Orilissa Tablets (Elagolix)

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ORILISSA (ELAGOLIX) - Canada Product Information

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Orilissa is a medication that contains elagolix, used to treat moderate to severe pain associated with endometriosis. Endometriosis is a condition where tissue similar to the lining inside the uterus grows outside the uterus, causing pain.

HOW TO TAKE ORILISSA

Orilissa comes in two strengths: 150 mg tablets (taken once daily) and 200 mg tablets (taken twice daily).

Take Orilissa at the same time each day, with or without food.

If you miss a dose, take it as soon as you remember on the same day. Do not take more than the prescribed daily dose.

WHO SHOULD NOT TAKE ORILISSA

If you are allergic to elagolix or any ingredients in Orilissa.

If you are pregnant, planning to become pregnant, or have unexplained vaginal bleeding.

If you have osteoporosis or severe liver problems.

If you are taking certain medications that may interact with Orilissa.

DOSAGE

Recommended Dosage:

For Moderate to Severe Pain Associated with Endometriosis:

150 mg Tablets: Take one tablet once daily.

200 mg Tablets: Take one tablet twice daily.

Duration of Treatment:

150 mg Once Daily: Can be used for up to 24 months.

200 mg Twice Daily: Use should be limited to 6 months due to the increased risk of bone mineral density loss.

Special Dosage Considerations:

Pregnancy: Ensure you are not pregnant before starting Orilissa. Use effective contraception while taking Orilissa.

Liver Impairment:

• Mild liver impairment: No dosage adjustment needed.
• Moderate liver impairment: Use 150 mg once daily for up to 6 months.
• Severe liver impairment: Orilissa is not recommended.

MISSED DOSE

If you miss a dose, take it as soon as you remember on the same day. Do not take more than the prescribed daily dose.

POSSIBLE SIDE EFFECTS

Common side effects include:

• Hot flashes
• Headaches
• Nausea
• Trouble sleeping (insomnia)
• Mood changes, such as depression

IMPORTANT SAFETY INFORMATION

Orilissa is not a contraceptive. Use effective non-estrogen contraceptives while on this medication.

Orilissa may cause a decrease in bone mineral density (BMD). Your doctor may monitor your BMD during treatment, especially if you use it for more than 6 months.

Orilissa can cause liver problems. Seek medical help if you experience symptoms like yellowing of the skin or eyes (jaundice).

Orilissa may affect menstrual bleeding patterns, often reducing menstrual flow or stopping periods.

PREGNANCY AND BREASTFEEDING

Do not take Orilissa if you are pregnant. It can harm the unborn baby.

It is not known if Orilissa passes into breast milk. Discuss with your doctor if you are breastfeeding or plan to breastfeed.

STORAGE

Store Orilissa between 36°F and 86°F.

Keep out of reach of children.

OVERDOSE

If you think you have taken too much Orilissa, contact your healthcare provider or go to the nearest emergency room immediately.

This provides a summary of information about Orilissa and does not cover all possible information. Always consult your healthcare provider to ensure the information displayed here applies to your personal circumstances.

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Reference: Orilissa Canada product information

Take Orilissa as prescribed: 150 mg once daily or 200 mg twice daily, at the same time each day, with or without food. Use effective non-estrogen contraception. If a dose is missed, take it as soon as remembered on the same day. Do not exceed the prescribed dose.