Elagolix tablets

What is this medication?

ELAGOLIX (el a GOE lix) is used to treat endometriosis in women. It reduces pain from the condition and may help reduce painful sexual intercourse.

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

COMMON BRAND NAME(S): Orilissa

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

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

• depression
• liver disease
• mental illness
• osteoporosis, weak bones
• suicidal thoughts, plans, or attempt; a previous suicide attempt by you or a family member
• an unusual or allergic reaction to elagolix, 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 a full glass of water. Take it as directed on the prescription label at the same time every day. You can take it with or without food. If it upsets your stomach, take it with food. 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 pediatrician regarding the use of this medicine in children. This medicine 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 as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

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

• cyclosporine
• enasidenib
• gemfibrozil

This medicine may also interact with the following medications:

• certain antivirals for HIV or hepatitis
• citalopram
• digoxin
• female hormones, like estrogens or progestins and birth control pills, patches, rings, or injections
• methadone
• midazolam
• omeprazole
• rifampin
• rosuvastatin

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.

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.

Patients and their families should watch out for new or worsening depression or thoughts of suicide. Also watch out for sudden changes in feelings such as feeling anxious, agitated, panicky, irritable, hostile, aggressive, impulsive, severely restless, overly excited and hyperactive, or not being able to sleep. If this happens, call your care team.

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 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. If you are using estrogen and/or progestin hormones for contraception, 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.

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 like skin rash, itching or hives, swelling of the face, lips, or tongue
• anxious
• depressed mood
• 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

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
• headache
• hot flashes or night sweats
• nausea
• joint pain
• trouble sleeping

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.

It is important to get rid of the medicine as soon as you no longer need it or it is expired. You can do this in two ways:

• 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, follow the directions in the MedGuide.

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.