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  • Emend
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    Active Ingredient
    Aprepitant 80 mg, 125 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Capsules

    1 x 125 mg + 2 x 80 mg

    partial basket chart 70091 5410

    Dosage

    This product is given for 3 days as part of a regimen that includes a corticosteroid and a 5-HT3 antagonist. The recommended posology is 125 mg orally once daily one hour before start of chemotherapy on Day 1 and 80 mg orallyonce daily on Days 2 and 3. Fosaprepitant 115 mg, a lyophilized prodrug of aprepitant, may be substituted for oral (125 mg), 30 minutes prior to chemotherapy, on Day 1 only of the chemotherapy-induced nausea and vomiting (CINV) regimen as an intravenous infusion administered over 15 minutes. Please refer to the Summary of Product Characteristics for fosaprepitant 115 mg.


    Indications

    In combination with other antiemetic agents, for the prevention of acute and delayed nausea and vomiting associated with initial and repeated courses of highly emetogenic cancer chemotherapy, including high-dose cisplatin.


    Contra-Indications

    Hypersensitivity to any component of the product. Emend is a moderate CYP3A4 inhibitor. Should not be used concurrently with pimozide, terfenadine, astemizole, or cisapride. Inhibition of cytochrome P450 isoenzyme 3A4 (CYP3A4) by aprepitant could result in elevated plasma concentrations of these drugs, potentially causing serious or life-threatening reactions.
    For full details see prescribing information.


    Special Precautions

    Use with caution in patients receiving concomitant medicdbinal products, including chemotherapy agents that are primarily metabolized through CYP3A4. Inhibition of CYP3A4 by aprepitant could result in elevated plasma concentrations of these concomitant medicdbinal products. The effect on the pharmacokinetics of orally administered CYP3A4 substrates is expected to be greater than the effect of Emend on the pharmacokinetics of I.V. administered CYP3A4 substrates. Severe hepatic insufficiency (Child-Pugh >9). Safety and effectiveness in patients below 18 years of age have not been established.
    Pregnancy and lactation: Alternative or back-up methods to oral contraceptives should be used. Should be used during pregnancy only if clearly needed. A decision should be made whether to discontinue nursing, taking into account the importance of the drug to the mother.
    For full details see prescribing information.


    Side Effects

    Most adverse experiences were mild to moderate in intensity: Asthenia, fatigue, constipation, diarrhea, anorexia, headache, hiccups.
    For full details see prescribing information.


    Drug interactions

    Warfarin, tolbutamide, phenytoin, midazolam, ketoconazole, rifampin, paroxetine.
    For full details see prescribing information.


    Pregnancy and Lactation

    Pregnancy: For aprepitant no clinical data on exposed pregnancies are available. The potential for reproductive toxicity of aprepitant has not been fully characterized, since exposure levels above the therapeutic exposure in humans at the 125 mg/80 mg dose could not be attained in animal studies. These studies did not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. The potential effects on reproduction of alterations in neurokinin regulation are unknown. This product should not be used during pregnancy unless clearly necessary.
    Fertility: The potential for effects of aprepitant on fertility has not been fully characterised because exposure levels above the therapeutic exposure in humans could not be attained in animal studies. These fertility studies did not indicate direct or indirect harmful effects with respect to mating performance, fertility, embryonic/foetal development, or sperm count and motility.


    Overdose

    In the event of overdose, this product should be discontinued and general supportive treatment and monitoring should be provided. Because of the antiemetic activity of aprepitant, emesis -induced by a medicinal product may not be effective. Aprepitant cannot be removed by haemodialysis.


    Important notes

    Contain sucrose.


    Manufacturer
    Merck Sharp & Dohme Corp., USA
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