VIENVA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for VIENVA (VIENVA).
Estrogen component (ethinyl estradiol) increases hepatic synthesis of sex hormone-binding globulin (SHBG) and thyroxine-binding globulin; progestin (drospirenone) has anti-mineralocorticoid and anti-androgenic activity.
| Metabolism | Ethinyl estradiol undergoes CYP3A4-mediated metabolism and conjugation (sulfation and glucuronidation); drospirenone is metabolized via CYP3A4 and to a lesser extent by CYP1A1 and CYP2C9, with no active metabolites. |
| Excretion | Rental (70% as unchanged drug, 20% as conjugates), biliary/fecal (10%) |
| Half-life | Terminal elimination half-life 24-32 hours; clinical context: once-daily dosing achieves steady-state within 7 days. |
| Protein binding | 96-98% bound to albumin and SHBG. |
| Volume of Distribution | Vd 2.8-3.5 L/kg; indicates extensive distribution into tissues, including reproductive organs. |
| Bioavailability | Oral: 90-100% (due to low first-pass metabolism); transdermal: 90% (patch). |
| Onset of Action | Oral: 2-4 hours for contraceptive effect; transdermal: 24-48 hours for therapeutic levels. |
| Duration of Action | 24 hours for contraceptive effect with once-daily oral dosing; transdermal patch maintains effective levels for 7 days. |
One tablet (ethinyl estradiol 0.03 mg and levonorgestrel 0.15 mg) orally once daily for 21 days, followed by 7 placebo tablets.
| Dosage form | TABLET |
| Renal impairment | No dose adjustment is required for mild to moderate renal impairment. Contraindicated in severe renal impairment or acute renal failure. |
| Liver impairment | Contraindicated in active liver disease, hepatic adenomas, or history of cholestatic jaundice. Not recommended in Child-Pugh class B or C. |
| Pediatric use | Not indicated for use before menarche. Post-menarche: same as adult dosing (one tablet daily). |
| Geriatric use | Not indicated for use after menopause. No specific geriatric dosing available. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for VIENVA (VIENVA).
| Breastfeeding | Small amounts of contraceptive steroids and/or metabolites are excreted in breast milk. No M/P ratio reported. Combination hormonal contraceptives may reduce milk production and affect composition; use is not recommended during breastfeeding. Progestin-only methods preferred. VIENVA should not be used by lactating women until the infant is weaned. |
| Teratogenic Risk | VIENVA (desogestrel/ethinyl estradiol) is contraindicated in pregnancy. First trimester: no increased risk of major birth defects from inadvertent exposure, but use is not indicated. Second/third trimester: no data from adequate studies; combination hormonal contraceptives should not be used during pregnancy. Available data do not suggest a teratogenic effect when inadvertently taken early in pregnancy. |
■ FDA Black Box Warning
Cigarette smoking increases risk of serious cardiovascular events from combined oral contraceptive use. Risk increases with age and heavy smoking (≥15 cigarettes/day). Women over 35 who smoke should not use combined oral contraceptives.
| Serious Effects |
Thrombophlebitis or thromboembolic disorders; cerebrovascular or coronary artery disease; known or suspected pregnancy; undiagnosed abnormal genital bleeding; known or suspected breast cancer; hepatic adenoma or carcinoma; severe renal insufficiency (CrCl <30 mL/min); jaundice with prior oral contraceptive use; use of certain Hepatitis C drug combinations (e.g., ombitasvir/paritaprevir/ritonavir with dasabuvir); hypersensitivity to any component.
| Precautions | Risk of thromboembolic disorders (especially in smokers, hypertension, hyperlipidemia, diabetes, obesity); increased risk of cervical cancer; hepatic adenoma; breast cancer risk; worsening of depression; elevated plasma potassium in patients with renal impairment or concomitant potassium-sparing drugs; bone mineral density changes; discontinuation before surgery with prolonged immobilization; exacerbation of gallbladder disease; cholestatic jaundice; hereditary angioedema; monitoring in patients with diabetes, dyslipidemia, and liver disease. |
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| Fetal Monitoring | If exposed during pregnancy, no specific fetal monitoring required beyond routine prenatal care. For maternal monitoring: assess blood pressure and signs of thromboembolism (especially if continued inadvertently). Women should be advised to discontinue if pregnancy is suspected. |
| Fertility Effects | VIENVA suppresses ovulation; fertility returns to baseline after discontinuation. No evidence of permanent adverse effects on fertility. Post-pill amenorrhea may occur but is transient. |