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  • Ubrelvy
    / AbbVie


    Active Ingredient
    Ubrogepant 50mg ,100mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Tablets

    10 tabs x 50 mg

    not in the basket chart

    Tablets

    10 tabs x 100 mg

    not in the basket chart

    Dosage

    50 mg or 100 mg taken orally with or without food. If needed, a second dose may be taken at least 2 hours after the initial dose. The maximum dose in a 24-hour period is 200 mg. The safety of treating more than 8 migraines in a 30-day period has not been established.


    Indications

    A calcitonin gene-related peptide receptor antagonist indicated for the acute treatment of migraine with or without aura in adults. Not indicated for the preventive treatment of migraine.


    Contra-Indications

    Concomitant use of strong CYP3A4 inhibitors.
    Hypersensitivity to the active substance or to any of the excipients.


    Special Precautions

    Renal Impairment
    The renal route of elimination plays a minor role in the clearance of ubrogepant. No dose adjustment is recommended for patients with mild or moderate renal impairment. Dose adjustment is recommended for patients with severe renal impairment (CLcr 15-29 mL/min). Avoid use in patients with end-stage renal disease (ESRD) (CLcr <15 mL/min).
    Hepatic Impairment
    In patients with pre-existing mild (Child-Pugh Class A), moderate (Child-Pugh Class B), or severe hepatic impairment (Child-Pugh Class C), ubrogepant exposure was increased by 7%, 50%, and 115%, respectively. No dose adjustment is recommended for patients with mild or moderate hepatic impairment. Dose adjustment is recommended for patients with severe hepatic impairment.


    Side Effects

    In clinical studies, the most common adverse reaction were nausea, Somnolence and dry Mouth. See prescribing information for full details.


    Drug interactions

    CYP3A4 Inhibitors
    Co-administration with ketoconazole, a strong CYP3A4 inhibitor, resulted in a significant increase in exposure of ubrogepant. The drug should not be used with strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin).
    Co-administration with verapamil, a moderate CYP3A4 inhibitor, resulted in an increase in ubrogepant exposure. Dose adjustment is recommended with concomitant use with moderate CYP3A4 inhibitors (e.g., cyclosporine, ciprofloxacin, fluconazole, fluvoxamine, grapefruit juice).
    No dedicated drug interaction study was conducted with ubrogepant and weak CYP3A4 inhibitors. Dose adjustment is recommended with concomitant use with weak CYP3A4 inhibitors.
    CYP3A4 Inducers
    Co-administration with rifampin, a strong CYP3A4 inducer, resulted in a significant reduction in ubrogepant exposure. In patients taking strong CYP3A4 inducers (e.g., phenytoin, barbiturates, rifampin, St. John’s Wort), loss of ubrogepant efficacy is expected, and concomitant use should be avoided.
    Co-administration with moderate or weak CYP3A4 inducers was not evaluated in a clinical study. Dose adjustment is recommended with concomitant use with moderate or weak CYP3A4 inducers.
    BCRP and/or P-gp Only Inhibitors
    Ubrogepant is a substrate of BCRP and P-gp efflux transporters. Use of BCRP and/or P-gp only inhibitors (e.g., quinidine, carvedilol, eltrombopag, curcumin) may increase the exposure of ubrogepant. Clinical drug interaction studies with inhibitors of these transporters were not conducted. Dose adjustment is recommended with BCRP and/or Pgp only inhibitors.


    Pregnancy and Lactation

    Pregnancy
    There are no adequate data o^n the developmental risk associated with the use in pregnant women. In animal studies, adverse effects on embryofetal development were observed following administration of ubrogepant during pregnancy (increased embryofetal mortality in rabbits) or during pregnancy and lactation (decreased body weight in offspring in rats) at doses greater than those used clinically and which were associated with maternal toxicity.
    Breast-feeding
    There are no data on the presence of ubrogepant in human milk, the effects of ubrogepant on the breastfed infant, or the effects of ubrogepant on milk production. In lactating rats, oral dosing with ubrogepant resulted in levelˆs of ubrogepant in milk comparable to peak plasma concentrations. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need and any potential adverse effects on the breastfed infant from the drug or from the underlying maternal condition.


    Overdose

    The elimination half-life of ubrogepant is approximately 5 to 7 hours; therefore, monitoring of patients after overdose should continue for at least 24 hours, or while symptoms or signs persist.


    Manufacturer
    Forest Laboratories Ireland Ltd., Dublin, Ireland
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