Use another birth control method such as male condoms with spermicide for the first 7 days in addition to NuvaRing. This is why the simultaneous use of two contraceptive methods lowers the failure risk consistently. Throw the applicator away in the trash immediately after use. When possible, advise the nursing mother to use non-estrogen-containing contraception until she has completely weaned her child. A Prevention Research Center Tool Showing Evidence of Effectiveness. Some of these studies indicate an approximate two-fold increased risk. We found that the perfect-use Pearl Index was 1.0 pregnancies per 100 woman-years (95% CI: 0.5-1.5). In the clinical studies, the percent of women who did not have withdrawal bleeding in a given cycle ranged from 0.3% to 3.8%. Ethinyl estradiol: Ethinyl estradiol is highly but not specifically bound to serum albumin (98.5%) and induces an increase in the serum concentrations of SHBG. NuvaRing can be rinsed with cool to lukewarm (not hot) water and reinserted as soon as possible, but at the latest within three hours. Pearl index is used for measuring the failure rate of a contraceptive. Co-administration of atorvastatin and certain CHCs containing ethinyl estradiol increase AUC values for ethinyl estradiol by approximately 20-25%. Some women have experienced a brief mild pinching feeling when using the applicator. These are present as free metabolites and as sulfate and glucuronide conjugates. Each NuvaRing (etonogestrel/ethinyl estradiol vaginal ring) is individually packaged in a reclosable aluminum laminate sachet consisting of three layers, from outside to inside: polyester, aluminum foil, and low-density polyethylene. Perform a pregnancy test prior to inserting a new ring and consult your healthcare provider. NuvaRing is not made with natural rubber latex. Squeeze opposite sides of the ring together and insert the ring into the barrel opening. Open the package only when you are ready to use the applicator. If NuvaRing breaks and slips out of your vagina, throw the broken ring in your household trash out of the reach of children and pets. Women on thyroid replacement therapy may need increased doses of thyroid hormone. This may increase the risk of seizures, so your healthcare provider may need to adjust your dose of lamotrigine. Do not use NuvaRing for a condition for which it was not prescribed. If a patient exhibits signs or symptoms of TSS, consider the possibility of this diagnosis and initiate appropriate medical evaluation and treatment. No Hormonal Contraceptive Use in the Preceding Cycle: The woman should insert NuvaRing on the first day of her menstrual bleeding. Two epidemiologic studies1, 2, 3 that assessed the risk of VTE associated with the use of NuvaRing are described below. The use of tampons had no effect on serum concentrations of etonogestrel and ethinyl estradiol during use of NuvaRing [see Dosage and Administration (2.5)]. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. However, this may be due to other reasons such as having more sexual partners. General information about the safe and effective use of NuvaRing. Manufactured by: Sonoco Plastics B.V., Berkel en Rodenrijs, The Netherlands. It offers essential resources for family planning (FP) and reproductive health trainers, supervisors, and program managers. Figure 2: Mean Serum Concentration-Time Profile of Etonogestrel and Ethinyl Estradiol during Three Weeks of NuvaRing Use. The Natural Cycles method of contraception had a 1-year typical use Pearl Index (PI) of 6.8±0.4. The Pearl index will be determined by the number of unintentional pregnancies related to 100 women. The following serious adverse reactions with the use of CHCs are discussed elsewhere in the labeling. There have been reports of inadvertent insertions of NuvaRing into the urinary bladder, which required cystoscopic removal. Etonogestrel: Etonogestrel is approximately 32% bound to sex hormone-binding globulin (SHBG) and approximately 66% bound to albumin in blood. The exact position of NuvaRing inside the vagina is not critical for its function. For example, if during a test 100 women use a certain contraceptive method and during a period of 12 months, 2 unintended pregnancies occur, the Pearl index is 2. 4) Trussell J. TSS has been associated with tampons and certain barrier contraceptives, and, in some cases the NuvaRing users were also using tampons. If the unplanned bleeding or spotting is heavy or lasts for more than a few days, you should discuss this with your healthcare provider. After dispensing to the user, NuvaRing can be stored for up to 4 months at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. What is the most important information I should know about NuvaRing? Fertility after continuous use. You must use another birth control method, such as male condoms with spermicide, until the new NuvaRing has been used for 7 days in a row. Pearl Index will be calculated for Years 4 and 5, as well as cumulatively through Years 4 and 5. cumulative pregnancy percentage [ Time Frame: Years 1 through 5 ] A life table analysis (using Kaplan-Meier) of pregnancies will be performed for the EP population to present the cumulative pregnancy percentage for Years 1 through 5. A woman will be considered not of childbearing potential if she is post-menopausal for greater than two years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) No adverse embryofetal effects were observed when the combination was administered to pregnant rats at a desogestrel/ethinyl estradiol dose that was 4/13 times, respectively, the anticipated vaginal human dose. Sidney, S. (primary author) http://www.fda.gov/downloads/Drugs/DrugSafety/UCM277384.pdf, accessed 23-Aug-2013. For the Dispenser: Store refrigerated 2-8°C (36- 46°F). NuvaRing is contraindicated in women with benign and malignant liver tumors [see Contraindications (4)]. Based on a model assumption that pregnancy duration is nine months, the rate is 7 to 27 per 10,000 WY. Biometrics; 22(2):310-21. If these symptoms occur, do not stop using NuvaRing. An increased risk of thromboembolic and thrombotic disease associated with the use of CHCs is well-established. Cases of TSS have been reported by NuvaRing users. There is substantial evidence that CHCs do not increase the incidence of breast cancer. Occasional missed periods may occur with the appropriate use of NuvaRing. The woman should reinsert the ring as soon as she remembers. If NuvaRing is lost, a new vaginal ring should be inserted and the regimen should be continued without alteration. We assessed contraceptive efficacy by the Pearl Index (PI) in women 18 to 35 years, excluding cycles without intercourse or when other contraceptive methods were used. (etonogestrel/ethinyl estradiol vaginal ring) Gently pull downward and forward to remove the NuvaRing and pull it out. The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins. Choose the best way for you: If you are changing from a birth control pill or patch to NuvaRing: If you have been using your birth control method correctly and are certain that you are not pregnant, you can change to NuvaRing any day. Place the used NuvaRing in the re-sealable foil pouch and put it in a trash can out of the reach of children and pets. If a woman discovers that her NuvaRing has disconnected, she should discard the ring and replace it with a new ring. The Creeping Pearl: Why Has the Rate of Contraceptive Failure Increased in Clinical Trials of Combined Hormonal Contraceptive Pills? NuvaRing may increase your risk of blood clots after surgery. If the ring stays in your vagina this should not lower NuvaRing's effectiveness at preventing pregnancy. Selected practice recommendations for contraceptive use. The Pearl formula is: Pearl index = (No. The better you follow the directions, the less chance you have of getting pregnant. CHCs can reduce milk production in breastfeeding mothers. If NuvaRing is out of the vagina for more than three continuous hours: During Weeks 1 and 2: Contraceptive efficacy may be reduced. Although the primary effect of this action is inhibition of ovulation, other alterations include changes in the cervical mucus (which increase the difficulty of sperm entry into the uterus) and the endometrium (which reduce the likelihood of implantation). Women with BMI ≥ 30 kg/m2 were excluded from these studies. 2) Trussell J, Hatcher RA, Cates W Jr, Stewart FH, Kost K. (1990) A guide to interpreting contraceptive efficacy studies. In the US study, the Pearl Index was 2.02 (95% CI [1.1, 3.4]) per 100 women-years of NuvaRing use. Ascorbic acid and acetaminophen may increase plasma ethinyl estradiol concentrations, possibly by inhibition of conjugation. Discontinue NuvaRing use if pregnancy is confirmed. This Pearl index calculator evaluates the effectiveness of a contraceptive method by taking into account the number of pregnancies occurred during the study period. They do not protect against HIV infection (AIDS) and other sexually transmitted infections. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. There may be new information. Studies have also revealed that the longer a couple uses a certain method, the more effective that appears for their particular case, meaning that in general, the longer the study, the lower the registered failure rate. The serum concentrations of etonogestrel and ethinyl estradiol were not affected by concomitant administration of oral amoxicillin or doxycycline in standard dosages during 10 days of antibiotic treatment. Contraception 2013; 87: 93–100. The ring should be replaced in this reclosable sachet after use and discarded in a waste receptacle out of the reach of children and pets. If the ring is accidentally expelled and is left outside of the vagina for less than three hours, contraceptive efficacy is not reduced. mood changes (including depression, especially if you had depression in the past). Step 4. Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Studies suggest a small increased relative risk of developing gallbladder disease among CHC users. If the ring-free interval has been extended beyond one week, consider the possibility of pregnancy, and an additional method of contraception, such as male condoms with spermicide, MUST be used until NuvaRing has been used continuously for seven days. NuvaRing is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease [see Contraindications (4)]. 148 The primary efficacy endpoint should be the pregnancy rate described by the Pearl Index (PI) 149 during the first year of use of the product. Small amounts of contraceptive steroids and/or metabolites, including etonogestrel and ethinyl estradiol are transferred to human milk. If you start using NuvaRing after an abortion or miscarriage: If you are starting NuvaRing after childbirth: If you are breastfeeding you should not use NuvaRing. Count the first day of your menstrual period as "Day 1" and start NuvaRing one of the following 2 ways below. In the meantime, she should be advised to use a non-hormonal contraceptive method. The Pearl Index is mainly used in the comparison of contraception methods related to the number of unintentional pregnancies to 100 women years. Pharmacokinetic data show that the use of tampons has no effect on the systemic absorption of the hormones released by NuvaRing. Do not prescribe NuvaRing to women who are known to have or use the following: Stop NuvaRing use if an arterial thrombotic or venous thromboembolic event (VTE) occurs. How long do antibiotics affect birth control? There are however other personal usage factors and respecting the manufacturer instructions which can alter the effectiveness of specific birth control methods. Your healthcare provider can suggest another method of birth control. In vitro data shows that both etonogestrel and ethinyl estradiol are metabolized in liver microsomes by the cytochrome P450 3A4 isoenzyme. MERCK & CO., INC., Whitehouse Station, NJ 08889, USA, Manufactured by: N.V. Organon, Oss, The Netherlands, a subsidiary of The woman may start using NuvaRing within the first five days following a complete first trimester abortion or miscarriage, and she does not need to use an additional method of contraception. Use of CHCs may also worsen existing gallbladder disease. If NuvaRing was out of the vagina for an unknown amount of time, the possibility of pregnancy should be considered. Typical use failure rate: 13%. In general, the risk is greatest among older (>35 years of age), hypertensive women who also smoke. The ring is pushed out of the applicator. IMPORTANT: Consider the possibility of ovulation and conception prior to the first use of NuvaRing. This is a health tool that employs the Pearl rate formula in order to help research in clinical trials in regard to the effectiveness of the tested birth control methods. Store NuvaRing at room temperature for up to 4 months after you receive it. If the expelled ring has been out of your vagina for less than 3 hours, rinse the expelled NuvaRing in cool to lukewarm (not hot) water and insert it again right away. Hypersensitivity reactions of anaphylaxis and angioedema have been reported during use of NuvaRing. The withdrawal bleed usually starts on Day 2-3 after removal of the ring and may not have finished before the next ring is inserted. No adverse embryofetal effects were observed when the combination was administered to pregnant rabbits at a desogestrel/ethinyl estradiol dose that was 2/5 times the anticipated vaginal human dose. Risk of sexually transmitted diseases is not accounted for in any of the calculations. This is not expected to affect the contraceptive effectiveness of NuvaRing. This means that the ring should be removed three weeks later on the same day of the week as it was inserted and at about the same time. [See Contraindications (4) and Warnings and Precautions (5.3).]. If the ring breaks, it does not release a higher dose of hormones. Last updated on Jan 1, 2020. The hydroxylated ethinyl estradiol metabolites have weak estrogenic activity. Family Planning - A global handbook for providers. Glosbe uses … When desogestrel/ethinyl estradiol was given to pregnant rabbits, pre-implantation loss was observed at a desogestrel/ethinyl estradiol dose that was 3/10 times, respectively, the anticipated vaginal human dose. The ring is to remain in place continuously for three weeks. If use of NuvaRing is not started within five days following a first trimester abortion or miscarriage, the woman should follow the instructions for "No Hormonal Contraceptive Use in the Preceding Cycle."