Oragon 150mg 6pcs

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 a higher incidence of depression and mood changes compared with placebo Patients with a history of suicidality or depression had a higher incidence of depression compared with subjects without such a history Promptly evaluate patients with depressive symptoms to determine whether the risks of continued therapy outweigh the benefits Patients with new or worsening depression, anxiety, or other mood changes should be referred to a mental health professional, as appropriate Advise patients to seek immediate medical attention for suicidal ideation and behavior Reevaluate the benefits and risks of continuing elagolix if such events occur

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%)