Formulary
Darolutamide: Indications, Dosing, Side Effects and Interactions
Darolutamide is an androgen receptor inhibitor that decreases tumour cell proliferation.
MedNext Academy | 3 min read
Darolutamide: Indications, Dosing, Side Effects and Interactions
Darolutamide is an androgen receptor inhibitor that decreases tumour cell proliferation.
Drug action
Darolutamide is an androgen receptor inhibitor that decreases tumour cell proliferation.
Indications and dose
**Prostate cancer (specialist use only)**
- **Adult** (By Mouth): 600 mg twice daily, for dose adjustments or interruption due to side-effects-consult product literature.
Cautions
History or risk of QT-interval prolongation; recent cardiovascular disease
Side effects
Common or very common Acute coronary syndrome; asthenia; atherosclerosis coronary artery; bone fracture; cardiogenic shock; heart failure; ischaemic heart disease; lethargy; malaise; pain; rash Frequency not known Neutropenia
Interactions
**Other interactions (27):**
- Effects of other medicinal products on darolutamide CYP3A4 and Pgp inducers Darolutamide is a substrate of CYP3A4 and Pglycoprotein (Pgp).
- Use of strong and moderate CYP3A4 inducers and Pgp inducers (e.g.
- John's Wort, phenytoin, and rifampicin) during treatment with darolutamide is not recommended, unless there is no therapeutic alternative.
- Repeated administration of rifampicin (600 mg), a strong CYP3A4 and a Pgp inducer, with a single dose of darolutamide (600 mg) together with food, resulted in a decrease of 72% in mean exposure...
- CYP3A4, Pgp and BCRP inhibitors Darolutamide is a substrate of CYP3A4, Pgp and breast cancer resistance protein (BCRP).
- Darolutamide may be given concomitantly with CYP3A4, Pgp or BCRP inhibitors.
Hepatic impairment
Manufacturer advises caution in moderate and severe impairment. Dose adjustments Manufacturer advises reduce initial dose in moderate or severe impairment to 300 mg twice daily.
Renal impairment
Manufacturer advises caution in severe impairment. Dose adjustments Manufacturer advises reduce initial dose in severe impairment to 300 mg twice daily.
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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