Elagolix; Estradiol; Norethindrone Acetate Capsules

What is this medication?

ELAGOLIX; ESTRADIOL; NORETHINDRONE (el a GOE lix; es tra DYE ole; nor eth IN drone) helps reduce heavy periods caused by uterine fibroids. Elagolix works by decreasing the amount of estrogen and other hormones your body makes, which reduces heavy bleeding and pain. Estradiol lowers the risk of bone loss caused by elagolix. Norethindrone helps lower the risk of cancer that can be caused by estradiol. This medication contains the hormones estrogen and progestin.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): ORIAHNN

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Blood vessel disease or blood clots
• Breast, cervical, endometrial, or uterine cancer
• Diabetes (high blood sugar)
• Gallbladder disease
• Heart disease
• High blood pressure
• High cholesterol
• Kidney disease
• Liver disease
• Lupus
• Mental health conditions
• Migraine headaches
• Osteoporosis, weak bones
• Porphyria
• Stroke
• Suicidal thoughts, plans, or attempt by you or a family member
• Tobacco use
• Unexplained vaginal bleeding
• An unusual or allergic reaction to elagolix, estrogens, progestins, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. You can take it with or without food. Take it as directed on the prescription label at the same time every day. Keep taking it unless your care team tells you to stop.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. It is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it within 4 hours of the time that it was supposed to be taken and take the next dose at the usual time. If more than 4 hours have passed, skip the missed dose. The next dose should be taken at the usual time. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Aromatase inhibitors, such as aminoglutethimide, anastrozole, exemestane, letrozole, testolactone
• Cyclosporine
• Enasidenib
• Gemfibrozil
• Trofinetide

This medication may also interact with the following:

• Benzodiazepines
• Bosentan
• Bromocriptine
• Certain antivirals for HIV or hepatitis
• Certain medications for seizures, such as carbamazepine, phenobarbital, phenytoin
• Cimetidine
• Citalopram
• Dantrolene
• Digoxin
• Estrogen or progestin hormones
• Grapefruit juice
• Griseofulvin
• Hydrocortisone, cortisone, or prednisolone
• Isoniazid (INH)
• Medications for diabetes
• Methadone
• Methotrexate
• Midazolam
• Mineral oil
• Omeprazole
• Raloxifene
• Rifabutin, rifampin, or rifapentine
• Rosuvastatin
• Tamoxifen
• Thyroid hormones
• Topiramate
• Tricyclic antidepressants
• Warfarin

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. You will need a regular breast and pelvic exam while on this medication. It may take several cycles of use to see improvement in your condition.

You may have a change in bleeding pattern or irregular periods. Many patients stop having periods while taking this medication.

Talk to your care team if you use tobacco products. Changes to your treatment plan may be needed. Tobacco increases the risk of getting a blood clot or having a stroke while you are taking this medication. This risk is higher if you are over the age of 35.

This medication can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your care team if you feel you are retaining fluid.

This medication may cause weak bones (osteoporosis). Only use this product for the amount of time your care team tells you to. The longer you use this product, the more likely you will be at risk for weak bones. Ask your care team how you can keep strong bones.

Talk to your care team if you wish to become pregnant or think you might be pregnant. This medication can cause serious birth defects. Estrogen and/or progestin hormones may not work as well while you are taking this medication. A barrier contraceptive, such as a condom or diaphragm, is recommended during and for 28 days after stopping treatment. Talk to your care team about other forms of contraception.

If you are going to need surgery or other procedure, tell your care team that you are using this medication.

If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your care team.

Using this medication does not protect you or your partner against HIV or other sexually transmitted infections (STIs).

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
• Gallbladder problems—severe stomach pain, nausea, vomiting, fever
• Increase in blood pressure
• Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
• Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
• Thoughts of suicide or self-harm, worsening mood, feelings of depression

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Fatigue
• Hair loss
• Headache
• Hot flashes
• Irregular menstrual cycles or spotting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.