Jennifer Griffin, MD, MPH
Jennifer Griffin, MD, MPH, associate professor, residency program director, department of obstetrics and gynecology, University of Nebraska Medical Center, Omaha.
Bottom Line: Tremendous potential...but also some cautions.
While uterine fibroids are unlikely to be as serious as cancer, having them can still be a pain—literally. Currently, treatment options leave a lot to be desired for some women. Coming soon, though, there may be a way to shrink fibroids by as much as 50%—without surgery or injections.
Elagolix (Orilissa) is an oral drug that has already been approved by the FDA for severe-to-moderate pain associated with endometriosis. Good news: By the end of 2019, the drug is expected to also be approved for treating uterine fibroids.
About 80% of women develop uterine fibroids, usually in their 40s or 50s. Most of these lumps that grow on the uterus never cause symptoms. In fact, women usually learn they have them only when the fibroids are found during an exam. For some women, though, the symptoms can be terribly disruptive—excessive menstrual bleeding (which can lead to anemia), periods that last longer, abdominal pressure and pain.
The first line of treatment for troublesome fibroids is usually birth control pills or IUDs containing the progesterone-like hormone progestin. If these don’t improve symptoms, more aggressive treatments are tried—destroying a thin layer of the lining of the uterus (endometrial ablation)…or surgery to remove the fibroids (myomectomy). Some women may choose surgery to remove the uterus completely (hysterectomy). Injectable drugs called gonadotropin-releasing hormone agonists (GnRH agonists) may also be tried. These injections into the abdomen or arm need to be repeated every three months.
Elagolix, a pill taken once or twice a day, works similarly to injectable GnRH agonist drugs—except it has the advantage of not needing to be injected. Both manipulate brain signals to turn off hormones from the ovaries (progesterone and estrogen) that may stimulate fibroid growth. With the hormones shut off, fibroids may shrink significantly…which reduces both excessive bleeding and also pain or feelings of pressure.
Biggest drawback: Without progesterone and estrogen, it’s as if you’re in temporary menopause. Not only do periods stop, but hot flashes, night sweats and other symptoms can start. Of greater concern are possible side effects from long-term use, such as weakened bones and increased risk for osteoporosis…and increased risk for heart disease. Therefore, these drugs generally are recommended for shorter term use—six to 12 months.
Possible solutions: Taking the drug for only six to 12 months can shrink fibroids sufficiently and improve blood counts to the point where traditional treatments may be easier and more effective. For instance, surgery on smaller fibroids is less risky and can be less invasive. Another option is to add back small amounts of progesterone and estrogen to suppress the more bothersome side effects, such as hot flashes. Lowering the dose of elagolix to reduce side effects would not produce the hormone-lowering effect needed. And while the drug potentially could be used for more than one cycle, right now there is no specific guidance on how frequently it can be used.
So far, elagolix looks like it will make it to the finish line and get FDA approval for treating uterine fibroids. Several other drugs are still in trials and may expand fibroid treatment even further, but other drugs have fallen by the wayside because of safety issues. Most recently, ulipristal acetate (Ella, Esyma), which is available in the US, Europe and Canada for emergency birth control. This drug was denied initial approval for treatment of fibroids in the US because of concerns about liver damage in the dosing regimen required for fibroids.
Note: The injectable drugs currently in use for fibroids are given only to women who are not able to use other common treatments or do not respond well to them. The same will likely to be the case for elagolix once it becomes available. The drug is also not cheap—more than $800/month. But if it gets FDA approval for uterine fibroids, insurance will likely cover the cost.
