Safety Information Update for Healthcare Providers

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

If endometriosis pain
has her on the sidelines,

help her
make a
move

with Orilissa

Help her find the relief she needs for her unresolved
MODERATE TO SEVERE endometriosis pain¹

Patient profiles

Learn how to recognize women that are ready for a treatment change

See profiles

Available in 2 oral dosages¹

150 mg QD 200 mg BID
Two different doses allow you to individually tailor treatment

See dosing

ORILISSA has been prescribed for over 60,000 patients^2*

*These data reflect the number of women prescribed since ORILISSA was FDA approved in July 2018. Data sourced as of October 2020.

A need for change

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.

References:

1. ORILISSA [package insert]. North Chicago, IL: AbbVie Inc. 2. Data on file. AbbVie Inc. IQVIA and UBC/Medvantx. August 2018-October 2020.

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 known 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

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

Safety Information Update for Healthcare Providers

help her make a move

with Orilissa

Help her find the relief she needs for her unresolved MODERATE TO SEVERE endometriosis pain1

Available in 2 oral dosages1

Indication and Important Safety Information

INDICATION1

IMPORTANT SAFETY INFORMATION1

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Bone Loss

Change in Menstrual Bleeding Pattern and Reduced Ability to Recognize Pregnancy

Suicidal Ideation, Suicidal Behavior, and Exacerbation of Mood Disorders

Hepatic Transaminase Elevations

Interactions with Hormonal Contraceptives

ADVERSE REACTIONS

References:

IMPORTANT SAFETY INFORMATION1

CONTRAINDICATIONS

INDICATION1

IMPORTANT SAFETY INFORMATION1

CONTRAINDICATIONS

INDICATION1

IMPORTANT SAFETY INFORMATION1

CONTRAINDICATIONS

INDICATION1

IMPORTANT SAFETY INFORMATION1

CONTRAINDICATIONS

INDICATION1

Indication and Important Safety Information

INDICATION1

IMPORTANT SAFETY INFORMATION1

CONTRAINDICATIONS

WARNINGS AND PRECAUTIONS

Bone Loss

Change in Menstrual Bleeding Pattern and Reduced Ability to Recognize Pregnancy

Suicidal Ideation, Suicidal Behavior, and Exacerbation of Mood Disorders

Hepatic Transaminase Elevations

Interactions with Hormonal Contraceptives

ADVERSE REACTIONS

help her
make a
move

Help her find the relief she needs for her unresolved
MODERATE TO SEVERE endometriosis pain¹

Available in 2 oral dosages¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹

INDICATION¹

INDICATION¹

IMPORTANT SAFETY INFORMATION¹