Oriahnn (Elagolix,Estradiol,Norethindrone acetate and Elagolix)

Prescription medicineOnly Available By Prescription
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Strength Pack Size Qty
Strength
300mg/1mg/0.5mg/300mg
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Description

Oriahnn (elagolix, estradiol, and norethindrone acetate) is a combination medication used to manage heavy menstrual bleeding caused by fibroids in premenopausal women. 


Fact Table

Formula

C32H29F5N3O5Na. C32H30F5N3O5. C18H24O2.C22H28O3

License

US DailyMed

Bioavailability

-

Legal status

Rx-Only

Chemical Name

Elagolix/estradiol/norethindrone acetate

Elimination half-life

5.9 and 14.5 hours

Dosage (Strength)

300mg/1mg/0.5mg/300mg

Pregnancy

Consult Doctor

Brands

Oriahnn

Protein binding

-

PubChem CID

-

MedlinePlus

a620042

ChEBI

-

ATC code

None

DrugBank

-

KEGG

D12137

Routes of administration

By mouth

Directions

Oriahnn comes in capsules: 

One capsule for morning administration contains 300 mg of elagolix, 1 mg of estradiol, and 0.5 mg of norethindrone acetate.

One capsule for evening administration contains 300 mg of elagolix.

Oriahnn Dosage: 

Take one capsule (elagolix 300 mg, estradiol 1 mg, norethindrone acetate 0.5 mg) by mouth every morning and one capsule (elagolix 300 mg) by mouth every evening for up to 2 years.

Ingredients

Elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin, are the active ingredients contained in Oriahnn.

Contraindications

WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS

See full prescribing information for complete boxed warning.

  • Estrogen and progestin combinations, including ORIAHNN, increase the risk of thrombotic or thromboembolic disorders, especially in women at increased risk for these events. 
  • ORIAHNN is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events including women over 35 years of age who smoke or women with uncontrolled hypertension. 

Avoid taking Oriahnn if you:

  • Are a smoker and are older than 35 years old 
  • Have or had blood clots in your legs, lungs, or eyes
  • Have a vascular disease such as cerebrovascular disease, coronary artery disease, or peripheral vascular disease
  • Have heart valve or heart rhythm problems
  • Have a condition that makes your blood clot more than normal
  • Have high blood pressure that is uncontrolled by medication
  • Have diabetes with injury to the kidneys, eyes, nerves, or blood vessels
  • Have headaches accompanied by numbness, weakness, or vision changes or if you are older than 35 and have migraines with aura

Avoid taking Oriahnn if you are pregnant.

Avoid taking Oriahnn if you have osteoporosis.

Avoid taking Oriahnn if you currently have or had breast cancer or any other hormonally-sensitive cancer.

Avoid taking Oriahnn if you have liver problems or liver disease.

Avoid taking Oriahnn if you have undiagnosed irregular vaginal bleeding.

Avoid taking Oriahnn if you are allergic to any of its ingredients or excipients.

Cautions

  • Before you start taking Oriahnn, inform your doctor:
    • Of all the medications you take, including prescription, over-the-counter, vitamins, and herbal supplements.
    • Of your allergies.
    • Of your health problems.
    • Of your pregnancy status.
    • Of your breastfeeding status.
  • Avoid consuming grapefruit or grapefruit juice while taking Oriahnn.
  • Your risk for heart attack, stroke, or blood clots is increased with the use of Oriahnn. Get emergency care right away if you have pain or swelling in your leg, breathing problems, vision problems, a sudden and severe headache, arm or leg weakness or numbness, trouble speaking, or chest, arm, or jaw pain or pressure.
  • Bone mineral density loss can occur with the use of Oriahnn.
  • Suicidal ideation can occur with the use Oriahnn. Get emergency care right away if you experience suidcidal ideation, suicidal thoughts, suicidal behavior, or anxiety, depression, or mood changes that are new or becoming worse.
  • Liver damage can occur with the use of Oriahnn. Get medical care immediately if you have yellowing of your skin or whites of your eyes, dark urine, tiredness, nausea, vomiting, swelling, stomach pain, or bruising.
  • High blood pressure can occur with the use of Oriahnn. Be sure to monitor your blood pressure during treatment with Oriahnn.
  • Changes in periods and the ability to recognize pregnancy can occur with the use of Oriahnn. Be sure to take a pregnancy test if you suspect that you are pregnant. If you are pregnant, Oriahnn should be discontinued. It is not known how hormonal birth control affects the way Oriahnn works. Women should use hormone-free birth control methods during treatment with Oriahnn and for 28 after stopping Oriahnn.
  • Increased blood sugar levels, cholesterol, and triglycerides can occur with the use of Oriahnn. 
  • The thinning or loss of hair can occur with the use of Oriahnn.
  • Laboratory tests, including tests for thyroid, cholesterol, and blood clotting, can be affected by Oriahnn.
  • Oriahnn contains FD and C Yellow No. 5 (tartrazine). This can cause an allergic reaction in patients who are sensitive.

Side Effects

Oriahnn can cause side effects that include, but are not limited to, headache, hot flashes, tiredness, and irregular vaginal bleeding. Contact your doctor immediately if you have side effects that bother you or won't go away.

References:

  1. Oriahnn (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), co-packaged for oral use. North Chicago, IL: AbbVie Inc.; 2021.
  2. Oriahnn. Important Safety Information. Accessed March 21, 2022.


IMPORTANT NOTE: The above information is intended to increase awareness of health information and does not suggest treatment or diagnosis. This information is not a substitute for individual medical attention and should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. See your health care professional for medical advice and treatment.

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