See Supplemental Patient Information
- Cigarette smoking increases the risk of serious cardiovascular side effects from combination oral contraceptive use. Women should be advised to avoid smoking during therapy [US Black Box Warning]
- Use of oral contraceptives may be associated with increased risks of several serious conditions such as venous and arterial thrombotic and thromboembolic events (MI, stroke, thromboembolism), hepatic neoplasia, gallbladder disease, and hypertension. Other risk factors that predispose to a higher morbidity or mortality include certain inherited thrombophilias, diabetes, hyperlipidemias, and obesity. Caution should be advised in women with cardiovascular disease risk factors
- Increased risk of thromboembolic and thrombotic disease has been reported with the use of combination contraceptives; risk of post-operative thromboembolic complications increases two- to four-fold with the use of combination contraceptives. Discontinue therapy if any thrombotic events occur
- Discontinue use of combination contraceptives at least 4 weeks before and for 2 weeks after elective surgery of a type associated with an increase in the risk of thromboembolism and during and following prolonged immobilization; initiate therapy after 4-6 weeks following delivery in women who elect not to breastfeed
- Combination contraceptives increase the risk of cerebrovascular events (thrombotic and hemorrhagic strokes), especially in older (>35 yrs), hypertensive women who also smoke
- As progestational agents reduce serum HDL and estrogens increase HDL cholesterol, the net effect of combination contraceptives depends on a balance attained between doses of estrogen and progestogen and the nature and total amount of progestogens used in the contraceptives
- Use of low-dose hormonal contraceptives by healthy non-smoking women >40 yrs ensures that their benefits outweigh the possible risks
- Use of combination contraceptives may increase the risk of breast and cervical cancer; however, the risk reduces over time after discontinuation of therapy. Avoid use in women with known or suspected carcinoma of the breast or personal history of breast cancer
- Rare cases of benign hepatic adenomas have been reported with the use of combination contraceptives. Rupture of rare, benign, hepatic adenomas may cause fatal intra-abdominal hemorrhage
- Retinal thrombosis may occur with use of combination contraceptives. Discontinue use if there is unexplained partial or complete loss of vision, proptosis/diplopia, papilledema, or retinal vascular lesions
- Hormonal contraceptives should not be used during pregnancy; avoid use during pregnancy to treat threatened or habitual abortion
- Combination contraceptives may exacerbate existing gallbladder disease and may augment the development of this condition in previously asymptomatic women
- Hypertension may occur during therapy; this is more common in older contraceptive users and with continued use. Closely monitor hypertensive women using combination contraceptives; discontinue use if significant elevation of blood pressure occurs
- The onset or worsening of migraine or development of headache with a new pattern that is recurrent, persistent or severe requires discontinuation of therapy
- Severe or persistent abnormal bleeding during therapy with ethinyl estradiol/etonogestrel should be investigated to exclude the possibility of organic pathology or pregnancy; appropriate treatment should be initiated if required
- Contraceptive failure may lead to ectopic and intrauterine pregnancy
- Use cautiously in prediabetic and diabetic women, as combination contraceptives may cause a decrease in glucose tolerance. Elevations in serum triglycerides and lipoprotein levels have been reported during therapy
- Women should be counseled that ethinyl estradiol/etonogestrel does not provide protection against HIV/AIDS and other STDs
- Physical examinations and relevant lab tests are recommended for all women treated with ethinyl estradiol/etonogestrel to check for cervical and breast cancer
- Closely monitor women treated for hyperlipidemias if they elect to use ethinyl estradiol/etonogestrel, as certain progestogens may increase LDL levels and may render the control of hyperlipidemias more difficult
- Discontinue therapy if the user develops jaundice, as the hormones in this product may be poorly metabolized in women with hepatic impairment
- Ethinyl estradiol/etonogestrel may cause fluid retention. Caution should be advised in women with conditions that might be aggravated by fluid retention
- Monitor women with a history of depression during therapy; discontinue treatment if depression recurs to a serious degree
- Occasionally, the product may be expelled while removing a tampon
- Toxic shock syndrome during combined contraceptive use has been reported in rare cases; however, it may be associated with concurrent tampon use
- Ethinyl estradiol/etonogestrel vaginal ring users wearing contact lenses may develop visual changes and intolerance to lenses
- Vaginal/cervical erosion or ulceration may rarely occur in women using ethinyl estradiol/etonogestrel ring. This product may interfere with the correct placement of diaphragm; hence, use of diaphragm as a back-up method should be avoided
- Vaginal ring may get inadvertently inserted in urinary bladder in rare cases, which may require cystoscopic removal
- Ethinyl estradiol/etonogestrel vaginal ring may get accidentally expelled. If the expelled ring is left outside the vagina for less than 3 hrs, it may be reinserted after rinsing. If the ring is lost or left outside for >3 hrs, a new vaginal ring should be promptly inserted
- Disconnection of the vaginal ring at the weld joint has been reported, which may cause vaginal discomfort or expulsion. In such cases, discard the disconnected ring and replace it with a new one
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Headaches without neurologic symptoms
- Non-smokers >40 yrs
Supplemental Patient Information
- Advise patients that ethinyl estradiol/etonogestrel vaginal ring does not provide protection against HIV/AIDS and other STDs
Pregnancy Category:X
Breastfeeding: Low levels of ethinyl estradiol are excreted in human milk. Ethinyl estradiol in daily doses of 30 mcg or greater may suppress lactation. The magnitude of the effect on lactation depends on the dose and the time of introduction postpartum. The etonogestrel implant can be inserted as early as 4 wks postpartum in nursing mothers. Expert opinion in the United States holds that the risks of combination contraceptives usually outweigh the benefits before 4 weeks postpartum. Between 4 weeks and 6 months postpartum, the advantages of using the method outweigh the theoretical or proven risks, although the evidence of lack of effect on lactation is poor and does not include preterm or ill infants. Combination contraceptives may be used after 6 months postpartum; however, use of progestin-only methods is preferred if breastfeeding is to be continued. This information is based upon LactMed database (available at http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT last accessed 23 June 2011). Manufacturer recommends avoiding use until the child is weaned.
US Trade Name(s)
US Availability
NuvaRing (ethinyl estradiol/etonogestrel)
- RING: [0.015 mg/0.12 mg]/day
Canadian Trade Name(s)
Canadian Availability
NuvaRing (ethinyl estradiol/etonogestrel)
- RING: [15 mcg/120 mcg]/day
UK Trade Name(s)
UK Availability
NuvaRing (ethinylestradiol/etonogestrel)
- RING: [0.015 mg/0.12 mg]/24 hrs
Australian Trade Name(s)
Australian Availability
NuvaRing (ethinylestradiol/etonogestrel)
- RING: [15 mcg/120 mcg]/day
[Outline]
Pricing data from www.DrugStore.com in U.S.A.
- NuvaRing 0.12-0.015 MG/24HR RING [Box] (ORGANON)
1 24hr = $86.99
2 24hr = $163.96
Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.
15 cigarettes/day) and is greatest in women over 35 yrs of age