What is a Generic Drug?
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (eg. different shape or color), as trademarks laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.
Oriahnn (Elagolix,Estradiol,Norethindrone acetate and Elagolix)
Prescription Required
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Product Details
Description
Oriahnn (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules) is a medication used to manage heavy periods due to fibroids in premenopausal women.
Elagolix is a gonadotropin-releasing hormone (GnRH) receptor antagonist, estradiol is an estrogen, and norethindrone acetate is a progestin.
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
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MedlinePlus
a620042
ChEBI
-
ATC code
None
DrugBank
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KEGG
D12137
Routes of administration
By mouth
Directions
Oriahnn is available as capsules. One capsule contains 300 mg of elagolix, 1 mg of estradiol, and 0.5 mg of norethindrone acetate while the other capsule contains 300 mg of elagolix.
Dosing:
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 24 months.
Ingredients
Elagolix, estradiol, and norethindrone acetate 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.
Do not take Oriahnn if you:
- Are older than 35 years old and smoke
- Have or had blood clots
- Have vascular disease such as cerebrovascular disease, coronary artery disease, or peripheral vascular disease
- Have heart valve or heart rhythm problems
- Have a condition that causes your blood to clot more than normal
- Have uncontrolled blood pressure
- Have diabetes with damage to the kidneys, eyes, nerves, or blood vessels
- Have headaches with numbness, weakness, or vision changes or if you are older than 35 and have migraines with aura
Do not take Oriahnn if you are pregant.
Do not take Oriahnn if you have osteoporosis.
Do not take Oriahnn if you have or have had breast cancer or other hormonally-sensitive cancers.
Do not take Oriahnn if you have liver problems or liver disease.
Do not take Oriahnn if you have abnormal vaginal bleeding that has not been diagnosed.
Do not take Oriahnn if you are allergic to any of its ingredients or excipients.
Cautions
- Before you start treatment with Oriahnn, tell your doctor:
- About all the medications you take. These include prescription, nonprescription, vitamins, and herbal supplements.
- About your allergies.
- About your medical conditions.
- If you are pregnant or plan to become pregnant.
- If you are breastfeeding or plan to breastfeed.
- Do not consume grapefruit or grapefruit juice while being treated with Oriahnn.
- Oriahnn can increase the risk of heart attack, stroke, or blood clots. Seek emergency care immediately if you develop pain or swelling in your leg, trouble breathing, vision problems, sudden and severe headache, arm or leg weakness or numbness, trouble speaking, or chest, arm, or jaw pain or pressure.
- Oriahnn can cause bone mineral density loss.
- Oriahnn can cause suicidal ideation. Seek emergency care immediately if you develop suidcidal ideation, suicidal thoughts, suicidal behavior, or anxiety, depression, or mood changes that are new or worsening.
- Oriahnn can cause liver damage. Seek medical care right away if you develop yellowing of your skin or whites of your eyes, dark urine, tiredness, nausea, vomiting, swelling, stomach pain, or bruising.
- Oriahnn can cause high blood pressure. Your blood pressure should be monitored during treatment with Oriahnn.
- Oriahnn can cause changes in period pattern and can decrease the ability to recognize pregnancy. If you think you are pregnant, take a pregnancy test. Oriahnn should be discontinued if you are pregnant. Hormonal birth control may affect the way Oriahnn works, but the effects are unknown. Women should use non-hormonal birth control methods during treatment with Oriahnn and for 4 weeks after stopping Oriahnn.
- Oriahnn can cause elevated blood sugar levels, cholesterol, and triglycerides.
- Oriahnn can cause hair thinning or loss.
- Oriahnn can affect laboratory tests, including tests for thyroid, cholesterol, and blood clotting.
- Because Oriahnn contains FD and C Yellow No. 5 (tartrazine), there is an increased risk of allergic reactions in sensitive patients.
Side Effects
The most common side effects of Oriahnn include headache, hot flashes, tiredness, and abnormal vaginal bleeding. However, these are not all the possible side effects of Oriahnn. If you develop side effects that are a concern to you, call your doctor right away.
References:
- Oriahnn (elagolix, estradiol, and norethindrone acetate capsules; elagolix capsules), co-packaged for oral use. North Chicago, IL: AbbVie Inc.; 2021.
- 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.Product Code : 13651
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