Oriahnn

Uterine Fibroids

Oriahnn is primarily prescribed to treat heavy menstrual bleeding caused by uterine leiomyomas, more commonly known as uterine fibroids. These are noncancerous growths that develop in or on the uterus. While many women with fibroids do not experience symptoms, others may have significantly heavy or prolonged periods that can interfere with daily activities.

Treatment Goals

The main goal of using Oriahnn is to reduce the volume of blood lost during the menstrual cycle. It is specifically indicated for women who have not yet gone through menopause. Because the medication can cause a decrease in bone mineral density over time, treatment is generally limited to a total duration of 24 months.

Important Considerations

While Oriahnn affects the menstrual cycle, it is not a birth control pill. It is typically used in situations where heavy bleeding is the primary symptom requiring management. Healthcare providers usually recommend using effective non-hormonal contraception while taking this medication and for a short time after the final dose.

Mechanism of Action

Oriahnn contains three active ingredients that work in combination to treat heavy menstrual bleeding from uterine fibroids. The primary component, elagolix, is a gonadotropin-releasing hormone (GnRH) receptor antagonist. It works by blocking the GnRH receptors in the pituitary gland, which reduces the production of two other hormones: luteinizing hormone (LH) and follicle-stimulating hormone (FSH).

When LH and FSH levels drop, the ovaries produce significantly less estrogen and progesterone. Since uterine fibroids rely on these hormones to grow and cause bleeding, lowering their levels helps reduce menstrual blood loss. Because very low estrogen levels can cause bone thinning and hot flashes, Oriahnn also includes small amounts of estradiol (an estrogen) and norethindrone (a progestin). These "add-back" hormones help protect bone health and manage side effects while the elagolix works on the fibroids.

Common Side Effects

• Hot flashes
• Headache
• Nausea
• Night sweats
• Irregular menstrual bleeding or spotting
• Fatigue
• Decreased interest in sex

Serious Side Effects

Contact a healthcare provider immediately if you experience any of the following:

• Bone loss: A decrease in bone mineral density that may not be completely reversible after stopping the medication.
• Mood changes: New or worsening depression, anxiety, or thoughts of harming yourself.
• Liver problems: Symptoms such as yellowing of the skin or eyes, dark urine, or pain in the upper right side of the stomach.
• High blood pressure: New or worsening hypertension.
• Blood clots: Signs may include sudden shortness of breath, chest pain, or swelling and pain in the legs.
• Gallbladder problems: Severe pain in the upper right abdomen, nausea, and vomiting.
• Allergic reactions: Rash, swelling of the face or tongue, or trouble breathing.

Boxed Warning: Cardiovascular Risks

Oriahnn increases the risk of serious cardiovascular events such as blood clots, stroke, and heart attack. This risk is significantly higher in individuals who smoke and are over the age of 35. Use is contraindicated in people with a history of blood clots or those at high risk for vascular disease.

Bone Loss

This medication can cause a decrease in bone mineral density (BMD). Bone loss is dose-dependent and may not be completely reversible after stopping treatment. Because of this risk, use is generally limited to a total duration of 24 months. Periodic bone density testing may be recommended during treatment.

Suicidal Ideation and Mood Changes

Some individuals taking Oriahnn have reported depression, anxiety, and suicidal thoughts or behavior. It is important to monitor for any new or worsening mood changes or signs of depression.

Liver Injury

Oriahnn may cause elevations in liver enzymes, which can indicate liver injury. Treatment should be discontinued if significant liver enzyme increases occur or if signs of liver problems, such as yellowing of the skin or eyes (jaundice), develop.

Contraindications

Oriahnn should not be used by individuals who:

• Are pregnant or planning to become pregnant.
• Have a history of blood clots, heart attack, or stroke.
• Have known osteoporosis.
• Have a history of breast cancer or other hormone-sensitive cancers.
• Have undiagnosed abnormal uterine bleeding.
• Have severe liver disease.

Other Precautions

The medication may also cause high blood pressure, gallbladder disease, and changes in glucose tolerance. It can change menstrual bleeding patterns, which may make it difficult to recognize pregnancy.

Pregnancy Considerations

Oriahnn should not be used by individuals who are pregnant or planning to become pregnant. The medication may cause early pregnancy loss. Because the drug often changes menstrual bleeding patterns, it can be difficult to detect a pregnancy while on treatment. If pregnancy is suspected or confirmed, the medication must be stopped immediately.

Healthcare providers typically recommend using effective non-hormonal birth control methods, such as condoms or spermicide, during treatment and for one week after the last dose. Hormonal contraceptives should be avoided while taking Oriahnn.

Breastfeeding Considerations

There is limited information regarding the presence of Oriahnn in breast milk or its effects on a nursing child. However, the estrogen component of the medication may decrease the production of breast milk. It is important to discuss the potential risks and benefits of using this medication while breastfeeding with a healthcare professional.

Oriahnn is supplied as a co-packaged product for oral administration. The treatment consists of two distinct capsules that are color-coded to help distinguish between morning and evening doses.

• Morning capsule: Contains elagolix, estradiol, and norethindrone acetate.
• Evening capsule: Contains elagolix.

These capsules are provided in blister packs designed to help patients follow the twice-daily dosing regimen over a 28-day cycle.

FDA Approval and Indication

The U.S. Food and Drug Administration (FDA) approved Oriahnn in May 2020. It is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. The treatment consists of a combination of elagolix, estradiol, and norethindrone acetate.

Boxed Warning

Oriahnn carries a Boxed Warning, the most serious safety warning required by the FDA, regarding the risk of thromboembolic disorders and vascular events. These risks include:

• Blood clots (venous thromboembolism)
• Stroke
• Heart attack (myocardial infarction)

The medication is contraindicated in women with a history of or high risk for these conditions, including women over age 35 who smoke and those with uncontrolled hypertension.

Usage Limitations

The FDA has established a specific limitation on the duration of use for Oriahnn. Treatment is limited to a total of 24 months because of the risk of bone mineral density loss. This bone loss may not be completely reversible even after the medication is stopped. Because of these and other risks, the FDA requires that a Medication Guide be provided to patients each time the prescription is filled.

Factors Influencing Cost

The price of Oriahnn depends on several factors, including your specific insurance plan, the pharmacy you use, and your location. Because Oriahnn is a brand-name medication and does not currently have a generic version, the out-of-pocket cost may be higher than for other treatments.

Typical Pricing

Without insurance coverage, the retail price for a 28-day supply of Oriahnn is approximately $1,200. However, the actual amount you pay will depend on your insurance provider's formulary and your deductible or co-pay requirements.

Financial Assistance and Savings

There are options available to help reduce the cost of Oriahnn:

• Manufacturer Savings Card: The drug manufacturer may offer a savings card for patients with commercial insurance that can significantly lower monthly out-of-pocket costs.
• Patient Assistance Programs: Individuals without insurance or those who are underinsured may qualify for assistance programs based on financial need.

It is recommended to check with your insurance provider and local pharmacies to compare prices and verify coverage before filling your prescription.