HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use LuciElag safely and effectively. See full prescribing information for LuciElag.

INDICATIONS AND USAGE

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

Limitations of Use:  

• Limit the duration of use based on the dose and coexisting condition.

DOSAGE AND ADMINISTRATION

Normal liver function or mild hepatic impairment: 150 mg once daily for up to 24 months or 200 mg twice daily for up to 6 months.

Moderate hepatic impairment: 150 mg once daily for up to 6 months.

DOSAGE FORMS AND STRENGTHS

Tablets: 200mg×56 tablets

CONTRAINDICATIONS

• Pregnancy.

• Known osteoporosis.

• Severe hepatic impairment.

• Organic anion transporting polypeptide (OATP) 1B1 inhibitors that significantly increase elagolix plasma concentrations. 

• Hypersensitivity reactions.

WARNINGS AND PRECAUTIONS

• Bone Loss: Dose- and duration-dependent decreases in bone mineral density (BMD) that may not be completely reversible. Assess BMD in women with additional risk factors for bone loss.

• Reduced Ability to Recognize Pregnancy: LuciElag may alter menstrual bleeding, which may reduce the ability to recognize pregnancy. Perform testing if pregnancy is suspected. Discontinue if pregnancy is confirmed.

• Suicidal Ideation and Mood Disorders: Advise patients to seek medical attention for suicidal ideation, suicidal behavior, new onset or worsening depression, anxiety, or other mood changes.

• Hepatic Transaminase Elevations: Dose-dependent elevations in serum alanine aminotransferase (ALT). Counsel patients on signs and symptoms of liver injury.

• Interactions with Hormonal Contraceptives: Use non-hormonal contraception during treatment and for 28 days after discontinuing LuciElag. Coadministration of LuciElag 200 mg twice daily with an estrogen-containing contraceptive is not recommended because of the potential for increased estrogen-associated risks. Coadministration of LuciElag with an estrogen-containing contraceptive may reduce the efficacy of LuciElag. Coadministration with progestin-containing oral contraceptives may reduce the efficacy of the contraceptive.

ADVERSE REACTIONS

Most common adverse reactions (>5%) in clinical trials included hot flushes and night sweats, headache, nausea, insomnia, amenorrhea, anxiety, arthralgia, depression-related adverse reactions and mood changes.

DRUG INTERACTIONS

See full prescribing information for a list of clinically important drug interactions.  

Storage

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.