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    / Stemline Israel Ltd.


    Active Ingredient
    Elacestrant 86 mg, 345 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    30 X 86 mg

    not in the basket chart 67869 להזמנת התכשיר - דרך בית המסחר לתרופות ס.ל.א בטלפון 1800-666663

    Film Coated Tablets

    30 X 345 mg

    not in the basket chart 63137

    Dosage

    The recommended dosage of Elacestrant is 345 mg taken orally with food once daily until disease progression or unacceptable toxicity occurs.
    See prescribing information for full details.


    Indications

    This medical product is indicated for the treatment of postmenopausal women or adult men with estrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER)-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients


    Special Precautions

    Dyslipidemia
    Hypercholesterolemia and hypertriglyceridemia were observed in patients using Elacestrant.
    Embryo-Fetal Toxicity
    There is a potential risk to a fetus. Pregnant women and females of reproductive should be aware of this potential risk. During treatment with this medical product and for one week following the last dose, females of reproductive potential should be advised to use effective contraception. Male patients with female partners of reproductive potential should be advised to use effective contraception as well.
    See prescribing information for full details.


    Side Effects

    Common: laboratory abnormalities, musculoskeletal pain, nausea, increased cholesterol, increased AST, increased triglycerides, fatigue, decreased hemoglobin, vomiting, increased ALT, decreased sodium, increased creatinine, decreased appetite, diarrhea, headache, constipation, abdominal pain, hot flush, and dyspepsia.
    See prescribing information for full details.


    Drug interactions

    Effect of Other Drugs on Elacestrant:
    Strong and Moderate CYP3A4 Inhibitors
    Avoid concomitant use of strong or moderate CYP3A inhibitors with Elacestrant.
    Elacestrant is a CYP3A4 substrate. Concomitant use of a strong or moderate CYP3A4 inhibitor including grapefruit or grapefruit juice increase elacestrant exposure which may increase the risk of adverse reactions of Elacestrant.
    Strong and Moderate CYP3A4 Inducers
    Avoid concomitant use of strong or moderate CYP3A inducers with Elacestrant. Concomitant use of a strong or moderate CYP3A4 inducer decreases elacestrant exposure which may decrease effectiveness of Elacestrant.
    Effect of Elacestrant on Other Drugs
    P-gp Substrates
    Elacestrant is a P-gp inhibitor. Concomitant use of Elacestrant with a P-gp substrate increased the concentrations of P-gp substrat, which may increase the adverse reactions associated with a P-gp substrate.
    BCRP Substrates
    Reduce the dosage of BCRP substrates per their Prescribing Information when minimal concentration changes may lead to serious or life-threatening adverse reactions. Elacestrant is a BCRP inhibitor. Concomitant use of Elacestrant with a BCRP substrate increased the plasma concentrations of BCRP substrate, which may increase the adverse reactions associated with a BCRP substrate.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: Based on findings in animals and its mechanism of action, Elacestrant can cause fetal harm when administered to a pregnant woman. There are no available human data on Elacestrant use in pregnant women to inform the drug-associated risk. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Females of reproductive potential should use effective contraception during treatment and for 1 week after the last dose.
    Lactation
    : There are no data on the presence of Elacestrant in human milk, its effects on milk production, or the breastfed child. Because of the potential for serious adverse reactions in the breastfed child, advise lactating women to not breastfeed during treatment with Elacestrant and for 1 week after the last dose.
    Males:
    Male patients with female partners of reproductive potential should use effective contraception during treatment and for 1 week after the last dose


    Manufacturer
    Stemline Therapeutics, Inc., USA
    Licence holder
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