Getting patients started

Help your patients with moderate to severe endometriosis pain take a next step

Patients prescribed ORILISSA should be counseled appropriately1




Administration1


  • Exclude pregnancy before starting ORILISSA or start ORILISSA within 7 days from the onset of menses
  • 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 due to concerns about bone loss
  • Treatment with ORILISSA 150 mg once daily is not recommended beyond 24 months. Treatment with ORILISSA 150 mg once daily is not recommended beyond 6 months for women with moderate hepatic impairment (Child-Pugh Class B)
  • Treatment with ORILISSA 200 mg twice daily is not recommended beyond 6 months. ORILISSA 200 mg twice daily is not recommended in women with moderate hepatic impairment
  • If a patient misses a dose, she should take it as soon as she remembers, as long as it is on the same day. She should then resume the regular dosing schedule
    • No more than 1 tablet of 150 mg should be taken each day
    • No more than 2 tablets of 200 mg should be taken each day
  • Instruct patients to dispose of unused medication via a take-back option if available or to otherwise follow FDA instructions for disposing of medication in the household trash, www.fda.gov/drugdisposal, and not to flush down the toilet.

Bone loss1


  • ORILISSA leads to a reduction in serum estradiol levels, which causes a dose-dependent decrease in bone mineral density (BMD)
  • BMD loss is greater with increasing duration of use. BMD loss 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 are unknown
  • Consider assessment of BMD in patients with a history of low-trauma fracture or other risk factors for osteoporosis or bone loss
  • Do not use in women with known osteoporosis
  • Limit the duration of use to reduce the extent of bone loss
  • Although there are no studies addressing whether calcium and vitamin D supplementation may impact BMD loss in women using ORILISSA, counsel your patients on the importance of adequate intake

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 a 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 disorders1


  • Suicidal ideation and behavior, including one completed suicide, occurred in subjects treated with ORILISSA in the endometriosis clinical trials
  • ORILISSA subjects 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
  • Advise patients to seek medical attention for suicidal ideation and behavior, new onset or worsening depression, anxiety, or other mood changes
  • Reevaluate the benefits and risks of continuing ORILISSA if such events occur

Hepatic transaminase elevations1


  • 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 with ORILISSA and for one week after discontinuing ORILISSA

Offer your patients on ORILISSA one-on-one support
Refer them to the ORILISSA nurse hotline 1-844-OriForMe (1-844-674-3676)