). For a complete listing of ingredients, see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING. • Women who are, suspected to be, or may become pregnant during the course of therapy. • Women with undiagnosed vaginal bleeding. • Women with known osteoporosis, due to the risk of further bone loss.
2 Recommended Dose and Dosage Adjustment). , cyclosporine and gemfibrozil), due to the risks of increased ORILISSA plasma concentrations. 1 Dosing Considerations • Women should use effective methods of contraception not containing estrogen while on treatment with ORILISSA.
• Treatment with ORILISSA should be initiated at the time of the menstrual flow to decrease the risk of an undiagnosed pregnancy. Pregnancy should be excluded before starting treatment with ORILISSA. • Clinical studies with ORILISSA have been limited to a 12-month exposure to the drug and therefore the safety and efficacy of ORILISSA beyond 12 months have not been established.
Because of the dose-dependent loss of bone mineral density (BMD) associated with ORILISSA treatment, the use of ORILISSA 200 mg twice daily should be limited to 6 months duration. 2 Recommended Dose and Dosage Adjustment ORILISSA is available as either 150 mg tablets (once daily) or 200 mg tablets (twice daily), to be taken orally.
Based on the severity of symptoms and treatment objectives, use the lowest effective dose (see 14 CLINICAL TRIALS). Administration of ORILISSA results in dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) levels, leading to decreased blood levels of the ovarian sex hormones, estradiol, and progesterone.
1 Mechanism of Action). Safety and effectiveness of ORILISSA in patients less than 18 years of age has not been established. No dose adjustment of ORILISSA is required in women with mild hepatic impairment (Child-Pugh A). ORILISSA 150 mg once daily is the recommended dose in women with moderate hepatic impairment (Child-Pugh B), with treatment duration limited to 6 months; the 200 mg twice daily dose is not recommended.
ORILISSA is contraindicated in women with severe hepatic impairment (Child-Pugh C). 3 Pharmacokinetics. No dose adjustment of ORILISSA is required in women with any degree of renal impairment or end-stage renal disease (including women on dialysis).
3 Pharmacokinetics. 1 Pediatrics). Dose Modifications for Geriatrics (> 65 years of age) ORILISSA is not indicated in postmenopausal women and has not been studied in women over 65 years of age. 3 Reconstitution Not applicable. 4 Administration ORILISSA should be taken at approximately the same time each day, with or without food.
5 Missed Dose If a woman misses a dose of ORILISSA she should be instructed to take it as soon as she remembers as long as it is on the same day. She should then resume the regular dosing schedule. • 150 mg once a day: no more than 1 tablet each day should be taken.
• 200 mg twice a day: no more than 2 tablets each day should be taken. 5 OVERDOSAGE In case of overdose, monitor the patient for any signs or symptoms of adverse reactions and initiate appropriate symptomatic treatment immediately. For management of a suspected drug overdose, contact your regional poison control centre.
0 mg of elagolix sodium) iron oxide red, magnesium stearate, mannitol, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, sodium carbonate monohydrate, talc, and titanium dioxide ORILISSA is available as 150 mg and 200 mg film-coated tablets.
ORILISSA 150 mg tablets are light pink, oblong, debossed with EL 150 on one side and available as weekly blisters containing 7 tablets for 1 week of treatment. Four weekly blisters may be packaged in a carton for a total of 28 tablets.
ORILISSA 200 mg tablets are light orange, oblong, debossed with EL 200 on one side and available as weekly blisters containing 14 tablets for 1 week of treatment. Four weekly blisters may be packaged in a carton for a total of 56 tablets.
7 WARNINGS AND PRECAUTIONS General ORILISSA is not a contraceptive drug. Therefore, women should use an effective method of contraception not containing an estrogen while being treated with ORILISSA. In case of a suspected pregnancy, treatment with ORILISSA should be interrupted until the diagnosis of pregnancy has been excluded (see subsection Reproductive Health: Female and Male Potential, Reproduction).
Endocrine and Metabolism Decrease in Bone Mineral Density ORILISSA 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 […]