ORILISSA Film-coated tablet Ref.[10902] Active ingredients: Elagolix

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:

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)].

2.3 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.

In case of overdose, monitor the patient for any signs or symptoms of adverse reactions and initiate appropriate symptomatic treatment, as needed.

Store at 2°C to 30°C (36°F to 86°F).

Dispose unused medication via a take-back option if available. Otherwise, follow FDA instructions for disposing medication in the household trash, www.fda.gov/drugdisposal. Do NOT flush down the toilet.