Norethindrone/​Ethinyl Estradiol

DEA Class; Rx

Common Brand Names; Aranelle, Balziva 28, Alyacen 1/35, Alyacen 7/7/7, Briellyn, Cyclafem 7/7/7, Cyclafem 0.5/35, Cyclafem 1/35, Dasetta 1/35, Dasetta 7/7/7, Leena, Necon 0.5/35, Norethin 1/35E, Norinyl 1+35, Nortrel 0.5/35, Nortrel 1/35, Nortrel 7/7/7, Philith, Pirmella 1/35, Pirmella 7/7/7, Wera, Cyonanz, Nylia 1/35, Nylia 7/7/7, Vyfemla

Indicated for routine contraception.

Documented hypersensitivity

Active or history of breast cancer

Arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease

Estrogen-dependent neoplasia

Liver disease, liver tumors

Undiagnosed abnormal uterine bleeding

Uncontrolled hypertension (ie, persistent BP values >160 mm Hg systolic or >100 mg Hg diastolic)

Diabetes mellitus with vascular involvement

Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders

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

• Edema
• Weakness
• Anorexia
• Amenorrhea
• Breakthrough bleeding
• Change in menstrual flow
• Spotting
• Deep vein thrombosis
• Thrombophlebitis
• Depression
• Dizziness
• Headache
• Nervousness
• Somnolence
• Breast tenderness
• Galactorrhea
• Abdominal pain
• Nausea
• Vomiting
• Weight change
• Cholestatic jaundice

Women with a history of hypertension or hypertension-related diseases, or renal disease should be encouraged to use another method of contraception

Family history of breast cancer and or DVT/PE, current/history of depression, endometriosis, DM, HTN, bone mineral density changes, renal/hepatic impairment, bone metabolic disease, SLE; conditions exacerbated by fluid retention (eg, migraine, asthma, epilepsy)

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

Monitor prediabetic and diabetic women taking eithinyl estradiol/norethindrone; consider alternative contraceptive method for women with uncontrolled dyslipidemia

Risk of thromboembolic disease associated with oral contraceptives gradually disappears after combined oral contraceptive (COC) use is stopped; VTE risk is highest in first year of use and when restarting hormonal contraception after a break of four weeks or longer

Discontinue 4 week before major surgery or prolonged immobilization

If thrombotic event occurs, stop at least 4 wk before through 2 wk after major surgery; start no earlier than 4 weeks after delivery, in women who are not breastfeeding

Patients on warfarin, oral anticoagulants (increase in anticoagulant dose may be warranted)

Some studies link OCP use with increased risk of breast cancer, whereas other studies have not shown a change in risk; woman’s risk depends on conditions where naturally high hormone levels persist for long periods of time including early onset menstruation before age 12, late onset menopause, after age 55, first child after age 30, nulliparity

Increased risk of cervical cancer with OCP use, however HPV remains as main risk factor for this cancer; evidence suggests long-term use of OCPs, 5 or more years, may be associated with increased risk

Increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use

Evaluate significant change in headaches and discontinue therapy if indicated

Evaluate irregular bleeding or amenorrhea

Discontinue hormonal therapy prior to starting therapy with combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; may restart approximately 2 weeks following completion of treatment with combination drug regimen

Pregnancy Category: X

Lactation: small amounts of steroids are excreted in breast milk; estrogens may reduce quality/quantity of milk; may be prudent to use other forms of birth control until full weaning (AAP Committee states compatible with nursing)