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Nuvaring Vaginal Ring Information:

NuvaRing (etonogestrel/ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring containing two active components, a progestin, etonogestrel and an estrogen, ethinyl estradiol. Interactions between contraceptive steroids and other drugs have been reported in the literature (see PRECAUTIONS). The pharmacokinetics of NuvaRing were evaluated in one cycle in 24 healthy female subjects randomized to a single-dose vaginal administration on Day 8 of 100 mg of a nonoxynol-9 spermicide gel or a 1200 mg miconazole nitrate antimycotic capsule. In this study, it was determined that the vaginally-administered, oil-based miconazole nitrate capsule increased the serum concentrations of etonogestrel and ethinyl estradiol by approximately 17% and 16%, respectively. The clinical significance of these findings is unknown; however, the contraceptive effectiveness of NuvaRing is not expected to change. It was determined that the single dose of 100 mg vaginally-administered, water-based nonoxynol-9 gel did not affect the serum concentrations of etonogestrel or ethinyl estradiol. The effects of chronic administration of either of these products with NuvaRing are unknown. NuvaRing is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Nuvaring Vaginal Ring Side Effects:

The most common adverse events reported by 5 to 14% of women using NuvaRing in clinical trials (n=2501) were the following: vaginitis, headache, upper respiratory tract infection, leukorrhea, sinusitis, weight gain, and nausea. NuvaRing should not be used in women who currently have the following conditions: • Thrombophlebitis or thromboembolic disorders • A past history of deep vein thrombophlebitis or thromboembolic disorders • Cerebral vascular or coronary artery disease (current or history) • Valvular heart disease with complications • Severe hypertension • Diabetes with vascular involvement • Headaches with focal neurological symptoms • Major surgery with prolonged immobilization • Known or suspected carcinoma of the breast or personal history of breast cancer • Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia • Undiagnosed abnormal genital bleeding • Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use • Hepatic tumors (benign or malignant), active liver disease • Known or suspected pregnancy • Heavy smoking (=15 cigarettes per day) and over age 35 • Hypersensitivity to any of the components of NuvaRing®

NuvaRing® does not protect against HIV infection and other sexually transmitted diseases. The use of combination oral contraceptives is associated with increased risks of several serious side effects, including thromboembolic diseases. Some studies suggest that this risk is slightly increased by combination oral contraceptives containing desogestrel; additional studies do not support this finding. It is unknown whether NuvaRing® has a different risk of VTE than second generation oral contraceptives. Cigarette smoking increases the risk of serious cardiovascular side effects; women who use combination hormonal contraceptives are strongly advised not to smoke.