OBGYNs discuss ORILISSA® (elagolix)

August 12, 2020

From patient counseling to identifying suitable patients, 3 OBGYNs share their real-world experience with ORILISSA.

Dr Jessica Shepherd

To help her patients understand and accept their treatment plan with ORILISSA, Dr Jessica Shepherd feels it’s essential to include her patients in the decision-making process. By helping her patients understand why she recommends ORILISSA, how it works, and highlighting the benefits and risks, she ensures her patients leave her office feeling well informed about the treatment decision they’ve made together. But it doesn’t stop there. She guides her patients throughout the treatment process by helping them understand what to expect, scheduling follow-up appointments during their initial visit, and ensuring they have access to their medication as quickly as possible. Watch the video to learn how Dr Jessica Shepherd supports her patients from day 1.

Dr Aileen Caceres

After many years as an OBGYN, Dr Aileen Caceres has adopted a big-picture approach when identifying patients who may be right for ORILISSA. She looks at each patient's pain symptoms and how they affect day-to-day life. Does moderate to severe pain negatively affect her daily routine? Are her pain symptoms beyond mild? Dr Aileen Caceres takes that into consideration, as well as assesses what previous pain management her patients have tried, which helps in evaluating when ORILISSA is an appropriate choice. Watch to see Dr Aileen Caceres present a quick and easy way to identify who may be right for ORILISSA.

Dr Charles Miller

With years of real-world experience, Dr Charles Miller knows that merely pushing through pain isn’t an option for many women with moderate to severe endometriosis pain. Many of his endometriosis patients find their pain negatively affecting their day-to-day lives. Dr Charles Miller explains that he recommends ORILISSA to appropriate patients because it works differently—by dialing down estradiol levels in a dose-dependent manner—so the dose is chosen based on specific pain symptoms and severity.¹ Learn about one patient Dr Charles Miller prescribed ORILISSA to, and why he often recommends this treatment in his practice.

_{Reference: 1. ORILISSA [package insert]. North Chicago, IL: AbbVie Inc.}

INDICATION¹
ORILISSA^® (elagolix) is indicated for the management of moderate to severe pain associated with endometriosis.
IMPORTANT SAFETY INFORMATION
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.

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

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