Elagolix sodium (Orilissa) from Lucius Pharmaceuticals has been launched

Lucius Pharmaceuticals (Lao) Co., Ltd. has launched a generic version of elagolix sodium (trade name LuciElag) for the treatment of moderate to severe pain associated with endometriosis.

Common side effects of elagolix sodium and their incidence

Because elagolix sodium works by reducing estrogen levels, its side effects are closely related to a low-estrogen state. In clinical trials, at least 5% of women taking either dose of elagolix reported the following common side effects: hot flushes (24% in the 150 mg group, 46% in the 200 mg group, 9% placebo), headache (17%, 20%, 12%), nausea (11%, 16%, 13%), insomnia (6%, 9%, 3%), mood changes/swings (6%, 5%, 3%), amenorrhea (4%, 7%, <1%), depressed mood/tearfulness (3%, 6%, 2%), anxiety (3%, 5%, 3%), and joint pain (3%, 5%, 3%). It is evident that the 200 mg dose, due to stronger estrogen suppression, has a higher overall incidence of side effects, especially hot flushes and amenorrhea. In addition, about 5.5% (150 mg) and 9.6% (200 mg) of patients discontinued treatment prematurely because of side effects, compared with 6% in the placebo group. The proportions of patients who discontinued due to hot flushes, headache, or nausea were all below 2%. Overall, about 1 in 10 treated patients stops treatment due to intolerable side effects, but most patients can complete the 6‑month course. All side effects should be closely monitored during treatment, and patients should promptly communicate with their doctor to adjust the dose or adopt supportive measures (e.g., calcium supplementation, improving sleep habits, etc.).

Skeletal side effects of elagolix sodium

Estrogen is crucial for bone health; it participates in regulating the balance between bone resorption and bone formation. When estrogen levels are low for a prolonged period, bone resorption may outpace bone formation, leading to a decrease in bone mineral density (BMD), i.e., bone loss. Because elagolix sodium lowers estrogen, it may cause BMD reduction, and although bone density may partially recover after stopping the drug, it may not fully return to pre‑treatment levels. There are currently no long‑term data to definitively determine whether this bone loss increases future fracture risk, especially with advancing age. Therefore, physicians usually limit the continuous duration of elagolix sodium use and may recommend dual‑energy X‑ray absorptiometry (DXA scanning) to monitor BMD changes during treatment. To reduce skeletal risks, patients should proactively inform their doctor if they have a history of osteoporosis, prior fractures, or are using other medications that may cause bone loss. Doctors may also recommend vitamin D and calcium supplementation as adjunctive measures to a healthy lifestyle. It is important to note that patients with osteoporosis are prohibited from using elagolix sodium. If you have concerns about bone health, be sure to discuss them in detail with your gynaecologist before starting treatment, and attend regular follow‑up evaluations. Do not stop the medication or adjust the dose on your own due to fear of side effects.

Efficacy of elagolix sodium on dyspareunia (painful intercourse)

In addition to menstrual pain and pelvic pain, endometriosis often causes dyspareunia, which severely affects patients' quality of life and intimate relationships. In clinical trials of elagolix sodium, the research team specifically evaluated the drug's effect on improving dyspareunia. The results showed that only the 200 mg twice‑daily dose of elagolix sodium was statistically proven to effectively reduce dyspareunia; the 150 mg once‑daily dose did not achieve a significant effect on this endpoint. Therefore, for patients whose primary complaint is dyspareunia, physicians may preferentially consider the 200 mg regimen. Notably, these women achieved relief from dyspareunia without an increase in analgesic use, indicating that elagolix sodium's analgesic effect is specific and does not rely on additional painkillers to mask symptoms. This finding provides a non‑surgical, non‑hormonal oral treatment option for endometriosis‑associated dyspareunia. Patients using this dose should be aware of the potentially higher side effects from stronger estrogen suppression (e.g., hot flushes, amenorrhea, etc.), and physicians will weigh the balance between efficacy and safety. If you are experiencing dyspareunia due to endometriosis, it is recommended that you clearly inform your doctor during the visit so that they can assess whether the 200 mg dose regimen is appropriate for you.