Oriahnn Capsules 56s
WARNING: This drug may raise the chance of blood clots, a stroke, or a heart attack. Talk with the doctor.Do not take this drug if you have or have ever had a blood clot or have been told you are at risk of getting a blood clot.Smoking cigarettes while using this drug raises the chance of severe heart and blood-related side effects. This chance is raised with age (mainly older than 35 years of age). It is also raised with the number of cigarettes smoked. It is strongly advised not to smoke. Do not use this drug if you smoke and are older than 35 years of age.If you have high blood pressure, talk with your doctor. This drug must not be used in people who have high blood pressure that is not controlled. @ COMMON USES: It is used to control heavy menstrual bleeding caused by uterine fibroids in people who have not been through menopause. If you have been given this drug for some other reason, talk with the doctor.
Drug Class
Gonadotropin-releasing hormone (GnRH) receptor antagonist, estrogen, progestin combination
Pharmacologic Class
GnRH receptor antagonist (Elagolix), Estrogen (Estradiol), Progestin (Norethindrone Acetate)
Pregnancy Category
Contraindicated
FDA Approved
Aug 2020
DEA Schedule
Not Controlled
Overview
What is this medicine?
Oriahnn is a medication used to help manage heavy menstrual bleeding caused by uterine fibroids. It works by lowering certain hormones in your body that contribute to fibroid growth and bleeding. It also contains small amounts of estrogen and a progestin to help reduce side effects like bone thinning and hot flashes that can occur when hormone levels are too low.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, it's essential to take it as directed by your doctor. Carefully read all the information provided with your prescription and follow the instructions closely. Take your medication at the same time every day, with or without food, as this will help you establish a routine. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, avoiding the bathroom. Keep all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it has been 4 hours or more since the missed dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To get the most benefit from your medication, it's essential to take it as directed by your doctor. Carefully read all the information provided with your prescription and follow the instructions closely. Take your medication at the same time every day, with or without food, as this will help you establish a routine. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry place, avoiding the bathroom. Keep all medications in a secure location, out of the reach of children and pets. When disposing of unused or expired medications, do not flush them down the toilet or pour them down the drain unless instructed to do so. Instead, consult with your pharmacist for guidance on the best disposal method. You may also want to explore local drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it has been 4 hours or more since the missed dose, skip it and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Do not smoke, especially if you are over 35 years old, as smoking increases the risk of serious cardiovascular side effects like blood clots.
- Maintain a healthy lifestyle, including regular exercise and a balanced diet.
- Discuss any new or worsening symptoms with your doctor promptly.
- Do not use any other hormonal birth control methods while taking Oriahnn.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One capsule orally once daily
Condition-Specific Dosing:
heavyMenstrualBleedingAssociatedWithUterineFibroids:
One capsule (elagolix 300 mg, estradiol 1 mg, norethindrone acetate 0.5 mg) orally once daily. Treatment duration should not exceed 24 months.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (safety and efficacy not established in patients under 18 years of age)
Dose Adjustments
Renal Impairment:
Mild:
No dose adjustment needed
Moderate:
No dose adjustment needed
Severe:
No dose adjustment needed
Dialysis:
No dose adjustment needed for End-Stage Renal Disease (ESRD)
Hepatic Impairment:
Mild:
Use with caution; no dose adjustment needed but monitor for adverse reactions.
Moderate:
Not recommended (exposure to elagolix, estradiol, and norethindrone is increased).
Severe:
Contraindicated (exposure to elagolix, estradiol, and norethindrone is significantly increased).
Pharmacology
Mechanism of Action
Oriahnn combines elagolix, a GnRH receptor antagonist, with estradiol and norethindrone acetate. Elagolix reduces endogenous ovarian hormone production by binding to and antagonizing the GnRH receptor in the pituitary gland, leading to dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), and subsequent reduction of ovarian estradiol and progesterone. The addition of estradiol and norethindrone acetate (add-back therapy) is intended to mitigate bone mineral density (BMD) loss and vasomotor symptoms associated with the hypoestrogenic state induced by elagolix, while maintaining the therapeutic effect on heavy menstrual bleeding associated with uterine fibroids.
Pharmacokinetics
Absorption:
Bioavailability:
Elagolix: ~90% (absolute bioavailability); Estradiol: Low due to extensive first-pass metabolism; Norethindrone: Low due to extensive first-pass metabolism
Tmax:
Elagolix: ~1 hour; Estradiol: ~6-8 hours; Norethindrone: ~1-2 hours
FoodEffect:
High-fat meal decreases elagolix Cmax and AUC slightly, but not clinically significant. Food may delay Tmax for estradiol and norethindrone.
Distribution:
Vd:
Elagolix: ~100 L; Estradiol: ~18 L; Norethindrone: ~4 L
ProteinBinding:
Elagolix: ~80%; Estradiol: ~98% (to albumin and SHBG); Norethindrone: ~96% (to albumin and SHBG)
CnssPenetration:
Limited (Elagolix); Yes (Estradiol, Norethindrone)
Elimination:
HalfLife:
Elagolix: ~4-6 hours; Estradiol: ~14-16 hours; Norethindrone: ~5-14 hours
Clearance:
Elagolix: ~15 L/hr; Estradiol: High; Norethindrone: High
ExcretionRoute:
Elagolix: Primarily fecal (~90%), minor renal (~10%); Estradiol: Renal; Norethindrone: Renal and fecal
Unchanged:
Elagolix: <1% (renal); Estradiol: <1%; Norethindrone: <1%
Pharmacodynamics
OnsetOfAction:
Suppression of LH/FSH and estradiol levels typically occurs within days to weeks.
PeakEffect:
Maximal suppression of ovarian hormones within 1-2 weeks.
DurationOfAction:
Effects persist as long as daily dosing is maintained.
Safety & Warnings
BLACK BOX WARNING
THROMBOEMBOLIC DISORDERS AND BONE LOSS
Thromboembolic Disorders: Oriahnn is contraindicated in women with a history of or current thromboembolic disorders. Discontinue Oriahnn if an arterial or venous thrombotic event occurs. Oriahnn is associated with an increased risk of thromboembolic disorders, including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, and myocardial infarction (MI), especially in women with risk factors for these events.
Bone Loss: Oriahnn may cause dose-dependent bone loss. The impact of Oriahnn-associated bone loss on peak bone mass and fracture risk in later life is unknown. Assess bone mineral density (BMD) before initiating treatment and periodically thereafter.
Thromboembolic Disorders: Oriahnn is contraindicated in women with a history of or current thromboembolic disorders. Discontinue Oriahnn if an arterial or venous thrombotic event occurs. Oriahnn is associated with an increased risk of thromboembolic disorders, including deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, and myocardial infarction (MI), especially in women with risk factors for these events.
Bone Loss: Oriahnn may cause dose-dependent bone loss. The impact of Oriahnn-associated bone loss on peak bone mass and fracture risk in later life is unknown. Assess bone mineral density (BMD) before initiating treatment and periodically thereafter.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of gallbladder problems: pain in the upper right abdomen, right shoulder, or between the shoulder blades, yellow skin and eyes, fever with chills, bloating, or severe stomach upset or vomiting.
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Weakness on one side of the body, difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Changes in eyesight or loss of vision, bulging eyes, or changes in how contact lenses feel.
Bone pain.
Breast lump, breast pain or tenderness, or nipple discharge.
New or worsening behavioral or mood changes, such as depression or suicidal thoughts.
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, or difficulty speaking or swallowing.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any others that concern you or do not go away, contact your doctor:
Flushing
Headache
Feeling tired or weak
* Changes in menstrual periods
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of gallbladder problems: pain in the upper right abdomen, right shoulder, or between the shoulder blades, yellow skin and eyes, fever with chills, bloating, or severe stomach upset or vomiting.
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Weakness on one side of the body, difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Changes in eyesight or loss of vision, bulging eyes, or changes in how contact lenses feel.
Bone pain.
Breast lump, breast pain or tenderness, or nipple discharge.
New or worsening behavioral or mood changes, such as depression or suicidal thoughts.
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, or difficulty speaking or swallowing.
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any others that concern you or do not go away, contact your doctor:
Flushing
Headache
Feeling tired or weak
* Changes in menstrual periods
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden severe leg pain, swelling, or redness (signs of DVT)
- Sudden chest pain, shortness of breath, or coughing up blood (signs of PE)
- Sudden severe headache, weakness or numbness on one side of the body, trouble speaking or seeing (signs of stroke)
- Sudden severe abdominal pain, especially on the right side
- Yellowing of skin or eyes (jaundice), dark urine, unusual tiredness (signs of liver problems)
- New or worsening depression, anxiety, or suicidal thoughts
- Unusual or heavy vaginal bleeding after initial treatment adjustment
- Sudden vision changes
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, such as:
+ Blood vessel problems in the brain or heart
+ Atrial fibrillation
+ Endocarditis (a heart infection)
+ History of heart attack or stroke
+ Other heart problems
+ Liver problems
+ Diabetes with complications, including kidney, eye, nerve, or blood vessel problems
+ Severe headache or migraine
+ Osteoporosis (soft, brittle bones)
A history of breast cancer or other hormone-sensitive cancers
Unexplained vaginal bleeding
Use of rifampin
Pregnancy or potential pregnancy. Note: This medication is contraindicated during pregnancy.
To avoid potential interactions, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins
* Existing health problems
Your doctor will assess the safety of taking this medication with your other medications and health conditions. Do not initiate, discontinue, or modify the dose of any medication without consulting your doctor first.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
Certain health conditions, such as:
+ Blood vessel problems in the brain or heart
+ Atrial fibrillation
+ Endocarditis (a heart infection)
+ History of heart attack or stroke
+ Other heart problems
+ Liver problems
+ Diabetes with complications, including kidney, eye, nerve, or blood vessel problems
+ Severe headache or migraine
+ Osteoporosis (soft, brittle bones)
A history of breast cancer or other hormone-sensitive cancers
Unexplained vaginal bleeding
Use of rifampin
Pregnancy or potential pregnancy. Note: This medication is contraindicated during pregnancy.
To avoid potential interactions, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter medications you are taking
Natural products and vitamins
* Existing health problems
Your doctor will assess the safety of taking this medication with your other medications and health conditions. Do not initiate, discontinue, or modify the dose of any medication without consulting your doctor first.
Precautions & Cautions
Important Information About Your Medication
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this medication before certain surgical procedures. If this is the case, your doctor will provide guidance on when to resume taking the medication after your surgery or procedure.
Monitoring Your Health
Regular blood pressure checks are essential, as medications like this one can cause high blood pressure. Follow your doctor's instructions for monitoring your blood pressure. Additionally, it is vital to maintain regular breast exams and gynecology check-ups, as well as perform breast self-exams as directed by your doctor.
Reducing the Risk of Blood Clots
If you will be stationary for extended periods, such as during long trips, bedrest after surgery, or illness, consult with your doctor. Prolonged periods of inactivity may increase your risk of developing blood clots.
Dietary Precautions
Avoid consuming grapefruit and grapefruit juice while taking this medication.
Managing Diabetes
If you have high blood sugar (diabetes), discuss this with your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as instructed by your doctor.
Cholesterol and Triglyceride Levels
This medication may cause elevated cholesterol and triglyceride levels. Consult with your doctor to discuss any concerns.
Allergies and Sensitivities
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient.
Bone Health
Long-term use of this medication may lead to a loss of bone density, which may not be reversible after stopping the medication. Follow your doctor's instructions for monitoring your bone density. Take calcium and vitamin D supplements as directed by your doctor.
Hair Loss
Hair loss and thinning are potential side effects of this medication, which may persist even after stopping the medication. The likelihood of hair regrowth after stopping the medication is unknown. If you have concerns, discuss them with your doctor.
Menstrual Changes and Pregnancy
This medication may cause changes in menstrual bleeding, including the cessation of periods, which can make it challenging to determine if you are pregnant. Be aware of other signs of pregnancy, such as tender breasts, weight gain, and stomach upset.
Birth Control
Birth control pills and other hormone-based birth control methods may be less effective while taking this medication. Use an alternative form of birth control, such as a condom, during treatment and for 28 days after stopping the medication. This medication can harm the unborn baby or cause pregnancy loss if taken during pregnancy.
Pregnancy Testing and Breastfeeding
Undergo a pregnancy test before starting this medication or initiate treatment within 7 days of your menstrual period. If you are unsure about starting the medication, consult with your doctor. If you become pregnant or suspect you may be pregnant, contact your doctor immediately. If you are breastfeeding, discuss the potential risks to your baby with your doctor.
It is crucial that you inform all of your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this medication before certain surgical procedures. If this is the case, your doctor will provide guidance on when to resume taking the medication after your surgery or procedure.
Monitoring Your Health
Regular blood pressure checks are essential, as medications like this one can cause high blood pressure. Follow your doctor's instructions for monitoring your blood pressure. Additionally, it is vital to maintain regular breast exams and gynecology check-ups, as well as perform breast self-exams as directed by your doctor.
Reducing the Risk of Blood Clots
If you will be stationary for extended periods, such as during long trips, bedrest after surgery, or illness, consult with your doctor. Prolonged periods of inactivity may increase your risk of developing blood clots.
Dietary Precautions
Avoid consuming grapefruit and grapefruit juice while taking this medication.
Managing Diabetes
If you have high blood sugar (diabetes), discuss this with your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as instructed by your doctor.
Cholesterol and Triglyceride Levels
This medication may cause elevated cholesterol and triglyceride levels. Consult with your doctor to discuss any concerns.
Allergies and Sensitivities
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient.
Bone Health
Long-term use of this medication may lead to a loss of bone density, which may not be reversible after stopping the medication. Follow your doctor's instructions for monitoring your bone density. Take calcium and vitamin D supplements as directed by your doctor.
Hair Loss
Hair loss and thinning are potential side effects of this medication, which may persist even after stopping the medication. The likelihood of hair regrowth after stopping the medication is unknown. If you have concerns, discuss them with your doctor.
Menstrual Changes and Pregnancy
This medication may cause changes in menstrual bleeding, including the cessation of periods, which can make it challenging to determine if you are pregnant. Be aware of other signs of pregnancy, such as tender breasts, weight gain, and stomach upset.
Birth Control
Birth control pills and other hormone-based birth control methods may be less effective while taking this medication. Use an alternative form of birth control, such as a condom, during treatment and for 28 days after stopping the medication. This medication can harm the unborn baby or cause pregnancy loss if taken during pregnancy.
Pregnancy Testing and Breastfeeding
Undergo a pregnancy test before starting this medication or initiate treatment within 7 days of your menstrual period. If you are unsure about starting the medication, consult with your doctor. If you become pregnant or suspect you may be pregnant, contact your doctor immediately. If you are breastfeeding, discuss the potential risks to your baby with your doctor.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Breast tenderness
- Dizziness
- Abdominal pain
- Drowsiness/fatigue
- Vaginal bleeding
What to Do:
There is no specific antidote. Treatment is symptomatic and supportive. In case of suspected overdose, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Strong OATP1B1 inhibitors (e.g., cyclosporine, gemfibrozil) with Elagolix (increases elagolix exposure significantly)
- Concomitant use with other hormonal contraceptives (e.g., oral contraceptives, patches, rings, injections, implants, IUDs)
Major Interactions
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort) - may significantly decrease concentrations of all components, reducing efficacy.
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) - may significantly increase concentrations of all components, increasing risk of adverse effects.
- Moderate CYP3A4 inducers (e.g., bosentan, efavirenz, etravirine, modafinil) - may decrease concentrations.
- Moderate CYP3A4 inhibitors (e.g., fluconazole, grapefruit juice) - may increase concentrations.
Moderate Interactions
- Drugs that are substrates of OATP1B1 (e.g., statins like rosuvastatin, pitavastatin, atorvastatin, simvastatin) - Elagolix is an OATP1B1 inhibitor, may increase exposure of these drugs.
- Drugs that are substrates of BCRP (e.g., rosuvastatin, sulfasalazine) - Elagolix is a BCRP inhibitor, may increase exposure of these drugs.
- Thyroid hormone replacement therapy - Estrogens can increase thyroid-binding globulin (TBG), requiring increased thyroid hormone dose.
Minor Interactions
- Not specifically listed as minor, but general caution with drugs affecting hepatic metabolism.
Monitoring
Baseline Monitoring
Bone Mineral Density (BMD)
Rationale: Elagolix can cause dose-dependent bone loss. Baseline assessment is crucial.
Timing: Before initiating treatment
Blood Pressure
Rationale: Hormonal components can affect blood pressure.
Timing: Before initiating treatment
Lipid Profile
Rationale: Estrogens can affect lipid metabolism.
Timing: Before initiating treatment
Liver Function Tests (LFTs)
Rationale: Hepatic impairment is a contraindication/caution; monitor for liver injury.
Timing: Before initiating treatment
Pregnancy Test
Rationale: Oriahnn is contraindicated in pregnancy.
Timing: Before initiating treatment
Routine Monitoring
Bone Mineral Density (BMD)
Frequency: After 12 months of treatment, and periodically thereafter if treatment continues beyond 12 months.
Target: Maintain within normal limits for age/sex.
Action Threshold: Significant bone loss (e.g., >3-5% decrease from baseline or T-score < -2.5) may warrant discontinuation or re-evaluation.
Blood Pressure
Frequency: Periodically during treatment.
Target: Maintain within normal limits.
Action Threshold: Significant or sustained elevation may require intervention or discontinuation.
Symptoms of Thromboembolic Events
Frequency: Ongoing patient education and monitoring.
Target: Absence of symptoms.
Action Threshold: New onset of severe leg pain, chest pain, shortness of breath, sudden vision changes, severe headache, or numbness/weakness requires immediate medical attention.
Liver Function Tests (LFTs)
Frequency: As clinically indicated, especially if symptoms of liver injury develop.
Target: Within normal limits.
Action Threshold: Significant elevations (e.g., >3x ULN) or symptoms of liver injury (jaundice, dark urine, fatigue) require discontinuation.
Symptom Monitoring
- Signs and symptoms of thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction)
- Signs and symptoms of liver dysfunction (e.g., jaundice, dark urine, abdominal pain, fatigue)
- Changes in mood or suicidal ideation
- New or worsening headaches
- Vision changes
- Abnormal vaginal bleeding patterns
- Symptoms of bone loss (e.g., new back pain, fractures)
Special Patient Groups
Pregnancy
Oriahnn is contraindicated in pregnant women. There is no benefit to using Oriahnn during pregnancy, and use during pregnancy may cause fetal harm. Discontinue Oriahnn if pregnancy occurs.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development due to hormonal exposure.
Second Trimester:
Potential for adverse effects on fetal development due to hormonal exposure.
Third Trimester:
Potential for adverse effects on fetal development due to hormonal exposure.
Lactation
Oriahnn is contraindicated during breastfeeding. Hormonal components (estradiol and norethindrone) are known to be excreted in human milk and may affect milk production and/or the breastfed infant. Elagolix is also excreted in rat milk, and human data are lacking.
Infant Risk:
L5 (Contraindicated - significant documented risk to infant or to milk production)
Pediatric Use
Safety and effectiveness have not been established in pediatric patients. Oriahnn is not indicated for use in pediatric patients.
Geriatric Use
Clinical studies of Oriahnn did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Oriahnn is not indicated in postmenopausal women.
Clinical Information
Clinical Pearls
- Oriahnn is a combination product designed to manage heavy menstrual bleeding associated with uterine fibroids by suppressing ovarian hormones while mitigating hypoestrogenic side effects like bone loss and hot flashes.
- It is crucial to assess bone mineral density (BMD) before and during treatment due to the risk of bone loss.
- Patients must be counseled on the increased risk of thromboembolic events (blood clots) and advised to seek immediate medical attention for any related symptoms.
- Oriahnn is not a contraceptive and should not be used with other hormonal contraceptives. Patients should use non-hormonal contraception if pregnancy prevention is desired.
- Treatment duration is limited to 24 months due to concerns about progressive bone loss and long-term safety data.
Alternative Therapies
- Other GnRH agonists (e.g., leuprolide, goserelin) - often used with add-back therapy.
- Progestin-only therapies (e.g., oral progestins, levonorgestrel IUD).
- Tranexamic acid (Lysteda) - for heavy menstrual bleeding.
- Nonsteroidal anti-inflammatory drugs (NSAIDs).
- Surgical options: Myomectomy (fibroid removal), Hysterectomy (uterus removal).
- Uterine artery embolization (UAE).
Cost & Coverage
Average Cost:
Typically high, ranging from $1000-$1500+ per 30 capsules
Insurance Coverage:
Tier 3 or higher (Specialty/Non-Preferred Brand)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe and effective treatment, never share your medication with others or take someone else's medication.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.
This medication is accompanied by a Medication Guide, which provides crucial information about its safe use. It is essential to read this guide carefully and review it again whenever your prescription is refilled. If you have any questions or concerns about this medication, consult your doctor, pharmacist, or other healthcare provider for clarification.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. When reporting the incident, be prepared to provide detailed information, including the name of the medication taken, the amount consumed, and the time it occurred.