150 mg QD
Recommended for
long-term use of up
to 24 months*
Tailor her treatment with 2 different doses of ORILISSA
Individually tailor treatment with 2 hormone-free dosing options that dial down estradiol to 2 different levels1
200 mg BID
Recommended for
up to 6 months
Pills pictured are not actual size.
*For patients with moderate hepatic impairment (Child-Pugh Class B), initiate treatment with ORILISSA 150 mg QD for up to 6 months. Limit the duration of use because of bone loss. Use of ORILISSA 200 mg BID is not recommended.
Dosing Schedule1,2
ORILISSA 150 mg QD
Take AM or PM
No more than 1 tablet a day
Dysmenorrhea
✓
Non-menstrual Pelvic Pain
✓
Dyspareunia
Pain relief not statistically significant in trials
Duration of use
24 months
ORILISSA 200 mg BID
Take AM and PM
No more than 2 tablets a day
Dysmenorrhea
✓
Non-menstrual Pelvic Pain
✓
Dyspareunia
✓
Duration of use
6 months
Dysmenorrhea
✓
✓
Non-menstrual Pelvic Pain
✓
✓
Dyspareunia
Pain relief not statistically significant in trials
✓
Duration of use
24 months
6 months
- 1 monthly carton contains 4 weekly blister packs
- Take at approximately the same time each day with or without food
- In case of a missed dose, take as soon as remembered, as long as it is on the same day; then resume regular dosing schedule
- Limit the duration of use based on the dose and coexisting conditions
Dosing with a coexisting condition1
- Use of ORILISSA 150 mg QD is recommended for women with moderate hepatic impairment (Child-Pugh B) with the duration of treatment limited to 6 months. Use of ORILISSA 200 mg BID is not recommended for women with moderate hepatic impairment
- No dosage adjustment of ORILISSA is required in women with mild hepatic impairment (Child-Pugh A)
Important next steps when prescribing ORILISSA1
- Exclude pregnancy before starting ORILISSA, or start ORILISSA within 7 days from the onset of menses
- Advise patients to take ORILISSA orally at approximately the same time each day, with or without food
- Based on the severity of symptoms and treatment objectives, use the lowest effective dose
- Duration of use is limited because of concerns about bone loss
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. Taylor HS, Giudice LC, Lessey BA, et al. Treatment of endometriosis-associated pain with elagolix, an oral GnRH antagonist. N Engl J Med. 2017;377(1):28-40.
