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SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS › PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES › HYPOTHALAMIC HORMONES › Anti-gonadotropin-releasing hormones
elagolix, estradiol and norethisterone
H01CC53
Forms & Strengths
- elagolix 60mg, estradiol 1mg, and norethindrone 0.5mg tablets
- elagolix 60mg, estradiol 1mg, and norethindrone 0.5mg modified-release tablets
Adult Dosing
- 1 tablet once daily for moderate to severe pain associated with endometriosis
- 1 tablet once daily for heavy menstrual bleeding associated with uterine fibroids
Pediatric Dosing
- Safety and efficacy not established in pediatric patients under 18 years old
Indications
- Treatment of moderate to severe pain associated with endometriosis
- Treatment of heavy menstrual bleeding associated with uterine fibroids
Mechanism of Action
- Elagolix: a gonadotropin-releasing hormone receptor antagonist reducing luteinizing hormone and follicle stimulating hormone production
- Estradiol: an estrogen, and norethindrone: a progestin, contributing to endometrial stability and hemostasis
Contraindications
- Known osteoporosis
- Severe hepatic impairment
- Undiagnosed abnormal uterine bleeding
- Breast cancer or other estrogen or progestin sensitive cancer
- Active or history of thromboembolic disorders
Adverse Reactions
- Hot flashes
- Night sweats
- Headache
- Nausea
- Amenorrhea
- Fatigue
- Weight changes
- Mood changes
- Bone loss
Drug Interactions
- CYP3A4 strong or moderate inducers (e.g. rifampin) may decrease elagolix efficacy
- CYP3A4 strong inhibitors (e.g. ketoconazole) may increase elagolix levels and risk of adverse effects
Curated Content: Needs Vetting Before Put to Clinical Use