Orilissa (Elagolix)

Orilissa is the brand name of the drug elagolix, an oral medicine that treats pain caused by endometriosis.

Endometriosis is one of the most common gynecologic conditions in the United States. It affects about 1 in 10 women between ages 15 and 44 and is associated with debilitating pain and, in some cases, infertility.

In July 2018, the U.S. Food and Drug administration (FDA) approved Orilissa (elagolix) in the United States for use in treating pain caused by endometriosis.

The FDA approved Orilissa (elagolix) under priority review, and it is the first approved oral treatment for the management of moderate to severe pain associated with endometriosis in more than a decade.

Produced by AbbVie Inc., a research-based global biopharmaceutical company, in cooperation with Neurocrine Biosciences Inc. Orilissa (elagolix) is the first oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate to severe endometriosis pain.

Currently, there is no cure for endometriosis. In the past, endometriosis treatments, including surgery, have focused on curbing the debilitating pain associated with the condition without adequate results.

As a gonadotropin-releasing hormone receptor antagonist, Orilissa works by reducing the production of the ovarian-stimulating hormones estrogen and progesterone, thus reducing pain. But unlike any other drug therapy, elagolix partially blocks estrogen and progesterone. This results in fewer side effects and safer long-term use.Clinical Trials on Orilissa (Elagolix)

Supporting data for the approval of elagolix came from two replicate six-month phase 3 trials, which evaluated 1,700 women with moderate to severe endometriosis pain, according to a statement from AbbVie. Findings published in July 2017 in the New England Journal of Medicine assessed women with moderate to significant endometriosis pain. Resulting data demonstrated that both higher and lower doses of elagolix were well-tolerated and reduced three types of pain associated with endometriosis:

• Daily menstrual pelvic pain
• Nonmenstrual pelvic pain
• Painful intercourse

Additionally, the safety of using Orilissa was consistent with reduced estrogen levels.

Other clinical trial data published in July 2018 in the journal Obstetrics and Gynecology demonstrated that women who took Orilissa 200 milligrams (mg) twice daily showed statistically significant greater reduction in pain during sex from the time they started elagolix to month three compared with women who took a placebo. A higher proportion of women who took Orilissa 150 mg once daily and 200 mg twice daily were responders for daily menstrual pain and nonmenstrual pelvic pain without an increase in analgesic use (nonsteroidal anti-inflammatory drug or opioid) for endometriosis-associated pain.

Additionally, elagolix significantly reduced heavy menstrual bleeding in women with fibroids. A low-dose add-back regimen substantially reduced any reported flushing.Back to TopOrilissa (Elgaolix) Drug Side Effects

The most common side effects of Orilissa include:

• Absence of periods
• Anxiety
• Depression and mood changes
• Difficulty sleeping or insomnia
• Headache
• Hot flashes or night sweats
• Joint pain
• Nausea

In addition, Orilissa may cause serious side effects, including:

• Bone loss (decreased bone mineral density [BMD])
• Effects on pregnancy

While these are not all the possible side effects of elagolix, it is important to know this information before taking the drug. The safety of elagolix was consistent with reduced estrogen levels and no new safety concerns were associated with long-term elagolix use.

Orilissa comes in oral tablets and is prescribed in a 150 mg once daily dose or 200 mg twice daily dose. Orilissa is recommended to be taken orally with or without food at the same time each day. The recommended duration is up to 24 months for the 150 mg once daily dose and 6 months for the 200 mg twice daily dose.Recommendations and Warnings

Bone mineral density (BMD) loss is greater the longer you take Orilissa and it may not be reversible upon stopping the medication. For those with liver impairment, the recommended dosage of Orilissa is 150 mg once daily for up to six months.

Pregnant women should not use Orilissa. While the background risk for major birth defects and miscarriage are unknown, exposure to Orilissa early in pregnancy may increase the risk of early pregnancy loss.

In case of overdose, call your healthcare provider immediately. Watch for any signs or symptoms of adverse reactions and initiate appropriate symptomatic treatment as needed.

Call your healthcare provider for medical advice about dose recommendations and side effects with Orilissa. You may report side effects to FDA at 1-800-FDA-1088.

Please see the full prescribing information and medication guide for additional important safety information. This information is not intended to replace discussions with your healthcare provider.