Elagolix

LuciElag (Elagolix) 150mg & 200mg

EACH LUCIELAG TABLET CONTAINS:

Elagolix (as Elagolix sodium) ………………… 150 mg / 200 mg

INDICATION:

LuciElag (Elagolix) is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the management of moderate to severe pain associated with endometriosis.

DOSAGE AND USE:

• Recommended dosage: 150 mg orally once daily (150 mg strength) / 200 mg orally twice daily (200 mg strength).
• Maximum treatment duration: up to 24 months (150 mg) / up to 6 months (200 mg).
• Use the lowest effective dose and shortest duration consistent with treatment goals.
• Tablets should be swallowed whole and not crushed or chewed.

CONTRAINDICATIONS:

• Pregnancy
• Known osteoporosis
• Severe hepatic impairment
• Concomitant use with strong OATP1B1 inhibitors (e.g., cyclosporine, gemfibrozil)

WARNINGS AND PRECAUTIONS:

• Bone loss (decreased BMD): Dose- and duration-dependent (150 mg) / May be dose- and duration-dependent (200 mg); may not be completely reversible.
• Menstrual changes / reduced ability to recognize pregnancy (150 mg) / Change in menstrual bleeding / reduced ability to recognize pregnancy (200 mg)
• Mood changes, depression, and suicidal ideation
• Hepatic transaminase elevations
• Use non-hormonal contraception during treatment and for at least 1 week after discontinuation

ADVERSE REACTIONS:

Most common adverse reactions include:

• Hot flushes / night sweats
• Headache
• Nausea
• Insomnia
• Amenorrhea
• Mood changes

DRUG INTERACTIONS:

• Avoid use with strong OATP1B1 inhibitors
• Use caution with CYP3A substrates
• Hormonal contraceptives may reduce effectiveness—non-hormonal methods recommended

USE IN SPECIAL POPULATIONS:

• Pregnancy: Contraindicated
• Lactation: Not recommended
• Hepatic impairment: Not recommended in severe impairment
• Pediatric use: Safety and effectiveness not established

STORAGE:

Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).
Keep out of reach of children.

PACKAGING:
Available in packs of

28 tablets (150 mg)

56 tablets (200 mg)

Manufactured and Marketed by:

LUCIUS PHARMACEUTICALS (LAO) CO., LTD
No. 26, Thongmang Village, Xaythany District, Vientiane Capital, Laos