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enzalutamide

Xtandi · ATC code L02BB04

Also known as: Enzalutamid · Brand names: Xtandi, Englabloc, Enzalutamide Sandoz, Enzalutamid Accord, Enzalutamid Al, Enzalutamid Hexal, Enzalutamid Ratiopharm, Enzalutamid Stada, Enzadre, Pronzamid

Key facts
Active substance
enzalutamide
ATC code
L02BB04
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Xtandi - 40 mg soft capsules · Xtandi - 40 mg film-coated tablets / Xtandi - 80 mg film-coated tablets
Marketing authorisation holder
Astellas Pharma Europe B.V.
Information as of
2026-10-27

Key facts

Enzalutamide is an androgen receptor inhibitor (Xtandi soft capsules and film-coated tablets). It is used in adult men with hormone-sensitive or castration-resistant prostate cancer.

What it is used for

  • High-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer (nmHSPC) unsuitable for salvage radiotherapy (alone or with androgen deprivation therapy)
  • Metastatic hormone-sensitive prostate cancer (mHSPC) with androgen deprivation therapy
  • High-risk non-metastatic castration-resistant prostate cancer (CRPC)
  • Metastatic CRPC: asymptomatic or mildly symptomatic after failure of androgen deprivation, or progressed on or after docetaxel

Dosing

  • 160 mg once daily (four 40 mg capsules or tablets, or two 80 mg tablets)
  • Continue LHRH-analogue castration in CRPC or mHSPC patients not surgically castrated
  • High-risk nmHSPC: treatment can be suspended if PSA is undetectable (< 0.2 ng/mL) after 36 weeks; reinitiate on PSA rise as set out in the full text
  • For ≥ Grade 3 toxicity: withhold for one week or until ≤ Grade 2, then resume at the same or a reduced dose (120 mg or 80 mg)
  • With strong CYP2C8 inhibitors: reduce to 80 mg once daily
  • No adjustment in hepatic impairment or mild to moderate renal impairment; caution in severe renal impairment

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Women who are or may become pregnant

Important warnings

  • Seizure; continuing treatment after a seizure is decided case by case
  • Posterior reversible encephalopathy syndrome (PRES), rare; discontinuation recommended
  • Second primary malignancies (e.g. bladder cancer) have been reported
  • QT prolongation: assess benefit and risk in patients with risk factors or QT-prolonging medicines
  • Potent enzyme inducer with many interactions

Side effects

  • Most common: asthenia/fatigue, hot flush, hypertension, fractures, fall, headache
  • Other important: ischaemic heart disease and seizure (0.6%)
  • Rare PRES; Stevens-Johnson syndrome has been reported

Interactions

  • Strong CYP2C8 inhibitors (e.g. gemfibrozil): avoid or reduce dose to 80 mg; gemfibrozil increased enzalutamide AUC by 326%
  • Enzalutamide is a potent enzyme inducer and may lower levels of many medicines
  • P-gp substrates with a narrow therapeutic range (e.g. colchicine, dabigatran etexilate, digoxin): use with caution
  • Falsely elevated digoxin results with the CMIA immunoassay

Pregnancy and breastfeeding

  • Not for use in women; may harm the unborn child
  • Men: condom during and for 3 months after treatment if partner is pregnant; condom plus another method if partner is of childbearing potential

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)

Source: European Medicines Agency (EMA), product information

Austria

  • EnglablocG.L. Pharma Gmbh · 1 register entry
  • Enzalutamid1a Pharma Gmbh, Sandoz Gmbh, Zentiva, K.S., Accord Healthcare B.V., Stada Arzneimittel Gmbh, Teva Gmbh · 6 register entries
  • Enzalutamide SandozSandoz Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Germany

  • Enzalutamid AccordAccord Healthcare B.V. · 1 register entry
  • Enzalutamid AlAliud Pharma Gmbh · 1 register entry
  • Enzalutamid HexalAdalvo Limited, Hexal Ag · 2 register entries
  • Enzalutamid RatiopharmRatiopharm Gmbh · 1 register entry
  • Enzalutamid StadaStadapharm Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-28

Turkey

  • EnzadreSABA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • PronzamidPOLİFARMA İLAÇ SAN. VE TİC. A.Ş. · 1 register entry
  • XtandiASTELLAS PHARMA İLAÇ TİC. VE SAN. A.Ş. · 1 register entry

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

Brand names in 28 more European countries
Belgium
Enzalutamide Accord, Enzalutamide Eg, Enzalutamide Teva
Bulgaria
Ензалутамид Sdz, Ензалутамид Сандоз, Ензалутамид Стада, Ензалутамид Тева, Ензалутамид Фармасайънс
Croatia
Enzalutamid Accord, Enzalutamid Pharmascience, Enzalutamid Sandoz D.O.O., Enzalutamid Stada, Enzalutamid Teva, Enzalutamid Zentiva, Enzalutamide Sandoz
Cyprus
Enzalutamide Accord, Enzalutamide Ebewe, Enzalutamide Sandoz, Enzalutamide Stada
Czechia
Enzalutamid Sandoz S.R.O., Enzalutamid Stada, Enzalutamid Teva, Enzalutamid Zentiva, Enzalutamide Accord, Enzalutamide Agmed, Enzalutamide Sandoz, Tagant
Denmark
Enzalutamide "sandoz", Enzalutamide Hexal, Enzalutamide Stada, Enzalutamide Teva, Enzalutamide Zentiva
Estonia
Enzalutamide Accord, Enzalutamide Norameda, Enzalutamide Sandoz, Enzalutamide Stada
Finland
Enzalutamide
France
Enzalutamide Accord, Enzalutamide Biogaran, Enzalutamide Eg, Enzalutamide Gnr, Enzalutamide Qilu, Enzalutamide Sandoz, Enzalutamide Sun, Enzalutamide Zentiva
Greece
Enzalutamide Accord, Enzalutamide Anabiosis, Enzalutamide Ebewe, Enzalutamide Pharmazac, Enzalutamide Sandoz, Enzalutamide Stada, Enzalutamide Zentiva, Inzamoda, Melediz
Hungary
Enzalutamid, Enzalutamide Accord, Enzalutamide Pharmascience, Enzalutamide Richter, Enzalutamide Sandoz, Enzalutamide Stada, Enzalutamide Zentiva, Tagant
Iceland
Enzalutamide Accordpharma, Enzalutamide Hexal, Enzalutamide Sandoz, Enzalutamide Teva, Enzalutamide Viatris, Xtandi
Ireland
Enzalutamide Accord, Enzalutamide Clonmel, Enzalutamide Rowex, Enzalutamide Sandoz, Enzalutamide Zentiva
Italy
Enzalutamide Accord, Enzalutamide Eg, Enzalutamide Sandoz, Enzalutamide Teva, Enzalutamide Zentiva, Midamid, Midanex
Latvia
Enzalutamide Accord, Enzalutamide Hexal, Enzalutamide Norameda, Enzalutamide Sandoz, Enzalutamide Stada
Liechtenstein
Enzalutamide Accordpharma, Enzalutamide Viatris, Xtandi
Lithuania
Enzalutamide Accord, Enzalutamide Hexal, Enzalutamide Norameda, Enzalutamide Sandoz, Enzalutamide Stada
Luxembourg
Enzalutamide Eg
Malta
Enzalutamid Pharos, Enzalutamide
Netherlands
Enzalutamide, Inzamoda, Midamid, Midanex, Tagant, Telauburite
Norway
Enzalutamide Accord, Enzalutamide Accordpharma, Enzalutamide Hexal, Enzalutamide Qilu, Enzalutamide Sandoz, Enzalutamide Stada, Enzalutamide Teva, Enzalutamide Viatris, Enzalutamide Zentiva, Xtandi
Poland
Enzalutamid Sandoz, Enzalutamide, Tagant
Portugal
Enzalutamida Stada, Enzalutamida Teva, Enzalutamida Zentiva
Romania
Enzalutamida Rhei, Enzalutamidă Accord, Enzalutamidă Sandoz, Enzalutamidă Stada, Enzalutamidă Terapia, Enzalutamidă Teva, Enzalutamidă Zentiva, Tagant
Slovakia
Englabloc, Enzalutamid Sandoz, Enzalutamide Agmed, Enzalutamide Stada, Tagant
Slovenia
Enzalutamid Sandoz, Enzalutamid Stada
Spain
Enzalutamida Accord, Enzalutamida Sandoz, Enzalutamida Stada, Enzalutamida Sun Pharma, Enzalutamida Tevagen, Enzalutamida Zentiva
Sweden
Enzalutamid Sun Pharma, Enzalutamide Hexal, Enzalutamide Sandoz, Enzalutamide Stada, Enzalutamide Sun, Enzalutamide Teva, Enzalutamide Zentiva

EMA – Article 57 product data (EU/EEA), 2026-10-28

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Sources

  1. European Medicines Agency. Xtandi – 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/xtandi-epar-product-information_en.pdf
  2. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-28. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. 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.