Estradiol and norethindrone-containing medications may raise the risk of heart attack, stroke, and blood clots in your legs and lungs. Inform your physician if you smoke, have ever experienced a heart attack or stroke, blood clots in your legs, lungs, or eyes, heart valve disease, a rapid or irregular heartbeat, thrombophilia (a condition where the blood clots easily), migraine headaches, high blood pressure, high cholesterol or fat levels, or diabetes that has impacted your circulation. If you currently have or have ever had any of these conditions, your doctor may advise against taking this drug. Your doctor might advise you to stop taking this medicine at least 4 to 6 weeks before to any surgery or bedrest if you will be undergoing either of those procedures.

Call your doctor right away if you suffer any of the following side effects: Sudden, intense headache, double vision, speech difficulties, dizziness or faintness, arm or leg weakness, sharp chest pain or heaviness, coughing up blood, sudden shortness of breath, or pain, tenderness, or redness in one leg are all symptoms that might occur suddenly.

When you start therapy with elagolix, estradiol, and norethindrone as well as each time you refill your prescription, your doctor or pharmacist will provide you the manufacturer’s patient information sheet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

The risks of taking elagolix, estradiol, and norethindrone should be discussed with your doctor.

Elagolix, estradiol, and norethindrone are used in conjunction to treat heavy menstrual bleeding brought on by uterine fibroids (uterine growths that are not cancerous). Elagolix belongs to a group of drugs known as GnRH receptor antagonists, which are used to treat various conditions. Estradiol belongs to the group of drugs known as estrogen hormones. The drug norethindrone belongs to the progestin drug class. Elagolix functions by reducing the body’s production of specific hormones. Estradiol functions by substituting for the estrogen that the body typically produces. Norethindrone inhibits uterine lining growth and stimulates the uterus to produce specific hormones, which is how it works.

Elagolix, estradiol, and norethindrone come in capsule form for oral use. It is often given twice a day, with or without food, for up to 24 months. A container of this medication contains enough pills for 28 days. Each weekly dose package contains two different types of capsules: seven yellow and white capsules containing elagolix, estradiol, and norethindrone, and seven blue and white capsules containing elagolix. Take one capsule each of elagolix, estradiol, and norethindrone in the morning, followed by one capsule of elagolix in the evening. Elagolix, estradiol, and norethindrone should be taken every day at around the same time(s). Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Take the prescribed dosages of elagolix, estradiol, and norethindrone. Never take it in larger or less amounts or more frequently than directed by your doctor.

During your treatment, your doctor might advise or prescribe a calcium and vitamin D supplement. As advised by your physician, you should take these supplements.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

Before taking the combination of elagolix, estradiol, and norethindrone,

• If you have any allergies, including to aspirin, tartrazine (a yellow dye used in some drugs), other medications, or any of the substances in elagolix, estradiol, or norethindrone capsules, notify your doctor and pharmacist right once. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
• Inform your doctor if you are taking gemfibrozil (Lopid) or cyclosporine (Gengraf, Neoral, Sandimmune). If you are currently on one or more of these drugs, your doctor may advise you not to take the combination of elagolix, estradiol, and norethindrone.
• Inform your doctor and pharmacist about any additional prescription and over-the-counter medications, vitamins, herbal items, nutritional supplements, and any drugs you are now taking or intend to take. Any of the following should be mentioned: Midazolam (Nayzilam), digoxin (Lanoxin), ketoconazole, levothyroxine (Levoxyl, Synthroid, Tirosint, and other brands), phenytoin (Dilantin, Phenytek), proton pump inhibitors such pantoprazole (Protonix), rabeprazole (Aciphex), and esomeprazole (Nexium, in Vimovo), as well as lansoprazole (Prevacid), omeprazole (Prilosec), and dexlansoprazole (Dexilant); steroids such as dexamethasone (Hemady), methylprednisolone (Medrol), prednisone, and prednisolone (Orapred ODT, Pediapred, Prelone), as well as rifampin (Rifadin, in Rifamate, in Rifater); rosuvastatin (Crestor). Additionally, let your doctor or pharmacist know if you’re taking iron-containing vitamin or mineral supplements. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Elagolix, estradiol, and norethindrone may also interact with many other drugs, so be careful to let your doctor know about all the drugs you are taking, even if they are not on this list.
• Inform your physician if you have or have ever had breast cancer, cervix, vaginal, or uterine cancer, osteoporosis (a disease in which the bones are brittle and more prone to breaking), unexplained abnormal vaginal bleeding, peripheral vascular disease (poor blood circulation in the blood vessels), heart or liver disease, or any other form of liver trouble. Your doctor may advise against using elagolix, estradiol, and norethindrone together.
• Inform your doctor if you have or have ever had broken bones, gall bladder disease, jaundice (yellowing of the skin or eyes), thyroid issues, adrenal insufficiency (condition where the adrenal glands do not produce enough of certain hormones needed for important body functions), depression, anxiety, unusual changes in behavior or mood, or thoughts about or attempted suicide.
• Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. If you are pregnant or suspect that you could be pregnant, avoid using elagolix, estradiol, and norethindrone. To ensure that you are not pregnant while taking elagolix, estradiol, and norethindrone, your doctor will perform a pregnancy test before you begin therapy or advise you to start treatment no later than seven days following the start of your period. You shouldn’t take elagolix, estradiol, or norethindrone as your sole form of birth control while receiving treatment since they may interfere with the effectiveness of some hormonal contraceptives. To avoid getting pregnant while receiving therapy and for one week following your last dose, you must use an effective non-hormonal birth control technique. Ask your doctor to assist you in selecting a birth control technique that will be effective for you. Call your doctor right away if you get pregnant while taking elagolix, estradiol, or norethindrone. The fetus could be harmed by elagolix, estradiol, and norethindrone.
• You should be aware that while using elagolix, estradiol, and norethindrone, your mental health may alter in unexpected ways and you may become suicidal (thinking about injuring or killing oneself, preparing to do so, or trying to do so). If you experience any of the following symptoms, you, your family, or your caregiver should contact your doctor right away: new or worsening irritability, anxiety, or depression; talking about or considering harming yourself or taking your own life; withdrawing from friends and family; preoccupation with death and dying; or any other unusual changes in behavior or mood. Make sure your family or caregiver is aware of any symptoms that could be significant so they can contact the doctor on your behalf if you are unable to call for help.

While using this medication, avoid grapefruit and grapefruit juice.

If you miss a dosage, take it as soon as you recall. Nevertheless, skip the missed dose and go on with your regular dosing plan if it has been more than 4 hours since your last dose. To make up for a missing dose, do not take a second one.

There may be negative effects from elagolix, estradiol, and norethindrone. If any of these symptoms are severe or do not go away, consult your doctor:

• Hair thinning or hair loss
• Hot flashes (an unexpected burst of light to strong bodily heat)
• Modifications to menstrual cycles (irregular bleeding or spotting, minimal or no bleeding, shorter periods)
• Headache
• Gaining weight
• Joints hurt
• Alteration of sexual desire
• Sluggishness or fatigue

Some adverse effects can be very harmful. Call your doctor right away or seek emergency medical attention if you develop any of these signs or any of the ones detailed in the IMPORTANT WARNING section:

• Eyes or skin that have a yellow tint
• Significant bruising or bleeding
• Reduced appetite
• Severe weakness, low energy, or exhaustion
• Urine with a dark color
• Stool with a light color
• Stomach’s upper right corner hurts
• Nausea
• Vomiting
• Swelling of the lower legs, foot, or hands

Osteoporosis may be brought on by or made worse by elagolix, estradiol, and norethindrone together. It can lessen the density of your bones and raise your risk of fractures and shattered bones. The dangers of using this drug should be discussed with your doctor.

Norethindrone, estradiol, and elagolix could all have additional adverse effects. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088 if you have a serious side event.

Keep this medication tightly closed in the original container and out of the reach of children. Keep it at room temperature and out of the bathroom and other places with excessive heat and moisture.

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilizing a medicine take-back program is the easiest approach to get rid of your medication. To find out about take-back programs in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back program, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Overdose symptoms could include:

• Nausea
• Vomiting
• Breast sensitivity
• Abdomen ache
• Sluggishness or fatigue
• Uterine bleeding

Keep all of your appointments with your physician and the lab. To determine how your body is responding to elagolix, estradiol, and norethindrone, your doctor will request specific lab tests.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.