elagolix-estrad-norethin 300-1-0.5 mg(AM)/elagolix 300 mg(PM) capsules

Generic name:
Elagolix/estradiol/norethindrone and elagolix - oral

Pronunciation
(EL-a-GOE-lix/ES-tra-DYE-ol/nor-ETH-in-drone and EL-a-GOE-lix)

Brand name(s)
Oriahnn

Combination hormone treatment increases the risk of blood clot problems, including clots in the legs, lungs, and heart. Do not use this medication if you smoke cigarettes/use tobacco and are over 35 years old. Smoking raises your risk of stroke, heart attack, blood clots, and high blood pressure from this product. The risk of these serious problems increases with age and with the number of cigarettes you smoke. Do not smoke or use tobacco.

This product has 2 different capsules. One capsule contains a combination of 3 medications: elagolix, estradiol, and norethindrone. The other capsule contains only elagolix.

It is used by women who have not gone through menopause to help manage heavy menstrual bleeding due to uterine fibroids. Elagolix works by decreasing your body's production of certain hormones (luteinizing hormone, follicle-stimulating hormone), which leads to lower amounts of female sex hormones (estrogens). Estradiol is used to decrease bone loss caused by elagolix, while norethindrone is used to help lessen the risk of cancer of the uterus due to estradiol.

Read the Medication Guide provided by your pharmacist before you start taking this product and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

To make sure you are not pregnant, your doctor may do a pregnancy test before you start taking this medication, or tell you to start taking it within 7 days after the start of your menstrual period. Start taking this medication only when directed by your doctor.

Take the combination medication capsule (elagolix, estradiol, norethindrone) by mouth with or without food as directed by your doctor, usually once daily in the morning. Take the single medication (elagolix) capsule by mouth with or without food as directed by your doctor, usually once daily in the evening. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. To lessen the risk of bone loss (osteoporosis), your doctor may tell you to stop taking this medication after 24 months. Talk with your doctor for details.

Avoid eating grapefruit or drinking grapefruit juice while using this medication unless your doctor or pharmacist says you may do so safely. Grapefruit can increase the chance of side effects with this medicine. Ask your doctor or pharmacist for more details.

Tell your doctor if your condition does not get better or if it gets worse.

Hot flashes, headache, tiredness, or menstrual period changes may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Hair thinning and hair loss may occur. It is unknown if normal hair growth will return after treatment has ended.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

Tell your doctor right away if you have any serious side effects, including:

• lumps in the breast
• mental/mood changes (such as new or worsening depression, anxiety, unusual changes in behavior)
• signs of liver damage (such as nausea/vomiting that doesn't stop, loss of appetite, stomach/abdominal pain, yellowing eyes/skin, dark urine)
• unusual changes in vaginal bleeding (such as continuous spotting, sudden heavy bleeding)
• symptoms of high blood sugar (such as increased thirst/urination)

Get medical help right away if you have any very serious side effects, including:

• thoughts of suicide

The elagolix in this medication lowers estrogen levels in your body. Low estrogen levels can lead to bone loss (osteoporosis). The risk is increased with higher doses or with longer use of this medication. Some bone loss may be permanent. Talk with your doctor about the risks and benefits of taking this medication, and ask about taking calcium supplements and vitamin D for bone health.

This medication may rarely cause serious (sometimes fatal) problems from blood clots (such as heart attack, stroke, blood clots in the lungs or legs). Get medical help right away if you have:

• shortness of breath/rapid breathing
• chest/jaw/left arm pain
• unusual sweating
• confusion
• sudden dizziness/fainting
• pain/swelling/warmth in the groin/calf
• sudden/severe headaches
• trouble speaking
• weakness on one side of the body
• sudden vision changes

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking this product, tell your doctor or pharmacist if you are allergic to elagolix, estradiol, or norethindrone; or to any estrogens (such as mestranol) or any progestins (such as desogestrel) or if you have any other allergies. This product may contain inactive ingredients (such as tartrazine), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• blood clotting disorders (such as protein C or protein S deficiency)
• high blood pressure
• abnormal breast exam
• bone loss (osteoporosis)
• cancer (especially endometrial or breast cancer)
• high cholesterol or triglyceride (blood fat) levels
• diabetes
• family or personal history of a certain swelling disorder (angioedema)
• gallbladder problems
• severe headaches/migraines
• heart problems (such as heart valve disease, irregular heartbeat, previous heart attack)
• history of yellowing eyes/skin (jaundice) during pregnancy or while using hormonal birth control (such as pills, patch)
• kidney disease
• liver disease (including tumors)
• mental/mood disorders (such as depression)
• obesity
• stroke
• swelling (edema)
• thyroid problems
• unexplained vaginal bleeding

This medication may cause blotchy, dark areas on your skin (melasma). Sunlight may worsen this effect. Avoid prolonged sun exposure, sunlamps, and tanning booths. Use a sunscreen, and wear protective clothing when outdoors.

Tell your doctor if you just had or will be having surgery or if you will be confined to a bed or chair for a long time (such as a long plane flight). These conditions increase your risk of getting blood clots, especially if you are using hormone replacement. You may need to stop this medication for a time (such as 4 to 6 weeks before surgery) or take special precautions. If your doctor tells you to stop this medication before surgery, ask for specific directions about when to restart this medication.

This product must not be used during pregnancy. It may harm an unborn baby. Ask about reliable forms of non-hormonal birth control (such as condoms, spermicide) while using this medication and for 4 weeks after stopping treatment. Because this medication affects menstruation, it may be harder to tell if you are pregnant. If you become pregnant or think you may be pregnant, tell your doctor right away.

It is unknown if elagolix passes into breast milk. A small amount of estradiol and norethindrone passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breastfeeding.

See also How to Use section.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug are:

• aromatase inhibitors (such as anastrozole, exemestane, letrozole)
• fezolinetant
• ospemifene
• tamoxifen
• tranexamic acid

Other medications can affect the removal of this medication from your body, which may affect how it works. Examples include asciminib, belumosudil, cyclosporine, encorafenib, gemfibrozil, letermovir, resmetirom, vadadustat, voclosporin, among others.

This medication can speed up the removal of other medications from your body, which may affect how they work. Examples of affected drugs include daridorexant, elacestrant, certain drugs for hepatitis C (such as asunaprevir, ombitasvir/paritaprevir/ritonavir), mavacamten, quizartinib, revumenib, among others.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

Lab and/or medical tests (such as liver function, cholesterol, pregnancy test, blood pressure, bone density tests) may be done before you start taking this medication and while you are taking it. Keep all medical and lab appointments.

If you miss a dose, take it as soon as you remember. If it is more than 4 hours after the missed dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.