trastuzumab
Herceptin, Tuznue · ATC code L01FD01
Brand names: Herceptin, Tuznue, Canhera, Herzuma, Teruvia, Trazimera
- Key facts
- Active substance
- trastuzumab
- ATC code
- L01FD01
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Herceptin 150 mg powder for concentrate for solution for infusion · Herceptin 600 mg solution for injection in vial · Tuznue 150 mg powder for concentrate for solution for infusion / Tuznue 420 mg powder for concentrate for solution for infusion
- Marketing authorisation holder
- Roche Registration GmbH, Prestige Biopharma Belgium
- Information as of
- 2026-10-27
Key facts
Trastuzumab (e.g. Herceptin, Tuznue) is a HER2-directed monoclonal antibody for HER2-positive breast cancer and HER2-positive metastatic gastric cancer in adults.
What it is used for
- HER2-positive metastatic breast cancer: monotherapy after at least two chemotherapy regimens, or with paclitaxel, docetaxel or an aromatase inhibitor
- HER2-positive early breast cancer: after surgery and chemotherapy, or with adjuvant or neoadjuvant chemotherapy
- HER2-positive metastatic adenocarcinoma of the stomach or gastro-oesophageal junction with capecitabine or 5-fluorouracil and cisplatin
Dosing
- HER2 testing is mandatory before starting
- Intravenous, three-weekly: loading dose 8 mg/kg, then 6 mg/kg every three weeks
- Intravenous, weekly (metastatic breast cancer): loading dose 4 mg/kg, then 2 mg/kg weekly
- Herceptin subcutaneous: 600 mg irrespective of body weight every three weeks over 2-5 minutes, no loading dose
- Early breast cancer: 1 year or until recurrence; metastatic disease: until progression
- No dose reduction; suspend treatment if LVEF drops (criteria in full text)
Contraindications
- Hypersensitivity to trastuzumab, murine proteins or any excipient (subcutaneous form: also hyaluronidase)
- Severe dyspnoea at rest due to advanced malignancy or requiring supplementary oxygen
Important warnings
- Cardiac dysfunction and congestive heart failure; monitor LVEF before and during treatment
- Serious infusion-related and hypersensitivity reactions including anaphylaxis
- Pulmonary adverse reactions
- Avoid confusion with trastuzumab emtansine or deruxtecan, and between intravenous and subcutaneous forms
Side effects
- Among the most serious and/or common: cardiac dysfunction, infusion-related reactions, haematotoxicity (in particular neutropenia), infections and pulmonary adverse reactions
Interactions
- No formal interaction studies; no clinically significant interactions observed in trials
- May increase exposure of one doxorubicin metabolite
Pregnancy and breastfeeding
- Effective contraception during and for 7 months after treatment
- Cases of oligohydramnios with foetal renal impairment, some with fatal pulmonary hypoplasia, reported in pregnancy
Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
Common questions – ask Medelix
For patients
Package leaflet, verbatim
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
EU – centrally authorised (all member states)
- Dazublys · biosimilarCuraTeQ Biologics (Malta) Limited · EMEA/H/C/006219
- HerceptinRoche Registration GmbH · EMEA/H/C/000278
- Herwenda · biosimilarSandoz GmbH · EMEA/H/C/005769
- Herzuma · biosimilarCelltrion Healthcare Hungary Kft. · EMEA/H/C/002575
- Kanjinti · biosimilarAmgen Europe B.V. · EMEA/H/C/004361
- Ogivri · biosimilarBiosimilar Collaborations Ireland Limited · EMEA/H/C/004916
- Ontruzant · biosimilarSamsung Bioepis NL B.V. · EMEA/H/C/004323
- Trazimera · biosimilarPfizer Europe MA EEIG · EMEA/H/C/004463
- TuznuePrestige Biopharma Belgium · EMEA/H/C/006252
- Zercepac · biosimilarAccord Healthcare S.L.U. · EMEA/H/C/005209
Source: European Medicines Agency (EMA), product information
Turkey
- CanheraABDİ İBRAHİM İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
- HerceptinROCHE MÜSTAHZARLARI SAN.A.Ş. · 2 register entries
- HerzumaCELLTRİON HEALTHCARE İLAÇ SAN. VE TİC. LTD. ŞTİ. · 1 register entry
- TeruviaYERLİKA BİOPHARMA İLAÇ SANAYİ VE TİCARET ANONİM ŞİRKETİ · 1 register entry
- TrazimeraPFİZER PFE İLAÇLARI A.Ş. · 1 register entry
Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16
Brand names in 3 more European countries
- Iceland
- Dazublys, Herceptin, Herwenda, Herzuma, Kanjinti, Ogivri, Trazimera, Tuznue, Zercepac
- Liechtenstein
- Dazublys, Herceptin, Herwenda, Herzuma, Ogivri, Trazimera, Tuznue, Zercepac
- Norway
- Dazublys, Herceptin, Herwenda, Herzuma, Kanjinti, Ogivri, Trazimera, Tuznue, Zercepac
EMA – Article 57 product data (EU/EEA), 2026-10-28
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
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Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Herceptin – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/herceptin-epar-product-information_en.pdf
- European Medicines Agency. Tuznue – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/tuznue-epar-product-information_en.pdf
- TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error
Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.