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Orilissa (elagolix)

Indications

• Endometriosis Pain: Orilissa is used to manage moderate to severe pain associated with endometriosis.
• Management of Endometriosis Symptoms: It helps reduce symptoms such as pelvic pain, painful menstrual periods, and pain during sexual intercourse.

Dosage and Administration

• Take Orilissa exactly as prescribed by your doctor.
• Swallow the tablet whole with a full glass of water.
• Take the medication at the same time each day to maintain consistent levels in your body.
• If you miss a dose, take it as soon as you remember unless it is almost time for your next dose.
• Discuss with your doctor the duration of treatment, as long-term use may require additional monitoring.
• Do not take more than the recommended dose.
• Avoid skipping doses or stopping the medication without consulting your doctor.
• Do not take Orilissa if you are pregnant or planning to become pregnant, as it can harm the unborn baby.
• Avoid using Orilissa if you have severe liver problems.

Mechanism of Action

Orilissa (elagolix) is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by reducing the production of estrogen in the ovaries, thereby decreasing the hormone levels that contribute to endometriosis pain. By lowering these hormone levels, Orilissa helps alleviate pain and symptoms associated with endometriosis.

Contraindications

• Do not use Orilissa if you are allergic to elagolix or any other components of the tablet.
• Avoid use if you are pregnant, as Orilissa can cause harm to the unborn baby.
• Not recommended for individuals with severe liver impairment.
• Avoid use if you have osteoporosis or are at high risk for bone loss.

Side Effects

Common Side Effects

• Hot flashes
• Night sweats
• Headache
• Nausea
• Difficulty sleeping
• Mood changes
• Reduced bone density

Serious Side Effects

• Severe liver problems (e.g., yellowing of the skin or eyes, dark urine)
• Suicidal thoughts or behavior
• Severe mood swings or depression
• Severe allergic reactions (e.g., rash, itching, swelling, severe dizziness, trouble breathing)
• Significant bone loss or osteoporosis

Precautions

• Inform your doctor of any pre-existing conditions, especially liver disease, depression, or osteoporosis.
• Be cautious when using Orilissa if you have a history of depression or suicidal thoughts.
• Regularly monitor your liver function and bone density through blood tests and scans as advised by your doctor.
• Discuss with your doctor if you are planning to become pregnant, as effective non-hormonal contraception should be used during treatment.
• Inform your doctor about all medications, supplements, and herbal products you are taking to avoid harmful interactions.

Storage Instructions

• Store Orilissa tablets at room temperature, between 20°C to 25°C (68°F to 77°F).
• Keep the medication in its original container, tightly closed, and out of reach of children.
• Protect from light and moisture.
• Do not store it in the bathroom.
• Dispose of any expired or unused medication properly.

References

https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/210450s004s005s006lbl.pdf