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Elagolix 300mg, Estradiol 1mg, Norethindrone Acetate 0.5mg, Oral capsule

Grapefruit juice

· Severity: Major

· Notes for Consumers: Do not take Grapefruit juice with Elagorix without approval from your prescriber. Side effects may get worse if you take if you take Grapefruit juice or grapefruit-containing foods. Discuss any new or worsening side effects, such as hot flashes, night sweats, headache, and mood changes, with your healthcare professional.

· Notes for Professionals: Advise patients to avoid grapefruit juice while taking elagolix due to increased elagolix exposure. Elagolix is a CYP3A substrate; grapefruit juice is a strong inhibitor of CYP3A. Coadministration may increase elagolix plasma concentrations. In drug interaction studies, coadministration of elagolix with another strong CYP3A inhibitor increased the Cmax and AUC of elagolix by 77% and 120%, respectively.

Elagolix 300mg, Estradiol 1mg, Norethindrone Acetate 0.5mg, Oral capsule

Tobacco

· Severity: Major

· Notes for Consumers: Do not smoke or use tobacco products while taking this medication. Smoking while taking this medication increases the risk for serious side effects such as blood clots, heart attack, and stroke. Call emergency services right away if you experience symptoms of a blood clot in your lung: shortness of breath or chest pain. You should also call emergency services right away if you experience symptoms of a heart attack: pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded. You should also call emergency services right away if you experience symptoms of a stroke: sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision. Contact your care team right away if you experience symptoms of a blood clot in your leg: pain, swelling, or warmth in the leg.

· Notes for Professionals: Advise patients to avoid cigarette smoking while taking estrogen hormones. Cigarette smoking increases the risk of serious cardiovascular events, such as myocardial infarction, stroke, deep vein thrombosis, and pulmonary embolism. Combined hormonal contraceptives are contraindicated in females who are over 35 years of age and smoke.

<b>DISCLAIMER:</b><em> This drug information content is provided for informational purposes only and is not intended to be a substitute for professional medical advice, diagnosis, or treatment. Patients should always consult their physician with any questions regarding a medical condition and to obtain medical advice and treatment. Drug information is sourced from GSDD (Gold Standard Drug Database ) provided by Elsevier.</em>