ORILISSA starts and stops working rapidly

Explore reversible and dose-dependent hormone suppression1,2*†

Hormone suppression1-3

Dose-dependent suppression of LH and FSH levels were observed 4 to 6 hours after administration*

Luteinizing Hormone (LH)

Luteinizing hormone suppression 4 to 6 hours after a single dose

Follicle-Stimulating Hormone (FSH)

Follicle-stimulating hormone suppression 4 to 6 hours after a single dose

* Does not imply onset of efficacy during this time.
For illustrative purposes only. LH and FSH levels and individual responses may vary.

Pain response was measured as early as 1 month1-3

Dose-dependent suppression of estradiol1-3*†

As opposed to nearly completely suppressing estradiol, 2 different ORILISSA doses dial down estradiol to 2 different levels, allowing you to initiate tailored treatments

Dose-dependent degree of estradiol suppression 24 hours after a single dose hormone suppression 4 to 6 hours after a single dose
  • After approximately 24 hours, subsequent suppression of estradiol levels occurs*
  • Estrogen levels return to baseline 24 to 48 hours after discontinuation

*Does not imply onset of efficacy during this time.

Average 28 day cycle is for illustrative purposes only. Estradiol levels can vary throughout the cycle and Individual responses may vary. 21 day results have been extrapolated to 28 days.

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If your patients’ plans change and they discontinue treatment, ORILISSA stops working rapidly, with estrogen levels returning to baseline 24 to 48 hours after discontinuation.2,3

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. Ng J, Chwalisz K, Carter DC, Klein CE. Dose-dependent suppression of gonadotropins and ovarian hormones by elagolix in healthy premenopausal women. J Clin Endocrinol Metab. 2017;102(5):1683-1691. 3. Struthers RS, Nicholls AJ, Grundy J, et al. Suppression of gonadotropins and estradiol in premenopausal women by oral administration of the nonpeptide gonadotropin-releasing hormone antagonist elagolix. J Clin Endocrinol Metab. 2009;94(2):545-551.

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.