You may have seen news articles and press releases flying around the Internet since yesterday regarding a new drug released to manage Endometriosis pain. I wanted to share this with you because, although I’ve no intention of taking the drug myself, I know that it may help women who suffer. And it may help better educate you on your decision.
I’ve been following it for a while and you can read my thoughts about AbbVie’s SpeakEndo commercials and website, as well as their expedited application for FDA approval, and the track records of other drugs that have done the same. And according to Business Insider, Orilissa may cost approximately $850 per month, or roughly $10,000 per year for prescriptions (I’m assuming those figures are calculated without health insurance). Orilissa is estimated to hit markets for prescriptions in August of this year.
So, here you go:
On July 23, 2018, the Food & Drug Administration approved AbbVie’s new drug to treat Endometriosis pain. You may have seen it referred to as Elagolix, but it has been officially named Orilissa. It is an oral GnRH antagonist.
Please do your own thorough research before talking to your physician.
In the Resources section below is a link to the FDA’s drug fact sheet, which includes a .pdf of the pamphlet that should come with the drug. Read it. Review the clinical trials. And decide for yourself. You can read the .pdf which I have downloaded, or by accessing the FDA’s site and downloading it for yourself.
It appears it has limited allowable dosing (6 months to 2 years), may cause liver issues, may cause bone loss, may cause depression and suicidal thoughts, and may interact with hormonal birth control. Some adverse reactions during clinical trials included appendicitis, abdominal pain, back pain, hot flashes, night sweats, nausea, decreased bone mass density, headache, insomnia, mood swings, depression, lack of a period, anxiety, joint pain, decreased libido, diarrhea, weight gain, dizziness, constipation, and irritability.
One participant in the clinical trials committed suicide two days after she stopped treating with the pill. She was 44 years old, had treated for one month, and had no medical history or life stressors that would have been indicative of suicidal thoughts.
Where did I get all this info? The FDA drug pamphlet.
Don’t trust me, read it for yourself.
Weigh the pros and cons.
And talk to your doctor.
A February 2019 study showed that women in Phase 3 Trials of Elagolix had improved period pain and non-period pelvic pain than those who were given the placebo pill. It stated that most adverse events were mild to moderate, but there was a risk of bone loss among patients.
And a June 2019 study showed that women in a 6-month clinical trial that were given Orilissa were at work 2-4 hours longer per week than women who were given the placebo, improving their attendance.
An August 2019 study funded by Abbvie was conducted to see if Elagolix could help reduced Endometriosis-induced fatigue. There were 860 women in the study, some of whom received a placebo. Both doses (150mg and 200mg) of Elagolix were tested. It was found that the participants who were given Elagolix had reduced levels of fatigue after taking it for six months. To those who stated they also had reduction in painful periods, pelvic pain, and pain with sex, their fatigue levels dropped even further. There have been studies that chronic pain, inflammation, stress, and depression can all affect fatigue and sleep patterns. So any reduction in those may help with symptoms of fatigue.
An October 2019 study written by Dr. Brian Ford of the Naval Hospital at Camp Pendleton shared a few warnings about Orilissa: Orilissa may decrease the effectiveness of some oral contraceptives, so non-hormonal contraception to avoid pregnancy while on Orilissa. The most common side effects that forced participants to drop out of the clinical trials were hot flashes and night sweats. There’s a risk of decreased bone density. Mood changes, depression, and/or suicidal thoughts may occur. The way the body metabolizes certain medications may be altered because of the way Orilissa affects liver enzymes. Other side effects reported in the trials were an absence of a period, headaches, and insomnia. Compared to the placebo group, after 3 months of trials, 46% of women taking the 150mg of Orilissa and 72% of those taking the higher 250mg dose had improved pain menstrual pain while on the drug. Dr. Ford stated that 28-day supply of Orilissa costs approximately $870. Due to the expensive nature of the drug, as well as the adverse side effects similar to other drugs (such as Lupron Depot), Dr. Ford recommends that ” Elagolix should be reserved for women who do not benefit from nonsteroidal anti-inflammatory drugs or hormonal therapy. ” Just a few thoughts to chew over and discuss with your physician…
A July 2020 study funded by Abbvie states that the “the lowest effective dose should be administered taking into account the treatment objections in conjunction with safety and coexisting conditions…” It may take some figurin’ out to find the right dose for you and your body, but start small. Another July 2020 Abbvie-funded study concluded that no Elagolix dosage changes were recommended if the patient was also taking add-back (norethindrone acetate) with Elagolix to help with some side effects.
In August of 2020, Abbvie funded a study to estimate how Elagolix may effect bone loss for post-menopausal women and lead to risk fractures. Due to its estrogen-reducing properties, there’s a risk in bone mineral density (BMD) loss. Having a lower BMD may lead to a greater risk of fractures and osteoporosis. The study used data collected from Abbvie’s Phase III trials, as well as BMD dadta from the National Health and Nutrition Examination Survey gathered from 2005-2010. Tricky math I don’t understand, but the study estimates that the risk of BMD loss, leading to fractures and osteoporosis later in life, is “minimal.” Is it a risk you’d like to take? That’s fine…just be informed.
Dr. Sanjay Agarwal of San Diego co-authored a February 2021 study wherein data from two clinical trials was analyzed to see if there was any difference in pelvic pain and menstrual bleeding for patients on Elagolix. The results point toward patients on Elagolix for three to six months reported less painful periods. Pelvic pain while not on their periods were also reportedly reduced. However, it also states, “Additionally, women in the placebo-treated group also reported a decrease in pain during both bleeding and non-bleeding days. It can be suggested that women would be more likely to report pain if bleeding occurs; therefore, given that women in the placebo group are reporting less pain during bleeding, we can infer that the reduction of pain seen in the elagolix treatment groups compared with the placebo group during bleeding is more remarkable.” In other words, the way I read it, participants reported less painful periods and pelvic pain EVEN ON THE PLACEBO…am I reading that wrong? But the study concludes that there was a greater reduction of pain all-around for patients who received Elagolix. Oh, and this study was paid for by Abbvie (the manufacture of Elagolix) and published in the Journal of Pain Research.
We are our best advocate. Do what you feel is best for you. But, please, do it informed and do it safely.
Knowing how poorly my body handled Lupron Depot (another AbbVie product that is incredibly similar), and how I became so severely depressed and suicidal on it, I will never again subject my body to something similar. It did nothing in the long-term to stem my Endometriosis. And was an incredibly difficult journey while on Lupron, as well as a long while before my body cleared itself of any side effects. That is why I choose not to take Orilissa. The decision is an individual one. Never again. But, again, I will never tell you not to try something; it may very well help you cope with your symptoms. Understand, though, that it is a band-aid. It will mask your symptoms; not clear your body of Endometriosis. I learned that one the hard way…
If you do your research and make a well-informed decision to start (or not start) Orilissa, I wish you all the best of luck and health. There are no judgments here. Only well-wishes. AND if you would like to leave a comment below with how Orilissa affected you, please do so! We can only be here to teach one another.
And, if you wish to see a quick snapshot of the participants and findings of the two clinical trials, please visit this FDA page.
**Updated March 26, 2021**
Resources:
AbbVie – (July 24, 2018; Press Release) AbbVie Receives US FDA Approval of Orilissa (elagolix) for the Management of Moderate to Severe Pain Associated with Endometriosis
American Family Physician (Oct. 15, 2019; Article) Elagolix (Orilissa) for Endometriosis Pain
American Society for Clinical Pharmacology & Therapeutics (July 2020; Article) Effect of Elagolix Exposure on Clinical Efficacy End Points in Phase III Trials in Women with Endometriosis-Associated Pain: An Application of Markov Model
Business Insider (July 24, 2018; Article) A New Treatment for a Condition that Can Feel Like Tiny People Skating on Razor Blades in Your Stomach and Affects an Estimated 200 Million Women Just Got Approved
Clinical Pharmacokinetics (Juyl 2020; Article) Drug Interaction Studies of Elagolix ith Oral and Transdermal Low-Dose Hormonal Add-Back Therapy
Drugs & Therapy Perspective (Feb. 2019; Abstract) Elagolix in Endometriosis-Related Pain: a Profile of its Use and Approved in the USA
Fertility & Sterility (June 2019; Abstract) Impact of elagolix on work loss due to endometriosis-associated pain: estimates based on the results of two phase III clinical trials
Fertility & Sterility (August 2019; Abstract) Impact of Elagolix Treatment on Fatigue Experienced by Women with Moderate to Severe Pain Associated with Endometriosis
Journal of Bone & Mineral Research (Aug. 2020; Abstract and Article) Estimating the Effect of Elagolix Treatment for Endometriosis on Post-Menopausal Bone Outcomes: a Model Bridging Registrational Phase III Trials to an Older Real-World Population
Journal of Pain Research (Feb. 2021; Abstract and Article) Endometriosis-Related Pain Reduction During Bleeding and Nonbleeding Days in Women Treated with Elagolix
Journal of Women’s Health (2020; Article) A Clinician’s Guide to the Treatment of Endometriosis with Elagolix
US Food & Drug Administration – Drug Database: Orilissa
~ Again, I am a layman. I do not hold any college degrees, nor mastery of knowledge. Please take what I say with a grain of salt. If curious, do your own research 😉 Validate my writings. Or challenge them. And ALWAYS feel free to consult with your physician. Always. Yours ~ Lisa
Bloomin' Uterus 
Ugh- it’s like they’re trying-not-trying…
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Hi Lisa! I have been trying (unsuccessfully) to find info on whether you can use Orilissa if you’ve already done Lupron, since it sounds to me like they are similar drugs. Do you happen to know anything about that? Thank you!
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Kelly, what an INCREDIBLE question. Let me see if I can get an answer for you.
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Over 80% of women in the Orilissa trials had previously been on other medications, including around 25% on Lupron and Lupron-like drugs. So I assume if someone has tried Lupron, they can still try Orilissa.
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I have been on lupron depot 2 separate times, many years apart. My newest doctor had me try Orilissa since it is (from my understanding) a newer version or option to lupron depot. I personally struggled on Orilissa. I didnt fimd much help with pain relief and had extremely bad hot flashes, night sweats and gained 20+ pounds in the 4-5 months I was on it. I dont know how bad the depression or emotional aspect of had since I had to start antidepressants earlier this year (chronic pain over 10 years finally became more than I could handle on my own). Everyones body is different. I tried it as a last resort before doing a hysterectomy. I already have the kileena iud so I didnt have any periods prior or during this medication. I can say that now (over 2 weeks after stopping it) the side effects have gone away but now I am struggling to get the weight off. My hysterectomy is now scheduled for November. I hope that whatever decision you go with will help you 💙
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A review of Orilissa by a fellow EndoWarrior, Tess Seda (published with her permission): I started Orilissa at the persistent suggestion from my doctor after my first surgery. She excised some endo during that surgery but left behind alot of what she didn’t have the skill to get so I was still in pain and was presented with the options of IUD, Orilissa, or hysterectomy. I gave the Orilissa a decent shot and was on it for ten weeks. I supplemented with D3 supplement and took in some extra calcium to help with the possible side effect of bone density loss. I continued to have periods regularly with no improvement in any symptom or pain. I have migraines and I had one strong migraine in the first couple days of taking it but after that no increase in headache frequency or severity. I experienced no hot flashes. I have anxiety and started to notice a slight increase in anxiety but it was bearable but as I continued with the Orilissa I felt noticeably different. I don’t know how else to describe it but I did not feel like myself. I felt like my brain was on overdrive and my emotions were hollow or all over the place. With no symptom improvement and me feeling so weird mentally I told my doc and she advised me to stop taking it especially since it had yet to do ANYTHING for me physically. I stopped taking it and plunged into a depression and it honestly felt like it took months for me to feel normal and myself again. With context, I’ve been on combination pills with minimal side effects and mini pills with little side effects and I eat healthy and workout regularly and maintain a healthy fit weight. I was also 28 when I tried Orilissa and have never been pregnant.
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A review of Orilissa by a fellow anonymous EndoWarrior (published with her permission): I did give it a try even though I had the gut to not try it because with Lupron I had a very bad side effects. With Orilissa I had a bad experience it gave me a bad depression. That I’m still recovering.
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I feel like the outlier here, but I’ve been on Orilissa since January and it’s really been helping me manage my symptoms. I stopped having a period prior to starting Orilissa. I take it daily with a vitamin D3 to aid in preventing any bone issues. I’ve had a bone density scan recently and I have zero damage thus far. We are also monitoring my liver, which seems to be taking everything well. The night sweats and hot flashes SUCK. I already had anxiety and desperation before this and just have always regularly gone to therapy, so I don’t feel any real change in my mental health. What has it actually done? Took my low pain from an average of a 6 down to a 3 (pain scale). When I’m having a flare, I still hit those 9’s, but I spend much more time below 5 these days. It is absolutely a bandaid for surgery, but it’s a bandaid that’s working for me. I’m so grateful for the last few months of functionality it has given me, even if it doesn’t last forever.
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We need more Outliers! SO THANK YOU for sharing your experience! I’m so glad that you’re on a daily dose of supplements to help combat potential negative effects and also monitoring your bone density! Keep enduring, for as long as you wish. Bandaids are absolutely, 100% an option for many and I’m so glad this one is helping you. ❤ You sound very in tune with your body and mind, and I'm grateful you're still tracking everything and have regained some function! ❤ SO VERY GLAD!!! I never want to sit here on my blog and poo-poo on a treatment option, so again, thank you for your positive experience! I hope we have many more posting here. Every person's treatment options and decisions are different, and I value alllll feedback. ❤
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Posting on behalf if a fellow Endo Warrior:
Hi everyone! With the encouragement and support of my amazing physical therapist, and fellow Endo Warrior, Jandra Mueller, I’ve decided to share a bit of my story with all of you to hopefully protect some of you from having the same experience as me as I begin my battle against Big Pharma and a local physician.
When I moved to San Diego a year ago, I began the search for an endometriosis specialist. My search brought me to Dr. Sanjay Agarwal of UCSD (link to UCSD profile in comments), who is described as “professor and director of fertility services in the UC San Diego Department of Reproductive Medicine” and “director of the innovative UC San Diego Center for Endometriosis Research and Treatment (CERT).” Obviously I was intrigued, and scheduled an appointment ASAP.
When I had my appointment on October 19th, 2021, I was pretty impressed. I’m always a bit suspicious of male OBGYNs, but I felt very validated and listened to. I had had an ablation a few months prior, and felt untrusting of doctors as a result of learning that wasn’t the best option, so I was thrilled when he told me it was unlikely I would ever need to have surgery again due to a miracle drug that was recently approved by the FDA: Orilissa. Of course I was thrilled, as my previous surgical experience sucked and I had felt worse afterwards. I immediately began the process of fighting my insurance to get this medication. He had warned me that it simply impacts my hormones, which could cause some hot flashes and headaches, but it should improve my pain greatly. I was on it until May of 2022, when I saw Dr. Spring-Robinson. My pain hadn’t improved, and had actually worsened, but I hadn’t noticed any side effects, so I thought it just needed time to build up in my system, like Dr. Agarwal had told me. Dr. S-R was horrified I was put on it at 19, and told me it would put me into menopause and I should stop it immediately. I did, and prepared for excision surgery to take place the following month.
During my excision, Dr. S-R found that my internal tissue was extremely fibrous and fragile due to an estrogen deficiency likely caused by Orilissa. My ovaries had shriveled to the like of someone post-menopause, and my urethra tore when they attempted to insert the Foley catheter, again most likely due to the estrogen issues.
I was also recently diagnosed with congenital neuroproliferative vestibulodynia (CNPV) by Dr. Irwin Goldstein, which means I have constant pain at the opening of my vagina (or the vestibule), and cannot bear any form of penetration. During the testing for this they used a close up camera to look at my genitalia and found that my labia minora had retracted back into my body. This happens during menopause and is also a side effect of hormonal medications like Orlissa and oral birth control pills. A part of my labia also tore when they attempted to open things up to take a better look, also thought to be due to the estrogen deficiency caused by Orlissa. While I was born with the CNPV, Orilissa severely weakened and deformed my genitalia. Dr. G was also horrified by the fact that I was put on Orilissa.
Now here’s the kicker… I spoke to Jandra and she informed me of this website (link in comments). It shows payments that physicians receive from different sources of income, particularly pharmaceutical companies. Dr. Agarwal received a great deal of money from a company called AbbVie, the pharmaceutical company associated with Orilissa. He was paid over $72,000 in 2021 from 52 separate occasions… I would guess that’s how many times he prescribed it. As previously mentioned, my appointment was on October 19th; over the next 2 days it shows he was paid $3,000 per day, so we can assume one of those $3000 payments was for his prescription to me.
At the advice of my physicians, I have made the decision to file a complaint for the California Department of Medicine, it’s just a lot of paperwork and will take some time. I know that it may not make a difference in his practice, and there may not be any permanent consequences for his prescribing me this drug, which has severely impacted my life in a negative way at just 19-years-old; I do feel strongly that sharing my story here, and elsewhere to this community, will hopefully have a positive impact and protect some of you. Look into your providers, and don’t blindly trust what they tell you like I did. Look into medications, get second opinions, even third and fourth opinions.
As a last note, if you’ve had good experiences with Dr. Agarwal and/or Orilissa, I’m incredibly happy for you. I do recognize that not everyone’s story is the same and there may be situations in which someone may choose to use this medication and it may provide benefits to them, I just hope that there was transparency and informed consent to you and anyone in the future who is considering this as an option for treatment. Informed consent means that all of the information is discussed – the risks and the benefits as well as knowledge that there may be/is financial gain to the provider recommending it if you are to take it. I wish I had, and that I wasn’t dealing with these consequences. If you’ve had a similar experience to me, please know that I am here for you, I support you, and I am always open to chatting, venting, and being a listening ear.
If you made it to the end, thank you so much for listening. I appreciate you and your time.
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