Endolix 150 mg (Tablet)

Indications

• Management of moderate to severe pain associated with endometriosis

Pharmacology

• GnRH receptor antagonist
• Inhibition of endogenous GnRH signaling
• Competitive binding to GnRH receptors in the pituitary gland
• Suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH)
• Decreased blood concentrations of estradiol and progesterone

Dosage & Administration

• Exclusion of pregnancy before starting treatment
• Initiate treatment within 7 days from the onset of menses
• Initial treatment with Elagolix 150 mg
• Initial treatment with Elagolix 200 mg
• Usage limitations for moderate hepatic impairment
• Use not established in children and adolescents

Interaction

• Potentiation of P-glycoprotein (P-gp) substrates
• Antagonism with CYP3A substrates
• Reduced efficacy with estrogen-containing contraceptives
• No known food interactions

Contraindications

• Pregnancy
• Known osteoporosis
• Severe hepatic impairment
• Concomitant use of strong organic anion transporting polypeptide 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

• Insufficient human data for use in pregnant women
• Increase in risk of early pregnancy loss
• Discontinuation required if pregnancy occurs
• No information on presence in human milk, effects on the breastfed child, or milk production

Precautions & Warnings

• Dose and duration-dependent decreases in bone mineral density (BMD)
• 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
• Safety and effectiveness not established in patients less than 18 years of age

Overdose Effects

• Monitoring for signs or symptoms of adverse reactions
• Initiation of appropriate symptomatic treatment

Therapeutic Class

• Gonadotropin-releasing hormone (GnRH) antagonist

Storage Conditions

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

Related Brands

• Endolix 200 mg (Tablet) - eskayef-pharmaceuticals-ltd