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Orilissa Dosage

Generic name: ELAGOLIX SODIUM 150mg
Dosage form: tablet, film coated

Medically reviewed by Drugs.com. Last updated on May 5, 2020.

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)

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)].

Missed Dose

Instruct the patient to take a missed dose of ORILISSA on the same day as soon as she remembers and then resume the regular dosing schedule.

  • 150 mg once daily: take no more than 1 tablet each day.
  • 200 mg twice daily: take no more than 2 tablets each day.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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