Names and pronunciation
(el′a-goe′lix) Orilissa
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Drug reference
(el′a-goe′lix) Orilissa
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Func. class.: Gonadotropin-releasing hormone (GnRH) receptor antagonist
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ACTION: Suppresses the pituitary, decreases estradiol, progesterone, and other hormones
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USES: Moderate to severe pain associ- ated with endometriosis, including endo- metriosis-related dyspareunia
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CONTRAINDICATIONS: Hyper- sensitivity, osteoporosis, pregnancy
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SIDE EFFECTS CNS: Headache, depression, anxiety, mood/behavior changes, dizziness, insomnia, excitability GI: Nausea, constipation, diarrhea, abdominal pain, increased LFTs GU: Decreased libido, amenorrhea MS: Arthralgia, bone loss, myalgia MISC: Hypersensitivity
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INTERACTIONS Increase: elagolix effect—CYP3A4 inhibitors Decrease: elagolix effect—CYP3A4 induc- ers, midazolam, hormonal contraceptives, strong OATP1B1 inhibitors Decrease: effect of—CYP3A4 substrates Drug/Lab Increase: LFTs, triglycerides, cholesterol, LDL, HDL
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DOSAGE AND ROUTES • Moderate-severe pain of endometriosis, not dyspareunia Adult female: PO Initiate at 150 mg daily; max duration 24 mo • Moderate-severe pain of endometriosis with dyspareunia Adult female: PO 200 mg bid, max dura- tion 6 mo Hepatic dose Adult female: PO Child-Pugh B 150 mg daily, max 6 mo (all uses)
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Available forms: Tablets 200, 300 mg Administer • Complete pregnancy test prior to use, or use within 7 days of start of menses • Give without regard to food, at same time of day • If dose is missed, give on same day and then start normal dosing • Store at room temperature
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Assess: • Endometriosis: assess for pain and pain associated with dyspareunia prior to starting product and after use • Suicidal ideation: assess for depres- sion, change in mood, product may need to be discontinued • Bone density: monitor for fractures, osteoporosis, obtain bone density test • Monitor LFTs baseline and periodically
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Evaluate: • Therapeutic response: decreasing pain in endometriosis
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • Pregnancy/breastfeeding: identify if pregnancy is planned or suspected, do not use in pregnancy, consider risks in breastfeeding, hormonal contracep- tives with estrogen will reduce the product’s effectiveness • Suicidal thoughts/behaviors: ad- vise caretakers, family, patient to notify provider immediately of depression, change in mood, suicidal thoughts, be- haviors • If dose is missed, take as soon as re- membered, then continue with regular dosing • Report yellowing eyes, skin, clay-col- E ored stool, dark urine, nausea, vomiting, which may signal liver injury • That the product will change menses • Bone density: advise patient bone loss may occur, that bone density test may be required, to supplement with calcium and vitamin D to prevent bone loss if prescribed
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PHARMACOKINETICS Onset unknown, peak 1 hr, duration unknown Half-life 4-6 hr
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• Moderate-severe pain of endometriosis, not dyspareunia Adult female: PO Initiate at 150 mg daily; max duration 24 mo
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• Moderate-severe pain of endometriosis with dyspareunia Adult female: PO 200 mg bid, max dura- tion 6 mo Hepatic dose Adult female: PO Child-Pugh B 150 mg daily, max 6 mo (all uses)
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