MedeliX
Start asking

apalutamide

Erleada · ATC code L02BB05

Also known as: Apalutamid

Key facts
Active substance
apalutamide
ATC code
L02BB05
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Erleada 60 mg film-coated tablets · Erleada 240 mg film-coated tablets
Marketing authorisation holder
Janssen-Cilag International NV
Information as of
2026-10-27

Key facts

Apalutamide is an androgen receptor inhibitor used in adult men with non-metastatic castration-resistant or metastatic hormone-sensitive prostate cancer.

What it is used for

  • Non-metastatic castration-resistant prostate cancer (nmCRPC) at high risk of metastasis
  • Metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (ADT)

Dosing

  • Erleada 60 mg: 240 mg (four 60 mg tablets) orally once daily.
  • Erleada 240 mg: 240 mg (one 240 mg tablet) orally once daily.
  • Medical castration with a GnRH analogue continues in patients not surgically castrated.
  • For ≥Grade 3 toxicity: hold until improvement, then resume at the same or a reduced dose (180 mg or 120 mg).
  • Severe hepatic impairment (Child-Pugh C): 120 mg once daily.
  • No adjustment for elderly patients or mild to moderate renal impairment; swallow tablets whole.

Contraindications

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

Important warnings

  • Seizure: not recommended with a history of seizures or predisposing factors; discontinue permanently if a seizure occurs
  • Falls and fractures: assess risk before starting and monitor
  • Ischaemic heart disease and ischaemic cerebrovascular disorders
  • Caution in severe renal impairment (not studied)

Side effects

  • Very common: fatigue (26%), skin rash (26%), hypertension (22%), hot flush (18%)
  • Arthralgia (17%), diarrhoea (16%), fall (13%), weight decreased (13%)
  • Fractures (11%), decreased appetite (11%), hypothyroidism (8%)
  • Seizure in 0.6% of patients in studies

Interactions

  • Apalutamide induces enzymes and transporters and may increase elimination of many medicines
  • Eliminated via CYP2C8 and CYP3A4; no clinically meaningful change expected with their inhibitors or inducers
  • Medicines lowering the seizure threshold may increase seizure risk

Pregnancy and breastfeeding

  • Contraindicated in women who are or may become pregnant; may cause foetal harm.
  • Men with female partners of reproductive potential: condom plus another highly effective contraceptive during treatment and for 3 months after.

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)

  • ErleadaJanssen-Cilag International NV · EMEA/H/C/004452

Source: European Medicines Agency (EMA), product information

Turkey

  • ErleadaJOHNSON AND JOHNSON SIHHİ MAL. SAN. VE 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
Erleada
Liechtenstein
Erleada
Norway
Erleada

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. Erleada – EPAR, Product Information. 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/erleada-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.