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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, and norethindrone acetate capsules; elagolix capsules) is a prescription medicine used to control heavy menstrual bleeding related to uterine fibroids in women before menopause. It should not be taken for more than 24 months. It is not known if ORIAHNN is safe and effective in children under 18 years of age.
ORIAHNN may cause serious side effects, including: Cardiovascular Conditions ORIAHNN may increase your chances of heart attack, stroke, or blood clots, especially if you are over 35 years of age and smoke, have uncontrolled high blood pressure, high cholesterol, diabetes, or are obese. Stop taking ORIAHNN and call your healthcare provider right away or go to the nearest hospital emergency room right away if you have: Leg pain or swelling that will not go away Sudden shortness of breath Double vision, bulging of the eyes, or sudden blindness (partial or complete) Pain or pressure in your chest, arm, or jaw Sudden, severe headache unlike your usual headaches Weakness or numbness in an arm or leg, or trouble speaking Bone Loss (Decreased Bone Mineral Density [BMD]) While taking ORIAHNN, your estrogen levels may be low. Low estrogen levels can lead to BMD loss. If you have bone loss on ORIAHNN, your BMD may improve after you stop taking ORIAHNN, but complete recovery may not occur. It is unknown if these BMD changes could increase your risk for broken bones as you age. For this reason, you should not take ORIAHNN for more than 24 months. Your healthcare provider may order an X-ray test called a DXA scan to check your bone mineral density when you start taking ORIAHNN and periodically after you start. Your doctor may advise you to take vitamin D and calcium supplements as part of a healthy lifestyle. Effects on Pregnancy Do not take ORIAHNN if you are pregnant or trying to become pregnant, as it may increase the risk of early pregnancy loss. If you think you may be pregnant, stop taking ORIAHNN right away and call your HCP. ORIAHNN can decrease your menstrual bleeding or result in no menstrual bleeding at all, making it hard to know if you are pregnant. Watch for other pregnancy signs like breast tenderness, weight gain, and nausea. ORIAHNN does not prevent pregnancy. You will need to use effective methods of birth control while taking ORIAHNN and for 1 week after you stop taking ORIAHNN. Examples of effective methods can include condoms or spermicide, which do not contain hormones. Talk to your HCP about which birth control to use during treatment with ORIAHNN. Your HCP may change the birth control you are on before you start taking ORIAHNN. What are the possible side effects of ORIAHNN? ORIAHNN can cause additional serious side effects, including: Suicidal thoughts, suicidal behavior, and worsening of mood. ORIAHNN may cause suicidal thoughts or actions. Call your HCP or get emergency medical help right away if you have any of these symptoms, especially if they are new, worse, or bother you: thoughts about suicide or dying, attempts to commit suicide, new or worse depression or anxiety, or other unusual changes in behavior or mood. Pay attention to any changes, especially sudden changes, in your mood, behaviors, thoughts, or feelings. Abnormal liver tests. Call your HCP right away if you have any of these signs and symptoms of liver problems: jaundice, dark amber-colored urine, feeling tired, nausea and vomiting, generalized swelling, right upper stomach area pain, or bruising easily. High blood pressure. You should see your HCP to check your blood pressure regularly. Gallbladder problems (cholestasis), especially if you had cholestasis of pregnancy. Increases in blood sugar, cholesterol, and fat (triglyceride) levels. Hair loss (alopecia). Hair loss and hair thinning can happen while taking ORIAHNN, and it can continue even after you stop taking ORIAHNN. It is not known if this hair loss or hair thinning is reversible. Talk to your HCP if this is a concern for you. Changes in laboratory tests, including thyroid and other hormone, cholesterol, and blood clotting tests. The most common side effects of ORIAHNN include: hot flashes, headache, fatigue, and irregular periods. These are not all of the possible side effects of ORIAHNN. Tell your HCP if you have any side effect that bothers you or that does not go away. Call your HCP for medical advice about side effects. Take ORIAHNN exactly as your HCP tells you. The recommended oral dosage of ORIAHNN is one yellow/white capsule in the morning and one blue/white capsule in the evening, with or without food. This is the most important information to know about ORIAHNN. For more information, talk to your doctor or HCP.
