Elagolix; Estradiol; Norethindrone acetate oral capsules

What is this medicine?

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.

How should I use this medicine?

Take this medicine by mouth with a glass of water. You can take it with or without food. Follow the directions on the prescription label. Take this medicine at the same times each day. Do not take your medicine more often than directed.

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 pediatrician regarding the use of this medicine in children. This medicine is not approved for use in children.

What side effects may I notice from receiving this medicine?

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

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

  • anxious

  • breast tissue changes or discharge

  • breathing problems

  • depressed mood

  • high blood pressure

  • signs and symptoms of a blood clot such as chest pain; shortness of breath; pain, swelling, or warmth in the leg

  • signs and symptoms of a stroke like 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

  • signs and symptoms of liver injury like dark yellow or brown urine; general ill feeling or flu-like symptoms; light-colored stools; loss of appetite; nausea; right upper belly pain; unusually weak or tired; yellowing of the eyes or skin

  • suicidal thoughts or other mood changes

  • swelling of the ankles, feet, hands

  • 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):

  • reduced or absent menstrual periods

  • hair loss

  • headache

  • hot flashes or night sweats

  • nausea

  • tiredness

What may interact with this medicine?

Do not take this medicine with any of the following medications:

  • aromatase inhibitors like aminoglutethimide, anastrozole, exemestane, letrozole, testolactone

  • cyclosporine

  • 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

  • cyclosporine

  • 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

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.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Throw away any unused medicine after the expiration date on the label.

What should I tell my health care provider before I take this medicine?

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

  • gallbladder disease

  • heart disease

  • high blood pressure

  • high cholesterol

  • kidney disease

  • liver disease

  • lupus

  • migraine headaches

  • mental illness

  • osteoporosis

  • 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

What should I watch for while using this medicine?

Visit your doctor or health care professional 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 1 week 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 have elective surgery, you may need to stop taking this medicine beforehand. Consult your health care professional for advice prior to scheduling the surgery.

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.