Orili 200

• Management of moderate to severe pain associated with endometriosis

Elagolix is a GnRH receptor antagonist that competitively binds to GnRH receptors in the pituitary gland, inhibiting endogenous GnRH signaling. Administration results in dose-dependent suppression of LH and FSH, leading to decreased blood concentrations of estradiol and progesterone.

Adult Dose:

• 150 mg: Once daily, up to 24 months (up to 6 months in moderate hepatic impairment).
• 200 mg: Twice daily, up to 6 months (with coexisting dyspareunia). 200 mg dose should not exceed 6 months (may decrease BMD).

Exclude pregnancy before starting treatment and start Elagolix within 7 days from onset of menses.

Common Side Effects:

• Hot flushes
• Night sweats
• Headache
• Nausea
• Amenorrhea
• Arthralgia
• Mood changes
• Bone loss (decreased BMD)

Rare Side Effects:

• Insomnia
• Anxiety
• Elevated hepatic transaminase

Limited human data on use in pregnancy. Exposure early in pregnancy may increase risk of early pregnancy loss. Contraindicated in pregnancy.

• Bone Loss: Dose and duration-dependent decreases in BMD that may not be completely reversible. Assess BMD in women with additional risk factors.
• Reduced Ability to Recognize Pregnancy: Elagolix may alter menstrual bleeding. Perform testing if pregnancy is suspected.
• Suicidal Ideation and Mood Disorders: Advise patients to seek medical attention for suicidal thoughts, new or worsening depression, anxiety or mood changes.
• Hepatic Transaminase Elevations: Dose-dependent elevations in serum ALT. Counsel patients on signs/symptoms of liver injury.

In case of overdose, monitor patients for signs/symptoms of adverse reactions and initiate appropriate symptomatic treatment.

Store in a cool & dry place, protect from light & moisture. Keep out of reach of children.