Orilissa

Before taking this medicine

Do not take Orilissa (elagolix) if you are pregnant, have known osteoporosis or severe liver impairment, or have had an allergic reaction to elagolix or any inactive ingredient. Reported allergic reactions include anaphylaxis and angioedema (swelling). Early pregnancy exposure may increase the risk of pregnancy loss. Do not take it with medicines that inhibit the liver transporter OATP1B1 and significantly increase elagolix levels. Orilissa can reduce bone mineral density, and this loss may not fully reverse. Bone density should be assessed if you have additional risk factors for bone loss. Changes in menstrual bleeding may make pregnancy harder to recognize. Have a pregnancy test if pregnancy is suspected, and stop Orilissa if pregnancy is confirmed. Use non-hormonal contraception during treatment and for 28 days after stopping. Estrogen-containing contraceptives may reduce Orilissa’s effectiveness and, with some regimens, increase estrogen-related risks. Orilissa may reduce the effectiveness of progestin-containing oral contraceptives. Seek medical attention for suicidal thoughts or behavior, new or worsening depression, anxiety, or other mood changes. Orilissa can also increase liver enzyme levels; discuss the signs and symptoms of liver injury with your prescriber.