relugolix/estradiol/norethindrone acetate
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Manufactured by various FDA-approved generic manufacturers.
*You can pay as little as $0 per fill using Drug Coupons or Patient Assistance Programs. Subject to applicability & eligibility requirements.
This content is intended for US audiences only
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relugolix/estradiol/norethindrone acetate key facts
What dosages is relugolix/estradiol/norethindrone acetate available in?
relugolix/estradiol/norethindrone acetate is a fixed-dose combination oral tablet containing relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg.
What is relugolix/estradiol/norethindrone acetate used for?
relugolix/estradiol/norethindrone acetate is a GnRH antagonist / Estrogen replacement / Progestin and is used to treat the following:
- Heavy menstrual bleeding related to uterine fibroids in women who haven’t reached menopause
- Moderate-to-severe pain related to endometriosis in women who haven’t reached menopause
How does relugolix/estradiol/norethindrone acetate work?
relugolix/estradiol/norethindrone acetate is a combination of three medications. Relugolix is a gonadotropin-releasing hormone (GnRH) antagonist. GnRH is a natural hormone in the body that plays a role in making estrogen and progesterone hormones. These hormones all play a role in maintaining your reproductive system. Relugolix blocks the actions of GnRH, which lowers the estrogen and progesterone levels in your body. This lessens bleeding that happens with uterine fibroids and pain from endometriosis. Estradiol is an estrogen replacement. It replaces some of the estrogen in your body that’s lost from relugolix. Replacing estrogen might help prevent bone loss. Norethindrone is a progestin (a lab-made form of progesterone). It replaces some of the progesterone in your body that’s lost from relugolix. This might help protect the uterus from damage from the effects of estrogen alone, which might help prevent uterine (endometrial) cancer.
How do I take relugolix/estradiol/norethindrone acetate?
relugolix/estradiol/norethindrone acetate is typically taken as 1 tablet by mouth once a day around the same time each day, with or without food. It’s recommended to take the medication for a maximum of 2 years because of the risk for bone loss.
Is it safe for me to take relugolix/estradiol/norethindrone acetate?
relugolix/estradiol/norethindrone acetate is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you. You should not use this medication in the following:
- High risk of arterial, venous thrombotic, or thromboembolic disorder
- Pregnancy
- Known osteoporosis
- Current or history of breast cancer or other hormone-sensitive malignancies
- Known hepatic impairment or disease
- Undiagnosed abnormal uterine bleeding
- Known hypersensitivity to components of relugolix/estradiol/norethindrone acetate
relugolix/estradiol/norethindrone acetate Common Side Effects
Common side effects of relugolix/estradiol/norethindrone acetate:
- New or worsening high blood pressure
- Unusual or irregular vaginal bleeding
- Hair loss or hair thinning
- Headache
- Hot flashes, a lot of sweating, or night sweats
- Mood problems or mood swings
- Unusual vaginal bleeding
- Nausea
relugolix/estradiol/norethindrone acetate Serious Side Effects
Serious side effects are rare with relugolix/estradiol/norethindrone acetate. Contact your healthcare provider immediately if you experience any of the following.
- Blood clot: swelling or redness in the leg, shortness of breath, chest pain
- Heart attack: shortness of breath, arm or chest pain, sweating
- Stroke: slurred speech, vision changes, facial drooping, sudden weakness on one side of the body, sudden headache
- Liver or gallbladder problems: yellowing of your skin or eyes (jaundice), pain in the upper right part of your stomach, nausea, vomiting, dark urine
- Uterine fibroid that comes out into the vagina: heavy menstrual bleeding, severe cramping
- Suicidal thoughts or behavior
- Serious allergic reaction: swelling in the face, tongue, or throat; trouble breathing; hives
Effects of other drugs, drug classes and over-the-counter products on relugolix/estradiol/norethindrone acetate
The following medications may interact with relugolix/estradiol/norethindrone acetate:
- Avoid use of relugolix/estradiol/norethindrone acetate with oral P-gp inhibitors
- Avoid use with combined P-gp and strong CYP3A inducers, as the exposure of the components of relugolix/estradiol/norethindrone acetate may be decreased
Who makes relugolix/estradiol/norethindrone acetate?
Various FDA-approved generic manufacturers
Is relugolix/estradiol/norethindrone acetate safe in pregnancy?
relugolix/estradiol/norethindrone acetate is contraindicated in pregnancy. Based on findings from animal studies and its mechanism of action, relugolix/estradiol/norethindrone acetate may cause early pregnancy loss. Discontinue relugolix/estradiol/norethindrone acetate if pregnancy occurs during treatmentThere is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to relugolix/estradiol/norethindrone acetate during pregnancy. Pregnant females exposed to relugolix/estradiol/norethindrone acetate and healthcare providers are encouraged to call the relugolix/estradiol/norethindrone acetate Pregnancy Exposure Registry at 1-855-428-0707.
The FDA's medical product safety reporting program for health professionals, patients and consumers.
Learn more about reporting side effectsDrug Savings Guide
A practical guide to saving money and receiving support with prescription costs
How can NowPatient help me to lower the cost of my relugolix/estradiol/norethindrone acetate prescription?
After you create a FREE account with NowPatient, you will have access to 4 programs that can help lower the cost of your relugolix/estradiol/norethindrone acetate prescription
Applicability to each program will be dependent on your insurance status.
How do the NowPatient relugolix/estradiol/norethindrone acetate savings programs work?
After you have created your FREE account with NowPatient, you can access the various programs from your account dashboard. Each program has clear instructions on how to check your eligibility. You can see how the process works by clicking on the feature link below and seeing the ‘How it works’ steps.
Drug Coupon and Patient Assistance Programs require an eligibility quiz to be completed.
Are the NowPatient relugolix/estradiol/norethindrone acetate savings programs suitable for everyone, regardless of insurance status?
No. Each program has its own eligibility and applicability requirements. The table below shows if a program is available to you, based on your insurance status.
| Rx Advantage Card* for relugolix/estradiol/norethindrone acetate | Canadian Prescription Savings* for relugolix/estradiol/norethindrone acetate | relugolix/estradiol/norethindrone acetate Drug Coupon* | relugolix/estradiol/norethindrone acetate Patient Assistance Program* | |
| Insured (federal, state or government) | Available | Available | Not Available | Available If Offered by Pharmaceutical Company |
| Insured (Commercial or Private) | Available | Available | Available If Offered by Pharmaceutical Company | Available If Offered by Pharmaceutical Company |
| Uninsured | Available | Available | Not Available | Available If Offered by Pharmaceutical Company |
| Insured but without pharmacy benefit or drug coverage | Available | Available | Not Available | Available If Offered by Pharmaceutical Company |
*This is not insurance.
Are the NowPatient drug savings programs suitable for brand and generic versions of relugolix/estradiol/norethindrone acetate?
No. Each program has applicability requirements. Please see below
| Rx Advantage Card* for relugolix/estradiol/norethindrone acetate | Canadian Prescription Savings* for relugolix/estradiol/norethindrone acetate | relugolix/estradiol/norethindrone acetate Drug Coupon* | relugolix/estradiol/norethindrone acetate Patient Assistance Program* | |
| Brand | Yes | Yes | Yes, If Offered by Pharmaceutical Company | Yes, If Offered by Pharmaceutical Company |
| Generic | Yes | Yes | No | No |
*This is not insurance.
If you have Medicare Part D or Medicare Advantage and none of the relugolix/estradiol/norethindrone acetate savings options are applicable or affordable for me, what can you do?
If you are insured with Medicare and the relugolix/estradiol/norethindrone acetate drug savings options are not applicable to you and still remain unaffordable, then you can check Medicaid eligibility in your state by following the instructions at HealthCare.gov.
The government site is easy to use and after you have selected your state, it will navigate you to the appropriate contact point to make the application. State Medicaid programs may cover the full cost of your medication.
People who qualify for both Medicare and Medicaid are called ‘dual eligibles’.
If you are denied Medicaid for relugolix/estradiol/norethindrone acetate, and you are still unable to afford your copay or co-insurance element (for example if you are in the coverage gap or Donut Hole) then you may be eligible for a federal support program like Low Income Subsidy. To be eligible for Low Income Subsidy, you need to be a resident in one of the 50 States or the District of Columbia. You can check eligibility online at SSA Medicare D Extra Help. You can also call Social Security at 1-800-772-1213 (TTY 1-800-325-0778).
I am uninsured or underinsured and none of the relugolix/estradiol/norethindrone acetate prescription saving options are applicable or affordable for me, what can I do?
If you are uninsured or underinsured (for example, relugolix/estradiol/norethindrone acetate is not covered by your plan) and the drug savings options are not applicable or still unaffordable, then you can check Medicaid eligibility in your state by following the instructions at HealthCare.gov.
The government site is easy to use and you can select your state and it will navigate you to the appropriate contact point to make the application. State Medicaid programs may cover the full cost of your medication.
If you are denied and all else fails, and if you have been prescribed relugolix/estradiol/norethindrone acetate for an FDA-approved indication, you can call the pharmaceutical company to see if they have any other assistance programs.
I am commercially or privately insured and none of the relugolix/estradiol/norethindrone acetate prescription saving options are applicable or affordable for me, what can I do?
If your medication is not covered by your plan, you can appeal your insurance company’s decision. Sometimes, a formal appeal can result in the drug being covered if it is deemed medically necessary.
If you cannot afford your copay contribution, then you can check Medicaid eligibility in your state by following the instructions at HealthCare.gov.
However, being privately insured might complicate your eligibility for Medicaid, as having private insurance may be considered in the financial eligibility assessment.
The government site is easy to use and you can select your state and it will navigate you to the appropriate contact point to make the application. If you qualify, state Medicaid may cover the full cost of your medication.
If I have federal, state or commercial insurance and none of the relugolix/estradiol/norethindrone acetate prescription saving options are applicable or affordable for me, are there any other support organisations that can help me with my co-insurance or copay contributions?
If you have already tried Medicaid and received a denial letter or if you are insured with Medicare and have been denied Low-Income Subsidy, then you can try one of the following organizational support programs:
1. Patient Access Network Foundation (PAN) assistance for relugolix/estradiol/norethindrone acetate
If you are having trouble paying for your relugolix/estradiol/norethindrone acetate medication due to unaffordable copays or deductibles, the Patient Access Network Foundation (PAN), may be able to assist you. To qualify for PAN assistance for relugolix/estradiol/norethindrone acetate you will need to meet one or all of the following criteria:
- Your income is below 400% of the federal poverty level
- relugolix/estradiol/norethindrone acetate is prescribed for an approved FDA indication
- You live in and receive treatment in the United States or U.S. territories, even if you do not have U.S. citizenship
- You have Medicare insurance coverage that covers relugolix/estradiol/norethindrone acetate
- If relugolix/estradiol/norethindrone acetate is listed on PAN’s list of covered medications
You can check the Patient Access Network Foundation Website for more information.
2. HealthWell Foundation Copay Program for relugolix/estradiol/norethindrone acetate
If you are having trouble paying for your relugolix/estradiol/norethindrone acetate medication due to unaffordable copays or deductibles, the HealthWell Foundation Copay Program may be able to assist you. To qualify for assistance for relugolix/estradiol/norethindrone acetate you will need to meet the following criteria:
- You live in and are being treated in the United States
- You are insured and your plan covers relugolix/estradiol/norethindrone acetate
- If relugolix/estradiol/norethindrone acetate is listed on the HealthWell Foundation’s list of covered medications
You can check the HealthWell Foundation Website for more information.
3. Patient Advocate Foundation Co-Pay Relief Program for relugolix/estradiol/norethindrone acetate
Patient Advocate Foundation’s Co-Pay Relief program exists to help reduce the financial distress you or your family may face when paying for your relugolix/estradiol/norethindrone acetate treatment. If you qualify and can demonstrate the need, the foundation will provide you with direct payment covering co-pays, co-insurance, and deductibles. To qualify for assistance for relugolix/estradiol/norethindrone acetate you will need to meet the following criteria:
- You must be currently insured and have coverage for relugolix/estradiol/norethindrone acetate
- You must have a confirmed diagnosis and treatment plan
- You must reside and receive treatment in the United States
- Your Income must fall at or below 300% or 400% of the Federal Poverty Guideline (FPG) with consideration for the Cost of Living Index (COLI) and number in the household
- Applications can also be completed by contacting the program sponsor, toll-free at 866-512-3861.
You can check the Patient Advocate Foundation Website for more information.
Medical Disclaimer
NowPatient has taken all reasonable steps to ensure that all material is factually accurate, complete, and current. However, the knowledge and experience of a qualified healthcare professional should always be sought after instead of using the information on this page. Before taking any drug, you should always speak to your doctor or another qualified healthcare provider.
The information provided here about medications is subject to change and is not meant to include all uses, precautions, warnings, directions, drug interactions, allergic reactions, or negative effects. The absence of warnings or other information for a particular medication does not imply that the medication or medication combination is appropriate for all patients or for all possible purposes.
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You can lower the cost of your prescription medications using our various savings programs which include drug coupons, savings card and manufacturer-sponsored patient assistance programs.
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