Thromboembolic Disorders and Other Vascular Conditions
- Do not use XULANE in women at high risk for arterial or venous thromboembolism diseases.
- Combination hormonal contraceptives (CHCs) increase the risk of thromboembolic disorders including venous thromboembolism (VTE). Known risk factors for VTE include smoking, obesity and family history of VTE. The risk of VTE is highest during the first year of CHC use and when restarting hormonal contraception after a break of 4 weeks or longer.
- Use of CHCs also increases the risk of arterial thromboses (e.g., stroke and myocardial infarction). The risk is greatest among hypertensive women who are >35 years old and smoke. Use CHCs with caution in women with cardiovascular disease risk factors.
- Stop XULANE if: * an arterial or VTE occurs; * there is unexplained loss of vision, proptosis, diplopia, papilledema, or retina vascular lesions; * at least 4 weeks before and through 2 weeks after major surgery or surgeries known to have an elevated risk of VTE.
- Start XULANE no earlier than 4 weeks after delivery in women who are not breastfeeding.
Ethinyl Estradiol Exposure
- Higher estrogen exposure may increase the risk of adverse reactions, including VTE.
- The Area Under the Curve (AUC) for Ethinyl Estradiol (EE) is approximately 60% higher in women using XULANE compared to oral contraceptives containing EE 35 mcg. In contrast, the peak concentration (Cmax) for EE is approximately 25% lower in women using norelgestromin and Ethinyl Estradiol transdermal system. [See Section 12.3 of the PI.]
- Do not use XULANE in women with liver disease or tumors.
- Discontinue XULANE if jaundice or acute or chronic disturbances of liver function develop.
- Hepatic adenomas are associated with CHC use. Rupture of hepatic adenomas may cause death.
- Studies have shown an increased risk of developing hepatocellular carcinoma in long-term (> 8 years) CHC users.
Risk of liver enzyme elevations with concomitant hepatitis C treatment
- Discontinue XULANE prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir.
High Blood Pressure
- XULANE is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease.
- For women with well-controlled hypertension, monitor blood pressure and stop XULANE if blood pressure rises significantly.
This is not a full list of all the XULANE Warnings and Precautions. Read the Important Safety Information below for more information.