STEPS

New Drug Reviews

Elagolix (Orilissa) for Endometriosis Pain

 

Am Fam Physician. 2019 Oct 15;100(8):502-504.

Elagolix (Orilissa) is an oral, nonpeptide, gonadotropin-releasing hormone (GnRH) antagonist used to treat moderate to severe pain related to endometriosis in reproductive-aged women.1 Inhibition of GnRH leads to estrogen suppression and subsequent dose-dependent inhibition of endometriotic proliferation.

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DrugDosageDose formCost*

Elagolix (Orilissa)

150 mg once daily or 200 mg twice daily

Tablets: 150 mg, 200 mg

$870


*—Estimated retail price of one month of treatment based on information obtained at https://www.goodrx.com (accessed August 28, 2019).

DrugDosageDose formCost*

Elagolix (Orilissa)

150 mg once daily or 200 mg twice daily

Tablets: 150 mg, 200 mg

$870


*—Estimated retail price of one month of treatment based on information obtained at https://www.goodrx.com (accessed August 28, 2019).

Safety

Severe adverse effects of elagolix were uncommon during clinical trials.2,3 The most common reason for discontinuation of treatment was hot flashes or night sweats.3 As with other medications that induce low estrogen states, a reduction in bone density may occur in patients taking elagolix, although an increase in fracture risk has not been observed in studies to date. Elagolix should not be used in patients with known osteoporosis.1 Mood changes, depression, and suicidal ideation may occur and are more likely in patients with a history of depression. Asymptomatic elevations in alanine transaminase greater than three times the upper limit of normal will occur in 0.2% of patients treated with the standard dosage (150 mg once daily) and 1.1% of patients taking the higher dosage (200 mg twice daily).3 Elagolix affects liver enzyme metabolism of certain medications and is known to increase serum levels of digoxin and decrease serum levels of rosuvastatin (Crestor). Combining treatment with rifampin will increase serum levels of elagolix.1

Elagolix does not reliably inhibit ovulation, and its effect on menstrual bleeding may make pregnancy difficult to recognize. In addition, elagolix may decrease the effectiveness of combined oral contraceptives.1 It is recommended that women taking elagolix use nonhormonal contraception during treatment. Women should continue using nonhormonal contraception for one week after discontinuing use of elagolix.1 Women suspected of being pregnant should discontinue treatment. There is no information on excretion or presence of elagolix in human breast milk or its effect on

Address correspondence to Brian Ford, MD, FAAFP, at Brian.s.ford16.mil@mail.mil. Reprints are not available from the author.

Author disclosure: No relevant financial affiliations.


The views expressed are those of the author and do not reflect the official policy or position of the Department of the Navy, the Department of Defense, or the U.S. government.

References

show all references

1. Daily Med. Drug label information: Orilissa—elagolix tablet, filmcoated. Updated September 5, 2019. Accessed September 22, 2019. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=a86757b3-09c5-fd3b-1223-244e94f50a66...

2. Surrey E, Taylor HS, Giudice L, et al. Long-term outcomes of elagolix in women with endometriosis: results from two extension studies. Obstet Gynecol. 2018;132(1):147–160.

3. 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.

4. Ács N, O'Brien C, Jiang P, et al. Treatment of endometriosis-associated pain with elagolix, an oral GnRH antagonist: results from a phase 2, randomized controlled study. J Endometr Pelvic Pain Disord. 2015;7(2):56–62.

STEPS new drug reviews cover Safety, Tolerability, Effectiveness, Price, and Simplicity. Each independent review is provided by authors who have no financial association with the drug manufacturer.

This series is coordinated by Allen F. Shaughnessy, PharmD, MMedEd, assistant medical editor.

A collection of STEPS published in AFP is available at https://www.aafp.org/afp/steps.

 

 

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