Levonorgestrel Oral/Ethinyl Estradiol

DEA Class; Rx

Common Brand Names; Altavera, Amethia, Amethia Lo, Amethyst, Ashlyna, Aubra, Aviane, Camrese, Camrese Lo, Chateal, Daysee, Elifemme, Enpresse, Falmina, Introvale, Jolessa, Kurvelo, Lessina 21, Lessina 28, Levonest, Levora, LoSeasonique, Lybrel, Marlissa, Microgynon, Nordette, Orsythia, Ovranette, Portia 21, Portia 28, Quasense, Quartette, Sronyx, Trivora 28, Seasonale, Seasonique, Setlakin, Lutera, Myzilra, FaLessa, FaLessa Kit, Delyla, Fayosim, Larissia, Lillow, Rivelsa, Vienva

Documented hypersensitivity

Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past

Arterial thromboembolic disease (stroke, myocardial infarction [MI]), thrombophlebitis, deep vein thrombosis or pulmonary embolism (DVT)/PE, thrombogenic valvular disease

Estrogen-dependent neoplasia

Liver tumors, benign or malignant, or liver disease

Undiagnosed abnormal vaginal bleeding

Uncontrolled hypertension or hypertension with vascular disease

Diabetes mellitus and over age 35, diabetes mellitus with hypertension or vascular disease or other end-organ damage, or diabetes mellitus of >20 years duration

Inherited or acquired hypercoagulopathies, smokers aged >35 years (Natazia)

Renal insufficiency, hepatic dysfunction, adrenal insufficiency

Headaches with focal neurological symptoms or have migraine headaches with aura

Women >35 with any migraine headaches

Smoking >15 cigarettes/day at age >35 years

Major surgery with prolonged immobilization

Cerebrovascular or coronary artery disease (current or past history)

Thrombogenic rhythm disorders

Hereditary or acquired thrombophilias

Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia

Undiagnosed abnormal vagina/uterine bleeding

Cholestatic jaundice of pregnancy or jaundice with prior pill use

Receiving Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir

Before starting therapy evaluate any past medical history or family history of thrombotic or thromboembolic disorders and consider whether the history suggests an inherited or acquired hypercoagulopathy; therapy is contraindicated in females with a high risk of arterial or venous thrombotic/thromboembolic diseases

Use caution in patients with family history of breast cancer, DVT/PE, or both; current or previous depression, endometriosis, diabetes mellitus, hypertension, bone mineral density changes, renal or hepatic impairment, bone metabolic disease, systemic lupus erythematosus (SLE); conditions exacerbated by fluid retention (eg, migraine, asthma, epilepsy)

Risk of VTE is highest during first year of use of a COCs and when restarting oral contraception after a break of 4 weeks or longer; risk of thromboembolic disease due to COCs gradually disappears after COC use is discontinued; use of COCs increases risk of arterial thromboses that result in strokes and myocardial infarctions, especially in women with other risk factors for these events; COCs have been shown to increase both relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes); risk increases with age, particularly in women over 35 years of age who smoke

Discontinue therapy if an arterial thrombotic event or venous thromboembolic (VTE) event occurs; if feasible, stop therapy at least 4 weeks before and through 2 weeks after major surgery or other surgeries known to have an elevated risk of VTE as well as during and following prolonged immobilization; initiate therapy no earlier than 4 weeks after delivery in women who are not breastfeeding; risk of postpartum VTE decreases after third postpartum week, whereas risk of ovulation increases after third postpartum week

Discontinue if the following develop: Jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, significant blood pressure increase, severe depression, increased risk of thromboembolic complications after surgery

Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy; studies also do not suggest a teratogenic effect, particularly insofar as cardiac anomalies and limb reduction defects are concerned, when taken inadvertently during early pregnancy

Small amounts of oral contraceptive steroids identified in the milk of nursing mothers, and a few adverse effects on child reported, including jaundice and breast enlargement; in addition, oral contraceptives given in postpartum period may interfere with lactation by decreasing quantity and quality of breast milk