Posology : מינונים

3. DOSAGE AND ADMINISTRATION

3.1. 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 (6.1, 6.3, 6.4) and Clinical Studies (14)].
• Limit the duration of use because of bone loss (Table 1) [see Warnings and Precautions (6.1)].


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

3.2. 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 (9.6) and Clinical Pharmacology (12.3)].
• ORILISSA is contraindicated in women with severe hepatic impairment (Child-Pugh C) [see Contraindications (5), Use in Specific Populations (9.6) and Clinical Pharmacology (12.3)].

3.3. 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.

4. DOSAGE FORMS AND STRENGTHS

The 150 mg tablets are light pink, oblong, film-coated tablets with “EL 150” debossed on one side. Each tablet contains 155.2 mg of elagolix sodium equivalent to 150 mg of elagolix.
The 200 mg tablets are light orange, oblong, film-coated tablets with “EL 200” debossed on one side. Each tablet contains 207.0 mg of elagolix sodium equivalent to 200 mg of elagolix.