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elacestrant

Orserdu · ATC code L02BA04

Also known as: Elasestrant

Key facts
Active substance
elacestrant
Drug class
Estrogen antagonist
ATC code
L02BA04
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
ORSERDU 86 mg film-coated tablets / ORSERDU 345 mg film-coated tablets
Marketing authorisation holder
Stemline Therapeutics B.V.
Information as of
2026-10-28

Key facts

Elacestrant (Orserdu) is an oral selective estrogen receptor degrader. It is used for advanced ER-positive, HER2-negative breast cancer with an ESR1 mutation.

What it is used for

  • Monotherapy for postmenopausal women, and men, with ER-positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation after progression on at least one line of endocrine therapy including a CDK 4/6 inhibitor.
  • The ESR1 mutation must be detected in plasma with a validated test.

Dosing

  • Recommended dose: 345 mg once daily (maximum dose), as long as clinical benefit is observed.
  • Dose reduction for adverse reactions: 258 mg once daily (three 86 mg tablets); if further reduction is needed, discontinue.
  • Hepatic impairment: moderate (Child-Pugh B) 258 mg, severe (Child-Pugh C) 86 mg once daily.
  • If a strong CYP3A4 inhibitor cannot be avoided: 86 mg once daily; with a moderate inhibitor 172 mg once daily.
  • A missed dose can be taken within 6 hours, otherwise skip it for that day; no additional dose after vomiting.

Contraindications

  • Hypersensitivity to the active substance or any of the excipients.

Important warnings

  • Hepatic impairment can increase the risk of adverse reactions; use cautiously with close monitoring.
  • Avoid strong and moderate CYP3A4 inhibitors (including grapefruit) and strong or moderate CYP3A4 inducers.
  • Thromboembolic events have been observed; consider this in patients at risk.
  • Fatigue, asthenia and insomnia may affect driving.

Side effects

  • Very common (≥10%): nausea, increased triglycerides and cholesterol, vomiting, fatigue, dyspepsia, diarrhoea, back pain, arthralgia, headache, hot flush, abdominal pain, anaemia, electrolyte changes, ALT increased.
  • Serious in ≥1%: nausea, dyspnoea and venous thromboembolism.

Interactions

  • Itraconazole increased elacestrant exposure 5.3-fold.
  • Strong or moderate CYP3A4 inducers may reduce its effect and should be avoided.
  • Elacestrant inhibits P-gp and BCRP and may increase levels of their substrates.

Pregnancy and breastfeeding

  • Should not be used during pregnancy; can cause foetal harm. Effective contraception during treatment and one week after the last dose.
  • Do not breast-feed during treatment and for one week after the last dose.

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.

Full official text →

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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)

  • OrserduStemline Therapeutics B.V. · EMEA/H/C/005898

Source: European Medicines Agency (EMA), product information

Turkey

  • OrserduMENARİNİ STEMLINE İLAÇ SAN. VE TİC. A.Ş. · 2 register entries

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

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

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

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Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Orserdu – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/orserdu-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85
  3. Wikidata (CC0): ATC L02BA.

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.