A patient’s journey to ORILISSA

Hear how these patients found ORILISSA

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Gillian’s story

The following video features Gillian, who managed her endometriosis pain with ORILISSA.

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What is ORILISSA?

ORILISSA is a prescription medicine used to treat moderate to severe pain associated with endometriosis. It is not known if ORILISSA is safe and effective in children.

Individual results may vary.

Do not take ORILISSA if you:

Are pregnant, have osteoporosis or severe liver disease, take medicines called organic anion transporting polypeptide (OATP) 1B1 inhibitors that are known or expected to significantly increase the blood levels of elagolix (the active ingredient in ORILISSA), or have had a serious allergic reaction to ORILISSA or any of the ingredients in ORILISSA.

Please see additional Important Safety information and the Full Prescribing Information, including Medication Guide, on this website.

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Gillian’s Story

Gillian:

My pain and trouble with my period started when I was 12. And as I got older, the pain got worse. It almost felt like a rake was just tearing down the front of my uterus. I decided this isn’t right. I shouldn’t be in this kind of pain.

Hi, I’m Gillian. And I have endometriosis. From my first painful period to endometriosis diagnosis, it took nine years. And it was a trying nine years. Because of my pain, I was having to take a lot of breaks. You know, I couldn’t walk for a long period of time, stand in line somewhere. You know, sit with friends.

Honestly, I was in pain every day and being on my period was just something worse. So when my doctor first suggested I take ORILISSA, I was a little bit wary. Just because I was worried it was gonna be like some other treatments I had tried in the past. But she really took the time to sit down with me and explain what ORILISSA was. And…I felt better about my decision.

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Please see Important Safety Information and the full Prescribing Information, including Medication Guide, on this website.

Gillian:

 

After three months of taking ORILISSA, I was in less pain.

 

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Please see Important Safety Information and the full Prescribing Information, including Medication Guide, on this website.

Gillian:

 

That cramping feeling had lessened. That every day pain had decreased. I was out shopping with my mom. And she’s like, you know, “do you need to take a break?” And I’m like, “no.”

“Are you sure?” “Yeah! Like. I feel good. Let’s keep shopping.” You know, I wasn’t having to say, like, you know, oh, I need a minute. Like I need to wait for this, you know, cramp to subside.

You know, then I was like, okay, yeah, this—this works.

On ORILISSA, I had less pain throughout the month. And I think that’s a definite reason why…other women should give it a chance. It’s something worth trying. Do your own research.

Don’t let other people dictate what treatment you should or shouldn’t take. Talk to your doctor. Talk to your doctor about ORILISSA. See if it works for you.

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SAFETY CONSIDERATIONS

Do not use ORILISSA if you are pregnant, have osteoporosis or severe liver disease, take medicines called organic anion transporting polypeptide (OATP) 1B1 inhibitors that are known or expected to significantly increase the blood levels of elagolix (the active ingredient in ORILISSA), or have had a serious allergic reaction to ORILISSA or any of the ingredients in ORILISSA. ORILISSA does not prevent pregnancy. It may alter your period, so watch for other signs of pregnancy. Stop taking ORILISSA if you become pregnant. Ask about proper birth control, as some may affect how ORILISSA works. ORILISSA may affect how some birth control works. ORILISSA can cause serious side effects, including bone loss, abnormal liver tests, suicidal thoughts or behaviors, and worsening mood. Talk to your healthcare provider right away if you notice changes such as jaundice, dark amber-colored urine, suicidal thoughts or actions, depression, or worsening mood.

Please see additional Important Safety Information and the Full Prescribing Information, including Medication Guide, on this website.

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.