Elagolix/​Estradiol/​Norethindrone Acetate

DEA Class; Rx

Common Brand Names; Oriahnn

Pregnancy

Osteoporosis

Current or history of breast cancer or other hormonally sensitive malignancies, and with increased risk for hormonally sensitive malignancies

Hepatic impairment or disease

Undiagnosed abnormal uterine bleeding

Anaphylactic reaction, angioedema, or hypersensitivity any of the drug components

OATP1B1 inhibitors

Decreased bone mineral density (BMD) >3% (27%)

Hot flush (22%)

Increased diastolic blood pressure (BP) ≥100 mmHg (11.3%)

1-10%

Headache (9%)

Increased systolic BP ≥160 mmHg (7.1%)

Fatigue (6%)

Metrorrhagia (5%)

Alopecia (3.5%)

Depression (3%)

Decreased BMD ≥8% (1.7%)

Increased ALT/AST (1.1-1.3%)

Estrogens and progestins increase risk of thromboembolism; discontinue if thrombotic event occurs or suspected; discontinue immediately if there is sudden unexplained partial or complete vision loss, proptosis, diplopia, papilledema, or retinal vascular lesions, and evaluate for retinal vein thrombosis; contraindicated with known thrombotic conditions or individuals at high risk

May decrease BMD in some patients; BMD loss is greater with increasing duration of use; contraindicated with known osteoporosis

Use of estrogen alone and estrogen plus progestin associated with increased risk for abnormal mammograms requiring further evaluation; surveillance measures, such as breast examinations and regular mammography, are recommended; discontinue drug if hormonally sensitive malignancy is diagnosed; contraindicated with current or history of breast cancer or other hormonally sensitive cancer

Suicidal ideation and behavior, including a completed suicide, occurred in women treated with lower doses of elagolix in clinical trials conducted for a different indication; promptly evaluate patients with depressive symptoms to determine whether the risks of continued therapy outweigh the benefits

Monitor transaminases; instruct patients to seek medical attention for signs of liver injury (eg, jaundice); contraindicated with hepatic impairment or disease

Monitor BP; for women with well-controlled hypertension, continue to monitor BP and stop drug if BP increases significantly; contraindicated with uncontrolled hypertension

Small increased risk of developing gallbladder disease; assess risk with history of cholestatic jaundice; discontinue if jaundice occurs

Alopecia reported; unknown if hair loss is reversible

Contains FD&C yellow no. 5 (tartrazine), which may cause allergic-type reactions (including bronchial asthma) in susceptible persons; although incidence is low, it is frequently seen in patients who also have aspirin hypersensitivity

Contraindicated in pregnant women

Exposure early in pregnancy may increase risk of early pregnancy loss

Discontinue drug if pregnancy occurs during treatment

Data are not available on the presence of elagolix in human milk, the effects on breastfed infants, or on milk production