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  • Elonva 100 mcg / 0.5 ml
    / MSD


    Active Ingredient
    Corifollitropin Alfa 100 mcg / 0.5 ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Syringe (solution for injection)

    1 x 100 mcg / 0.5 ml

    partial basket chart 19924 5528

    Related information


    Dosage

    In women with a body weight ≤ 60 kilograms a single dose of 100 micrograms should be administered.
    In women with a body weight > 60 kilograms a single dose of 150 micrograms should be administered.
    See prescribing information for full details.


    Indications

    Controlled Ovarian Stimulation (COS) in combination with a GnRH antagonist for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients. Tumors of the ovary, breast, uterus, pituitary or hypothalamus. Abnormal (not menstrual) vaginal bleeding without a known/diagnosed cause. Primary ovarian failure. Ovarian cysts or enlarged ovaries. A history of Ovarian Hyperstimulation Syndrome (OHSS). A previous COS cycle that resulted in more than 30 follicles equal to or higher than 11 mm measured by ultrasound examination. A basal antral follicle count > 20. Fibroid tumors of the uterus incompatible with pregnancy. Malformations of the reproductive organs incompatible with pregnancy.


    Special Precautions

    Before starting treatment, the couple’s infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated. Women should be evaluated for hypothyroidism, adrenocortical deficiency, hyperprolactinemia and pituitary or hypothalamic tumors, and appropriate specific treatment given. Treatment is intended as a single subcutaneous injection only. Additional injections should not be given within the same treatment cycle. In the first seven days after administration, no (rec)FSH should be administered. In patients with mild, moderate or severe renal insufficiency the excretion of corifollitropin alfa might be impaired. Therefore, treatment in these women is not recommended. There are limited data on the use in combination with a GnRH agonist. Results of a small uncontrolled study suggest a higher ovarian response than in combination with a GnRH antagonist. Therefore, the use is not recommended in combination with a GnRH agonist. Elonva has not been studied in patients with polycystic ovarian syndrome (PCOS). In these women the use is not recommended. The ovarian response was shown to be higher after treatment with Elonva than after treatment with daily (rec)FSH. Therefore, women with known risk factors for a high ovarian response may be especially prone to the development of OHSS during or following treatment. For women having their first cycle of ovarian stimulation, for whom risk factors are only partially known, careful monitoring for potential ovarian hyperresponse is recommended.
    See prescribing information for full details.


    Side Effects

    OHSS, pelvic pain, discomfort, headache, nausea, fatigue, breast complaints (including tenderness).
    See prescribing information for full details.


    Drug interactions

    No interaction studies have been performed. Since corifollitropin alfa is not a substrate of cytochrome P450 enzymes, no metabolic interactions with other medicdbinal products are anticipated.


    Manufacturer
    NV Organon
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