Laos Pharma No.2 Elagolix 150mg

Product Information

• Product name: Elagolix mg 150mg
• Manufacturer / brand: Laos State Pharmaceutical No.2
• Active ingredient: Elagolix
• Current strength: 150mg
• SKU: L2-ITEM-28
• Site category: general medicines

Product Summary

Elagolix mg 150mg is an AISTIKA-listed product supplied by Laos State Pharmaceutical No.2. This page summarizes the product identity, strength, SKU, site category, and public medical reference information. Product name, manufacturer, packaging, and strength follow this AISTIKA product page.

Active Ingredient and Reference Data

Elagolix is the active ingredient used for this product page. Public prescribing information for Elagolix was used for the medical reference sections. Medical details are provided for reference and must be interpreted by a qualified healthcare professional.

Mechanism of Action

Elagolix combines elagolix and estradiol/norethindrone acetate (E2/NETA), a combination of estrogen and progestin. Elagolix is a 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 and reduces bleeding associated with uterine fibroids.

Reference Indications

Elagolix is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Limitation of Use: Use of Elagolix should be limited to 24 months due to the risk of continued bone loss, which may not be reversible . Elagolix is a combination of elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin, indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Limitation of Use: Use of Elagolix should be limited to 24 months due to the risk of continued bone loss, which may not be reversible.

Reference Dosage and Administration

Recommended dosage of Elagolix is: ○ One elagolix 300 mg, estradiol 1 mg, and norethindrone acetate 0. Take the morning and evening capsules at approximately the same time each day, with or without food.

With this 150mg product, that corresponds to 2 x 150mg tablets when that reference dose is clinically appropriate.

This reference dosage is not an individualized prescription. Dose changes, treatment interruptions, or discontinuation must be directed by a physician.

Important Safety Information

WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS Estrogen and progestin combinations, including Elagolix, increase the risk of thrombotic or thromboembolic disorders including pulmonary embolism, deep vein thrombosis, stroke and myocardial infarction, especially in women at increased risk for these events . Elagolix is contraindicated in women with current or a history of thrombotic or thromboembolic disorders and in women at increased risk for these events, including women over 35 years of age who smoke and women with uncontrolled hypertension . WARNING: THROMBOEMBOLIC DISORDERS AND VASCULAR EVENTS See for complete boxed warning. Estrogen and progestin combinations, including Elagolix, increase the risk of thrombotic or thromboembolic disorders, especially in women at increased risk for these events.

Common Adverse Reactions and Monitoring

Mean Percent Change From Baseline in Lumbar Spine BMD in Women Who Received 12 Months of Elagolix (On-Treatment) and 12 Months of Follow Up (Off Treatment) The safety of Elagolix was evaluated in two 6-month, randomized, double-blind, placebo-controlled trials (Studies UF-1 and UF-2), in which 790 premenopausal women received at least 1 dose of Elagolix (n=395), elagolix 300 mg twice daily (n=199), or placebo (n=196) . Women who completed 6-month treatment in either Study UF-1 or Study UF-2 and met eligibility criteria (n=433) entered a 6-month extension study (Study UF-3), receiving either Elagolix (n=276) or elagolix 300 mg twice daily (n=157).

Drug Interactions and Special Populations

Co-administration with Elagolix may decrease plasma concentrations of drugs that are substrates of CYP3A. A weak inhibitor of CYP2C19. Co-administration with Elagolix may increase plasma concentrations of drugs that are substrates of CYP2C19 (see Table 3). An inhibitor of efflux transporter P-glycoprotein (P-gp). Co-administration with Elagolix may increase plasma concentrations of drugs that are substrates of P-gp (see Table 3). If Elagolix is discontinued, increase monitoring of digoxin concentrations. Benzodiazepines: oral midazolam ↓ midazolam Consider increasing the dose of midazolam by no more than 2-fold and individualize midazolam therapy based on the patient’s response. Statins: rosuvastatin ↓ rosuvastatin Monitor lipid levels and adjust the dose of rosuvastatin, if necessary.

Storage and Purchase Notes

Store according to the package or pharmacist instructions and keep out of reach of children. Before ordering, confirm product name, strength, quantity, price, shipping details, and payment method. After receipt, check packaging, batch number, expiration date, and storage conditions.

Sources

Sources: Oriahnn public prescribing information; openFDA/DailyMed public label data. These sources are used for public medical reference. Product information follows this AISTIKA product page.

DisclaimerThis page is for product information and public-label reference only. It does not provide diagnosis, prescription, or individualized medical advice. Consult a physician for treatment decisions.