Drospirenone/Ethinyl Estradiol/Levomefolate

DEA Class; Rx

Common Brand Names; Beyaz, Safyral, Tydemy

Indicated for routine contraception and to increase folate levels in women who desire to use oral contraception.

Documented hypersensitivity

Active/history of breast cancer or estrogen- or progestin-sensitive caner

Active/history of arterial thromboembolic disease (stroke, MI), thrombophlebitis, DVT/PE, thrombogenic valvular disease

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

• Premenstrual syndrome (13.2%)
• Migraine/headache (10.7%)
• Breast pain/discomfort/tenderness (8.3%)
• Menstrual irregularities (4.7%)
• Nausea/vomiting (4.5%)
• Abdominal pain/discomfort/tenderness (2.3%)
• Mood changes, including affect lability, depression, alteration of mood, mood swings, and irritability (2.3%)
• Irregular uterine bleeding
• Venous/arterial thromboembolic events, including DVT, PE, stroke, MI, intracardiac thrombosis, sagittal sinus thrombosis, intracranial venous sinus thrombosis, retinal vein thrombosis
• Hypertension
• Hypersensitivity
• Hyperkalemia
• Chloasma
• Gallbladder disease
• Toxic skin eruption
• Uterine leiomyoma

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

Pregnancy category: X

Lactation: Small amounts of steroids are excreted in breast milk; estrogens may reduce quality or quantity of milk; may be prudent to use other forms of birth control until full weaning (American Academy of Pediatrics committee states that agent is compatible with nursing); not recommended