Safety Information Update for Healthcare Providers

There has been a change to the Prescribing Information. Click here to see changes.

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ORILISSA® (elagolix) 150 mg and 200 mg Tablets

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ORILISSA Healthcare Provider Patient Counseling Guide PDF Download.

Healthcare Provider Patient Counseling Guide

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ORILISSA Patient Brochure PDF Download.

ORILISSA Patient Brochure

Provide your patients with additional information about ORILISSA, from dosing to potential side effects and more.

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Patient counseling

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.

Indication and Important Safety Information

INDICATION1

ORILISSA® (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis. Limit the duration of use based on the dose and coexisting condition.

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, in women taking organic anion transporting polypeptide (OATP) 1B1 inhibitors that are known or expected to significantly increase elagolix plasma concentrations, and in women with known hypersensitivity reaction to ORILISSA or any of its inactive components. Reactions have included anaphylaxis and angioedema.

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. ORILISSA is contraindicated in women with known osteoporosis. Consider assessment of BMD in patients with a history of low-trauma fracture or other risk factors for osteoporosis or bone loss.
  • 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.

Interactions with Hormonal Contraceptives

  • Advise women to use effective non-hormonal contraceptives during treatment and for 28 days after discontinuing ORILISSA.
  • Coadministration of ORILISSA 200 mg twice daily with an estrogen-containing contraceptive is not recommended because of the potential for increased estrogen-associated risks including thromboembolic disorders and vascular events. Coadministration of ORILISSA with an estrogen-containing contraceptive is expected to reduce the efficacy of ORILISSA.
  • Coadministration with progestin-containing oral contraceptives may reduce the efficacy of the contraceptive. The effect of progestin-only contraceptives on the efficacy of ORILISSA is unknown. Coadministration of ORILISSA with progestin-containing intrauterine contraceptive systems has not been studied.

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 pediatric patients have not been established.

US-ORIL-210045

For more information, please click here for full Prescribing Information.

Reference:

1. ORILISSA [package insert]. North Chicago, IL: AbbVie Inc.

Legal Notices/Privacy Policy. Copyright 2021, AbbVie Inc., North Chicago, Illinois, U.S.A. If you have any questions about AbbVie’s ORILISSA.com website that have not been answered, click here. This website and the information contained herein is intended for use by US residents only, is provided for informational purposes only and is not intended to replace a discussion with a healthcare provider. All decisions regarding patients must be made with a healthcare provider and consider the unique characteristics of each patient.

©2021 AbbVie Inc. North Chicago, IL 60064

US-ORIL-210099

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Dysmenorrhea results in ELARIS EM-2

Co-primary endpoint: Responder rate for dysmenorrhea at month 31*

ELARIS EM-2

ORILISSA 150 mg QD
43%
(n=221)
Placebo
23%
(n=353)

P≤0.001 vs placebo

Secondary endpoint: Mean dysmenorrhea pain reduction from baseline on the Endometriosis Daily Pain Impact Scale1,3,6†‡§

ELARIS EM-2

Mean dysmenorrhea score at month 6:
ORILISSA 150 mg QD (n=185): 1.06
Placebo (n=273): 1.64

*Dysmenorrhea responder threshold was ≥0.81-point decrease from baseline in ELARIS EM-1 and ≥0.85-point decrease from baseline in ELARIS EM-2. NMPP responder threshold was ≥0.36-point decrease from baseline in ELARIS EM-1 and ≥0.43-point decrease from baseline in ELARIS EM-2.

†In ELARIS EM-1 and EM-2, the mean changes in dysmenorrhea and NMPP scores from baseline to month 6 were secondary endpoints.

‡In ELARIS EM-1 and EM-2, the mean changes in dysmenorrhea and NMPP scores from baseline to each month (except month 6) were non-ranked secondary endpoints. Appropriate multiplicity adjustments were not applied.

§Baseline and monthly visit values were based on a 35-day mean.

Dysmenorrhea results in ELARIS EM-2

Co-primary endpoint: Responder rate for dysmenorrhea at month 31*

ELARIS EM-2

ORILISSA 200 mg BID
72%
(n=225)
Placebo
23%
(n=353)

P≤0.001 vs placebo

Secondary endpoint: Mean dysmenorrhea pain reduction from baseline on the Endometriosis Daily Pain Impact Scale1,3,6†‡§

ELARIS EM-2

Mean dysmenorrhea score at month 6:
ORILISSA 200 mg BID (n=187): 0.43
Placebo (n=273): 1.64

*Dysmenorrhea responder threshold was ≥0.81-point decrease from baseline in ELARIS EM-1 and ≥0.85-point decrease from baseline in ELARIS EM-2. NMPP responder threshold was ≥0.36-point decrease from baseline in ELARIS EM-1 and ≥0.43-point decrease from baseline in ELARIS EM-2.

†In ELARIS EM-1 and EM-2, the mean changes in dysmenorrhea and NMPP scores from baseline to month 6 were secondary endpoints.

‡In ELARIS EM-1 and EM-2, the mean changes in dysmenorrhea and NMPP scores from baseline to each month (except month 6) were non-ranked secondary endpoints. Appropriate multiplicity adjustments were not applied.

§Baseline and monthly visit values were based on a 35-day mean.

Dyspareunia results in ELARIS EM-2

Secondary endpoint: Mean dyspareunia pain reduction from baseline on the Endometriosis Daily Pain Impact Scale3*†

ELARIS EM-2

ORILISSA 150 mg QD
Mean change in dyspareunia score at month 3 was not statistically significant3

*Baseline and monthly visit values were based on a 35-day mean.

†In ELARIS EM-1 and EM-2, the mean changes from baseline in dyspareunia scores were evaluated as secondary endpoints vs placebo at month 3 and as non-ranked secondary endpoints at each month (except month 3). Appropriate multiplicity adjustments were not applied to the non-ranked secondary endpoints.

Dyspareunia results in ELARIS EM-2

Secondary endpoint: Mean dyspareunia pain reduction from baseline on the Endometriosis Daily Pain Impact Scale1,3,6*†

ELARIS EM-2

Mean dyspareunia score at month 6:
ORILISSA 200 mg BID (n=137): 0.71
Placebo (n=189): 1.11

*Baseline and monthly visit values were based on a 35-day mean.

†In ELARIS EM-1 and EM-2, the mean changes from baseline in dyspareunia scores were evaluated as secondary endpoints vs placebo at month 3 and as non-ranked secondary endpoints at each month (except month 3). Appropriate multiplicity adjustments were not applied to the non-ranked secondary endpoints.

Non-menstrual pelvic pain (NMPP) results in ELARIS EM-2

Co-primary endpoint: Responder rate for NMPP at month 31*

ELARIS EM-2

ORILISSA 150 mg QD
50%
(n=221)
Placebo
37%
(n=353)

P≤0.001 vs placebo

Secondary endpoint: Mean NMPP pain reduction from baseline on the Endometriosis Daily Pain Impact Scale1,3,6†‡§

ELARIS EM-2

Mean NMPP score at month 6:
ORILISSA 150 mg QD (n=185): 1.00
Placebo (n=273): 1.07

*Dysmenorrhea responder threshold was ≥0.81-point decrease from baseline in ELARIS EM-1 and ≥0.85-point decrease from baseline in ELARIS EM-2. NMPP responder threshold was ≥0.36-point decrease from baseline in ELARIS EM-1 and ≥0.43-point decrease from baseline in ELARIS EM-2.

†In ELARIS EM-1 and EM-2, the mean changes in dysmenorrhea and NMPP scores from baseline to month 6 were secondary endpoints.

‡In ELARIS EM-1 and EM-2, the mean changes in dysmenorrhea and NMPP scores from baseline to each month (except month 6) were non-ranked secondary endpoints. Appropriate multiplicity adjustments were not applied.

§Baseline and monthly visit values were based on a 35-day mean.

Non-menstrual pelvic pain (NMPP) results in ELARIS EM-2

Co-primary endpoint: Responder rate for NMPP at month 31*

ELARIS EM-2

ORILISSA 200 mg BID
58%
(n=225)
Placebo
37%
(n=353)

P≤0.001 vs placebo

Secondary endpoint: Mean NMPP pain reduction from baseline on the Endometriosis Daily Pain Impact Scale1,3,6†‡§

ELARIS EM-2

Mean NMPP score at month 6:
ORILISSA 200 mg BID (n=187): 0.73
Placebo (n=273): 1.07

*Dysmenorrhea responder threshold was ≥0.81-point decrease from baseline in ELARIS EM-1 and ≥0.85-point decrease from baseline in ELARIS EM-2. NMPP responder threshold was ≥0.36-point decrease from baseline in ELARIS EM-1 and ≥0.43-point decrease from baseline in ELARIS EM-2.

†In ELARIS EM-1 and EM-2, the mean changes in dysmenorrhea and NMPP scores from baseline to month 6 were secondary endpoints.

‡In ELARIS EM-1 and EM-2, the mean changes in dysmenorrhea and NMPP scores from baseline to each month (except month 6) were non-ranked secondary endpoints. Appropriate multiplicity adjustments were not applied.

§Baseline and monthly visit values were based on a 35-day mean.

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. Limit the duration of use based on the dose and coexisting condition.

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. Limit the duration of use based on the dose and coexisting condition.

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. Limit the duration of use based on the dose and coexisting condition.

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. Limit the duration of use based on the dose and coexisting condition.

Indication and Important Safety Information

INDICATION1

ORILISSA® (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis. Limit the duration of use based on the dose and coexisting condition.

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, in women taking organic anion transporting polypeptide (OATP) 1B1 inhibitors that are known or expected to significantly increase elagolix plasma concentrations, and in women with known hypersensitivity reaction to ORILISSA or any of its inactive components. Reactions have included anaphylaxis and angioedema.

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. ORILISSA is contraindicated in women with known osteoporosis. Consider assessment of BMD in patients with a history of low-trauma fracture or other risk factors for osteoporosis or bone loss.
  • 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.

Interactions with Hormonal Contraceptives

  • Advise women to use effective non-hormonal contraceptives during treatment and for 28 days after discontinuing ORILISSA.
  • Coadministration of ORILISSA 200 mg twice daily with an estrogen-containing contraceptive is not recommended because of the potential for increased estrogen-associated risks including thromboembolic disorders and vascular events. Coadministration of ORILISSA with an estrogen-containing contraceptive is expected to reduce the efficacy of ORILISSA.
  • Coadministration with progestin-containing oral contraceptives may reduce the efficacy of the contraceptive. The effect of progestin-only contraceptives on the efficacy of ORILISSA is unknown. Coadministration of ORILISSA with progestin-containing intrauterine contraceptive systems has not been studied.

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 pediatric patients have not been established.

US-ORIL-210045