Name: Orili 200 Tablet - (200mg)
SKU: 54352
Availability: InStock

Orili 200 Tablet – (200mg)

Square Pharmaceuticals PLC.

Generic: Elagolix sodium

Weight

0.015 kg

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Indication

Endometriosis

Administration

Take at approximately the same time each day, with or without food

Adult Dose

Endometriosis Indicated for management of moderate-to-severe pain associated with endometriosis Initiate with 150 mg PO qDay for up to 24 months Hepatic impairment Mild (Child-Pugh A): No dosage adjustment required Moderate (Child-Pugh B): Only the 150-mg qDay regimen is recommended for women with moderate hepatic impairment, and the duration of treatment should be limited to 6 months Severe (Child-Pugh C): Contraindicated

Renal Dose

Renal impairment No dosage adjustment required with any degree of renal impairment or end-stage renal disease (including dialysis)

Contraindication

Pregnancy Known osteoporosis Severe hepatic impairment Coadministration of strong organic anion transporting polypeptide (OATP) 1B1 inhibitors (eg, cyclosporine and gemfibrozil)

Mode of Action

Oral gonadotropin-releasing hormone (GnRH) receptor antagonist; inhibits endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland Administration of elagolix results in dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to decreased blood concentrations of the ovarian sex hormones, estradiol and progesterone

Precaution

May reduce the amount, intensity, or duration of menstrual bleeding, which may decrease the ability to recognize the occurrence of a pregnancy in a timely manner; perform pregnancy testing if pregnancy is suspected, and discontinue drug if pregnancy confirmed Dose-dependent elevations of ALT >3x ULN occurred with elagolix; use the lowest effective dose and instruct patients to promptly seek medical attention in case of symptoms or signs that may reflect liver injury Suicidal behavior and mood disorders Suicidal ideation and behavior, including 1 completed suicide, occurred in subjects treated with elagolix in the endometriosis clinical trials Patients taking elagolix had…

Side Effect

>10% Hot flush or night sweats (24-36%) Headache (17-20%) Nausea (11-16%) 1-10% Insomnia (6-9%) Mood altered, mood swings (5-6%) Amenorrhea (4-7%) Depressed mood, depression, depressive symptoms and/or tearfulness (3-6%) Hypersensitivity reactions (5.8%) Anxiety (3-5%) Arthralgia (3-5%)

Pregnancy Category Note

Pregnancy Contraindicated in pregnant women Drug exposure early in pregnancy may increase the risk of early pregnancy loss Discontinue elagolix if pregnancy occurs during treatment The limited human data with use in pregnant women are insufficient in determining whether there is a risk for major birth defects or miscarriage; although 2 cases of congenital malformations were reported in clinical trials with elagolix, no pattern was identified and miscarriages were reported at a similar incidence across treatment groups Animal data When pregnant rats and rabbits were orally dosed with elagolix during the period of organogenesis, postimplantation loss was observed in pregnant…

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