Elago 200 mg Tablet
Elago 200 mg Tablet Uses, Dosage, Side Effects, Food Interaction and all others data.
Endometriosis develops when tissue that is similar to the kind that is normally located in the uterus starts to grow outside of the uterus. Such growth leads to various symptoms like pain during periods, pelvic pain between periods, and pain during sexual intercourse. The growths themselves are referred to as lesions and frequently develop on the ovaries, fallopian tubes, and other areas around the uterus, including the bowel or bladder. The growth of these lesions is dependent upon the estrogen hormone.Elago 200 mg Tablet is an orally-administered, nonpeptide small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist that inhibits endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland Label. Administration of elagolix results in dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to decreased blood concentrations of the ovarian sex hormones, estradiol and progesterone.
During a three menstrual cycle study in healthy women, an elagolix 150 mg once daily regimen and a 200 mg twice daily regimen resulted in an ovulation rate of about 50% and 32%, respectively . In Phase 3 trials in women with endometriosis, elagolix caused a dose-dependent reduction in median estradiol concentrations to approximately 42 pg/mL for the 150 mg once daily regimen and 12 pg/mL for the 200 mg twice daily regimen .
Furthermore, the effect of elagolix on the QTc interval was investigated in a randomized, placebo- and positive-controlled, open-label, single-dose, crossover thorough QTc study in 48 healthy adult premenopausal women . Elago 200 mg Tablet concentrations in subjects administered a single dose of 1200 mg was seventeen times higher than the concentration in subjects given elagolix 200 mg twice daily. Nevertheless, there was no clinically relevant prolongation of the QTc interval .
Trade Name | Elago 200 mg Tablet |
Availability | Prescription only |
Generic | Elagolix |
Elagolix Other Names | Elagolix |
Related Drugs | Orilissa, norethindrone, medroxyprogesterone, Provera, leuprolide, Sprintec |
Weight | 200 mg |
Type | Tablet |
Formula | C32H30F5N3O5 |
Weight | Average: 631.6 Monoisotopic: 631.210561893 |
Protein binding | The percentage bound to human plasma proteins for elagolix has been documented as 80% . |
Groups | Approved, Investigational |
Therapeutic Class | Gonadotropin-releasing hormone (GnRH) antagonist |
Manufacturer | ACME Laboratories Ltd. |
Available Country | Bangladesh |
Last Updated: | September 24, 2024 at 5:38 am |
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Uses
Elago 200 mg Tablet is used for the management of moderate to severe pain associated with endometriosis.
- No dose adjustment of Elago 200 mg Tablet is required in women with any degree of renal impairment or end-stage renal disease (including women on dialysis)
- No dosage adjustment of Elago 200 mg Tablet is required in women with mild hepatic impairment.
- Safety and effectiveness of Elago 200 mg Tablet in patients less than 18 years of age have not been established.
Elago 200 mg Tablet is also used to associated treatment for these conditions: Heavy Menstrual Bleeding, Moderate Endometriosis related pain, Severe Endometriosis related pain
How Elago 200 mg Tablet works
Endometriosis develops when tissue that is similar to the kind that is normally located in the uterus starts to grow outside of the uterus . Such growth leads to various symptoms like pain during periods, pelvic pain between periods, and pain during sexual intercourse . The growths themselves are referred to as lesions and frequently develop on the ovaries, fallopian tubes, and other areas around the uterus, including the bowel or bladder . The growth of these lesions is dependent upon the estrogen hormone .
Elago 200 mg Tablet is an orally-administered, nonpeptide small molecule gonadotropin-releasing hormone (GnRH) receptor antagonist that inhibits endogenous GnRH signaling by binding competitively to GnRH receptors in the pituitary gland . Administration of elagolix results in dose-dependent suppression of luteinizing hormone (LH) and follicle-stimulating hormone (FSH), leading to decreased blood concentrations of the ovarian sex hormones, estradiol and progesterone.
Dosage
Elago 200 mg Tablet dosage
Exclude pregnancy before starting Elago 200 mg Tablet or start Elago 200 mg Tablet within 7 days from the onset of menses. Take Elago 200 mg Tablet at approximately the same time each day, with or without food.
Initiate treatment with Elago 200 mg Tablet 150 mg once daily-
- Maximum Treatment Duration: 24 months
- Coexisting Condition: None
- Maximum Treatment Duration: 6 months
- Coexisting Condition: Dyspareunia
- Maximum Treatment Duration: 6 months
- Coexisting Condition: Moderate hepatic impairment (Child-Pugh Class B)
Side Effects
Most common adverse reactions (>5%) in clinical trials included hot flushes and night sweats, headache, nausea, insomnia, amenorrhea, anxiety, arthralgia, depression-related adverse reactions and mood changes.
Toxicity
In case of overdose, monitor the patient for any signs or symptoms of adverse reactions and initiate appropriate symptomatic treatment, as needed . Common adverse reactions of elagolix include hot flush, headache, nausea, insomnia, mood alterations, amenorrhea, depression, anxiety, arthralgia, bone loss, changes in menstrual bleeding patterns, suicidal ideation and behavior, exacerbation of existing mood disorders, and/or hepatic transaminase elevations .
The recommended duration of use for elagolix is up to 24 months for the 150 mg once daily dose and up to six months for the 200 mg twice daily dose, as it causes a dose-dependent decrease in bone mineral density (BMD) . BMD loss is greater with increasing duration of use and may not be completely reversible after stopping treatment . For women with moderate hepatic impairment, the recommended dosage is 150 mg once daily for up to six months .
Precaution
- Bone Loss: Dose- and duration-dependent decreases in bone mineral density (BMD) that may not be completely reversible. Assess BMD in women with additional risk factors for bone loss
- Reduced Ability to Recognize Pregnancy: Elago 200 mg Tablet may alter menstrual bleeding, which may reduce the ability to recognize pregnancy. Perform testing if pregnancy is suspected. Discontinue if pregnancy is confirmed
- Suicidal Ideation and Mood Disorders: Advise patients to seek medical attention for suicidal ideation, suicidal behavior, new onset or worsening depression, anxiety, or other mood changes
- Hepatic Transaminase Elevations: Dose-dependent elevations in serum alanine aminotransferase (ALT). Counsel patients on signs and symptoms of liver injury
- Potential for Reduced Efficacy with Estrogen-Containing Contraceptives: Use non-hormonal contraception during treatment and for one week after discontinuing Elago 200 mg Tablet.
Food Interaction
- Administer calcium supplement. This will minimize the risk of bone mineral density loss.
- Administer vitamin supplements. Administer Vitamin D supplements to minimize the risk of bone mineral density loss.
- Take at the same time every day.
- Take with or without food.
Elago 200 mg Tablet Drug Interaction
Unknown: dicyclomine, acetazolamide, lamotrigine, acetaminophen, sertraline
Elago 200 mg Tablet Disease Interaction
Major: hepatic impairment, osteoporosisModerate: depression/anxiety
Volume of Distribution
The apparent volume of distribution at steady state (Vdss/F) of elagolix is reported to be 1674 for a 150 mg daily regimen and 881 for a 200 mg twice daily regimen .
Elimination Route
The Tmax of elagolix is reported as being 1.0 hours . The effect of a high-fat meal (relative to fasting) can result in a reduction of the AUC and Cmax by as much as 24% and 36%, respectively .
Half Life
The terminal phase elimination half-life of elagolix is recorded as being 4 to 6 hours .
Clearance
The oral clearance (CL/F) of elagolix is 123 L/hr for a 150 mg once daily regimen and 144 L/hr for a 200 mg twice daily regimen .
Elimination Route
The primary route of elimination of elagolix is via hepatic metabolism .
Pregnancy & Breastfeeding use
Exposure to Elago 200 mg Tablet early in pregnancy may increase the risk of early pregnancy loss. Use of Elago 200 mg Tablet is contraindicated in pregnant women. Discontinue Elago 200 mg Tablet if pregnancy occurs during treatment. The limited human data with the use of Elago 200 mg Tablet in pregnant women are insufficient to determine whether there is a risk for major birth defects or miscarriage. Although two cases of congenital malformations were reported in clinical trials with Elago 200 mg Tablet, no pattern was identified and miscarriages were reported at a similar incidence across treatment groups. There is no information on the presence of elagolix or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production.
There are no adequate animal data on the excretion of Elago 200 mg Tablet in milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Elago 200 mg Tablet and any potential adverse effects on the breastfed child from Elago 200 mg Tablet.
Contraindication
Elago 200 mg Tablet is contraindicated in women:
- Who are pregnant
- Exposure to ORILISSA early in pregnancy may increase the risk of early pregnancy loss.
- With known osteoporosis because of the risk of further bone loss
- With severe hepatic impairment because of the risk of bone loss
- With concomitant use of strong organic anion transporting polypeptide (OATP) 1B1 inhibitors (e.g., cyclosporine and gemfibrozil)
Storage Condition
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Innovators Monograph
You find simplified version here Elago 200 mg Tablet
Elago 200 mg Tablet contains Elagolix see full prescribing information from innovator Elago 200 mg Tablet Monograph, Elago 200 mg Tablet MSDS, Elago 200 mg Tablet FDA label