WARNING

A heart attack, stroke, and blood clots in the lungs and legs are among the health risks associated with medications containing estradiol and norethindrone. Tell your doctor 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 have any of the conditions listed above or have ever had any of them, 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.

Please contact your physician right away if you suffer any of the following negative effects: abrupt, severe headache; abrupt partial or total loss of vision; double vision; speech difficulties; dizziness or faintness; weakness or numbness in one arm or leg; sharp chest pain; coughing up blood; sudden shortness of breath; or pain, tenderness, or redness in one leg.

When you start taking elagolix, estradiol, and norethindrone as well as whenever you need a prescription refill, your doctor or pharmacist will provide you the manufacturer’s patient information sheet (Medication Guide). If you have any questions, thoroughly read the material, then consult your physician or pharmacist. Discuss the potential risks of taking elagolix, estradiol, and norethindrone with your doctor.

Why is this medication prescribed?

Heavy monthly bleeding brought on by uterine fibroids (uterine growths that are not cancerous), which are treated with the combination of elagolix, estradiol, and norethindrone. Elagolix belongs to a group of drugs known as gonadotropin-releasing hormone (GnRH) receptor antagonists. As an estrogen hormone, estradiol belongs to a group of drugs. A group of drugs known as progestins includes norethindrone. By reducing the body’s production of specific hormones, elagolix works. The mechanism through which estradiol functions is to replace the body’s natural production of estrogen. Norethindrone inhibits uterine lining growth and stimulates the production of specific hormones in the uterus, which is how it works.

How should this medicine be used?

You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: new or worsening irritability, anxiety, or depression; talking or thinking about wanting to hurt yourself or end your life; withdrawing from friends and family; preoccupation with death and dying; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you think this drug may be recommended for other conditions.

What special precautions should I follow?

Regarding special precautions, here are some important considerations when using Orilissa:

• Inform your doctor and pharmacist if you have any allergies to elagolix, estradiol, norethindrone, aspirin, tartrazine (a yellow medicine color), other drugs, or any of the components in elagolix, estradiol, or norethindrone capsules. For a list of the ingredients, consult your pharmacist or the Medication Guide.
• If you use gemfibrozil (Lopid) or cyclosporine (Gengraf, Neoral, Sandimmune), let your doctor know. In the event that you are already on one or more of these drugs, your doctor may advise against taking the combination of elagolix, estradiol, and norethindrone.
• Inform your doctor and pharmacist about any additional prescription and non-prescription drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Make sure you bring up any of the following: Digoxin (Lanoxin), ketoconazole, levothyroxine (Levoxyl, Synthroid, Tirosint, among others), midazolam (Nayzilam), phenytoin (Dilantin, Phenytek), proton pump inhibitors like dexlansoprazole (Dexilant), esomeprazole (Nexium, in Vimovo), lansoprazole (Prevacid), steroids such dexamethasone (Hemady), methylprednisolone (Medrol), prednisone, and prednisolone (Orapred ODT, Pediapred, Prelone); rifampin (Rifadin, in Rifamate, in Rifater); rosuvastatin (Crestor); and rabeprazole (Aciphex); among others. If you take iron-containing vitamin or mineral supplements, let your doctor or pharmacist know as well. Your doctor might need to adjust your medication doses or keep a close eye out for any negative side effects. Elagolix, estradiol, and norethindrone may interact with a variety of other drugs as well. As a result, it is important to inform your doctor about all the drugs you are taking, even ones that are not on this list.
• Inform your doctor if you have or have ever had breast cancer, cervix, vaginal, or uterine cancer, osteoporosis (a condition in which the bones are brittle and more likely to break), 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. If you take elagolix, estradiol, and norethindrone together, your doctor may advise against it.
• Inform your doctor if you currently have or ever had broken bones, depression, anxiety, unusual changes in behavior or mood, thoughts of or attempts at suicide, gall bladder disease, jaundice (yellowing of the skin or eyes), thyroid issues, or adrenal insufficiency (condition in which the adrenal glands do not produce enough of certain hormones needed for important body functions).
• Be sure to let your doctor know if you’re nursing a baby or expecting a baby. Elagolix, estradiol, and norethindrone should not be taken if you are pregnant or suspect that you might be. To ensure that you are not pregnant while taking elagolix, estradiol, and norethindrone, your doctor will perform a pregnancy test prior to commencing therapy or advise you to start treatment no later than 7 days following the start of your period. During your therapy, you shouldn’t rely solely on elagolix, estradiol, or norethindrone as a means of birth control because these medications may interfere with the effectiveness of some hormonal contraceptives.
• During therapy and for one week following your last dose, you must use a trustworthy non-hormonal method of birth control to avoid getting pregnant. To help you select a birth control technique that will be effective for you, consult your doctor. While taking elagolix, estradiol, and norethindrone, call your doctor right away if you become pregnant. The fetus may suffer side effects from elagolix, estradiol, and norethindrone.
• You should be aware that taking elagolix, estradiol, and norethindrone may cause unexpected changes in your mental health and increase your risk of being suicidal (thinking about injuring or killing yourself, preparing to do so, or trying to do so).

What special dietary instructions should I follow?

While consuming this medication, avoid eating or drinking grapefruit.

What should I do if I forget a dose?

When you recall, immediately take the missed dose. To continue with your regular dosing plan, skip the missed dose if it has been more than 4 hours since your last dose. If you miss a dose, don’t take a second one to make up for it.

What side effects can this medication cause?

Aside effects are possible with elagolix, estradiol, and norethindrone. Any of these symptoms that are severe or do not go away should be discussed with your doctor:

• The thinned or lost hair
• A sudden surge of mild to extreme body heat is referred to as a “hot flash.”
• Variations in menstrual cycles, including irregular or sporadic bleeding, minimal to no blood, and shorter cycles
• Headache
• Adding pounds
• Joint discomfort
• Alterations in sexual aversion
• Somnolence or exhaustion

There can be major negative effects. Call your doctor right away or seek emergency medical care if you have any of the following symptoms or any of those in the IMPORTANT WARNING section:

• The skin or eyes becoming yellow
• Unexpected bruising or bleeding
• Appetite loss
• Excessive exhaustion, sluggishness, or lack of energy
• Urine with a deep hue
• Stool in a pale color
• Stomach ache in the top right corner
• Nausea
• Vomiting
• Hands, feet, or lower legs swelling

Osteoporosis may be brought on by or exacerbated by the use of elagolix along with estradiol and norethindrone. Your bones’ mineral content may decline, which raises your risk of fractures and shattered bones. About the dangers of using this drug, see your doctor.

Other negative effects may be brought on by elagolix, estradiol, and norethindrone. If you have any strange side effects while taking this medicine, contact your doctor right away.

What should I know about storage and disposal of this medication?

Keep this medication out of the reach of children and tightly closed in the original container. Keep it at normal temperature, away from sources of extreme heat, and dry (not in the bathroom).

All medications should be kept out of the sight and reach of children, as many of the containers (such as weekly pill containers and those for eye drops, lotions, patches, and inhalers) are not child-resistant and are simple for small children to open. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and out of reach to prevent poisoning.

In order to prevent pets, kids, and other people from ingesting leftover pharmaceuticals, they should be disposed of in a specific manner. This drug should not, however, be flushed down the toilet. A medicine take-back program is the preferable method for getting rid of your medication. To find out about take-back initiatives in your area, speak to your pharmacist or get in touch with the local garbage/recycling department.

In case of emergency/overdose

• In case of an emergency or suspected overdose, call your local emergency services or go to the nearest emergency room immediately.
• It is important to have the medication packaging or information readily available to provide accurate details to healthcare professionals.

What other information should I know?

• Be sure to inform your healthcare provider about any allergies, existing medical conditions, or medications you are taking, including over-the-counter drugs, supplements, or herbal products.
• Attend regular follow-up appointments with your healthcare provider to monitor your response to the medication and address any concerns or questions.
• If you experience any unexpected or severe side effects, contact your healthcare provider promptly.
• It is advisable to carry a list of your medications, including their names, dosages, and prescribing healthcare providers’ information, in case of emergencies or visits to different healthcare providers.

Remember to carefully read and follow the specific instructions provided with each medication and consult your healthcare provider or pharmacist for detailed information on storage, disposal, and emergency procedures related to the specific medication you are using.