ORILISSA was rigorously studied to determine its effectiveness and safety profile1,2

The largest endometriosis Phase 3 study program conducted to date (N=1686)

Summary

Two robust similar multicenter, double-blind, placebo-controlled Phase 3 trials of 6-month treatment at 2 doses.

  • 150 mg once daily (lower-dose group).
  • 200 mg twice daily (higher-dose group).

The studies enrolled women with surgically diagnosed endometriosis and moderate or severe endometriosis-associated pain.

Two blinded extension studies were conducted, EM-3 and EM-4, in which the subjects who were originally on ORILISSA in the controlled studies EM-1 and EM-2 were maintained on their dose for an additional 6 months. Subjects who were originally on placebo in the controlled studies EM-1 and EM-2 were re-randomized to either ORILISSA 150 mg QD or 200 mg BID dose groups.3

ORILISSA 150 mg and 200 mg clinical trial design ORILISSA 150 mg and 200 mg clinical trial design ORILISSA 150 mg and 200 mg clinical trial design

aOne woman in ELARIS EM-1 and two women in ELARIS EM-2 were randomized but not treated.2

R = Randomization     QD = Once daily     BID = Twice daily

Endpoints

ORILISSA was rigorously studied in 2 clinical trials and 2 extension studies with strictly defined endpoints and responses.1-3

Co-primary endpoints1,2

  • Proportion of responders for dysmenorrhea at month 3 compared to placebo*
  • Proportion of responders for non-menstrual pelvic pain (NMPP) at month 3 compared to placebo*

*Women were defined as responders if they experienced clinically meaningful pain reduction and stable/decreased rescue analgesic use for endometriosis-associated pain. Clinically meaningful reduction in pain was defined as a calculated threshold of improvement in pain score in each study. The threshold was determined based on an analysis of the change in pain score that corresponded to “much improved” or “very much improved” on the Patient Global Impression of Change questionnaire.

Select ranked secondary endpoints1,2

  • Change from baseline to Month 6 in dysmenorrhea
  • Change from baseline to Month 6 in non-menstrual pelvic pain
  • Change from baseline to Month 3 in dyspareunia
    • Only participants who were sexually active during the trial were included in the results for dyspareunia
Pain Scale
Enrollment Criteria

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.

References:

1. ORILISSA [package insert]. North Chicago, IL: AbbVie Inc. 2. 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. 3. Surrey E, Taylor HS, Giudice L, et al. Long-term outcomes of elagolix in women with endometriosis. Obstet Gynecol.2018;132(1):147-160. 4. Data on file. ABVRRTI66652. 5. Data on file. ABVRRTI65829.  6. Data on file. ABVRRTI66680. 7. Data on file. ABVRRTI66358. 8. Data on file. ABVRRTI66357. 

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...

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 osteoporosis or severe hepatic impairment...

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...

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 osteoporosis or severe hepatic impairment...

INDICATION1

ORILISSA® (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis.

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.