Elagolic 200, 1 Strip

✔️ Common Side Effects

Very Common (More than 10%)

• Hot flashes or night sweats
• Headache
• Nausea

Common (1–10%)

• Insomnia
• Mood swings or altered mood
• Absence of menstruation (amenorrhea)
• Depression or depressive symptoms
• Anxiety
• Joint pain (arthralgia)
• Hypersensitivity reactions

✔️ Dosage and Administration

Recommended Adult Dose

Endometriosis:

• 150 mg orally once daily for up to 24 months

Administration Instructions

• Take at approximately the same time each day.
• Can be taken with or without food.
• Follow your doctor's instructions regarding dose and treatment duration.

Hepatic Impairment

• Mild impairment (Child-Pugh A): No dose adjustment needed.
• Moderate impairment (Child-Pugh B): Only the 150 mg once-daily regimen is recommended, with treatment limited to 6 months.
• Severe impairment (Child-Pugh C): Use is contraindicated.

Renal Impairment

• No dosage adjustment is required, including in patients with end-stage renal disease or those receiving dialysis.

✔️ Elagolic should not be used in patients with:

• Pregnancy
• Known osteoporosis
• Severe liver impairment
• Concurrent use of strong OATP1B1 inhibitors such as:
  • Cyclosporine
  • Gemfibrozil

✔️ Pregnancy and Contraception

Pregnancy

• Contraindicated during pregnancy.
• Exposure during pregnancy may increase the risk of early pregnancy loss.
• Treatment should be discontinued immediately if pregnancy occurs.

Pregnancy Testing

• Pregnancy should be ruled out before starting therapy.
• Testing is recommended whenever pregnancy is suspected during treatment.

Contraception

Women should use effective non-hormonal contraception while taking Elagolic and for at least one week after stopping treatment.

Breastfeeding

It is not known whether elagolix passes into human breast milk. The benefits of breastfeeding should be weighed against the mother's need for treatment and any potential risk to the infant. Consult a healthcare provider before using this medication while breastfeeding.

✔️ Precautions and Warnings

Menstrual Changes

Elagolic may reduce menstrual bleeding or stop periods altogether, making it more difficult to recognize pregnancy. Pregnancy testing should be performed if pregnancy is suspected.

Liver Function

The medication may cause elevated liver enzymes. Patients should seek medical attention immediately if they experience symptoms of liver injury, such as:

• Yellowing of the skin or eyes
• Dark urine
• Persistent nausea
• Unusual fatigue
• Upper abdominal pain

Mental Health Risks

Elagolic has been associated with:

• Depression
• Mood changes
• Anxiety
• Suicidal thoughts or behavior

Patients with a history of depression or suicidal behavior may be at higher risk. Any new or worsening mood symptoms should be reported to a healthcare professional immediately.

✔️ Seek immediate medical attention if you experience:

• Severe depression or suicidal thoughts
• Signs of liver problems
• Severe allergic reactions
• Unusual or persistent mood changes

✔️ Storage:

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