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ORILISSA is a brand name for Elagolix, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: ORILISSA (elagolix) is indicated for the treatment of moderate to severe pain associated with endometriosis. 1.1 Pediatrics Pediatrics (< 18 years of age): Safety and effectiveness of ORILISSA in patients less than 18 years of age has not been established; therefore, Health Canada has not authorized an indication for…
Verbatim from this product's HC label. Tap a section to expand.
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.
). 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.
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 loss. 3 Less Common Clinical Trial Adverse Reactions. Clinical trials evaluating the effect of ORILISSA on bone mineral density beyond 12 months are not available. If use of ORILISSA continues for longer than 12 months, it is recommended that BMD be assessed by dual energy X-ray absorptiometry (DXA).
0. The loss of BMD in premenopausal women should be considered in the benefit/risk assessment for women receiving ORILISSA. ORILISSA (elagolix) Page 7 of 38 Consider assessment of BMD sooner than at 12 months in patients who are at greater risk of low BMD.
Risk factors include patients taking ORILISSA 200 mg twice daily, prior use of gonadotropin-releasing hormone (GnRH) agonists, metabolic bone disease, chronic alcohol and/or tobacco use, anorexia nervosa, strong family history of osteoporosis, or chronic use of drugs that can reduce bone mass such as anticonvulsants or corticosteroids.
Although there were no studies addressing whether calcium and vitamin D may lessen BMD loss in women using ORILISSA, all patients should have adequate calcium and vitamin D intake. Hepatic/Biliary/Pancreatic 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 ORILISSA.
ORILISSA is contraindicated in: • Patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. Reactions have included anaphylaxis and angioedema (see 8 ADVERSE REACTIONS).
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.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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• 200 mg twice a day: no more than 2 tablets each day should be taken.
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 […]
Use the lowest effective dose of ORILISSA and instruct patients to promptly seek medical attention in case of symptoms or signs that may reflect liver injury, such as jaundice. 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data).
Monitoring and Laboratory Tests See subsections Endocrine and Metabolism, Decrease in Bone Mineral Density and Hepatic/Biliary/Pancreatic, Hepatic Transaminase Elevations. Psychiatric Suicidal Ideation, Suicidal Behavior, and Exacerbation of Mood Disorders Suicidal ideation and behavior, including one completed suicide, occurred in patients treated with ORILISSA in the endometriosis clinical trials.
3 Less Common Clinical Trial Adverse Drug Reactions). Promptly evaluate patients with depressive symptoms to determine whether the risks of continued therapy outweigh the benefits. 3 Pharmacokinetics).
Reproductive Health:
Female and Male Potential • Fertility There are no data available in humans for effects of elagolix on male or female fertility. In a 3-month healthy female volunteer study, ORILISSA did not affect anti-Mullerian hormone (AMH), a biomarker used to estimate ovarian reserve; the effect of ORILISSA on antral follicle count is unknown.
In a 3-month folliculogenesis study in young women who received multiple doses of elagolix, the median number of days from last dose of elagolix to return of light bleeding (menses) was 16 and 21 days for the 150 mg once daily and 200 mg twice daily groups, respectively.
ORILISSA (elagolix) Page 8 of 38 No effect on fertility was observed in the rat fertility study; however, the results from this study are limited, due to relatively low binding affinity of elagolix to rat GnRH receptors (see 16 NON-CLINICAL TOXICOLOGY).
2 Study Results). Women should be counseled regarding the bleeding pattern changes they may experience. Upon stopping ORILISSA therapy, the majority of women reported a menstrual period within 1 month. • Reproduction Exclude pregnancy before initiating treatment with ORILISSA.
Perform pregnancy testing if pregnancy is suspected, and discontinue ORILISSA if pregnancy is confirmed (see 2 CONTRAINDICATIONS). Exposure to ORILISSA during pregnancy may increase the risk of early pregnancy loss. 2 Pharmacodynamics).
Women should use effective methods of contraception. Effect on ORILISSA Based on the mechanism of action of ORILISSA, estrogen containing contraceptives are expected to reduce the efficacy of ORILISSA. g. g. norethindrone acetate). The effect of progestin-only contraceptives on the efficacy of […]