Egolix 200 mg (Tablet)

Indications

• Management of moderate to severe pain associated with endometriosis

Pharmacology

• GnRH receptor antagonist
• Inhibits endogenous GnRH signaling
• Suppresses luteinizing hormone (LH) and follicle-stimulating hormone (FSH)
• Decreases blood concentrations of estradiol and progesterone

Dosage & Administration

• Initial treatment with Elagolix 150 mg once daily for up to 24 months
• Initial treatment with Elagolix 200 mg twice daily for up to 6 months
• Start within 7 days from onset of menses
• Not recommended in moderate to severe hepatic impairment
• No established use in children and adolescents <18 years

Interaction

• May potentiate P-gp substrates (e.g. digoxin)
• May antagonize CYP3A substrates
• Reduced efficacy with estrogen-containing contraceptives
• No known food interaction

Contraindications

• Pregnant women
• Known osteoporosis
• Severe hepatic impairment
• Concomitant use of strong OATP1B1 inhibitors

Side Effects

• Common: hot flushes, night sweats, headache, nausea, amenorrhea, arthralgia, mood changes, bone loss
• Rare: insomnia, anxiety, elevated hepatic transaminase

Pregnancy & Lactation

• Contraindicated in pregnant women
• Discontinue if pregnancy occurs during treatment
• No information on presence in human milk or effects on breastfed child

Precautions & Warnings

• Bone loss
• Reduced ability to recognize pregnancy
• Suicidal ideation and mood disorders
• Hepatic transaminase elevations
• Potential for reduced efficacy with estrogen-containing contraceptives

Use in Special Populations

• No dose adjustment required in women with renal impairment or end-stage renal disease
• No dosage adjustment required in women with mild hepatic impairment
• Not established in patients <18 years of age

Overdose Effects

• Monitor for signs or symptoms of adverse reactions
• Initiate appropriate symptomatic treatment

Therapeutic Class

• Gonadotropin-releasing hormone (GnRH) antagonist

Storage Conditions

• Store in a cool & dry place
• Protect from light & moisture
• Keep out of reach of children

Related Brands