Estetrol/Drospirenone

DEA Class; Rx

Common Brand Names; Nextstellis

Indicated for use by females of reproductive potential to prevent pregnancy

Current or history of a hormonally-sensitive malignancy (eg, breast cancer)

Hepatic adenoma, hepatocellular carcinoma, acute hepatitis, or severe (decompensated) cirrhosis

Use of hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir

Abnormal uterine bleeding with undiagnosed etiology

Renal impairment

Adrenal insufficiency

Bleeding irregularities (9.7-10.8%)

Mood disturbance (9.1-10.9%)

Headache (4.8-6.3%)

Breast symptoms (5.3-5.4%)

Dysmenorrhea (3.7-4.1%)

Weight increased (3-3.3%)

Acne (3.2-3.7%)

Libido decreased/lost (1.3-2%)

Depression (1.7%)

Thromboembolic event reported in a female who had been taking therapy for 75 days and had normal BMI < 25 kg/m²

Increased blood pressure (BP) reported in females using COCs; increase is more likely in older females with extended duration of use; monitor BP periodically and discontinue if BP rises significantly

Migraine headaches with aura increase the risk for stroke; stroke risk is further increased in females who have migraine headaches with aura with use of CHCs; discontinue if new migraine headaches develop that are recurrent, persistent, or severe or increased frequency or severity of migraine headaches (which may be prodromal of a cerebrovascular event)

May promote growth of any hormone receptor–positive tumor, both within and external to female reproductive tract (eg, hormone receptor–positive include melanoma, adenocarcinoma of the lung, meningioma); discontinue if a hormonally sensitive malignancy is diagnosed

May cause elevated liver enzymes; withhold or permanently discontinue for persistent or significant elevation of liver enzymes

CHCs increase the risk of hepatic tumors, particularly hepatic adenomas; rupture of hepatic adenomas may cause death from abdominal hemorrhage

May decrease glucose tolerance; carefully monitor females with prediabetes and diabetes during therapy

Females with hypertriglyceridemia or with family history may have increase serum triglyceride concentrations during use, which may increase risk of pancreatitis; consider alternative contraception

Studies suggest an increased risk of developing gallbladder disease among CHC users; use of CHCs may also worsen existing gallbladder disease; females with a history of pregnancy-related cholestasis may be at an increased risk for CHC-related cholestasis; consider discontinuing treatment in females with symptomatic gallbladder disease or cholestatic disease

Limited data are available on association of COCs with onset of depression or exacerbation of existing depression; monitor females with a history of depression and discontinue if depression recurs to a serious degree

Discontinue if pregnancy occurs

Epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (eg, cardiac anomalies, limb-reduction defects) following COC exposure before conception or during early pregnancy

Contraceptive hormones and/or metabolites are present in human milk

COCs can reduce milk production in breastfeeding females; reduction may occur at any time, but less likely to occur once breastfeeding is well established