NuvaRing (etonogestrel and ethinyl estradiol) Drug Information
- Special Dietary
- Side Effects
- Storage Conditions
- Other Information
- Brand Names
Why is this medication prescribed?
NuvaRing® is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Like oral contraceptives, NuvaRing® is highly effective if used as recommended in this label.
How should this medicine be used?
NuvaRing® contains a combination of a progestin and estrogen, two kinds of female hormones. You insert the ring in your vagina and leave it there for three weeks. After the ring is inserted, it releases a continuous low dose of hormones into your body. You then remove it for a one-week ring-free period.
What special precautions should I follow?
It is routine medical practice for women using NuvaRing®, as for all women, to have an annual medical evaluation including physical examination and relevant laboratory tests. The physical examination should include special reference to blood pressure, breasts, abdomen, pelvic organs and vagina (including cervical cytology). In case of undiagnosed, persistent or recurrent abnormal vaginal bleeding, appropriate measures should be conducted to rule out malignancy. Women with a family history of breast cancer or who have breast nodules should be monitored with particular care.
Women who are being treated for hyperlipidemias should be followed closely if they elect to use NuvaRing®. Some progestogens may elevate LDL levels and may render the control of hyperlipidemias more difficult.
In women with familial defects of lipoprotein metabolism receiving estrogen-containing preparations, there have been case reports of significant elevations of plasma triglycerides leading to pancreatitis.
If jaundice develops in any woman using NuvaRing®, product use should be discontinued. The hormones in NuvaRing® may be poorly metabolized in women with impaired liver function.
Steroid hormones like those in NuvaRing®, may cause some degree of fluid retention. NuvaRing® should be prescribed with caution, and only with careful monitoring, in women with conditions which might be aggravated by fluid retention.
Women becoming significantly depressed while taking hormonal contraceptives should stop the medication and use an alternate method of contraception in an attempt to determine whether the symptom is drug related. Women with a history of depression should be carefully observed and the drug discontinued if depression recurs to a serious degree.
On rare occasions, NuvaRing® may be expelled while removing a tampon (see EXPULSION). Pharmacokinetic data show that the use of tampons has no effect on the systemic absorption of the hormones released by NuvaRing®.
Cases of toxic shock syndrome have been associated with tampons and certain barrier contraceptives. Very rare cases of TSS have been reported by NuvaRing® users; in some cases the women were also using tampons. No causal relationship between the use of NuvaRing® and TSS has been established. If a patient exhibits signs or symptoms of TSS, the possibility of this diagnosis should not be excluded and appropriate medical evaluation and treatment initiated.
Contact lens wearers who develop visual changes or changes in lens tolerance should be assessed by an ophthalmologist.
What special dietary instructions should I follow?
Unless your doctor tells you otherwise, continue your normal diet.
What side effects can this medication cause?
NuvaRing may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- Gastrointestinal symptoms (such as abdominal pain, cramps and bloating)
- Breakthrough bleeding
- Change in menstrual flow
- Temporary infertility after discontinuation of treatment
- Edema/fluid retention
- Melasma/chloasma which may persist
- Breast changes: tenderness, pain, enlargement, and secretion
- Decrease in serum folate levels
- Exacerbation of porphyria
- Aggravation of varicose veins
- Change in weight or appetite (increase or decrease)
- Change in cervical ectropion and secretion
- Possible diminution in lactation when given immediately postpartum
- Cholestatic jaundice
- Migraine headache
- Rash (allergic)
- Mood changes, including depression
- Vaginitis, including candidiasis
- Change in corneal curvature (steepening)
- Intolerance to contact lenses
- Exacerbation of systemic lupus erythematosus
- Exacerbation of chorea
- Anaphylactic/anaphylactoid reactions, including urticaria, angioedema, and severe reactions with respiratory and circulatory symptoms
What storage conditions are needed for this medicine?
Prior to dispensing to the user, store refrigerated 2–8°C (36–46°F). After dispensing to the user, NuvaRing® can be stored for up to four months at 25°C (77°F); excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Avoid storing NuvaRing® in direct sunlight or at temperatures above 30°C (86°F). For the Dispenser: When NuvaRing® is dispensed to the user, place an expiration date on the label. The date should not exceed either four months from the date of dispensing or the expiration date, whichever comes first.
In case of emergency/overdose
Overdosage of combination hormonal contraceptives may cause nausea, vomiting, vaginal bleeding, or other menstrual irregularities. Given the nature and design of NuvaRing® it is unlikely that overdosage will occur. If NuvaRing® is broken, it does not release a higher dose of hormones. Serious ill effects have not been reported following acute ingestion of large doses of oral contraceptives by young children. There are no antidotes and further treatment should be symptomatic.
What other information should I know?
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 thrombogenic 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) or 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®