Safety Information Update for Healthcare Providers
There has been a change to the Prescribing Information. Click here to see changes.
>
Who is appropriate for ORILISSA?
Hear Dr. Aileen Caceres outline the best way to assess if a patient may be appropriate for ORILISSA
Dr. Caceres
[Text on Screen]
Please see Important Safety Information at the end of this video and accompanying full Prescribing Information.
INDICATION
ORILISSA® (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis.
SAFETY CONSIDERATIONS
ORILISSA is contraindicated in women who are pregnant, women with known osteoporosis, women with severe hepatic impairment, or in women taking strong organic anion transporting polypeptide (OATP) 1B1 inhibitors such as cyclosporine and gemfibrozil.
Please see additional Important Safety Information at the end of this video and accompanying full Prescribing Information.
Dr. Caceres: |
Hi, my name is Dr. Aileen Caceres and I’m the Director of Minimally Invasive Gynecologic Surgery and founder of the Endometriosis Center of Central Florida. By now, you’ve heard of ORILISSA, an oral treatment for the management of moderate to severe endometriosis pain. The longer ORILISSA has been available, the more my peers and I are recognizing appropriate patients who could benefit from the treatment. Some of our peers, however, aren’t exactly sure which patients are right for the treatment. Let’s take a look at who may or may not be an appropriate patient for ORILISSA. |
[Text on Screen]
Considering symptoms and impact
Dr. Caceres:
|
In my own practice, I first consider a patient’s symptom presentation. I assess the type and intensity of pain she’s suffering from. ORILISSA is proven to relieve the 3 most common types of endometriosis pain. So, if my patient has dysmenorrhea, non-menstrual pelvic pain, and/or dyspareunia, and those symptoms are beyond mild, she could be considered for ORILISSA.
|
[Text on Screen]
1. Dysmenorrhea1-2
2. Non-menstrual pelvic pain1,2
3. Dyspareunia1,2*
*Statistical significance for dyspareunia was not achieved with the 150 mg QD dose of ORILISSA.
Dr. Caceres: |
Then, I look at the impact those symptoms have on her day-to-day life. I ask if and how this moderate or severe pain is affecting her time with her family and friends at home, work, or school. If any of these types of pain are negatively impacting my patient’s daily life in any way, my goal is to help her get pain relief, and I know ORILISSA is an option. |
[Text on Screen]
Not an actual patient (@1:16-1:19)
Uncovering pain beyond mild
Dr. Caceres: |
Remember, ORILISSA is indicated for the management of moderate to severe endometriosis pain. That means a patient in your practice who has endometriosis pain that is beyond mild could be considered appropriate for ORILISSA therapy. The ORILISSA clinical trials defined moderate pain as causing some difficulty doing the things patients usually do. Severe pain was defined as causing great difficulty doing the things patients usually do. |
[Text on Screen]
Endometriosis Daily Pain Impact Scale1-3
SEVERE - Great difficulty
MODERATE - Some difficulty
MILD - Easily able
NONE - No discomfort
Dr. Caceres: |
Patients with mild pain were easily able to do the things they usually do. So, unless your patients’ endometriosis pain is mild, you should consider prescribing ORILISSA to them. |
[Text on Screen]
Assessing treatments
Dr. Caceres: |
You can also consider the treatments your patients have already tried or are currently on. Are they still in pain despite initial treatment? Have they tried a few different oral contraceptives but still experience pain that negatively affects their day-to-day lives? As you know, managing endometriosis pain can be a lifelong journey, and it may be time for your patients to manage their pain with something different. In my own practice, I have prescribed ORILISSA to a number of appropriate patients. Really listen to each woman who comes in with pelvic pain, especially since we now have an additional tool in our arsenal. It’s so important to uncover how your patients’ endometriosis pain is affecting their lives and to continually reassess them, as this condition is chronic and can affect women in different ways throughout their lives. I like to proactively bring patients back at 1 month and 3 months after prescribing a new treatment to reassess each type of endometriosis pain they may be experiencing. A helpful way to remember who could benefit from ORILISSA is the acronym READY: |
[Text on Screen]
R.E.A.D.Y.
Dr. Caceres: |
R for Recurring dysmenorrhea, non-menstrual pelvic pain, and/or dyspareunia E for Endometriosis pain that is beyond mild A for Available at all stages of the patient journey, depending on the patient’s needs D for Discomfort despite taking initial first-line treatment or cycling through multiple first-line treatments And Y for use Your clinical judgment |
[Text on Screen]
Recurring dysmenorrhea, non-menstrual pelvic pain, and/or dyspareunia1
Endometriosis pain that is beyond mild1
Available at all stages of the patient journey, depending on the patient’s needs1,4,5
Discomfort despite taking or cycling through first-line treatments1,4,5
Your clinical judgment.
Dr. Caceres: |
Now, who is ORILISSA not appropriate for? ORILISSA has 4 contraindications: pregnancy, known osteoporosis, severe hepatic impairment, and strong organic anion transporting polypeptide 1B1 inhibitors. |
[Text on Screen]
Contraindications1
1. Pregnancy
2. Known osteoporosis
3. Severe hepatic impairment
4. Strong organic anion transporting polypeptide 1B1 inhibitors
Dr. Caceres: |
And as you know, because of these and other risks associated with ORILISSA, you should use your clinical judgment to determine whether ORILISSA is appropriate for a patient. Like some of my colleagues, I wasn’t sure at first who might be a candidate for ORILISSA. But as I saw patients returning to my office with positive experiences, I grew more confident about prescribing ORILISSA to appropriate patients who are in need of, and deserve, relief from their endometriosis pain. |
[Text on Screen]
ORILISSA logo
SCROLLING ISI (FULL)
INDICATION
ORILISSA® (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
- ORILISSA is contraindicated in women who are pregnant (exposure to ORILISSA early in pregnancy may increase the risk of early pregnancy loss), in women with known osteoporosis or severe hepatic impairment, or with concomitant use of strong organic anion transporting polypeptide (OATP) 1B1 inhibitors (e.g., cyclosporine and gemfibrozil).
WARNINGS AND PRECAUTIONS
Bone Loss
- ORILISSA causes a dose-dependent decrease in bone mineral density (BMD), which is greater with increasing duration of use and may not be completely reversible after stopping treatment.
- The impact of ORILISSA-associated decreases in BMD on long-term bone health and future fracture risk is unknown. Consider assessment of BMD in patients with a history of low-trauma fracture or other risk factors for osteoporosis or bone loss, and do not use in women with known osteoporosis.
- Limit the duration of use to reduce the extent of bone loss.
Change in Menstrual Bleeding Pattern and Reduced Ability to Recognize Pregnancy
- Women who take ORILISSA may experience a reduction in the amount, intensity, or duration of menstrual bleeding, which may reduce the ability to recognize the occurrence of pregnancy in a timely manner. Perform pregnancy testing if pregnancy is suspected, and discontinue ORILISSA if pregnancy is confirmed.
Suicidal Ideation, Suicidal Behavior, and Exacerbation of Mood Disorders
- Suicidal ideation and behavior, including one completed suicide, occurred in subjects treated with ORILISSA in the endometriosis clinical trials.
- ORILISSA users had a higher incidence of depression and mood changes compared to placebo and ORILISSA users with a history of suicidality or depression had anincreased incidence of depression. Promptly evaluate patients with depressive symptoms to determine whether the risks of continued therapy outweigh the benefits. Patients with new or worsening depression, anxiety, or other mood changes should be referred to a mental health professional, as appropriate.
- Advise patients to seek immediate medical attention for suicidal ideation and behavior. Reevaluate the benefits and risks of continuing ORILISSA if such events occur.
Hepatic Transaminase Elevations
- In clinical trials, dose-dependent elevations of serum alanine aminotransferase (ALT) at least 3 times the upper limit of the reference range occurred with ORILISSA.
- Use the lowest effective dose and instruct patients to promptly seek medical attention in case of symptoms or signs that may reflect liver injury, such as jaundice.
- Promptly evaluate patients with elevations in liver tests to determine whether the benefits of continued therapy outweigh the risks.
Reduced Efficacy with Estrogen-Containing Contraceptives
- Based on the mechanism of action of ORILISSA, estrogen-containing contraceptives are expected to reduce the efficacy of ORILISSA. The effect of progestin-only contraceptives on the efficacy of ORILISSA is unknown.
- Advise women to use non-hormonal contraceptives during treatment and for one week after discontinuing ORILISSA.
ADVERSE REACTIONS
- The most common adverse reactions (>5%) in clinical trials included hot flushes and night sweats, headache, nausea, insomnia, amenorrhea, anxiety, arthralgia, depression-related adverse reactions, and mood changes.
These are not all the possible side effects of ORILISSA.
Safety and effectiveness of ORILISSA in patients less than 18 years of age have not been established.
For more information, see accompanying full Prescribing Information.
References: 1. ORILISSA [package insert]. North Chicago, IL: AbbVie Inc. 2. Fuldeore MJ, Soliman AM. Prevalence and symptomatic burden of diagnosed endometriosis in the United States: national estimates from a cross-sectional survey of 59,411 women. Gynecol Obstet Invest. 2017;82(5):453-461. 3. Taylor HS, Giudice LC, Lessey BA, et al. Treatment of endometriosis-associated pain with elagolix, an oral GnRh antagonist. N Engl J Med. 2017;377(1):28-40. 4. Practice Committee of the American Society for Reproductive Medicine. Treatment of pelvic pain associated with endometriosis: a committee opinion [published correction appears in Fertil Steril. 2015;104(2):498]. Fertil Steril. 2014;101(4):927-935. 5. American College of Obstetricians and Gynecologists. Practice bulletin no. 114: management of endometriosis. Obstet Gynecol. 2010;116(1):223-236.
[Text on Screen]
Please see accompanying full Prescribing Information.
US-ORIL-190696
Indication and Important Safety Information
INDICATION1
ORILISSA® (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis.
IMPORTANT SAFETY INFORMATION1
CONTRAINDICATIONS
- ORILISSA is contraindicated in women who are pregnant (exposure to ORILISSA early in pregnancy may increase the risk of early pregnancy loss), in women with known osteoporosis or severe hepatic impairment, or with concomitant use of strong organic anion transporting polypeptide (OATP) 1B1 inhibitors (e.g., cyclosporine and gemfibrozil).
WARNINGS AND PRECAUTIONS
Bone Loss
- ORILISSA causes a dose-dependent decrease in bone mineral density (BMD), which is greater with increasing duration of use and may not be completely reversible after stopping treatment.
- The impact of ORILISSA-associated decreases in BMD on long-term bone health and future fracture risk is unknown. Consider assessment of BMD in patients with a history of low-trauma fracture or other risk factors for osteoporosis or bone loss, and do not use in women with known osteoporosis.
- Limit the duration of use to reduce the extent of bone loss.
Change in Menstrual Bleeding Pattern and Reduced Ability to Recognize Pregnancy
- Women who take ORILISSA may experience a reduction in the amount, intensity, or duration of menstrual bleeding, which may reduce the ability to recognize the occurrence of pregnancy in a timely manner. Perform pregnancy testing if pregnancy is suspected, and discontinue ORILISSA if pregnancy is confirmed.
Suicidal Ideation, Suicidal Behavior, and Exacerbation of Mood Disorders
- Suicidal ideation and behavior, including one completed suicide, occurred in subjects treated with ORILISSA in the endometriosis clinical trials.
- ORILISSA users had a higher incidence of depression and mood changes compared to placebo and ORILISSA users with a history of suicidality or depression had an increased incidence of depression. Promptly evaluate patients with depressive symptoms to determine whether the risks of continued therapy outweigh the benefits. Patients with new or worsening depression, anxiety, or other mood changes should be referred to a mental health professional, as appropriate.
- Advise patients to seek immediate medical attention for suicidal ideation and behavior. Reevaluate the benefits and risks of continuing ORILISSA if such events occur.
Hepatic Transaminase Elevations
- In clinical trials, dose-dependent elevations of serum alanine aminotransferase (ALT) at least 3 times the upper limit of the reference range occurred with ORILISSA.
- Use the lowest effective dose and instruct patients to promptly seek medical attention in case of symptoms or signs that may reflect liver injury, such as jaundice.
- Promptly evaluate patients with elevations in liver tests to determine whether the benefits of continued therapy outweigh the risks.
Reduced Efficacy with Estrogen-Containing Contraceptives
- Based on the mechanism of action of ORILISSA, estrogen-containing contraceptives are expected to reduce the efficacy of ORILISSA. The effect of progestin-only contraceptives on the efficacy of ORILISSA is unknown.
- Advise women to use non-hormonal contraceptives during treatment and for one week after discontinuing ORILISSA.
ADVERSE REACTIONS
- The most common adverse reactions (>5%) in clinical trials included hot flushes and night sweats, headache, nausea, insomnia, amenorrhea, anxiety, arthralgia, depression-related adverse reactions, and mood changes.
These are not all the possible side effects of ORILISSA.
Safety and effectiveness of ORILISSA in patients less than 18 years of age have not been established.
US-ORIL-200330
For more information, please click here for full Prescribing Information.
Reference:
1. ORILISSA [package insert]. North Chicago, IL: AbbVie Inc.