Contraception:

Indications for: VIENVA

Oral contraception.

Adult Dosage:

1 tab daily for 28 days; repeat. Take pills in order (21 levonorgestrel + ethinyl estradiol tabs, then 7 inert tabs).

Children Dosage:

Premenarchal: not recommended.

VIENVA Contraindications:

Thrombophlebitis or thromboembolic disorders. History of DVT or thromboembolism, cerebrovascular or coronary artery disease. Thrombogenic valvular disease or rhythm disorders. Hereditary or acquired thrombophilias. Major surgery with prolonged immobilization. Diabetes with vascular involvement. Headaches with focal neurological symptoms. Uncontrolled hypertension. Known or suspected breast carcinoma, endometrial carcinoma or other estrogen-dependent neoplasia. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior pill use. Hepatic disease or tumors. Pregnancy (Cat.X). Concomitant HCV drugs containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

Boxed Warning:

Cigarette smoking increases risk of serious cardiovascular events.

VIENVA Warnings/Precautions:

Increased risk of cardiovascular events (eg, MI, stroke, DVT, VTE) esp. smokers >35 years of age. Discontinue if thrombotic event, unexplained visual changes, persistently elevated BP, migraine or other severe headaches, or jaundice occurs, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism, and during and after prolonged immobilization. Cardio- or cerebrovascular diseases. Increased risk of breast or cervical cancer and hepatic neoplasia. Gallbladder disease. Obesity. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Hypertriglyceridemia. Hypertension. Evaluate significant changes in headaches, abnormal vaginal bleeding, amenorrhea. Ectopic pregnancy. Depression. Conditions aggravated by fluid retention; monitor. Do regular complete physical exams (eg, Pap smear, mammogram, BP). Nursing mothers: not recommended.

VIENVA Classification:

Progestin + estrogen.

VIENVA Interactions:

See Contraindications. Risk of ALT elevations with concomitant HCV therapy containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. May be antagonized by antibiotics, anticonvulsants or other enzyme inducers (eg, rifampin, rifabutin, barbiturates, primidone, phenylbutazone, phenytoin, dexamethasone, carbamazepine, felbamate, oxcarbazepine, topiramate, griseofulvin, modafinil, St. John’s wort); use back-up contraception. May be affected by HIV protease inhibitors. May be potentiated by atorvastatin, ascorbic acid, acetaminophen, or CYP3A4 inhibitors (eg, indinavir, itraconazole, ketoconazole, fluconazole, troleandomycin). May potentiate cyclosporine, theophylline, prednisolone, or other corticosteroids. May antagonize acetaminophen, temazepam, salicylic acid, morphine, or clofibric acid. May affect lab tests (eg, coagulation factors, binding proteins, lipids, glucose tolerance, serum folate).

Adverse Reactions:

Nausea, vomiting, breakthrough bleeding, weight changes, breast tenderness/pain/enlargement, amenorrhea, edema, melasma, headache, GI symptoms, intolerance to contact lenses; oligomenorrhea, cholasma, liver disease.

How Supplied:

Blister packs—3