Elagox 200

Indications

Elagolix is a hormone medicine taken by mouth. It is used in women for:

• Moderate to severe pain caused by endometriosis (tissue like the womb lining growing outside the womb)
• Heavy menstrual bleeding caused by uterine fibroids, in a combination product that also contains Estradiol and Norethindrone

It is prescribed by a gynaecologist or specialist.

How It Works

Elagolix blocks the action of gonadotropin-releasing hormone (GnRH) on the pituitary gland. This lowers the hormones that tell the ovaries to make oestrogen. Lower oestrogen levels reduce the growth of endometriosis tissue and fibroids, easing pain and bleeding.

Dosage and Administration

Take exactly as prescribed, usually once or twice a day, with or without food, at about the same time each day. The dose and how long it can be used depend on the condition and on liver function. Because it can thin the bones, treatment is time-limited (often 6 to 24 months depending on the dose), as the doctor advises. Treatment is usually started within the first days of a period to avoid taking it during an unknown pregnancy.

Interactions

• Cyclosporine and Gemfibrozil greatly raise Elagolix levels and must not be used with it.
• Strong CYP3A inhibitors such as Ketoconazole and Clarithromycin, and Rifampicin, change its levels; the doctor may avoid them or limit the dose.
• Hormonal contraceptives that contain oestrogen may make Elagolix less effective, and Elagolix may make some contraceptives less reliable. Use a non-hormonal method.
• It can raise levels of Digoxin and lower levels of Midazolam and Rosuvastatin.

Contraindications

• Pregnancy
• Known osteoporosis (thin bones)
• Severe liver disease
• Use with Cyclosporine or Gemfibrozil
• Allergy to Elagolix

Side Effects

Common: hot flushes, night sweats, headache, nausea, trouble sleeping, mood changes, absent or irregular periods, joint pain and raised cholesterol. Long-term use can reduce bone density.

Get urgent medical help if you notice:

• New or worsening depression, anxiety, severe mood changes, or thoughts of harming yourself
• Yellowing of the skin or eyes, dark urine or pain in the upper right abdomen (possible liver problem)
• Swelling of the face, lips or throat, or difficulty breathing

Pregnancy and Lactation

Elagolix must not be used in pregnancy, as it may increase the risk of early pregnancy loss. Use non-hormonal contraception during treatment and for at least one week after stopping. Because periods may become light or stop, a pregnancy can be hard to notice; take a pregnancy test if you suspect pregnancy and stop the medicine if positive. It is not known whether it passes into breast milk; ask the doctor before breastfeeding.

Precautions and Warnings

• Bone density may be checked during longer treatment; ensure enough calcium and vitamin D.
• Tell the doctor about any history of depression or mood problems.
• Liver tests may be needed; tell the doctor about liver disease.
• It may raise cholesterol.

Overdose

Experience with overdose is limited. If too much is taken, seek medical advice; treatment is supportive.

Therapeutic Class

Gonadotropin-releasing hormone (GnRH) receptor antagonist; hormone therapy.

Storage

Store below 30°C in a dry place, away from light and out of the reach of children.