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  • ORILISSA
    / AbbVie


    Active Ingredient
    Elagolix (as sodium) 150 mg, 200 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Film Coated Tablets

    28 X 150 mg

    not in the basket chart

    Film Coated Tablets

    56 X 200 mg

    not in the basket chart

    Dosage

    Important Dosing Information:
    Exclude pregnancy before starting ORILISSA or start ORILISSA within 7 days from the onset of menses.
    Take ORILISSA at approximately the same time each day, with or without food.
    Use the lowest effective dose, taking into account the severity of symptoms and treatment objectives.
    Limit the duration of use because of bone loss:
    Initiate treatment with Elagolix 150 mg once daily, Maximum Treatment Duration-24 months.
    Consider initiating treatment with 200 mg twice daily, Maximum Treatment Duration-6 months, with Coexisting Condition- Dyspareunia.
    Initiate treatment with Elagolix 150 mg once daily. Use of 200 mg twice daily is not recommended. Maximum Treatment Duration-6 months, with Coexisting Condition- Moderate hepatic impairment (Child-Pugh Class B).
    Hepatic Impairment: No dosage adjustment of Elagolix is required in women with mild hepatic impairment (Child-Pugh A).
    Compared to women with normal liver function, those with moderate hepatic impairment had approximately 3-fold higher Elagolix exposures and those with severe hepatic impairment had approximately 7-fold higher Elagolix exposures. Because of these increased exposures and risk for bone loss:
    Elagolix 150 mg once daily is recommended for women with moderate hepatic impairment (Child-Pugh B) with the duration of treatment limited to 6 months. Use of Elagolix 200 mg twice daily is not recommended for women with moderate hepatic impairment.
    Elagolix is contraindicated in women with severe hepatic impairment (Child-Pugh C).
    Missed Dose: Instruct the patient to take a missed dose of ORILISSA on the same day as soon as she remembers and then resume the regular dosing schedule.
    150 mg once daily: take no more than 1 tablet each day.
    200 mg twice daily: take no more than 2 tablets each day.


    Indications

    Management of moderate to severe pain associated with endometriosis.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.
    Pregnancy.
    Women with known osteoporosis.
    Women with severe hepatic impairment.


    Special Precautions

    Bone Loss: This drug causes a dose-dependent decrease in bone mineral density (BMD). BMD loss is greater with increasing duration of use and may not be completely reversible after stopping treatment. The impact of these BMD decreases on long-term bone health and future fracture risk are unknown. Consider assessment of BMD in patients with a history of a low-trauma fracture or other risk factors for osteoporosis or bone loss, and do not use in women with known osteoporosis. Limit the duration of use to reduce the extent of bone loss.
    Although the effect of supplementation with calcium and vitamin D was not studied, such supplementation may be beneficial for all patients.
    Change in Menstrual Bleeding Pattern and Reduced Ability to Recognize Pregnancy: Women who take Elagolix may experience a reduction in the amount, intensity or duration of menstrual bleeding, which may reduce the ability to recognize the occurrence of a pregnancy in a timely manner. Perform pregnancy testing if pregnancy is suspected, and discontinue Elagolix if pregnancy is confirmed.
    Suicidal Ideation, Suicidal Behavior, and Exacerbation of Mood Disorders: Suicidal ideation and behavior, including one completed suicide, occurred in subjects treated with Elagolix in the endometriosis clinical trials. Elagolix subjects had a higher incidence of depression and mood changes compared to placebo, and Elagolix subjects with a history suicidality or depression had a higher incidence of depression compared to subjects without such a history.
    Hepatic Transaminase Elevations: In clinical trials, dose-dependent elevations of serum alanine aminotransferase (ALT) at least 3-times the upper limit of the reference range occurred with elagolix. use the lowest effective dose of elagolix and instruct patients to promptly seek medical attention in case of symptoms or signs that may reflect liver injury, such as jaundice. Promptly evaluate patients with elevations in liver tests to determine whether the benefits of continued therapy outweigh the risks.
    Reduced Efficacy with Estrogen-Containing Contraceptives: Based on the mechanism of action of elagolix, estrogen containing contraceptives are expected to reduce the efficacy of Elagolix. The effect of progestin-only contraceptives on the efficacy of Elagolix is unknown. Advise women to use non-hormonal contraceptives during  treatment with Elagolix and for one week after discontinuing.
    See prescribing information for full details.


    Side Effects

    Most common: Bone loss, Change in menstrual bleeding pattern and reduced ability to recognize pregnancy, Suicidal ideation, suicidal behavior, and exacerbation of mood disorders, Hepatic transaminase elevations.
    See prescribing information for full details.


    Drug interactions

    Elagolix is a substrate of CYP3A, P-gp, and OATP1B1.
    Concomitant use of Elagolix 200 mg twice daily and strong CYP3A inhibitors for more than 1 month is not recommended. Limit concomitant use of Elagolix 150 mg once daily and strong CYP3A inhibitors to 6 months.
    Co-administration of Elagolix with drugs that induce CYP3A may decrease elagoli plasma concentrations.
    The effect of concomitant use of P-gp inhibitors or inducers on the pharmacokinetics of Elagolix is unknown. Co-administration of Elagolix with drugs that inhibit OATP1B1 may increase elagolix plasma concentrations. Concomitant use of Elagolix and strong OATP1B1 inhibitors (e.g., cyclosporine and gemfibrozil) is contraindicated.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: Exposure to Elagolix early in pregnancy may increase the risk of early pregnancy loss. Use of Elagolix is contraindicated in pregnant women. Discontinue Elagolix if pregnancy occurs during treatment.
    Lactation: There is no information on the presence of Elagolix or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production.
    See prescribing information for full details.


    Overdose

    In case of overdose, monitor the patient for any signs or symptoms of adverse reactions and initiate appropriate symptomatic treatment, as needed.


    Important notes

    Storage: Store at 2°C to 30°C.


    Manufacturer
    Abbvie Inc., USA
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