Home Drug Guide Elagolix

Drug Guide

Generic Name

Elagolix

Brand Names Orilissa

Classification

Therapeutic: Endometriosis-associated pain, Uterine fibroids (off-label)

Pharmacological: GnRH antagonist

FDA Approved Indications

Management of pain associated with endometriosis in premenopausal women

Mechanism of Action

Elagolix is a gonadotropin-releasing hormone (GnRH) antagonist. It works by competitively binding to GnRH receptors in the pituitary, decreasing the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to reduced estrogen production.

Dosage and Administration

Adult: Initial dose of 150 mg once daily; can be adjusted based on response and tolerability.

Pediatric: Not approved for pediatric use.

Geriatric: Limited data; use with caution, typically similar to adult dosing.

Renal Impairment: No dose adjustment necessary.

Hepatic Impairment: Use with caution; monitor liver function.

Pharmacokinetics

Absorption: Rapid absorption with oral administration.

Distribution: Widely distributed in body tissues.

Metabolism: Metabolized primarily by CYP3A4 enzyme system.

Excretion: Primarily via feces, with some renal excretion.

Half Life: Approximately 4 to 6 hours.

Contraindications

Pregnancy (category X)
Known hypersensitivity

Precautions

Use with caution in women with hepatic impairment or osteoporosis.
Avoid in women who are pregnant or breastfeeding.
Monitor bone mineral density during prolonged therapy.

Adverse Reactions - Common

Hot flashes (Common)
Insomnia (Common)
Mood changes (Common)
Decreased bone mineral density (Less common)

Adverse Reactions - Serious

Osteoporosis and increased fracture risk (Less common)
Liver enzyme elevations (Rare)

Drug-Drug Interactions

CYP3A4 inhibitors and inducers may alter elagolix levels.

Drug-Food Interactions

N/A

Drug-Herb Interactions

N/A

Nursing Implications

Assessment: Monitor for hot flashes, mood changes, bone mineral density, and liver function.

Diagnoses:

Risk for osteoporosis
Altered mood/stress response

Implementation: Administer as prescribed, monitor side effects, consider calcium and vitamin D supplementation for bone health.

Evaluation: Assess relief of endometriosis pain, monitor for adverse effects, especially bone density.

Patient/Family Teaching

Report any severe hot flashes, mood changes, or signs of liver problems.
Maintain adequate calcium and vitamin D intake.
Follow up on bone density testing if on long-term therapy.
Avoid pregnancy during treatment.

Special Considerations

Black Box Warnings:

Osteoporosis and bone fracture risk with long-term use.

Genetic Factors: No specific genetic tests needed.

Lab Test Interference: None known.

Overdose Management

Signs/Symptoms: Nausea, vomiting, dizziness, fatigue.

Treatment: Supportive care; no specific antidote. Manage symptoms and provide supportive interventions.

Storage and Handling

Storage: Store at room temperature, 20°C to 25°C (68°F to 77°F).

Stability: Stable under recommended storage conditions.