Elagolix Brand Name– ORILISSA
What is Elagolix
Elagolix is an oral gonadotropin-releasing hormone (GnRH) receptor antagonist. It is indicated for the management of moderate to severe pain associated with endometriosis.
Due to a potential for dose-related reduction in bone mineral density after 12 months of use, treatment courses are limited to 24 months or less, depending on the dosage prescribed.
Nearly 1,700 women with moderate to severe endometriosis pain were evaluated in premarketing phase III trials. In trials, elagolix significantly reduced the most common types of endometriosis pain: daily menstrual pelvic pain, non-menstrual pelvic pain and dyspareunia.
Women were defined as responders if they experienced a reduction in daily menstrual pain and non-menstrual pelvic pain with no increase in analgesic use (nonsteroidal anti-inflammatory drug or opioid) for endometriosis-associated pain.
At months 3 and 6, both elagolix dose groups showed statistically significant greater mean decreases from baseline compared to placebo in daily menstrual pain and non-menstrual pelvic pain; the daily reduction in self-assessed pain scores was also statistically significant for treated women vs. those receiving placebo.
Women taking elagolix at a dose of 200 mg twice daily also showed a statistically significant reduction in dyspareunia vs. placebo.
Extension studies have shown that continued elagolix treatment provided sustained reductions in dysmenorrhea, nonmenstrual pelvic pain, and dyspareunia at 12 months.
Elagolix was FDA-approved in July 2018.
Indications
- dyspareunia
- endometriosis
For the treatment of moderate pain or severe pain associated with endometriosis, which may include endometriosis-related dyspareunia
Side Effects
- abdominal pain
- amenorrhea
- anxiety
- arthralgia
- back pain
- bone fractures
- constipation
- depression
- diarrhea
- dizziness
- elevated hepatic enzymes
- emotional lability
- headache
- hot flashes
- hypercholesterolemia
- hyperlipidemia
- hypertriglyceridemia
- insomnia
- irritability
- libido decrease
- menstrual irregularity
- nausea
- night sweats
- osteopenia
- osteoporosis
- rash
- suicidal ideation
- weight gain
Monitoring Parameters
- bone mineral density
- pelvic exam
- pregnancy testing
Contraindications
- breast-feeding
- children
- contraception requirements
- depression
- hepatic disease
- infants
- menstrual irregularity
- osteopenia
- osteoporosis
- pregnancy
- pregnancy testing
- reproductive risk
- suicidal ideation
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