Finished product reference
Imlunestrant
Tablet · Oral · 200 mg
- List code
- 53786
- Pharmacologic class
- Antineoplastic: oral selective oestrogen receptor degrader (SERD)
What it is and how it works
Imlunestrant is an oral oestrogen receptor antagonist and degrader. It binds to wild-type and mutant (including ESR1-mutated) oestrogen receptor alpha, blocks oestrogen-driven transcription and promotes receptor degradation, inhibiting growth of ER-positive breast cancer cells.
Indications
Treatment of adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression after at least one line of endocrine therapy.
Dosage and administration (summary)
400 mg orally once daily on an empty stomach, continued until disease progression or unacceptable toxicity; dose interruption or reduction is used to manage adverse reactions.
Contraindications
Hypersensitivity to imlunestrant or excipients.
Warnings and precautions
Common adverse effects include fatigue, diarrhoea, nausea, musculoskeletal pain and raised liver enzymes; monitor as clinically indicated. Exposure is affected by strong CYP3A inhibitors and inducers, which should be avoided. Effective contraception is required in women of childbearing potential.
Pregnancy
May cause fetal harm based on its mechanism; not to be used in pregnancy.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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