Elagolix Tablets - Uses, Contraindications, and Side Effects

Introduction

Endometriosis is a condition that occurs when tissue resembling the uterine lining grows outside the uterus (womb) such as ovaries or other organs causing severe pain in the pelvic region and also making it difficult for the female to get pregnant. It affects approximately ten percent of females of reproductive age globally. It may begin at the individual’s first menstrual period lasting until menopause affecting the ability to perform daily activities. Some women may not experience any symptoms, while for some, it causes irregular menstruation, heavy bleeding, pain during sex, fatigue, chronic pelvic pain, nausea, bloating sensation, depression, or anxiety. This condition's exact cause is unclear, and there is no cure or way to prevent it. However, medications are available which are recommended based on the severity of the condition to control or manage the symptoms.

What Are Elagolix Tablets?

Elagolix tablets are used in the management of moderate to severe pain caused due to endometriosis. It belongs to a group of medications called gonadotropin-releasing hormone (GnRH) and acts by reducing the production of hormones such as follicle-stimulating hormone (FSH) and luteinizing hormone (LH). This causes a decrease in estrogen (female sex hormone) levels, further leading to a reduction in the symptoms of endometriosis. It was approved by the United States Food and Drug Administration (USFDA) in July 2018. The doctor usually prescribes calcium and vitamin supplements along with this medication, and all the medicines must be taken exactly as prescribed for maximum benefits.

How Is Elagolix Tablet Taken?

Elagolix tablets are recommended to be taken orally, with or without food, at 150 mg (milligrams) once daily for up to 24 months. It may be initiated with a dose of 200 mg two times a day for six months in females with dyspareunia (genital pain during or after sex). In the case of women with moderate liver impairment or Child-Pugh B disease (liver cirrhosis), the treatment is limited to six months, and the tablets must be taken at a dose of 150 mg once daily. A normal diet can be followed unless the doctor recommends any specific restrictions. Elagolix tablets must be taken regularly and not discontinued without the doctor’s approval.

How Effective Are Elagolix Tablets?

The safety and effectiveness of 150 mg (once daily) and 200 mg Elagolix tablets (twice daily) were demonstrated by various studies. Clinical trials included 1686 women aged around 32 years with moderate to severe pain of endometriosis. The assessment duration was six months for any signs and symptoms of the condition. The participants were also told to perform a daily self-assessment by rating the pain on a scale from zero (no pain) to ten (worst pain ever) using a certain numeric rating scale (NRS). The results showed both doses were effective and led to a significant reduction in pelvic pain and other symptoms reported by most participants. It also improved their quality of life and decreased the use of analgesics (painkillers).

What Are the Contraindications of Elagolix Tablets?

The contraindications of Elagolix tablets include:

• In pregnant women, exposure to the drug during early pregnancy can harm the fetus or increase the chances of pregnancy loss.

• Patients with severe liver disorders.

• Individuals with a known case of osteoporosis (weak and brittle bones) as the drug is associated with an increased risk of bone loss.

• In patients below 18 years of age.

What Are the Side Effects of Elagolix Tablets?

The possible side effects of Elagolix tablets include:

• It can cause or worsen depression.

• It can cause or worsen anxiety.

• Suicidal thoughts.

• Behavioral or mood changes.

• Nausea and vomiting.

• Generalized swelling.

• Abdominal pain.

• Easy bruises.

• Yellow discoloration of eyes or skin.

• Feeling tired (fatigue).

• Dark-colored urine.

Some of the common side effects include:

• Joint pain.

• Absence of periods.

• Difficulty sleeping.

• Hot flashes (sudden feeling of warmth).

• Night sweats.

• Headache.

What Must the Patient Inform the Doctor Before Taking Elagolix Tablets?

• Before starting the treatment, patients must tell the doctor if they are allergic to Elagolix, its ingredients, or any other medications.

• If the patient suffers from liver disease, osteoporosis, or any other medical condition, the doctor should be informed before taking Elagolix tablets.

• Female patients must notify the doctor if they are pregnant, breastfeeding, or suspect pregnancy before treatment, as it may harm the baby.

• Patients must inform the doctor if they are taking medicines such as cyclosporine, Ketoconazole, Rifampin, Digoxin, Rosuvastatin, herbal or vitamin supplements, over-the-counter (OTC) drugs, or any other medications before starting the treatment.

• The doctor must be notified if the patient is suffering from depression, anxiety, mood changes, or has previously experienced suicidal behavior before taking Elagolix tablets.

What Are the Precautions Necessary While Taking Elagolix Tablets?

• Elagolix tablets must be stored at room temperature, away from excess heat and moisture.

• In case of an overdose, or if the patient experiences severe side effects, has seizures, or has trouble breathing, a healthcare professional must be contacted immediately.

• Elagolix tablets will reduce estrogen levels, leading to a loss in the density of the bones. However, it can improve after the treatment is stopped, but complete recovery may not be possible. Therefore, doctors recommend calcium and vitamin D supplementation during the treatment.

• The doctor will recommend a pregnancy test before starting treatment with Elagolix tablets just to confirm that the patient is not pregnant. Elagolix can interfere with certain contraceptive methods, so a non-hormonal birth control method (condoms) can be followed during and for up to one week after the final dose of treatment to prevent pregnancy.

• The mental health condition of the patient may alter in some patients during the treatment with Elagolix tablets, such as behavioral changes or the development of suicidal thoughts. Therefore, the doctor must be consulted immediately in such situations.

Conclusion

Elagolix tablet is a prescription medicine, the first oral therapy approved by the US Food and Drug Adminstration for the management of pain due to endometriosis. Clinical evidence has demonstrated that the drug is effective, well-tolerated by many women, has less pronounced side effects, and improves the quality of life. It is suggested as an appropriate alternative to other injectable agents. However, the decision regarding the suitability of the drug must be taken considering factors such as osteoporosis and the condition of the liver. Further research may be necessary to determine the safety and efficacy in a larger population and to lower the side effects.