Elagolix is used to treat pain brought on by endometriosis, a condition that results in infertility, discomfort before and during menstruation, pain during and after sexual activity, and heavy or irregular bleeding. Endometriosis is caused by the growth of tissue similar to that which lines the uterus (womb) in other parts of the body. Elagolix belongs to a group of drugs known as GnRH receptor antagonists, which are used to treat various conditions. It functions by lowering the body’s levels of specific hormones.

Elagolix is available as an oral tablet. It is often taken once daily for up to 24 months, with or without meals, or twice daily for up to 6 months. Every day, take elagolix at about the same time(s). Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following. Elagolix should be taken as prescribed. Never take it in larger or less amounts or more frequently than directed by your doctor.

During your treatment, your doctor might advise or prescribe a calcium and vitamin D supplement. As advised by your physician, you should take these supplements.

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

Before taking elagolix,

• If you have an allergy to elagolix, any other medications, or any of the substances in elagolix tablets, inform your doctor and pharmacist right away. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
• Inform your doctor if you are taking gemfibrozil (Lopid) or cyclosporine (Gengraf, Neoral, Sandimmune). If you are currently using one of these drugs, your doctor generally won’t recommend that you take elagolix.
• Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Mention any of the following: rifampin (Rifadin, Rimactane, in Rifamate, in Rifater), midazolam, ketoconazole (Nizoral), digoxin (Lanoxin), and rosuvastatin (Crestor). Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Tell your doctor about all the drugs you are taking, even any not on this list, as many other drugs may also interact with elagolix.
• Inform your doctor if you have liver illness or if you have previously had osteoporosis (a condition in which the bones deteriorate and become brittle and susceptible to breaking). Your physician could advise against taking elagolix.
• Inform your doctor if you have ever attempted suicide, had suicidal thoughts, broken bones, depression, anxiety, or any of these conditions.
• Inform your physician if you are nursing a baby, intend to get pregnant, or are already pregnant. If you are or suspect that you could be pregnant, avoid using elagolix. To ensure that you are not pregnant while taking elagolix, your doctor will perform a pregnancy test before you begin treatment or advise you to start therapy no later than seven days following the start of your period. You shouldn’t rely only on hormonal contraceptives as your method of birth control while receiving therapy for elagolix because they may interfere with its effectiveness. To avoid getting pregnant while receiving therapy and for one week following your last dose, you must use an effective non-hormonal birth control technique. Ask your doctor to assist you in selecting a birth control technique that will be effective for you. Call your doctor as soon as possible if you find out you’re pregnant while taking elagolix. The fetus could suffer from elagolix.
• You should be aware that while taking elagolix, your mental health may alter in unexpected ways and you could develop suicidal thoughts (plans or attempts to hurt or kill yourself). Any of the following symptoms should prompt you, your family, or your caregiver to call your doctor immediately away: anxiety, despair, or irritation that is new or getting worse; talking about hurting yourself or taking your own life, retreating from friends and family, obsessing over death and dying, or exhibiting any other strange behavioral or emotional changes. Make sure your family or caregiver is aware of any symptoms that could be significant so they can contact the doctor on your behalf if you are unable to call for help.

Keep eating normally unless your doctor instructs you otherwise.

Take the missed dose as soon as you recollect it on the same day. Continue taking your medication as usual. If you are taking it once daily, do not take more than that; if you are taking it twice daily, do not take more than that. To make up for a missing dose, do not take a second one.

Elagolix could have negative effects. If any of these symptoms are severe or do not go away, let your doctor know right once:

• Hot flashes (an unexpected burst of light to strong bodily heat)
• Morning sweats
• Headache
• Nausea
• Diarrhea
• Constipation
• Abdominal pain
• Gaining weight
• Having trouble falling or staying asleep
• Modifications to menstrual cycles (irregular bleeding or spotting, minimal or no bleeding, shorter periods)
• Joints hurt
• Alteration of sexual desire

Some adverse effects can be very harmful. Call your doctor right away if you encounter any of these symptoms, or seek emergency care:

• Extreme fatigue, dark urine, nausea and vomiting, right upper abdominal pain, or unusual bleeding or bruising are all symptoms to watch out for

Osteoporosis may be exacerbated or caused by elagolix. It can lessen the density of your bones and raise your risk of fractures and shattered bones. The dangers of using this drug should be discussed with your doctor.

Other negative effects of elagolix are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online at http://www.fda.gov/Safety/MedWatch or by phone at 1-800-332-1088 if you have a serious side event.

Keep this medication tightly closed in the original container and out of the reach of children. Store the pills away from excessive heat and moisture (not in the bathroom) and at room temperature or in the refrigerator (2-30°C).

As many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning.http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilizing a medicine take-back program is the easiest approach to get rid of your medication. To find out about take-back programs in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back program, see the FDA’s Safe Disposal of Medicines website at http://goo.gl/c4Rm4p for additional information.

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Additionally, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Keep all of your appointments with your physician and the lab. To monitor how your body is responding to elagolix, your doctor may request specific lab tests both before and throughout your therapy.

No one else should take your medication. Any queries you may have regarding medication refills should be directed to your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.