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. |
| Molecular Weight | 312.4 |
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 | Contraindicated due to risk of teratogenicity (skeletal and visceral malformations). |
| 2nd trimester | Contraindicated due to risk of fetal harm; may cause fetal renal impairment and oligohydramnios. |
| 3rd trimester | Contraindicated due to risk of neonatal renal impairment and premature closure of ductus arteriosus. |
Clinical note
Comprehensive clinical and safety monograph for VIENVA (VIENVA).
| Placental transfer | Crosses placenta extensively; demonstrated in animal and human studies. |
| Breastfeeding | Not recommended. Excreted in breast milk; potential for serious adverse effects in nursing infants (e.g., renal impairment). |
| Lactation Rating |
■ 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 |
PregnancyHypersensitivity to NSAIDsActive peptic ulcer diseaseSevere renal impairment (eGFR <30 mL/min)Severe hepatic impairmentHistory of asthma exacerbation with NSAIDs
| 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. |
| Food/Dietary | No specific food interactions. Grapefruit juice may slightly increase estrogen levels but not clinically significant. Avoid alcohol if you have liver disease. Maintain consistent intake of potassium-rich foods (bananas, oranges, spinach) as drospirenone can increase potassium levels. |
Loading safety data…
| L5 (Contraindicated) |
| 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. |
| 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. |
| Clinical Pearls | VIENVA (combination of ethinyl estradiol and drospirenone) is a combined oral contraceptive. Counsel patients about increased risk of venous thromboembolism, especially in smokers over 35. Monitor for hyperkalemia due to drospirenone's antimineralocorticoid effect; avoid in renal impairment. Use with caution in patients with liver disease or history of depression. |
| Patient Advice | Take one tablet daily at the same time, even if you do not have sexual intercourse. · Missed dose management: If you miss one pill, take it as soon as you remember, even if that means taking two pills in one day. If you miss two or more pills, use backup contraception and consult your doctor. · This medication does not protect against HIV or other sexually transmitted diseases. · Report symptoms of blood clots such as leg pain/swelling, sudden shortness of breath, or chest pain. · Avoid smoking while taking this medication, especially if you are over 35 years old. · Inform your doctor if you have kidney, liver, or adrenal gland problems, or if you are breastfeeding. |