MedeliX
Start asking

brentuximab vedotin

Adcetris · ATC code L01FX05

Key facts
Active substance
brentuximab vedotin
ATC code
L01FX05
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
ADCETRIS 50 mg powder for concentrate for solution for infusion.
Marketing authorisation holder
Takeda Pharma A/S
Information as of
2026-10-27

Key facts

Brentuximab vedotin (Adcetris) is a CD30-directed antibody-drug conjugate for CD30-positive Hodgkin lymphoma, systemic anaplastic large cell lymphoma and cutaneous T-cell lymphoma in adults.

What it is used for

  • Previously untreated CD30+ Stage III or IV Hodgkin lymphoma in combination with AVD
  • Previously untreated CD30+ Hodgkin lymphoma (Stage IIB with risk factors, III or IV) in combination with BrECADD
  • CD30+ Hodgkin lymphoma at increased risk of relapse after autologous stem cell transplant, and relapsed/refractory disease
  • Previously untreated systemic anaplastic large cell lymphoma (sALCL) with CHP, and relapsed/refractory sALCL
  • CD30+ cutaneous T-cell lymphoma after at least 1 prior systemic therapy

Dosing

  • With AVD: 1.2 mg/kg infused over 30 minutes on days 1 and 15 of each 28-day cycle for 6 cycles; primary G-CSF prophylaxis recommended
  • With BrECADD: 1.8 mg/kg every 3 weeks for up to 6 cycles; G-CSF from day 5 of each cycle and antibiotic prophylaxis
  • Increased relapse risk after transplant: 1.8 mg/kg every 3 weeks, up to 16 cycles
  • Relapsed/refractory HL: 1.8 mg/kg every 3 weeks until progression or unacceptable toxicity
  • sALCL with CHP: 1.8 mg/kg every 3 weeks for 6 to 8 cycles
  • Further regimens and dose adjustments (e.g. for neutropenia) in the full text

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Combined use with bleomycin (pulmonary toxicity)

Important warnings

  • Progressive multifocal leukoencephalopathy (PML) from JCV reactivation, including death; hold dosing if suspected, discontinue permanently if confirmed
  • Monitor for new neurological, cognitive or behavioural signs
  • Pancreatitis may occur (details in full text)
  • Batch number should be recorded for traceability

Side effects

  • Monotherapy, most frequent: infections, peripheral sensory neuropathy, nausea, fatigue, diarrhoea, pyrexia, neutropenia
  • Also frequent: arthralgia, rash, cough, vomiting, pruritus, peripheral motor neuropathy, infusion-related reactions

Interactions

  • Strong CYP3A4 and P-gp inhibitors (e.g. ketoconazole) increase MMAE exposure and may increase neutropenia
  • Rifampicin appeared to reduce concentrations of MMAE metabolites
  • Bleomycin: contraindicated

Pregnancy and breastfeeding

  • Women of childbearing potential: two effective contraceptive methods during and until 6 months after treatment
  • Not to be used in pregnancy unless the benefit to the mother outweighs the potential risk to the foetus

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.

Full official text →

Common questions – ask Medelix

For patients

Package leaflet, verbatim

Package leaflet for patients →

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)

  • AdcetrisTakeda Pharma A/S · EMEA/H/C/002455

Source: European Medicines Agency (EMA), product information

Turkey

  • AdcetrisTAKEDA İLAÇ SAĞLIK SAN. TİC. LTD. ŞTİ. · 1 register entry

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 3 more European countries
Iceland
Adcetris
Liechtenstein
Adcetris
Norway
Adcetris

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.

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

  1. European Medicines Agency. Adcetris – 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/adcetris-epar-product-information_en.pdf
  2. 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.