Orilissa Dosage

Generic name: ELAGOLIX SODIUM 150mg
Dosage form: tablet, film coated
Drug class: Gonadotropin-releasing hormone antagonists

Medically reviewed by Drugs.com. Last updated on Jun 5, 2023.

2.1 Important Dosing Information

Exclude pregnancy before starting ORILISSA or start ORILISSA within 7 days from the onset of menses.
Take ORILISSA at approximately the same time each day, with or without food.
Use the lowest effective dose, taking into account the severity of symptoms and treatment objectives [see Warnings and Precautions (5.1, 5.3, 5.4) and Clinical Studies (14)].
Limit the duration of use because of bone loss (Table 1) [see Warnings and Precautions (5.1)].

Table 1. Recommended Dosage and Duration of Use
Dosing Regimen	Maximum Treatment Duration	Coexisting Condition
Initiate treatment with ORILISSA 150 mg once daily	24 months	None
Consider initiating treatment with ORILISSA 200 mg twice daily	6 months	Dyspareunia
Initiate treatment with ORILISSA 150 mg once daily. Use of 200 mg twice daily is not recommended.	6 months	Moderate hepatic impairment (Child-Pugh Class B)

2.2 Hepatic Impairment

No dosage adjustment of ORILISSA is required in women with mild hepatic impairment (Child-Pugh A).

Compared to women with normal liver function, those with moderate hepatic impairment had approximately 3-fold higher elagolix exposures and those with severe hepatic impairment had approximately 7-fold higher elagolix exposures. Because of these increased exposures and risk for bone loss:

ORILISSA 150 mg once daily is recommended for women with moderate hepatic impairment (Child-Pugh B) with the duration of treatment limited to 6 months. Use of ORILISSA 200 mg twice daily is not recommended for women with moderate hepatic impairment [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
ORILISSA is contraindicated in women with severe hepatic impairment (Child-Pugh C) [see Contraindications (4), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].