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Orilissa Generic Name & Formulations
Legal Class
Rx
General Description
Elagolix 150mg, 200mg; tabs.
Pharmacological Class
GnRH antagonist.
How Supplied
Tabs 150mg—28; 200mg—56
Manufacturer
Generic Availability
NO
Mechanism of Action
Elagolix binds competitively to GnRH receptors in the pituitary gland, thereby inhibiting endogenous GnRH signaling. This results in dose-dependent suppression of LH and FSH, leading to decreased blood concentrations of the ovarian sex hormones, estradiol and progesterone.
Orilissa Indications
Indications
Moderate to severe pain associated with endometriosis.
Limitations of Use
Limit the duration of use based on the dose and coexisting condition.
Orilissa Dosage and Administration
Adult
Exclude pregnancy prior to starting or begin within 7 days from onset of menses. Use lowest effective dose. Initiate at 150mg once daily for up to 24 months. If dyspareunia: consider initiating with 200mg twice daily for up to 6 months. Concomitant strong CYP3A inhibitors, rifampin, or if moderate hepatic impairment: limit to 150mg once daily for up to 6 months.
Children
<18yrs: not established.
Orilissa Contraindications
Contraindications
Pregnancy. Osteoporosis. Severe hepatic impairment. Concomitant OATP 1B1 inhibitors.
Orilissa Boxed Warnings
Not Applicable
Orilissa Warnings/Precautions
Warnings/Precautions
Risk of decrease in bone mineral density (BMD). Consider BMD assessment in those with a history of low-trauma fracture or other risk factors for osteoporosis or bone loss; supplementation with calcium and Vit.D may be beneficial. History of suicidality or depression. Evaluate if new onset or worsening depression, anxiety, other mood changes occur. Evaluate if signs/symptoms of liver injury (eg, jaundice, elevated liver tests) occurs. Reduced ability to recognize pregnancy. Perform pregnancy testing if suspected; discontinue if confirmed. Advise women to use effective non-hormonal contraceptives during therapy and for 28 days after discontinuation. Nursing mothers.
Orilissa Pharmacokinetics
See Literature
Orilissa Interactions
Interactions
See Adults and Contraindications. May potentiate P-gp substrates (eg, digoxin; monitor), CYP2C19 substrates (eg, omeprazole; limit doses to ≤40mg daily). May antagonize CYP3A substrates. Antagonizes oral midazolam, rosuvastatin: consider increasing their doses. May be antagonized by strong CYP3A inducers (eg, rifampin). Potentiates ethinyl estradiol. Antagonizes levonorgestrel. Reduced efficacy with estrogen-containing contraceptives.
Orilissa Adverse Reactions
Adverse Reactions
Hot flushes, night sweats, headache, nausea, insomnia, amenorrhea, anxiety, arthralgia, depression-related adverse reactions, mood changes; bone loss, elevated hepatic transaminase, change in lipid parameters or menstrual bleeding pattern.
Orilissa Clinical Trials
See Literature
Orilissa Note
Notes
To enroll patients in the Pregnancy Exposure Registry: call (833) 782-7241 or visit www.bloompregnancyregistry.com.
Orilissa Patient Counseling
See Literature
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