Elagolix, estradiol, and norethindrone (Oriahnn) is used to control heavy menstrual bleeding in adult women with uterine fibroids.

Oriahnn is not for use in women who have entered menopause.

Oriahnn may also be used for purposes not listed in this medication guide.

Do not use this medicine if you are pregnant.

You should not use this medicine if you have: uncontrolled high blood pressure, heart disease, circulation problems (especially with diabetes), undiagnosed vaginal bleeding, liver disease, severe migraine headaches, osteoporosis, if you smoke and are over 35, or if you have ever had a heart attack, a stroke, a blood clot, or cancer of the breast, uterus/cervix, or vagina.

Taking this medicine can increase your risk of blood clots, stroke, or heart attack. Your risk of these side effects is highest if you are older than 35 and you smoke, or if you have high cholesterol, diabetes, uncontrolled high blood pressure, or if you are overweight.

Stop taking this medicine and seek medical attention right away if you have chest pain spreading to your jaw or shoulder, a sudden severe headache, problems with vision or speech, or swelling or pain in your leg.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. You should not take Oriahnn for longer than 24 months.

This medicine comes in different capsule colors. The white/yellow capsule is usually taken in the morning, and the white/blue capsule is taken in the evening. Follow your doctor's dosing instructions very carefully.

Take the medicine at the same times each day, with or without food.

Your doctor may have you take extra vitamin D and calcium while you are taking Oriahnn. Take these supplements only as your doctor has prescribed. Avoid taking iron supplements if you also take vitamin D and calcium supplements.

If you need surgery, tell your surgeon you currently use this medicine. You may need to stop for a short time.

Your blood pressure will need to be checked often. You may also need scans to check your bone mineral density before and during treatment with Oriahnn.

Oriahnn can affect the results of certain medical tests. Tell any doctor who treats you that you are using this medicine.

Store at room temperature away from moisture and heat.

Do not keep leftover capsules. Ask your pharmacist where to locate a drug take-back disposal program. Do not flush the unused medicine down a toilet.

Usual Adult Dose for Uterine Fibroids:

One capsule orally twice a day
-Morning capsule contains elagolix 300 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg
-Evening capsule contains elagolix 300 mg
Duration of therapy: 24 months

Comments:
-Rule out pregnancy prior to starting therapy or start therapy within 7 days from the onset of menses.
-Take capsules twice a day at approximately the same time each day.
-Duration of use should be limited to 24-months due to risk of bone loss.

Use: For the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women.

You should not use elagolix, estradiol, and norethindrone if you are allergic to elagolix, estradiol, or norethindrone, or if you have:

• a history of heart attack, stroke;

• a blood clot in your heart, lungs, legs, or eyes;

• blood circulation problems;

• a heart valve disorder or heart rhythm problems;

• uncontrolled high blood pressure;

• problems caused by diabetes that affect your eyes, kidneys, nerves, or blood vessels;

• severe migraine headaches (with aura), especially if you are older than 35;

• gallbladder problems;

• a history of hormone-related cancer (such as cancer of the breast, uterus/cervix, or vagina);

• osteoporosis; or

• abnormal vaginal bleeding that has not been checked by a doctor.

Taking Oriahnn can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, or if you are overweight.

Smoking can greatly increase your risk of blood clots, stroke, or heart attack. You should not take this medicine if you smoke and are over 35 years old.

Oriahnn may also cause bone loss, which may be partially permanent. It is not known if this could increase your risk of bone fracture.

Oriahnn is not a birth control medication and will not prevent pregnancy. You may need to have a negative pregnancy test before starting this treatment.

Do not take this medicine if you are pregnant or trying to get pregnant. Oriahnn may increase your risk of miscarriage. Use effective birth control to prevent pregnancy while taking this medicine and for at least 1 week after your last dose.

To prevent pregnancy while using Oriahnn, use a non-hormonal form of birth control: condom, diaphragm, cervical cap, or contraceptive sponge. Avoid using birth control pills, injections, implants, skin patches, and vaginal rings.

Stop taking Oriahnn and call your doctor right away if you think you might be pregnant.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of Oriahnn on the baby.

Oriahnn may change your menstrual periods (decreased or no bleeding), which could make it harder to know if you are pregnant. Watch for other signs of pregnancy such as breast tenderness, weight gain, and nausea.

Tell your doctor if you have ever had:

• bone problems, including broken bones;

• depression, a mood disorder, or suicidal thoughts; or

• jaundice (yellowing of your skin or eyes) caused by pregnancy or birth control.

Use the medicine as soon as you can, but skip the missed dose if you are more than 4 hours late for the dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose may cause nausea, vomiting, stomach pain, breast tenderness, severe drowsiness or tiredness, or vaginal bleeding.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Do not eat grapefruit or drink grapefruit juice while taking this medication.

Do not smoke while taking this medicine, especially if you are older than 35 years of age.

Grapefruit may interact with Oriahnn and lead to unwanted side effects. Avoid the use of grapefruit products.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Oriahnn may increase your risk of heart attack, stroke, or blood clot. Stop using this medicine and seek medical attention right away if you have:

• chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;

• swelling, pain, warmth, or redness in an arm or leg;

• sudden shortness of breath;

• sudden numbness, weakness, or severe headache;

• vision problems, bulging eyes; or

• trouble speaking.

Elagolix, estradiol, and norethindrone may cause serious side effects. Call your doctor at once if you have:

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor;

• any new or worsening mood symptoms--mood or behavior changes, depression, anxiety, thoughts about suicide or hurting yourself; or

• liver or gallbladder problems--loss of appetite, nausea, vomiting, stomach pain (upper right side), tiredness, bruising, swelling, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

This medicine may cause hair loss that may be permanent.

Common side effects of elagolix, estradiol, and norethindrone may include:

• hot flashes;

• feeling tired;

• hair loss (may be permanent);

• headache; or

• irregular menstrual periods.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• thyroid medicine; or

• cortisol replacement therapy;

Other drugs may affect elagolix, estradiol, and norethindrone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests to check your body's response to elagolix, estradiol, and norethindrone.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.