Egolix 150mg Tablet 1 Strip

Egolix is prescribed for the treatment of moderate to severe pain associated with endometriosis in adult women.

Pregnancy should be ruled out before starting treatment. Therapy should begin within 7 days of the onset of menstruation.

Egolix 150 mg

• Recommended dose: 150 mg once daily.
• Maximum treatment duration: up to 24 months.
• In patients with moderate liver impairment: use for no longer than 6 months.

Egolix 200 mg

• Recommended dose: 200 mg twice daily, particularly for patients with painful intercourse (dyspareunia).
• Maximum treatment duration: 6 months due to the risk of bone mineral density loss.
• Not recommended in patients with moderate or severe hepatic impairment.

Children and Adolescents

• Safety and effectiveness in individuals under 18 years of age have not been established.

Drug Interactions

With medicines:

• May increase the effects of P-glycoprotein (P-gp) substrates such as digoxin.
• Can increase exposure to CYP2C19 substrates (e.g., omeprazole); omeprazole doses should generally remain below 40 mg daily.
• May reduce the effectiveness of certain CYP3A substrate medications.
• May lower the effectiveness of oral midazolam and rosuvastatin; dosage adjustments may be required.
• CYP3A inducers may reduce the effectiveness of Elagolix.
• Estrogen-containing contraceptives may be less effective when used alongside Egolix.

With food:

• No significant food interactions are known.

Contraindications

Egolix should not be used in:

• Pregnant women, as it may increase the risk of early pregnancy loss.
• Patients with known osteoporosis due to the risk of further bone loss.
• Individuals with severe liver impairment.
• Patients taking strong OATP1B1 inhibitors such as cyclosporine or gemfibrozil.

Side Effects

Common side effects:

• Hot flashes
• Night sweats
• Headache
• Nausea
• Absence of menstruation (amenorrhea)
• Joint pain (arthralgia)
• Mood changes
• Bone mineral density loss

Less common side effects:

• Insomnia
• Anxiety
• Elevated liver enzymes

Pregnancy & Breastfeeding

Egolix is contraindicated during pregnancy. Exposure during early pregnancy may increase the risk of miscarriage or pregnancy loss. Treatment should be stopped immediately if pregnancy occurs.

It is not known whether Elagolix passes into breast milk or affects milk production. Therefore, caution is advised during breastfeeding.

Precautions & Warnings

Bone Loss

• Egolix can cause dose- and duration-dependent reductions in bone mineral density, which may not be fully reversible.
• Bone health should be assessed in patients with risk factors for osteoporosis.

Pregnancy Recognition

• Changes in menstrual bleeding patterns may make pregnancy harder to detect.
• Pregnancy testing should be performed if pregnancy is suspected.

Mood Changes

• Depression, anxiety, mood disturbances, and suicidal thoughts or behavior have been reported.
• Patients should seek immediate medical attention if significant mood changes occur.

Liver Effects

• Elagolix may cause increases in liver enzymes.
• Patients should be monitored for symptoms of liver injury, such as jaundice, dark urine, or persistent abdominal pain.

Contraception

• Hormonal contraceptives containing estrogen may be less effective.
• Use non-hormonal contraception during treatment and for at least one week after stopping Egolix.

Use in Special Populations

Renal Impairment

• No dose adjustment is required for patients with kidney disease, including those receiving dialysis.

Hepatic Impairment

• No dosage adjustment is needed for mild liver impairment.
• Higher-dose therapy is not recommended in moderate to severe liver impairment.

Pediatric Use

• Safety and efficacy have not been established in patients younger than 18 years.

Overdose

In the event of an overdose, patients should be monitored for adverse effects and treated with supportive and symptomatic care as needed.

Therapeutic Class

Gonadotropin-Releasing Hormone (GnRH) Receptor Antagonist.

Storage

Store in a cool, dry place away from light and moisture. Keep out of the reach of children.