Medically reviewed by Drugs.com. Last updated on Feb 1, 2021.
Generic name: ELAGOLIX SODIUM 150mg
Dosage form: tablet, film coated
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)].
|Initiate treatment with
ORILISSA 150 mg once daily
|Consider initiating treatment with
ORILISSA 200 mg twice daily
|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)].
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- Drug class: gonadotropin-releasing hormone antagonists
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