04.12.2013

Can't get pregnant after nuvaring

To achieve maximum contraceptive effectiveness, NuvaRing must be used as directed [see Dosing and Administration (2.2)].
The user can choose the insertion position that is most comfortable to her, for example, standing with one leg up, squatting, or lying down. NuvaRing can be removed by hooking the index finger under the forward rim or by grasping the rim between the index and middle finger and pulling it out.
After a one-week break, during which a withdrawal bleed usually occurs, a new ring is inserted on the same day of the week as it was inserted in the previous cycle. IMPORTANT: Consider the possibility of ovulation and conception prior to the first use of NuvaRing.
The woman may switch from her previous CHC on any day, but at the latest on the day following the usual hormone-free interval, if she has been using her hormonal method consistently and correctly, or if it is reasonably certain that she is not pregnant.
The woman may switch from the POP on any day; instruct her to start using NuvaRing on the day after she took her last POP. 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. Start NuvaRing no earlier than four weeks after a second trimester abortion or miscarriage, due to the increased risk of thromboembolism.
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.
If a woman begins using NuvaRing postpartum, instruct her to use an additional method of contraception, such as male condoms with spermicide, for the first seven days. NuvaRing can be accidentally expelled, for example, while removing a tampon, during intercourse, or with straining during a bowel movement.
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.
If NuvaRing has been left in place for longer than four weeks, instruct the woman to remove the ring, and rule out pregnancy. If the woman has not adhered to the prescribed regimen (NuvaRing has been out of the vagina for more than three hours or the preceding ring-free interval was extended beyond one week), consider the possibility of pregnancy at the time of the first missed period and discontinue NuvaRing use if pregnancy is confirmed.
If the woman has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Pharmacokinetic data show that the use of tampons has no effect on the systemic absorption of the hormones released by NuvaRing. If feasible, stop NuvaRing at least four weeks before and through two weeks after major surgery or other surgeries known to have an elevated risk of thromboembolism, and during and following prolonged immobilization. Two epidemiologic studies1, 2, 3 that assessed the risk of VTE associated with the use of NuvaRing are described below.
In these studies, which were required or sponsored by regulatory agencies, NuvaRing users had a risk of VTE similar to COC users (see Table 1 for adjusted hazard ratios). The risk of VTE is highest during the first year of CHC use and after restarting a CHC following a break of at least four weeks.
Figure 1 shows the risk of developing a VTE for women who are not pregnant and do not use CHCs, for women who use CHCs, for pregnant women, and for women in the postpartum period.
Several epidemiology studies indicate that third generation oral contraceptives, including those containing desogestrel (etonogestrel, the progestin in NuvaRing, is the biologically active metabolite of desogestrel), may be associated with a higher risk of VTE than oral contraceptives containing other progestins. Do not use NuvaRing in women with liver disease such as acute viral hepatitis or severe (decompensated) cirrhosis of the liver [see Contraindications (4)].
NuvaRing is contraindicated in women with benign and malignant liver tumors [see Contraindications (4)]. NuvaRing is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease [see Contraindications (4)]. NuvaRing may not be suitable for women with conditions that make the vagina more susceptible to vaginal irritation or ulceration.
Some women are aware of the ring on occasion during the 21 days of use or during intercourse, and sexual partners may feel NuvaRing in the vagina. If a woman using NuvaRing develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue NuvaRing if indicated. Consider discontinuation of NuvaRing in the case of an increased frequency or severity of migraine during CHC use (which may be prodromal of a cerebrovascular event) [see Contraindications (4)]. If the patient has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.
Some women may experience amenorrhea or oligomenorrhea after discontinuing CHC use, especially when such a condition was pre-existent. There have been reports of inadvertent insertions of NuvaRing into the urinary bladder, which required cystoscopic removal.
Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. Carefully observe women with a history of depression and discontinue NuvaRing use if depression recurs to a serious degree. NuvaRing is contraindicated in women who currently have or have had breast cancer because breast cancer is a hormonally-sensitive tumor [see Contraindications (4)].
Some studies suggest that CHCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. A woman who is using NuvaRing should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. There is little or no increased risk of birth defects in women who inadvertently use CHCs during early pregnancy. The administration of CHCs to induce withdrawal bleeding should not be used as a test for pregnancy. NuvaRing has not been studied in postmenopausal women and is not indicated in this population.
The pharmacokinetic profile of etonogestrel and ethinyl estradiol during use of NuvaRing is shown in Figure 2. The pharmacokinetic parameters of etonogestrel and ethinyl estradiol were determined during one cycle of NuvaRing use in 16 healthy female subjects and are summarized in Table 3. 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)]. Based on pooled data from the three trials, 2,356 women aged < 35 years completed 23,515 evaluable cycles of NuvaRing use (cycles in which no back-up contraception was used). For the Dispenser: When NuvaRing is dispensed to the user, place an expiration date on the label. Cigarette smoking increases the risk of serious cardiovascular events from use of NuvaRing, and women who are over 35 years old and smoke should not use NuvaRing. The increased risk of VTE compared to non-users of CHCs is greatest after initially starting a CHC or restarting (following a 4-week or greater CHC-free interval) the same or a different CHC.
NuvaRing does not protect against HIV infection (AIDS) and other sexually transmitted infections. The proper usage of NuvaRing and what to do if she does not comply with the labeled timing of insertion and removal. The need to use a barrier method of contraception when the ring is out for more than three continuous hours until NuvaRing has been used continuously for at least seven days. Use a back-up or alternative method of contraception when enzyme inducers are used with NuvaRing. Women who start NuvaRing postpartum and have not yet had a normal period should use an additional non-hormonal method of contraception for the first seven days. NuvaRing (NEW-vah-ring) is a flexible birth control vaginal ring used to prevent pregnancy. Your chance of getting pregnant depends on how well you follow the directions for using NuvaRing. Based on the results of a US clinical study, approximately 1 to 3 women out of 100 women may get pregnant during the first year they use NuvaRing.
The following chart shows the chance of getting pregnant for women who use different methods of birth control.


Hormonal birth control methods may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy or related to previous use of hormonal birth control. Use an additional birth control method (such as a male condom with spermicide) when you take medicines that may make NuvaRing less effective. Read the Instructions for Use at the end of this Patient Information that comes with your NuvaRing for information about the right way to use NuvaRing. After your 1 week (7 days) break, you should insert a new NuvaRing on the next Monday at 8:00 am. While using NuvaRing, you should not use a vaginal diaphragm as your back-up method of birth control because NuvaRing may interfere with the correct placement and position of a diaphragm. Use of spermicides or vaginal yeast products will not make NuvaRing less effective at preventing pregnancy. If NuvaRing has been left inside your vagina for more than 4 weeks (28 days), you may not be protected from pregnancy and you should see your healthcare provider to be sure you are not pregnant.
Your healthcare provider should examine you at least 1 time a year to see if you have any signs of side effects from using NuvaRing. In some studies of women who used NuvaRing, the risk of getting a blood clot was similar to the risk in women who used combination birth control pills.
Other studies have reported that the risk of blood clots was higher for women who use combination birth control pills containing desogestrel (a progestin similar to the progestin in NuvaRing) than for women who use combination birth control pills that do not contain desogestrel. To put the risk of developing a blood clot into perspective: If 10,000 women who are not pregnant and do not use hormonal birth control are followed for one year, between 1 and 5 of these women will develop a blood clot. Other side effects seen with NuvaRing include allergic reaction, hives, breast discharge, and penis discomfort of the partner (such as irritation, rash, itching).
Place the used NuvaRing in the re-closable foil pouch and properly throw it away in your household trash out of the reach of children and pets. Women who use hormonal birth control methods may have a slightly higher chance of getting cervical cancer. When you use NuvaRing you may have bleeding and spotting between periods, called unplanned bleeding. Like pregnancy, combination hormonal birth control methods increase the risk of serious blood clots (see graph below), especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. If NuvaRing has been left inside your vagina for more than 4 weeks (28 days), you may not be protected from pregnancy and you should see your health care provider to be sure you are not pregnant. Inserting NuvaRing: After washing and drying your hands, remove NuvaRing from the foil pouch. Removing NuvaRing: Remove the ring 3 weeks (21 days) after insertion on the same day of the week it was inserted at about the same time. It is important to consult with your health care provider to make sure you are not pregnant before starting NuvaRing. Although some women may be aware of NuvaRing in the vagina, most women can't feel NuvaRing once it's in place. Rest assured, there is no danger of NuvaRing being pushed too far up in the vagina or getting lost. NuvaRing can slip or accidentally come out of (be expelled from) your vagina during sexual intercourse, bowel movements, use of tampons, or if it breaks. 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.
You should pay attention when removing a tampon to be sure that your NuvaRing is not accidentally pulled out.
If you accidentally pull out your NuvaRing while using tampons, rinse your NuvaRing in cool to lukewarm (not hot) water and insert it again right away.
NuvaRing can be pushed out of (expelled from) your vagina, for example, during sexual intercourse or during a bowel movement. 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.
During Week 3, do not reinsert the NuvaRing that has been out of your vagina; but throw it away in your household trash away from children and pets. Note: You should only choose to do option 2 if you used NuvaRing for 7 days in a row, prior to the day that your previous NuvaRing was accidently removed or expelled. If you leave NuvaRing in your vagina for up to 4 weeks (28 days) you will still be getting pregnancy protection. If you leave NuvaRing in your vagina longer than 4 weeks (28 days), remove the ring and check to make sure you are not pregnant.
Dispose of NuvaRing by placing the used ring in the resealable foil pouch and properly dispose of it in a waste receptacle out of the reach of children and pets.
Place the used NuvaRing in the resealable foil pouch and properly throw it away in your household trash out of the reach of children and pets. Read these Instructions for Use before you start using NuvaRing and each time you get a refill. If your answer is yes to any of the above, you may want to ask your health care provider about NuvaRing. The chart below helps you compare the dosing frequency of NuvaRing to some other forms of birth control so you can assess your options and have an informed discussion with your health care provider. The use of a CHC, like NuvaRing, is associated with increased risks of several serious side effects, including blood clots, stroke, or heart attack.
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.
NuvaRing may also be started on Days 2-5 of the woman's cycle, but in this case a barrier method, such as male condoms with spermicide, should be used for the first seven days of NuvaRing use in the first cycle. 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." In the meantime, she should be advised to use a non-hormonal contraceptive method.
If she has not yet had a period, consider the possibility of ovulation and conception occurring prior to initiation of NuvaRing.
NuvaRing should be removed and the woman should insert a new ring after a one-week ring-free interval.
If pregnancy is ruled out, NuvaRing may be restarted, and an additional method of contraception, such as male condoms with spermicide, MUST be used until a new NuvaRing has been used continuously for seven days. Stop NuvaRing use if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week. A large prospective, observational study, the Transatlantic Active Surveillance on Cardiovascular Safety of NuvaRing (TASC), investigated the risk of VTE for new users, and women who were switching to or restarting NuvaRing or COCs in a population that is representative of routine clinical users. Although the absolute VTE rates are increased for users of CHCs compared to non-users, the rates associated with pregnancy are even greater, especially during the post-partum period (see Figure 1). To put the risk of developing a VTE into perspective: If 10,000 women who are not pregnant and do not use CHCs are followed for one year, between 1 and 5 of these women will develop a VTE.
Based on a model assumption that pregnancy duration is nine months, the rate is 7 to 27 per 10,000 WY. TSS has been associated with tampons and certain barrier contraceptives, and, in some cases the NuvaRing users were also using tampons. However, the attributable risk of liver cancers in CHC users is less than one case per million users.
For women with well-controlled hypertension, monitor blood pressure and stop NuvaRing use if blood pressure rises significantly.
Women with a history of pregnancy-related cholestasis may be at an increased risk for CHC-related cholestasis. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. If the patient has not adhered to the prescribed dosing schedule, consider the possibility of pregnancy at the time of the first missed period and take appropriate diagnostic measures. Assess for ring insertion into the urinary bladder in NuvaRing users who present with persistent urinary symptoms and are unable to locate the ring. Studies also do not suggest a teratogenic effect, particularly in so far as cardiac anomalies and limb reduction defects are concerned, when taken inadvertently during early pregnancy. Although some past studies have suggested that CHCs might increase the incidence of breast cancer, more recent studies have not confirmed such findings.


Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while using NuvaRing. Epidemiologic studies and meta-analyses have not found an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to low dose CHCs prior to conception or during early pregnancy. The bioavailability of ethinyl estradiol after vaginal administration is approximately 56%, which is comparable to that with oral administration of ethinyl estradiol. 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 pregnancy is planned or occurs during treatment with NuvaRing, instruct the patient to discontinue NuvaRing use. Rule out pregnancy in the event of amenorrhea if NuvaRing has been out of the vagina for more than three consecutive hours, if the ring-free interval was extended beyond one week, if the woman has missed a period for two or more consecutive cycles, and if the ring has been retained for longer than four weeks.
Hormonal birth control methods that contain estrogen, like NuvaRing, may decrease the amount of milk you make.
Continue back-up birth control for 28 days after stopping the medicine to help prevent you from becoming pregnant. Until you know the results of your pregnancy test, you should use an extra method of birth control, such as male condoms with spermicide, until the new NuvaRing has been in place for 7 days in a row.
Like pregnancy, combination hormonal birth control methods increase the risk of serious blood clots (see following graph), especially in women who have other risk factors, such as smoking, obesity, or age greater than 35. The figure below shows the likelihood of developing a serious blood clot for women who are not pregnant and do not use hormonal birth control, for women who use hormonal birth control, for pregnant women, and for women in the first 12 weeks after delivering a baby. Some of the symptoms are much the same as the flu, but they can become serious very quickly.
However, if you have breast cancer now or have had it in the past, do not use hormonal birth control, including NuvaRing, because some breast cancers are sensitive to hormones.
This increased risk is highest when you first start using a combination hormonal birth control method or when you restart the same or different combination hormonal birth control method after not using it for a month or more. Based on a model assumption that pregnancy duration is 9 months, the rate is 7 to 27 per 10,000 woman-years.
After washing and drying your hands, hook your index finger under the forward rim or hold the rim between your index and middle fingers. The cervix (the narrow, lower end of the uterus) will block NuvaRing from going any farther. If you have pain during or after insertion and you cannot find NuvaRing in your vagina, call your health care provider right away. As with other hormonal birth control methods, NuvaRing does not protect against HIV infection (AIDS) or other sexually transmitted infections. If the ring stays in your vagina, this should not lower NuvaRing's effectiveness at preventing pregnancy. Rest assured that once inserted in the vagina, there is no risk of NuvaRing being pushed too far up or getting lost.
Remove your old NuvaRing for 1 week (7 days) and insert a new NuvaRing 1 week (7 days) later. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop using NuvaRing.
NuvaRing is not for women with a history of these conditions or any condition that makes your blood more likely to clot.
Smoking increases your risk of serious heart and blood vessel problems from combination hormonal contraceptives (CHCs) including heart attack, blood clots, or stroke which can be fatal. For this reason, CHCs, including NuvaRing, should not be used by women who are over 35 years of age and smoke. In order to maintain contraceptive effectiveness, the new ring must be inserted exactly one week after the previous one was removed even if menstrual bleeding has not finished.
If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different CHC. The serum etonogestrel and ethinyl estradiol concentrations observed during three weeks of NuvaRing use are summarized in Table 2. The serum ethinyl estradiol concentrations observed during three weeks of NuvaRing use are summarized in Table 2. You should stop using NuvaRing at least 4 weeks before you have surgery and not restart it until at least 2 weeks after your surgery.
You can ask your pharmacist or healthcare provider for information about NuvaRing that is written for health professionals.
Unplanned bleeding occurs most often during the first few months of NuvaRing use, but may also occur after you have been using NuvaRing for some time. Keep a list of them to show your health care provider and pharmacist when you get a new medicine. Talk with your health care provider about your risk of getting a blood clot before using NuvaRing or before deciding which type of birth control is right for you.
NuvaRing can accidentally slip out of the vagina while removing a tampon, during intercourse, or straining during a bowel movement.
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 and immediately insert a new ring. The risk of getting blood clots may be greater with the type of progestin in NuvaRing than with some other progestins in certain low-dose birth control pills. NuvaRing can be rinsed with cool to lukewarm (not hot) water and reinserted as soon as possible, but at the latest within three hours. If a woman discovers that her NuvaRing has disconnected, she should discard the ring and replace it with a new ring. Co-administration of vaginal miconazole nitrate and NuvaRing increases the serum concentrations of etonogestrel and ethinyl estradiol by up to 40% [see Clinical Pharmacology (12.3)]. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women. In case of suspected overdose, all NuvaRing rings should be removed and symptomatic treatment given.
The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant. Talk with your healthcare provider about your risk of getting a blood clot before using NuvaRing or before deciding which type of birth control is right for you.
After that time, you need to remove it, take a week off from NuvaRing, and insert a new one 7 days after removal.
Place the used NuvaRing in the re-sealable foil pouch and dispose of it in a waste receptacle out of the reach of children and pets. If you are experiencing pain during or after insertion and you cannot find your NuvaRing in your vagina, call your health care provider right away. Store NuvaRing at room temperature for up to 4 months after you receive it and throw it away if the expiration date on the label has passed. The risk of blood clots is highest when you first start using CHCs and when you restart the same or different CHC after not using it for a month or more. If NuvaRing is lost, a new vaginal ring should be inserted and the regimen should be continued without alteration. Counsel women to use an alternative method of contraception or a back-up method when enzyme inducers are used with NuvaRing, and to continue back-up contraception for 28 days after discontinuing the enzyme inducer to ensure contraceptive reliability. In that case, just use your finger to gently push the NuvaRing as far as you can into your vagina.
Once inserted in the vagina, there is no risk of NuvaRing being pushed too far up or getting lost.
Your menstrual period will usually start 2 or 3 days after the ring is removed and may not have finished before the next ring is inserted. To continue to have pregnancy protection, you must insert a new ring 1 week (7 days) after the last one was removed even if your period has not stopped.



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