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Oriahnn is the brand name for elagolix/estradiol/norethindrone acetate and elagolix oral capsules.

Oriahnn 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

• Oriahnn is a Gonadotropin-releasing hormone (GnRH) antagonist/estrogen/progestin and is used to treat heavy menstrual bleeding associated with uterine fibroids in premenopausal women

Oriahnn 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.

• Oriahnn 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

Oriahnn 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 Oriahnn
• Organic anion transporting polypeptide (OATP)1B1 inhibitors that are known or expected to significantly increase elagolix plasma concentrations

Common side effects of Oriahnn:

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

Serious side effects are rare with Oriahnn. 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 Oriahnn:
• Increase monitoring of digoxin concentrations and potential signsand symptoms of clinical toxicity when initiating Oriahnn in patients who are taking digoxin. If Oriahnn 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 Oriahnn. When Oriahnn is used concomitantly with higher doses of omeprazole, consider dosage reduction of omeprazole

AbbVie Inc.

Exposure to Oriahnn 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 Oriahnn. Oriahnn 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 Oriahnn if pregnancy is confirmed.

• Elagolix, Estradiol, Norethindrone Acetate Capsules; Elagolix Capsules