Uncontrolled hypertension Diabetes mellitus with vascular involvement History of migraine with aura Undiagnosed abnormal uterine bleeding Benign or malignant liver tumors, hepatic impairment or development of jaundice with prior oral contraceptive use Pregnancy Renal impairment Adrenal insufficiency Receiving hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir Cautions Due to increased risk of hyperkalemia, monitor serum potassium during first month if coadministered with potassium-elevating/sparing drugs (eg, spironolactone); consider monitoring serum potassium concentration in high-risk patients who take a strong CYP3A4 inhibitor long-term and concomitantly; strong CYP3A4 inhibitors include azole antifungals (e.g. ketoconazole, itraconazole, voriconazole), HIV/HCV protease inhibitors (e.g., indinavir, boceprevir), and clarithromycin 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 immediately if any of the following occur: jaundice, visual problems (may cause contact lens intolerance), any signs of VTE, migraine with unusual severity, significant increase in BP, severe depression, increased risk of thromboembolic complications after surgery Discontinue therapy 4 weeks before major surgery or prolonged immobilization; may resume 2 weeks afterwards Monitor patients on oral anticoagulants (eg, warfarin); increased anticoagulant dose may be warranted due to thromboembolic risk with oral contraceptives Studies have shown an increased risk of cervical cancer with OCP use; however, HPV remains the main risk factor for cervical cancer; evidence suggests long-term use of OCPs (≥5 yr) may be associated with increased risk Studies have shown a significantly decreased endometrial cancer risk with OCP use; protective effect increases with longer duration of OCP use and may continue to persist years after OCP discontinuation Risk of ovarian cancer may decrease with increasing duration of OCP use 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 Increased risk of liver cancer with OCP use; risk increases with longer duration of OCP use Monitor prediabetic and diabetic women with dyslipidemias Breast cancer Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk; studies do not show an association between ever (current or past) use of COCs and risk of breast cancer Some studies report a small increase in risk of breast cancer among current or recent users(<6 months since last use) and current users with longer duration of COC use A 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 Thromboembolic disorders Discontinue immediately if thrombotic event occurs Risk of VTE is highest during the first year of use; interim data from a large, prospective cohort safety study of various combined oral contraceptives (COCs) suggest that this increased risk, as compared with that in non-COC users, is greatest during the first 6 months of COC use Women taking drospirenone-containing contraceptives may have up to a 3-fold increased risk for developing VTE compared with women taking other combined hormonal contraceptives To decrease risk of VTE events, CDC guidelines recommend waiting at least 3 weeks following vaginal birth or 6 weeks after cesarean section before initiating use of combined hormonal contraceptives; women with additional risk factors for VTE (besides postpartum) should not use combined hormonal contraceptives Pregnancy There is no use for contraception in pregnancy; therefore, discontinue use during pregnancy There is little or no increased risk of birth defects in women who inadvertently use COCs during early pregnancy Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose COCs prior to conception or during early pregnancy The administration of COCs to induce withdrawal bleeding should not be used as a test for pregnancy. COCs should not be used during pregnancy to treat threatened or habitual abortion Women who do not breastfeed may start COCs no earlier than four weeks postpartum Lactation Estrogen-containing COCs can reduce milk production in breastfeeding mothers; this is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women; small amounts of oral contraceptive steroids and/or metabolites are present in breast milk When possible, advise nursing female to use other methods of contraception until she discontinues breast-feeding After oral administration, about 0.02% of the DRSP dose was excreted into the breast milk of postpartum women within 24 hours; this results in a maximal daily dose of about 0.003 mg DRSP in an infant Developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on breastfed child from this medication or from underlying maternal conditionPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action Ethinyl estradiol: Reduces LHRH release from hypothalamus, reduces gonadotropin release from pituitary; increases synthesis of DNA, RNA, and various proteins in target tissues; other possible mechanisms include changes in cervical mucus that cause inhibition of sperm penetration and endometrial changes that reduce likelihood of implantation Drospirenone: Progestin; spironolactone analogue with anti-mineralocorticoid and anti-androgenic activity Absorption Bioavailability: 76% (drospirenone); 40% (ethinyl estradiol) Peak plasma time: 1-2 hr Peak plasma concentration: 88 ng/mL (drospirenone); 99 pg/mL (ethinyl estradiol) AUC: 830-970 ng.hr/mL (drospirenone); 350-470 pg.hr/mL (ethinyl estradiol) Distribution Protein bound Ethinyl estradiol: >98% bound to serum albumin Drospirenone: 97% bound to serum proteins (not SHBG or corticosteroid-binding globulin) Metabolism Hepatic metabolization Metabolites: Two acid forms of DSRP (inactive) Elimination Half-life: 24 hr (ethinyl estradiol); 30 hr (drospirenone) Excretion: Urine (38-47% as inactive metabolites), feces (17-20% as inactive metabolites) No images available for this drug. No images available for this drug.A Patient Handout is not currently available for this monograph.Print FormularyPatient DiscountsAdding plans allows you to compare formulary status to other drugs in the same class.To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.Create Your List of PlansAdding plans allows you to:View the formulary and any restrictions for each plan.Manage and view all your plans together – even plans in different states.Compare formulary status to other drugs in the same class.Access your plan list on any device – mobile or desktop. The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information. View explanations for tiers and restrictions Tier Description 1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs. 2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs. 3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs. 4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. 6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products. NC NOT COVERED – Drugs that are not covered by the plan. Code Definition PA Prior Authorization Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription. 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