Dosage & Administration
One NuvaRing is inserted in the vagina. The ring must remain in place continuously for three weeks, followed by a one-week ring-free interval.
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NuvaRing Prescribing Information
Cigarette smoking increases the risk of serious cardiovascular events from combination hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including NuvaRing, should not be used by women who are over 35 years of age and smoke. [See Contraindications (4).]
FOR VAGINAL USE ONLY
NuvaRing® is indicated for use by females of reproductive age to prevent pregnancy.
How to Use NuvaRing
To achieve maximum contraceptive effectiveness, NuvaRing must be used as directed [see Dosage and Administration (2.2)]. 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.
The user can choose the insertion position that is most comfortable to her, for example, standing with one leg up, squatting, or lying down. The ring is to be compressed and inserted into the vagina. The exact position of NuvaRing inside the vagina is not critical for its function. The vaginal ring must be inserted on the appropriate day and left in place for three consecutive weeks. 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.
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. The used ring should be placed in the sachet (foil pouch) and discarded in a waste receptacle out of the reach of children and pets (do not flush in toilet).
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. 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. 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.
How to Start Using NuvaRing
IMPORTANT: Consider the possibility of ovulation and conception prior to the first use of NuvaRing.
No Hormonal Contraceptive Use in the Preceding Cycle:
The woman should insert NuvaRing on the first day of her menstrual bleeding. 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.
Changing From a CHC:
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.
Changing From a Progestin-Only Method (progestin-only pill [POP], Implant, or Injection or a Progestin-Releasing Intrauterine System [IUS]):
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. She should switch from an implant or the IUS on the day of its removal, and from an injectable on the day when the next injection would be due. In all of these cases, the woman should use an additional barrier method such as a male condom with spermicide, for the first seven days.
Use After Abortion or Miscarriage:
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. 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.
Start NuvaRing no earlier than four weeks after a second trimester abortion or miscarriage, due to the increased risk of thromboembolism. [See Contraindications (4) and Warnings and Precautions (5.1).]
Following Childbirth:
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. [See Contraindications (4) and Warnings and Precautions (5.1).]
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. If she has not yet had a period, consider the possibility of ovulation and conception occurring prior to initiation of NuvaRing.
Deviations from the Recommended Regimen
To prevent loss of contraceptive efficacy, advise women not to deviate from the recommended regimen. NuvaRing should be left in the vagina for a continuous period of three weeks. Advise women to regularly check for the presence of NuvaRing in the vagina (for example, before and after intercourse).
Inadvertent Removal or Expulsion:
NuvaRing can be accidentally expelled, for example, while removing a tampon, during intercourse, or with straining during a bowel movement. NuvaRing should be left in the vagina for a continuous period of three weeks. If the ring is accidentally expelled and is left outside of the vagina for less than three hours, contraceptive efficacy is not reduced. 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 NuvaRing is lost, a new vaginal ring should be inserted and the regimen should be continued without alteration.
If NuvaRing is out of the vagina for more than three continuous hours:
During Weeks 1 and 2: Contraceptive efficacy may be reduced. The woman should reinsert the ring as soon as she remembers. A barrier method such as male condoms with spermicides must be used until the ring has been used continuously for seven days.
During Week 3: The woman should discard that ring. One of the following two options should be chosen:
- Insert a new ring immediately. Inserting a new ring will start the next three-week use period. The woman may not experience a withdrawal bleed from her previous cycle. However, breakthrough spotting or bleeding may occur.
- Insert a new ring no later than seven days from the time the previous ring was removed or expelled, during which time she may have a withdrawal bleed. This option should only be chosen if the ring was used continuously for at least seven days prior to inadvertent removal/expulsion.
In either case, a barrier method such as male condoms with spermicides must be used until the new ring has been used continuously for seven days.
If NuvaRing was out of the vagina for an unknown amount of time, the possibility of pregnancy should be considered. A pregnancy test should be performed prior to inserting a new ring.
Prolonged Ring-Free Interval:
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.
Prolonged Use of NuvaRing:
If NuvaRing has been left in place for up to one extra week (i.e., up to four weeks total), the woman will remain protected. NuvaRing should be removed and the woman should insert a new ring after a one-week ring-free interval.
If NuvaRing has been left in place for longer than four weeks, instruct the woman to remove the ring, and rule out pregnancy. 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.
Ring Breakage:
There have been reported cases of NuvaRing disconnecting at the weld joint. This is not expected to affect the contraceptive effectiveness of NuvaRing. In the event of a disconnected ring, vaginal discomfort or expulsion (slipping out) is more likely to occur. Vaginal injury associated with ring breakage has been reported [see Adverse Reactions (6.2)].
If a woman discovers that her NuvaRing has disconnected, she should discard the ring and replace it with a new ring.
In the Event of a Missed Menstrual Period
- 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.
- If the woman has retained one NuvaRing for longer than four weeks, rule out pregnancy.
Use with Other Vaginal Products
NuvaRing may interfere with the correct placement and position of certain female barrier methods such as a diaphragm, cervical cap or female condom. These methods are not recommended as back-up methods with NuvaRing use.
Pharmacokinetic data show that the use of tampons has no effect on the systemic absorption of the hormones released by NuvaRing.
NuvaRing (etonogestrel/ethinyl estradiol vaginal ring) is a non-biodegradable, flexible, transparent, colorless to almost colorless, combination contraceptive vaginal ring, with an outer diameter of 54 mm and a cross-sectional diameter of 4 mm. It is made of ethylene vinylacetate copolymers and magnesium stearate, and contains 11.7 mg etonogestrel and 2.7 mg ethinyl estradiol. When placed in the vagina, each ring releases on average 0.120 mg/day of etonogestrel and 0.015 mg/day of ethinyl estradiol over a three-week period of use. NuvaRing is not made with natural rubber latex.
Pregnancy
Risk Summary
NuvaRing is contraindicated during pregnancy because there is no need for pregnancy prevention in a woman who is already pregnant. Epidemiologic studies and meta-analyses have not shown an increased risk of genital or non-genital birth defects (including cardiac anomalies and limb-reduction defects) following maternal exposure to low dose CHCs prior to conception or during early pregnancy. No adverse developmental outcomes were observed in pregnant rats and rabbits with the administration of etonogestrel during organogenesis at doses approximately 300 times the anticipated daily vaginal human dose (~0.002 mg/kg/day).
No adverse developmental outcomes were observed in pregnant rats and rabbits with the co-administration of the combination desogestrel/ethinyl estradiol during organogenesis at desogestrel/ethinyl estradiol doses at least 2/5 times, respectively, the anticipated daily vaginal human dose (~0.002 desogestrel/0.00025 ethinyl estradiol mg/kg/day).
Discontinue NuvaRing use if pregnancy is confirmed.
Data
Animal Data
In rats and rabbits at dosages up to 300 times the anticipated dose, etonogestrel is neither embryotoxic nor teratogenic. Co-administration of a maternally toxic dose of desogestrel/ethinyl estradiol to pregnant rats was associated with embryolethality and wavy ribs at a desogestrel/ethinyl estradiol dose that was 40/130 times, respectively, the anticipated vaginal human dose (0.002 desogestrel/0.00025 ethinyl estradiol mg/kg/day). 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. 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. 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.
Lactation
Risk Summary
Small amounts of contraceptive steroids and/or metabolites, including etonogestrel and ethinyl estradiol are transferred to human milk. Harmful effects have not been observed in breastfed infants exposed to CHCs through breast milk. CHCs can reduce milk production in breastfeeding mothers. This is less likely to occur once breastfeeding is well-established; however, it can occur at any time in some women.
When possible, advise the nursing mother to use non-estrogen-containing contraception until she has completely weaned her child. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for NuvaRing and any potential adverse effects on the breastfed child from NuvaRing or from the underlying maternal condition.
Pediatric Use
Safety and efficacy of NuvaRing have been established in women of reproductive age. Efficacy is expected to be the same for postpubertal adolescents under the age of 18 and for users 18 years and older. Use of this product before menarche is not indicated.
Geriatric Use
NuvaRing has not been studied in postmenopausal women and is not indicated in this population.
Hepatic Impairment
The effect of hepatic impairment on the pharmacokinetics of NuvaRing has not been studied. Steroid hormones may be poorly metabolized in patients with impaired liver function. Acute or chronic disturbances of liver function may necessitate the discontinuation of CHC use until markers of liver function return to normal. [See Contraindications (4) and Warnings and Precautions (5.3).]
Renal Impairment
The effect of renal impairment on the pharmacokinetics of NuvaRing has not been studied.
NuvaRing is contraindicated in females who are known to have or develop the following conditions:
- A high risk of arterial or venous thrombotic diseases. Examples include women who are known to:
- Smoke, if over age 35 [see Boxed Warning and Warnings and Precautions (5.1)]
- Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)]
- Have cerebrovascular disease [see Warnings and Precautions (5.1)]
- Have coronary artery disease [see Warnings and Precautions (5.1)]
- Have thrombogenic valvular or thrombogenic rhythm diseases of the heart (for example, subacute bacterial endocarditis with valvular disease, or atrial fibrillation) [see Warnings and Precautions (5.1)]
- Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)]
- Have uncontrolled hypertension [see Warnings and Precautions (5.5)]
- Have diabetes mellitus with vascular disease [see Warnings and Precautions (5.9)]
- Have headaches with focal neurological symptoms or migraine headaches with aura [see Warnings and Precautions (5.10)]
- Women over age 35 with any migraine headaches [see Warnings and Precautions (5.10)]
- Liver tumors, benign or malignant or liver disease [see Warnings and Precautions (5.3) and Use in Specific Populations (8.6)]
- Undiagnosed abnormal uterine bleeding [see Warnings and Precautions (5.11)]
- Pregnancy, because there is no reason to use CHCs during pregnancy [see Use in Specific Populations (8.1)]
- Current diagnosis of, or history of, breast cancer, which may be hormone-sensitive [see Warnings and Precautions (5.14)]
- Hypersensitivity reactions, including anaphylaxis and angioedema, to any of the components of NuvaRing [see Warnings and Precautions (5.6) and Adverse Reactions (6)]
- Use of Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, due to potential for ALT elevations [see Warnings and Precautions (5.4) and Drug Interactions (7)]