Indicated for use by females of reproductive age to prevent pregnancy.

To achieve maximum contraceptive effectiveness, NuvaRing must be used as directed. One NuvaRing is inserted in the vagina. The ring is to remain in place continuously for three weeks. It is removed for a one-week break, during which a withdrawal bleed usually occurs. A new ring is inserted one week after the last ring was removed.

NuvaRing may not be suitable for women with conditions that make the vagina more susceptible to vaginal irritation or ulceration. Vaginal/cervical erosion or ulceration in women using NuvaRing has been reported. In some cases, the ring adhered to vaginal tissue, necessitating removal by a healthcare provider and in some instances (i.e., when the tissue had grown over the ring), removal was achieved by cutting the ring without incising the overlying vaginal tissue.

Women over 35 years old who smoke should not use NuvaRing. Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. 

Use of this product before menarche is not indicated.

Cases of Toxic Shock Syndrome have been reported by NuvaRing users.

Do not use NuvaRing in women with liver disease such as acute viral hepatitis or severe (decompensated) cirrhosis of the liver.

Consider alternative contraception for women with uncontrolled dyslipidemia.

Studies suggest a small increased relative risk of developing gallbladder disease among CHC users. Use of CHCs may also worsen existing gallbladder disease.

Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using CHCs.

Carefully monitor prediabetic and diabetic women who are using NuvaRing. CHCs may decrease glucose tolerance.

Carefully observe women with a history of depression and discontinue NuvaRing use if depression recurs to a serious degree.

Studies have shown an increased risk of developing hepatocellular carcinoma in long term (>8 years) CHC users.

Hypersensitivity reactions of anaphylaxis and angioedema have been reported during use of NuvaRing.

An increased risk of thromboembolic and thrombotic disease associated with the use of CHCs is well-established.

Use NuvaRing with caution in women with cardiovascular disease risk factors.

Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while using NuvaRing.

NuvaRing is contraindicated in patients with: A high risk of arterial or venous thrombotic diseases. Examples include women who:

• Are known smoke, if over age 35
• Have deep vein thrombosis or pulmonary embolism, now or in the past
• Have cerebrovascular disease
• Have coronary artery disease
• Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (subacute bacterial endocarditis with valvular disease, or atrial fibrillation)
• Have inherited or acquired hypercoagulopathies
• Have uncontrolled hypertension
• Have diabetes mellitus with vascular disease
• Have headaches with focal neurological symptoms or migraine headaches with aura
• Women over age 35 with any migraine headaches
• Breast cancer or other estrogen-or progestin-sensitive cancer, now or in the past
•  Liver tumors, benign or malignant or liver disease
• Undiagnosed abnormal uterine bleeding
• Pregnancy
• Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations

Discontinue NuvaRing prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. NuvaRing can be restarted approximately 2 weeks following completion of treatment with the Hepatitis C combination drug regimen.

Drugs or herbal products that induce certain enzymes, including cytochrome P450 3A4 (CYP3A4), may decrease the plasma concentrations of CHCs and potentially diminish the effectiveness of CHCs or increase breakthrough bleeding. Some drugs or herbal products that may decrease the effectiveness of hormonal contraceptives include: phenytoin, barbiturates, carbamazepine, bosentan, felbamate, griseofulvin, oxcarbazepine, rifampicin, topiramate, rifabutin, rufinamide, aprepitant, and products containing St. John’s wort. Interactions between CHCs and other drugs may lead to breakthrough bleeding and/or contraceptive failure.

Co-administration of atorvastatin and certain CHCs containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20-25%. Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol concentrations, possibly by inhibition of conjugation. Concomitant administration of strong or moderate CYP3A4 inhibitors such as itraconazole, voriconazole, fluconazole, grapefruit juice, or ketoconazole may increase plasma estrogen and/or progestin concentrations. Co-administration of vaginal miconazole nitrate and NuvaRing increases the serum concentrations of etonogestrel and ethinyl estradiol by up to 40%.

CHCs containing ethinyl estradiol may inhibit the metabolism of other compounds (e.g., cyclosporine, prednisolone, theophylline, tizanidine, and voriconazole) and increase their plasma concentrations. CHCs have been shown to decrease plasma concentrations of acetaminophen, clofibric acid, morphine, salicylic acid and temazepam. A significant decrease in the plasma concentrations of lamotrigine has been shown, likely due to induction of lamotrigine glucuronidation. This may reduce seizure control; therefore, dosage adjustments of lamotrigine may be necessary. Women on thyroid hormone replacement therapy may need increased doses of thyroid hormone because serum concentrations of thyroid-binding globulin increase with use of CHCs.

The use of NuvaRing may be initiated no sooner than four weeks postpartum in women who elect not to breastfeed, due to the increased risk of thromboembolism in the postpartum period.

Advise women who are breastfeeding not to use NuvaRing but to use other forms of contraception until the child is weaned.

GoToSource

• Use in patients before menarche. GoToSource 

• Polycystic ovary syndrome. GoToSource 

• Migraine aura and menstrual-related migraine. GoToSource 

• Menorrhagia, dysmenorrhea, premenstrual symptoms and hypertension. GoToSource

 Galactorrhea (nipple discharge). GoToSource

Thromboembolism (obstruction of blood vessel by blood clot). GoToSource

Headache, vaginitis and weight gain. GoToSource

Cerebral venous sinus thrombosis (blood clot in venous sinuses of the brain). GoToSource

Increased risk of breast cancer. GoToSource

Increased risk of heart attack and stroke. GoToSource

Pulmonary embolism (blockage in one of pulmonary arteries in lungs). GoToSource

Lawsuits filed for pulmonary embolism, deep vein thrombosis, strokes, heart attacks and sudden death.