Indications for: SAFYRAL

Oral contraception. To raise folate ­levels in women who choose to use an OC for contraception.

Adult Dosage:

1 tab daily for 28 days; repeat. Take at the same time daily. Use Day 1 or Sunday start for 1st cycle; use backup method for first 7 days.

Children Dosage:

Pre-menarche: not applicable.

SAFYRAL Contraindications:

Renal impairment. Adrenal insufficiency. High risk of arterial or venous thrombotic disease (eg, smokers or migraineurs over age 35, history of DVT or thromboembolism, cerebrovascular or coronary artery disease, thrombogenic valvular disease, atrial fibrillation, subacute bacterial endocarditis, hypercoagulopathies, uncontrolled hypertension, diabetes with vascular disease, headaches with focal neurologic symptoms). Current diagnosis or history of breast cancer, which may be hormone-sensitive. Hepatic disease or tumors. Undiagnosed abnormal uterine bleeding. Pregnancy. Concomitant ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.

Boxed Warning:

Cigarette smoking increases risk of serious cardiovascular events.

SAFYRAL Warnings/Precautions:

Increased risk of cardiovascular events (eg, stroke, MI) esp. in cigarette smokers >35yrs of age. Discontinue if thrombotic event, unexplained visual changes, or jaundice occurs, and at least 4 weeks before through 2 weeks after surgery associated with increased risk of thromboembolism. Hyperkalemia or risk thereof. Malignant neoplasms. Diabetes. Prediabetes. Uncontrolled dyslipidemias. Hypertriglyceridemia. Gallbladder disease. Pregnancy-related cholestasis. History of depression; monitor and discontinue if serious depression recurs. Hereditary angioedema. Evaluate significant changes in headaches, irregular uterine bleeding, amenorrhea. Do regular complete physical exams. Monitor BP; discontinue if significant rise occurs. May need barrier contraception with Sunday starts or postpartum use (see full labeling). Postmenopausal women or nursing mothers: not recommended.

SAFYRAL Classification:

Progestin + estrogen + folate.

SAFYRAL Interactions:

See Contraindications. ALT elevations with HCV regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir; discontinue Safyral prior to starting HCV regimen and restart 2wks after completion. Monitor serum K+ during 1st cycle with drugs that increase potassium (eg, ACEIs, ARBs, NSAIDs, K+-sparing diuretics, K+ supplements, heparin, aldosterone antagonists); consider monitoring in high-risk patients taking concomitant long-term strong CYP3A4 inhibitors (eg, ketoconazole, itraconazole, voriconazole, indinavir, boceprevir, clarithromycin). May be antagonized by CYP3A4 or other enzyme inducers (eg, barbiturates, bosentan, carbamazepine, felbamate, griseofulvin, oxcarbazepine, phenytoin, rifampin, St. John's wort, topiramate) (use backup contraception). May be potentiated by atorvastatin, acetaminophen, ascorbic acid, or CYP3A4 inhibitors. May be affected by pro­tease inhibitors, NNRTIs. May antagonize lamotrigine. May affect laboratory tests (eg, coagulation factors, lipids, glucose tolerance, binding proteins). May need dose adjustment of thyroid hormones. May mask vitamin B12 deficiency (folate).

Adverse Reactions:

Premenstrual syndrome, headache/migraine, breast pain/tenderness, nausea, vomiting, mood changes, abdominal pain/tenderness/discomfort, breakthrough bleeding, amenorrhea, intolerance to contact lenses; chloasma, hypertension, serious thromboembolic events, liver disease.

How Supplied:

Packs—3 (blister cards)