Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Orilissa (Elagolix).
Birth control: It is possible to become pregnant while taking Orilissa (Elagolix). Women taking Orilissa (Elagolix) should use effective methods of birth control that do not contain estrogen while taking Orilissa (Elagolix) and for at least 1 week after the last dose.
Bone health: Orilissa (Elagolix) can cause a decrease in the density of bones. Higher doses taken for longer periods of time increase the amount of bone lost. The lowest dose of Orilissa (Elagolix) to control the symptoms, taken for the shortest period of time, is less likely to cause these problems. If you have risk factors for osteoporosis, such as previous use of other medications that decrease bone density, metabolic bone disease, anorexia, long term use of alcohol or tobacco, or family history of osteoporosis, discuss with your doctor whether any special monitoring is needed.
Depression and suicidal behaviour: Orilissa (Elagolix) can cause mood swings and symptoms of depression. People taking Orilissa (Elagolix) may feel agitated (restless, anxious, aggressive, emotional, and feeling not like themselves), or they may want to hurt themselves or others. Symptoms of depression such as poor concentration, changes in weight, changes in sleep, and decreased interest in activities may also occur. If you experience these side effects or notice them in a family member who is taking Orilissa (Elagolix), contact your doctor immediately. Your doctor should closely monitor your emotional and behavioural changes while taking Orilissa (Elagolix).
If you have depression or a history of depression, discuss with your doctor how Orilissa (Elagolix) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Orilissa (Elagolix), and whether any special monitoring is needed.
Liver function: Liver disease or reduced liver function may cause Orilissa (Elagolix) to build up in the body, causing side effects. Orilissa (Elagolix) may also reduce liver function and can cause liver damage. If you have liver problems, discuss with your doctor how Orilissa (Elagolix) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Orilissa (Elagolix), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Orilissa (Elagolix).
If you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.
Pregnancy: The use of Orilissa (Elagolix) may cause miscarriage or other complications if the mother takes it during pregnancy. If you become pregnant while taking Orilissa (Elagolix), contact your doctor immediately.
Breast-feeding: It is not known if Orilissa (Elagolix) passes into breast milk. If you are a breast-feeding mother and are taking Orilissa (Elagolix), it may affect your baby. Talk to your doctor about whether you should continue breast-feeding.
Children: The safety and effectiveness of using Orilissa (Elagolix) have not been established for children.
Seniors: Orilissa (Elagolix) has not been studied in women over 65 years of age. It is not intended for use by women who have reached Menopause.
