Elagolix, estradiol and norethindrone

Elagolix, estradiol and norethindrone

Elagolix, estradiol and norethindrone

What is Elagolix, Estradiol and Norethindrone?

Oriahnn is not intended for use in menopausal women.

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

Side effects of elagolix, estradiol and norethindrone

If necessary, get emergency medical helpSigns of an allergic reaction:hives; difficult breathing; Swelling of your face, lips, tongue, or throat.

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

• pain or pressure in the chest, pain spreading to the 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

• Difficulty speaking.

Elagolix, estradiol, and norethindrone can cause serious side effects. Call your doctor immediately if you have:

• high blood sugar – increased thirst, increased urination, dry mouth, fruity breath smell;

• any new or worsening mood symptoms – mood or behavior changes, depression, anxiety, suicidal thoughts or thoughts of self-harm; or

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

This medicine can cause permanent hair loss.

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

• hot flashes;

• feel 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 can report side effects to FDA at 1-800-FDA-1088.

Warnings

Do not use this medicine if you are pregnant.

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

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

Stop taking this medicine and see a doctor immediately if this happens to youChest pain spreading to the jaw or shoulder, sudden severe headache, problems with vision or speech, or swelling or pain in the leg.

Before you take this medicine

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;

• circulatory disorders;

• heart valve disease or cardiac arrhythmias;

• 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 over 35 years old;

• gallbladder problems;

• a history of hormone-related cancer (e.g. breast, uterine/cervical, or vaginal cancer);

• Osteoporosis; or

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

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

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

Oriahnn can also cause bone loss, some of which can be permanent. It is not known whether this could increase your risk of bone fractures.

Oriahnn is not a contraceptive and does 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 become pregnant.Oriahnn may increase your risk of miscarriage. Use effective birth control to prevent pregnancy while taking this medication and for at least 1 week after the 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 immediately if you think you may 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 period (reduced or no bleeding), which could make it harder to tell 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 bone fractures;

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

• Jaundice (yellowing of your skin or eyes) caused by pregnancy or contraception.

How should I take Oriahnn?

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

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

Take the medicine at the same time every day with or without food.

Your doctor may ask you to take extra vitamin D and calcium while you are taking Oriahnn. Only take these supplements as directed by your doctor. Avoid taking iron supplements if you also take vitamin D and calcium supplements.

If you need surgery, tell your surgeon that you are currently using this medicine. You may need to take a short break.

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

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

Store at room temperature, protected from moisture and heat.

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

Elagolix, estradiol, and norethindrone dosage information

Usual adult dose for uterine fibroids:

Take one capsule orally twice daily
-Morning capsule contains 300 mg elagolix, 1 mg estradiol and 0.5 mg norethindrone acetate
-Evening capsule contains Elagolix 300 mg
Duration of therapy: 24 months

Comments:
-Exclude pregnancy before starting therapy or initiate therapy within 7 days of the start of menstruation.
– Take the capsules twice daily at approximately the same time.
– Due to the risk of bone loss, the duration of use should be limited to 24 months.

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

What happens if I miss a dose?

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

What happens if I overdose?

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

An overdose may cause nausea, vomiting, stomach pain, breast tenderness, severe sleepiness or fatigue, or vaginal bleeding.

What should I avoid while taking Elagolix, Estradiol, and Norethindrone?

Do not smoke while taking this medicine.especially if you are over 35 years old.

Grapefruit can interact with Oriahnn and cause unwanted side effects. Avoid using grapefruit products.

What other drugs affect elagolix, estradiol, and norethindrone?

Tell your doctor about all other medicines you are taking, especially:

• thyroid medications; or

• cortisol replacement therapy;

Other medications can affect elagolix, estradiol, and norethindrone, including prescription and over-the-counter medications, vitamins, and herbal products. Tell your doctor about all medications you are currently taking and any medications you are taking or stopping.

More information

Remember to keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medicine only for the prescribed indication.