Contraception:

Indications for: CYCLESSA

Oral contraception.

Adult Dosage:

1 tab daily for 28 days; repeat.

Children Dosage:

Not applicable.

CYCLESSA Contraindications:

Thrombophlebitis or thromboembolic disorders. Cerebral vascular or coronary artery disease. Valvular heart disease with thrombogenic complications. Severe hypertension. Diabetes with vascular involvement. Headaches with focal neurologic symptoms. Major surgery with prolonged immobilization. Breast or other estrogen-dependent neoplasms. Undiagnosed abnormal genital bleeding. Cholestatic jaundice of pregnancy or jaundice with prior OC use. Hepatic disease or tumors. Smokers (≥15 cigarettes/day) over age 35. Pregnancy (Cat.X). Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

Boxed Warning:

Cigarette smoking increases risk of serious cardiovascular events.

CYCLESSA Warnings/Precautions:

Increased risk of cardiovascular events (eg, MI, stroke, VTE) esp. in cigarette smokers >35yrs of age. Discontinue if thrombotic event, unexplained visual changes, jaundice, migraine or other severe headaches occur, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Gallbladder disease. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Hypertriglyceridemia. Depression. Fluid rentention. Monitor blood pressure. Do regular complete physical exams. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Nursing mothers: not recommended.

CYCLESSA Classification:

Progestin + estrogen.

CYCLESSA Interactions:

See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Cyclessa prior to starting HCV regimen and restart 2wks after completion. May be antagonized by barbiturates, rifampin, phenylbutazone, phenytoin, carbamazepine, felbamate, oxcarbazepine, topiramate, griseofulvin, St. John's wort. May be potentiated by atorvastatin, ascorbic acid, acetaminophen, itraconazole, ketoconazole. May be affected by HIV protease inhibitors. May potentiate cyclosporine, prednisolone, theophylline. May antagonize acetaminophen, temazepam, salicylic acid, morphine, clofibric acid. May affect laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins).

Adverse Reactions:

Nausea, vomiting, breakthrough bleeding, amenorrhea, transient delay of ovulation after discontinuation, edema, chloasma, headache, weight changes, intolerance to contact lenses; serious thromboembolic events, liver disease, hypertension.

How Supplied:

Pack—1