Orserdu Special Precautions

Hepatic impairment: ORSERDU is metabolised by the liver, and impaired hepatic function can increase the risk for adverse reactions. Therefore, ORSERDU should be used cautiously in patients with hepatic impairment and patients should be regularly and closely monitored for adverse reactions. Administration of elacestrant should be undertaken with caution at a dose of 258 mg once daily in patients with moderate hepatic impairment (see Dosage & Administration). In the absence of clinical data, elacestrant is not recommended in patients with severe hepatic impairment (Child-Pugh C) (see Dosage & Administration).
Concomitant use with CYP3A4 inhibitors: Concomitant administration of ORSERDU with strong CYP3A4 inhibitors including, but not limited to: clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, voriconazole, and grapefruit or grapefruit juice should be avoided. An alternative concomitant medicinal product with no or minimal potential to inhibit CYP3A4 should be considered. If the strong CYP3A4 inhibitor cannot be avoided, ORSERDU dose adjustment should be applied (see Dosage & Administration and Interactions).
Concomitant administration of ORSERDU with moderate CYP3A4 inhibitors including, but not limited to: aprepitant, ciprofloxacin, conivaptan, crizotinib, cyclosporine, diltiazem, dronedarone, erythromycin, fluconazole, fluvoxamine, grapefruit juice, imatinib, isavuconazole, tofisopam and verapamil should be avoided. An alternative concomitant medicinal product with no or minimal potential to inhibit CYP3A4 should be considered. If the moderate CYP3A4 inhibitor cannot be avoided, ORSERDU dose adjustment should be applied (see Dosage & Administration and Interactions).
Concomitant use with CYP3A4 inducers: Concomitant administration of ORSERDU with strong CYP3A4 inducers including, but not limited to: phenytoin, rifampicin, carbamazepine and St John's Wort (Hypericum perforatum) should be avoided. An alternative concomitant medicinal product with no or minimal potential to induce CYP3A4 should be considered. If the strong CYP3A4 inducer cannot be avoided, ORSERDU dose adjustment should be applied (see Dosage & Administration and Interactions).
Concomitant administration of ORSERDU with moderate CYP3A4 inducers including, but not limited to: bosentan, cenobamate, dabrafenib, efavirenz, etravirine, lorlatinib, phenobarbital, primidone and sotorasib should be avoided. An alternative concomitant medicinal product with no or minimal potential to induce CYP3A4 should be considered. If the moderate CYP3A4 inducer cannot be avoided, ORSERDU dose adjustment should be applied (see Dosage & Administration and Interactions).
Thromboembolic events: Thromboembolic events are commonly observed in patients with advanced breast cancer and have been observed in clinical studies with ORSERDU (see Adverse Reactions). This should be taken into consideration when prescribing ORSERDU to patients at risk.
Effects on ability to drive and use machines: ORSERDU has no or negligible influence on the ability to drive and use machines. However, since fatigue, asthenia, and insomnia have been reported in some patients taking elacestrant (see Adverse Reactions), caution should be observed by patients who experience those adverse reactions when driving or operating machinery.