pertuzumab
Perjeta · ATC code L01FD02
- Key facts
- Active substance
- pertuzumab
- ATC code
- L01FD02
- Authorisation
- centrally authorised across the EU (EMA)
- Dosage forms
- Perjeta 420 mg concentrate for solution for infusion
- Marketing authorisation holder
- Roche Registration GmbH
- Information as of
- 2026-10-28
Key facts
Pertuzumab (Perjeta) is a HER2-directed monoclonal antibody used for HER2-positive early and metastatic breast cancer, in combination with trastuzumab and chemotherapy.
What it is used for
- Early breast cancer: neoadjuvant treatment of HER2-positive locally advanced, inflammatory or early breast cancer at high risk of recurrence, and adjuvant treatment of HER2-positive early breast cancer at high risk of recurrence, with trastuzumab and chemotherapy.
- Metastatic breast cancer: with trastuzumab and docetaxel for HER2-positive metastatic or locally recurrent unresectable breast cancer without prior anti-HER2 therapy or chemotherapy for metastatic disease.
- Requires HER2-positive tumour status (IHC 3+ and/or ISH ratio ≥ 2.0).
Dosing
- Initial loading dose 840 mg as a 60 minute intravenous infusion, then 420 mg every 3 weeks over 30 to 60 minutes; observe for 30 - 60 minutes after each infusion.
- Neoadjuvant: 3 to 6 cycles; adjuvant: a total of one year (up to 18 cycles).
- Metastatic: until disease progression or unmanageable toxicity, even if docetaxel is discontinued.
- With a taxane: give Perjeta and trastuzumab before the taxane; with an anthracycline regimen, after its completion.
- Delayed or missed dose (less than 6 weeks): give 420 mg as soon as possible; otherwise see the full text.
Contraindications
- Hypersensitivity to the active substance or any excipient.
Important warnings
- Left ventricular dysfunction including congestive heart failure; assess LVEF before and regularly during treatment. Not studied with LVEF < 50% or prior heart failure.
- Infusion-related and hypersensitivity reactions, including fatal events; observe patients closely.
- Febrile neutropenia, especially with docetaxel.
- Severe diarrhoea may occur; treat early.
Side effects
- Most common (≥30%): diarrhoea, alopecia, nausea, fatigue, neutropenia and vomiting.
- Most common Grade 3-4 reactions (≥10%): neutropenia and febrile neutropenia.
- Others: rash, mucosal inflammation, peripheral neuropathy, interstitial lung disease, left ventricular dysfunction.
Interactions
- No pharmacokinetic interactions with trastuzumab, docetaxel, paclitaxel, gemcitabine, capecitabine, carboplatin or erlotinib.
Pregnancy and breastfeeding
- Not recommended during pregnancy; effective contraception during treatment and for 6 months after the last dose.
- Breast-feeding: weigh breast-feeding against therapy.
Summary of the official product information, written with AI on 2026-10-29. 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
This product has no separate US patient information.
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)
Source: European Medicines Agency (EMA), product information
Turkey
- PectunaYERLİKA İLAÇ SANAYİ VE TİCARET ANONİM ŞİRKETİ · 1 register entry
- PerjetaROCHE MÜSTAHZARLARI SAN.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
- Perjeta, Poherdy
- Liechtenstein
- Perjeta, Poherdy
- Norway
- Perjeta, Poherdy
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
Another question about this substance?
Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- European Medicines Agency. Perjeta – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/perjeta-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 2026-10-28 · 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.