Usual Adult Dose for Endometriosis

150 mg orally once a day for 24 months

For Women with Dyspareunia:

• Consider 200 mg orally twice a day for 6 months

• Exclude pregnancy before starting or start therapy within 7 days from onset of menses.
• Use lowest effective dose, considering the severity of symptoms and treatment objectives.
• Limit the duration of use because of bone loss; for women with dyspareunia or moderate hepatic impairment, duration of use is limited to 6 months.

Renal Dose Adjustments

No adjustment recommended

Liver Dose Adjustments

Mild hepatic impairment (Child-Pugh A): No adjustment recommended
Moderate hepatic impairment (Child-Pugh B): 150 mg orally once a day for up to 6 months
Severe hepatic impairment (Child-Pugh C): Contraindicated

Precautions

CONTRAINDICATIONS:

• Hypersensitivity to the active substance or any product ingredients
• Pregnancy
• Osteoporosis
• Severe hepatic impairment
• Concomitant use of strong organic anion transporting polypeptide (OATP) 1B1 inhibitors

Dialysis

No adjustment recommended

Other Comments

Administration advice:

• Take orally at approximately the same time each day, with or without food

• Store at 36F to 86F (2C to 30C)

• The effect of supplementation with calcium and vitamin D has not been studied, but supplementation is suggested due to the potential for bone loss.

• Patients should be instructed to read the US FDA-approved medication guide
• Patients should understand effective non-hormonal contraceptives should be used during therapy and for 28 days after stopping therapy; pregnancy is contraindicated during use.
• Patients should understand that menstrual changes are expected during therapy.
• Patients should understand there is a risk of bone loss and adequate calcium and vitamin D intake should be encouraged.
• Patients should seek immediate medical attention for suicidal ideation and behavior; patients with new or worsening depression, anxiety, or other mood changes should seek prompt medical advice.
• Patients should be instructed to promptly report signs or symptoms of liver injury.
• Patients should be advised to dispose of unused medication via a take-back option if possible. Otherwise, follow FDA instructions for disposing of in household trash (www.fda.gov/drugdisposal); do not flush down the toilet.

Frequently asked questions

• Can Elagolix be used for heavy menstrual bleeding in women?
• What types of birth control work with Orilissa?