Elagolix; Estradiol; Norethindrone acetate Oral Capsules

What is this medication?

ELAGOLIX; ESTRADIOL; NORETHINDRONE (el a GOE lix; es tra DYE ole; nor eth IN drone) is used to treat heavy menstrual bleeding due to uterine fibroids.

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
• cigarette smoker
• diabetes (high blood sugar)
• gallbladder disease
• heart disease
• high blood pressure
• high cholesterol
• kidney disease
• liver disease
• lupus
• migraine headaches
• mental health disease
• osteoporosis, weak bones
• porphyria
• stroke
• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• unexplained vaginal bleeding
• an unusual or allergic reaction to elagolix, estrogens, progestins, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine 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 health care provider 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 health care provider about the use of this medicine 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 medicine with any of the following medications:

• aromatase inhibitors like aminoglutethimide, anastrozole, exemestane, letrozole, testolactone
• cyclosporine
• enasidenib
• gemfibrozil

This medicine may also interact with the following medications:

• benzodiazepines
• bosentan
• bromocriptine
• certain antivirals for HIV or hepatitis
• certain medicines for seizures like carbamazepine, phenobarbital, phenytoin
• cimetidine
• citalopram
• dantrolene
• digoxin
• grapefruit juice
• griseofulvin
• hydrocortisone, cortisone, or prednisolone
• isoniazid (INH)
• medicines for diabetes
• methadone
• methotrexate
• midazolam
• mineral oil
• omeprazole
• other female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections
• 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 health care provider for regular checks on your progress. You will need a regular breast and pelvic exam while on this medicine. 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 females stop having periods while taking this drug.

Smoking increases the risk of getting a blood clot or having a stroke while you are taking this medicine, especially if you are more than 35 years old. You are strongly advised not to smoke.

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

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

This medicine does not prevent pregnancy. Women must use effective birth control with this medicine. Use a non-hormonal form of birth control while taking this medicine and for 28 days after stopping it. Talk to your health care professional about how to prevent pregnancy. Do not become pregnant while taking this medicine. Women should inform their doctor if they wish to become pregnant or think they might be pregnant. There is a potential for serious side effects to an unborn child. Talk to your health care professional or pharmacist for more information.

If you are going to need surgery or other procedure, tell your health care provider that you are using this medicine.

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

This medicine does not protect you against HIV infection (AIDS) or any other sexually transmitted diseases.

What side effects may I notice from receiving this medication?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions (skin rash, itching or hives, swelling of the face, lips, or tongue)
• anxious
• blood clot (chest pain, shortness of breath, pain, swelling, or warmth in the leg)
• breast tissue changes or discharge
• depressed mood
• increase in blood pressure
• light-colored stool
• liver injury (dark yellow or brown urine; general ill feeling or flu-like symptoms; loss of appetite, right upper belly pain; unusually weak or tired, yellowing of the eyes or skin)
• stroke (changes in vision, confusion, trouble speaking or understanding, severe headaches, sudden numbness or weakness of the face, arm or leg, trouble walking, dizziness, loss of balance or coordination)
• suicidal thoughts, mood changes
• swelling of the ankles, feet, hands
• trouble breathing
• unusual vaginal bleeding

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

• hair loss
• headache
• hot flashes or night sweats
• missed menstrual periods
• nausea
• tiredness

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 medicine after the expiration date.

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

• Take the medicine to a medicine take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medicine, check the label or package insert to see if the medicine should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your health care provider. If it is safe to put it in the trash, take the medicine out of the container. Mix the medicine 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.