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Elagolix, Estradiol, Norethindrone Acetate Capsules; Elagolix Capsules is available as the following:

• Morning (AM) capsule: elagolix 300 mg, estradiol 1 mg, norethindrone acetate 0.5 mg
• Evening (PM) capsule: elagolix 300 mg

• Elagolix, Estradiol, Norethindrone Acetate Capsules; Elagolix Capsules is a Gonadotropin-releasing hormone (GnRH) antagonist/estrogen/progestin and is used to treat heavy menstrual bleeding associated with uterine fibroids in premenopausal women

Elagolix, Estradiol, Norethindrone Acetate Capsules; Elagolix Capsules is a combination of three medications that help manage heavy menstrual bleeding associated with uterine fibroids: Elagolix is a gonadotropin-releasing hormone (GnRH) antagonist, meaning that it attaches to and blocks GnRH receptors (a protein that responds to signals) in your pituitary gland. With these receptors blocked, they don’t release hormones that worsen bleeding associated with uterine fibroids. Estradiol lowers the risk of bone loss (osteoporosis) caused by elagolix alone. Norethindrone works to protect the uterus from harmful side effects caused by estrogen (estradiol) alone, like uterine cancer.

• Elagolix, Estradiol, Norethindrone Acetate Capsules; Elagolix Capsules is typically taken as 1 capsule (elagolix 300 mg, estradiol 1 mg, norethindrone acetate 0.5 mg)
• in the morning and 1 capsule (elagolix 300 mg) in the evening for up to 24 months

Elagolix, Estradiol, Norethindrone Acetate Capsules; Elagolix Capsules is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication in any of the following:

• High risk of arterial, venous thrombotic, or thromboembolic disorder
• Pregnancy
  Known osteoporosis
• Current or history of breast cancer or other hormonally-sensitive malignancies
• Known liver impairment or disease
• Undiagnosed abnormal uterine bleeding
• Known hypersensitivity to ingredients of Elagolix, Estradiol, Norethindrone Acetate Capsules; Elagolix Capsules
• Organic anion transporting polypeptide (OATP)1B1 inhibitors that are known or expected to significantly increase elagolix plasma concentrations

Common side effects of Elagolix, Estradiol, Norethindrone Acetate Capsules; Elagolix Capsules:

• Hot flush Headache
• Feeling low energy
• Abnormal vaginal bleeding or spotting

Serious side effects are rare with Elagolix, Estradiol, Norethindrone Acetate Capsules; Elagolix Capsules. Contact your healthcare provider immediately if you experience any of the following.

• Liver damage: yellowing of your skin and whites of your eyes, stomach pain, nausea, vomiting, loss of appetite, dark urine, tiredness
• Serious allergic reaction: rash, swelling of lips, tongue, or throat, difficulty breathing

• The following medications may interact with Elagolix, Estradiol, Norethindrone Acetate Capsules; Elagolix Capsules:
• Increase monitoring of digoxin concentrations and potential signsand symptoms of clinical toxicity when initiating Elagolix, Estradiol, Norethindrone Acetate Capsules; Elagolix Capsules in patients who are taking digoxin. If Elagolix, Estradiol, Norethindrone Acetate Capsules; Elagolix Capsules is discontinued increase monitoring of digoxin concentrations
• Consider increasing the dose of midazolam by no more than 2-fold and individualize midazolam therapy based on the patient’s response
• Monitor lipid levels and adjust the dose of rosuvastatin, if necessary
• No dose adjustment needed for omeprazole 40 mg once daily when co-administered with Elagolix, Estradiol, Norethindrone Acetate Capsules; Elagolix Capsules. When Elagolix, Estradiol, Norethindrone Acetate Capsules; Elagolix Capsules is used concomitantly with higher doses of omeprazole, consider dosage reduction of omeprazole

Various FDA-approved generic manufacturers

Exposure to Elagolix, Estradiol, Norethindrone Acetate Capsules; Elagolix Capsules early in pregnancy may increase the risk of early pregnancy loss. Women should use non-hormonal contraception during treatment and for 28 days after discontinuing Elagolix, Estradiol, Norethindrone Acetate Capsules; Elagolix Capsules. Elagolix, Estradiol, Norethindrone Acetate Capsules; Elagolix Capsules may delay the ability to recognize the occurrence of a pregnancy because it alters menstrual bleeding. Perform pregnancy testing if pregnancy is suspected and discontinue Elagolix, Estradiol, Norethindrone Acetate Capsules; Elagolix Capsules if pregnancy is confirmed.

• Oriahnn