Elagolix

What is Elagolix?

Elagolix belongs to a class of drugs called gonadotropin-releasing hormone (GnRH) receptor antagonists. It is an oral tablet that is used to treat discomfort due to endometriosis.

Endometriosis is a disease in which tissues that are supposed to cover the uterus or the womb develop outside of the uterus, forming lesions. It affects around one in 10 women of reproductive age.

During menstrual cycles, the lesions develop due to the increase of oestrogen, a hormone, and then break down and shed throughout your menstrual cycle. It can lead to pain throughout your menstrual cycle.

Elagolix aids in reducing the pain that you experience by reducing the amount of oestrogen you make, which causes the lesions to increase. Elagolix functions by binding GnRH receptors located in the pituitary gland. This reduces the luteinizing hormone (LH) and follicle-stimulating hormone (FSH) and causes the reduction of oestrogen.

What are the uses of Elagolix?

Elagolix is a prescribed medicine for treating moderate to extreme pain associated with endometriosis. It isn't known whether elagolix is safe or effective for children.

Important information

Elagolix can have serious negative side effects, such as:

• the loss of bone (decreased the density of bone minerals).
  • When you take Elagolix, your levels of oestrogen will be lower. Insufficient oestrogen levels could cause the loss of bone mineral density.
  • If you suffer from osteoporosis due to elagolix, your bone density might increase when you stop taking the drug; however, complete recovery might not happen. It is unclear whether these bone changes increase your risk of breaking bones as you get older. Therefore, your doctor may restrict the time that you are taking the elagolix.
  • Your physician may recommend that you consume calcium and vitamin D supplements to help you live a balanced lifestyle that supports bone health.
  • If you suffer from any conditions or other medications that can lead to bone loss, or if you've broken a bone that has suffered only a minor or no injury, your doctor might recommend an X-ray scan known as the DXA scan to determine the density of your bone.
• impacts on the pregnancy
  • Don't take Elagolix when you are trying to become pregnant or are already pregnant. It could increase the chance of an early loss of pregnancy.
  • If you suspect that you're pregnant, take Elagolix off immediately and consult your doctor.
  • If you are pregnant when taking elagolix, then you are advised to join the Pregnancy Registry. The goal of the registry is to gather information on the health of both you and your child. Speak to your physician or dial 1-833-782-7241 for enrollment in this registry.
  • Elagolix could alter your menstrual cycles (irregular blood flow or spots, a reduction in menstrual blood flow, or no bleeding in any way), which makes it difficult to determine if you're pregnant. Also, look out for other indicators of pregnancy, such as swelling of the breasts and nausea.
  • Elagolix is not a preventative for pregnancy. It is necessary to employ effective birth control methods during the course of taking elagolix and for a period of 28 days after you have stopped taking the drug. Methods that work include condoms and spermicides that do not contain hormones.
  • Birth contraceptives that contain oestrogen could reduce the effectiveness of elagolix. It's unclear how effective elagolix is when you're taking only progestin birth control, like implants or injections.
  • Discuss with your doctor which birth control you should use while taking Elagolix. Your doctor may alter the birth control regimen you had before you began using the drug.

Warnings

Avoid taking elagolix if:

• are pregnant
• are prone to osteoporosis.
• Have a severe liver disease that is severe
• You are taking medicines known as organic anion-transporting polypeptide (OATP) 1B1 inhibitors, which are believed or anticipated to substantially raise blood levels of Elagolix. Consult your physician. If you're not sure that you're taking one of these medications,
• Have experienced a severe allergic reaction to elagolix or any other ingredient in the drug. Check out the following list of the components in the medication elagolix: Consult your doctor to confirm the ingredients if you're unsure.

Before you Take this Drug

Before taking Elagolix, inform your physician of any medical issues you have. For example, if you

• are or have suffered from broken bones or other injuries that could cause bone issues.
• are or have experienced mood issues, depression, suicidal thoughts, behaviours, or ideas
• Have liver issues

How to Take Elagolix?

• Follow the exact instructions that your physician gives you on how to use it.
• Your doctor will offer the test for pregnancy prior to you beginning to take elagolix. They will require you to begin taking elagolix 7 days after you begin your period.
• If your doctor recommends:
  • Elagolix is 150mg (a pink tablet). Take one every day.
  • Elagolix 200 mg (an orange tablet) Take it twice per day.
• Begin taking elagolix around the same time throughout the day, with and without meals.

What Happens If I Miss a Dose?

If you are missing the dose of elagolix,

• 150 mg (1 daily) It is best to take it whenever you remember, so long as it's at the exact time. Take only one tablet per day.
• 200mg (2 times daily) It is best to take it when you remember, so long as it's the exact day. Do not exceed two tablets per day.

What Happens If I Overdose?

If you are taking too much elagolix, contact your doctor or go to the closest hospital emergency room immediately.

Details on Dosage

Two dosing regimens are available:

• Elagolix 150 mg daily for as long as 24 weeks
• Elagolix, 200 mg twice a day until 6 months
• Read the full prescribing information for further information.

Side effects of Elagolix

Elagolix may produce serious side effects, including:

• Read "Important information."
• suicidal ideas, suicidal behaviours, and a worsening in mood. Elagolix can trigger suicidal thoughts or behaviors. Contact your doctor or seek emergency medical attention immediately if you experience any of the symptoms listed below, particularly when they're new, aggravated, or bother you:
  • Thoughts of suicide or the idea of dying
  • attempt to commit suicide
  • New or more severe depression
  • Anxiety that is new or worse
  • Other unusual behaviour changes or moods
• The abnormality of liver testing Consult your physician immediately if you experience any of the following signs and symptoms of liver trouble:
  • The skin's complexion becomes yellow, or the eyes' whites (jaundice).
  • Urine with a dark, amber-coloured colour
  • feeling exhausted (fatigue or fatigue)
  • nausea and vomiting
  • generalised swelling
  • Right upper stomach area (abdomen) abdominal pain
  • The risk of bruising is high.

Your carer or you must be attentive to any changes, particularly abrupt changes in your mood, behaviour, thoughts, feelings, or mood.

The most frequent side effects of elagolix are hot flashes and night sweats, headaches, and insomnia, nausea, absence of menstrual cycles, joint pain, anxiety, depression, and mood swings

These aren't all the possible side effects that elagolix may cause. Contact your physician to get medical advice on possible side effects.

You can report any unwanted side effects in writing to the FDA at 1-800-FDA-1088.