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Orserdu

Orserdu

Manufacturer:

Catalent Greenville

Distributor:

Zuellig

Marketer:

A. Menarini
Concise Prescribing Info
Contents
Elacestrant diHCl
Indications/Uses
Monotherapy for estrogen receptor +ve, HER2 -ve, locally advanced or metastatic breast cancer w/ an activating ESR1 mutation in postmenopausal women, & men, who have disease progression following at least 1 line of endocrine therapy including a CDK 4/6 inhibitor.
Dosage/Direction for Use
345 mg (one 345-mg tab) once daily. Max daily dose: 345 mg. Patient w/ moderate hepatic impairment (Child-Pugh B) Reduce dose to 258 mg (three 86-mg tab) once daily.
Administration
Should be taken with food: Administer w/ a light meal. Swallow whole. Do not chew/crush/split.
Contraindications
Special Precautions
Consider risk of thromboembolic events when prescribing to patients at risk. Avoid concomitant use w/ strong or moderate CYP3A4 inhibitors; strong or moderate CYP3A4 inducers. Not recommended in patients w/ severe hepatic impairment (Child-Pugh C). Has not been studied in patients w/ severe renal impairment. Should not be used during pregnancy or in women of childbearing potential not using contraception. Can cause foetal harm. Females of reproductive potential should use effective contraception during treatment & 1 wk after the last dose. Lactating women should not breast-feed during treatment & 1 wk after the last dose. May impair fertility in females & males of reproductive potential. Safety & efficacy in childn from birth to 18 yr have not been established. Limited data available in patients ≥75 yr.
Adverse Reactions
Anaemia; decreased appetite; headache; hot flush; nausea, vomiting, diarrhoea, constipation, abdominal pain, dyspepsia; arthralgia, back pain; fatigue; increased AST, triglycerides, cholesterol, ALT, creatinine, & decreased Ca, Na, K. UTI; decreased lymphocyte count; insomnia; dizziness, syncope; dyspnoea, cough; stomatitis; rash; pain in extremity, musculoskeletal chest pain, bone pain; asthenia; increased blood alkaline phosphatase.
Drug Interactions
Increased exposure w/ strong CYP3A4 inhibitors (eg, clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, voriconazole, & grapefruit or grapefruit juice); moderate CYP3A4 inhibitors (eg, aprepitant, ciprofloxacin, conivaptan, crizotinib, cyclosporine, diltiazem, dronedarone, erythromycin, fluconazole, fluvoxamine, grapefruit juice, imatinib, isavuconazole, tofisopam & verapamil); OATP2B1 inhibitors. Decreased exposure w/ strong CYP3A4 inducers (eg, phenytoin, rifampicin, carbamazepine & St. John's wort); moderate CYP3A4 inducers (eg, bosentan, cenobamate, dabrafenib, efavirenz, etravirine, lorlatinib, phenobarb, primidone & sotorasib). Increased exposure of digoxin & other P-gp substrates; rosuvastatin & other BCRP substrates.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L02BA04 - elacestrant ; Belongs to the class of anti-estrogens. Used in treatment of neoplastic diseases.
Presentation/Packing
Form
Orserdu FC tab 345 mg
Packing/Price
4 × 7's
Form
Orserdu FC tab 86 mg
Packing/Price
4 × 7's
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