Finished product reference
Pertuzumab / Trastuzumab
Injection · Parenteral · 80 mg/40 mg/1mL · 15 mL
- List code
- 53124
- Pharmacologic class
- Antineoplastic; combination of two anti-HER2 monoclonal antibodies
What it is and how it works
Pertuzumab binds the extracellular dimerisation domain II of HER2 and blocks ligand-dependent heterodimerisation with other HER receptors, while trastuzumab binds domain IV and inhibits ligand-independent HER2 signalling and mediates antibody-dependent cellular cytotoxicity. Together they produce a more complete blockade of HER2 signalling.
Indications
HER2-positive early breast cancer (neoadjuvant and adjuvant treatment in patients at high risk of recurrence) and HER2-positive metastatic or locally recurrent unresectable breast cancer, in combination with chemotherapy.
Dosage and administration (summary)
For the fixed-dose subcutaneous combination: loading dose pertuzumab 1200 mg/trastuzumab 600 mg, then pertuzumab 600 mg/trastuzumab 600 mg every 3 weeks; intravenous co-administered products are dosed per their own labels.
Contraindications
Hypersensitivity to pertuzumab, trastuzumab or any excipient.
Warnings and precautions
May reduce left ventricular ejection fraction and cause heart failure; assess LVEF before and regularly during treatment. Injection- or infusion-related and hypersensitivity reactions, including anaphylaxis, may occur. Diarrhoea and, with chemotherapy, febrile neutropenia are common.
Pregnancy
Avoid: may cause embryo-fetal toxicity including oligohydramnios; effective contraception is required during and for 7 months after the last dose.
Storage and supply
Store at 2–8 °C in a refrigerator; do not freeze; keep in the outer carton to protect from light.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Other presentations of the same active ingredient
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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