bystander effect), which enables activity even in HER2-low tumours.
Indications
Unresectable or metastatic HER2-positive breast cancer after prior anti-HER2 therapy; unresectable or metastatic HER2-low breast cancer after prior chemotherapy in the metastatic setting (or relapse soon after adjuvant chemotherapy); advanced HER2-mutant non-small cell lung cancer; advanced HER2-positive gastric or gastro-oesophageal junction adenocarcinoma after a prior trastuzumab-based regimen.
Dosage and administration (summary)
By intravenous infusion every 3 weeks: 5.4 mg/kg for breast and lung cancer and 6.4 mg/kg for gastric cancer, with dose reductions or interruptions for toxicity.
Contraindications
Hypersensitivity to trastuzumab deruxtecan or excipients.
Warnings and precautions
Interstitial lung disease/pneumonitis, including fatal cases, may occur; monitor for respiratory symptoms and permanently discontinue in symptomatic (grade 2 or higher) ILD. Neutropenia, left ventricular dysfunction and marked nausea occur; monitor blood counts and LVEF and use antiemetic prophylaxis. Not interchangeable with trastuzumab or trastuzumab emtansine; check product names to avoid medication errors.
Pregnancy
Can cause fetal harm and should not be used in pregnancy; effective contraception is required during and for several months after treatment.
Storage and supply
Store unopened vials refrigerated at 2–8 °C in the original carton to protect from light; do not freeze.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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