Etonogestrel and Ethinyl Estradiol Vaginal Ring

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Etonogestrel and Ethinyl Estradiol Vaginal Ring
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alonso Alvarado, M.D. [2]

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Black Box Warning

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
See full prescribing information for complete Boxed Warning.
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS: 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.

Overview

Etonogestrel and Ethinyl Estradiol Vaginal Ring is an estrogen and progestin combination that is FDA approved for the {{{indicationType}}} of to prevent pregnancy. There is a Black Box Warning for this drug as shown here. Common adverse reactions include mood disorder, vaginal discharge, vaginitis.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

How to Use Etonogestrel and Ethinyl Estradiol Vaginal Ring
  • To achieve maximum contraceptive effectiveness, etonogestrel and ethinyl estradiol vaginal ring must be used as directed . One etonogestrel and ethinyl estradiol vaginal ring 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 etonogestrel and ethinyl estradiol vaginal ring 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.
  • Etonogestrel and ethinyl estradiol vaginal ring 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 Etonogestrel and Ethinyl Estradiol vaginal ring

Consider the possibility of ovulation and conception prior to the first use of etonogestrel and ethinyl estradiol vaginal ring.

  • No Hormonal Contraceptive Use in the Preceding Cycle: The woman should insert etonogestrel and ethinyl estradiol vaginal ring on the first day of her menstrual bleeding. etonogestrel and ethinyl estradiol vaginal ring 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 etonogestrel and ethinyl estradiol vaginal ring use in the first cycle.
  • Changing From a Combined Hormonal Contraception (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 etonogestrel and ethinyl estradiol vaginal ring 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 etonogestrel and ethinyl estradiol vaginal ring 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 etonogestrel and ethinyl estradiol vaginal ring 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.
  • Following Childbirth: The use of etonogestrel and ethinyl estradiol vaginal ring 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.
Deviations from the Recommended Regimen
  • To prevent loss of contraceptive efficacy, advise women not to deviate from the recommended regimen. Etonogestrel and ethinyl estradiol vaginal ring should be left in the vagina for a continuous period of three weeks.
  • Inadvertent Removal or Expulsion: Etonogestrel and ethinyl estradiol vaginal ring can be accidentally expelled, for example, while removing a tampon, during intercourse, or with straining during a bowel movement. Etonogestrel and ethinyl estradiol vaginal ring 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. Etonogestrel and ethinyl estradiol vaginal ring can be rinsed with cool to lukewarm (not hot) water and reinserted as soon as possible, but at the latest within three hours. If etonogestrel and ethinyl estradiol vaginal ring is lost, a new vaginal ring should be inserted and the regimen should be continued without alteration.
  • If etonogestrel and ethinyl estradiol vaginal ring 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 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:
  1. 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.
  2. 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 condoms with spermicides must be used until the new ring has been used continuously for seven days.
  • 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 etonogestrel and ethinyl estradiol vaginal ring has been used continuously for seven days.
  • Prolonged Use of Etonogestrel and Ethinyl Estradiol Vaginal Ring : If etonogestrel and ethinyl estradiol vaginal ring has been left in place for up to one extra week (i.e., up to four weeks total), the woman will remain protected. Etonogestrel and ethinyl estradiol vaginal ring should be removed and the woman should insert a new ring after a one-week ring-free interval.
  • If etonogestrel and ethinyl estradiol vaginal ring 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, etonogestrel and ethinyl estradiol vaginal ring may be restarted, and an additional method of contraception, such as male condoms with spermicide, must be used until a new etonogestrel and ethinyl estradiol vaginal ring has been used continuously for seven days.
  • Ring Breakage: There have been reported cases of etonogestrel and ethinyl estradiol vaginal ring disconnecting at the weld joint. This is not expected to affect the contraceptive effectiveness of etonogestrel and ethinyl estradiol vaginal ring. In the event of a disconnected ring, vaginal discomfort or expulsion (slipping out) is more likely to occur. If a woman discovers that her etonogestrel and ethinyl estradiol vaginal ring has disconnected, she should discard the ring and replace it with a new ring.
In the Event of a Missed Menstrual Period
  1. If the woman has not adhered to the prescribed regimen (etonogestrel and ethinyl estradiol vaginal ring 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 etonogestrel and ethinyl estradiol vaginal ring use if pregnancy is confirmed.
  2. If the woman has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy.
  3. If the woman has retained one etonogestrel and ethinyl estradiol vaginal ring for longer than four weeks, rule out pregnancy.
Use with Other Vaginal Products

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Etonogestrel and Ethinyl Estradiol Vaginal Ring in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Etonogestrel and Ethinyl Estradiol Vaginal Ring in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Etonogestrel and Ethinyl Estradiol Vaginal Ring FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Etonogestrel and Ethinyl Estradiol Vaginal Ring in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Etonogestrel and Ethinyl Estradiol Vaginal Ring in pediatric patients.

Contraindications

Warnings

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
See full prescribing information for complete Boxed Warning.
CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS: 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.
Thromboembolic Disorders and Other Vascular Problems
  • Stop etonogestrel and ethinyl estradiol vaginal ring use if an arterial thrombotic or venous thromboembolic event (VTE) occurs. Stop etonogestrel and ethinyl estradiol vaginal ring use if there is unexplained loss of vision, proptosis, diplopia, papilledema, or retinal vascular lesions. Evaluate for retinal vein thrombosis immediately.
  • If feasible, stop etonogestrel and ethinyl estradiol vaginal ring 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.
  • Start etonogestrel and ethinyl estradiol vaginal ring no earlier than 4 weeks after delivery, in women who are not breastfeeding. The risk of postpartum thromboembolism decreases after the third postpartum week, whereas the risk of ovulation increases after the third postpartum week.
  • The use of CHCs increases the risk of VTE. Known risk factors for VTE include smoking, obesity, and family history of VTE, in addition to other factors that contraindicate use of CHCs.
  • Two epidemiologic studies1, 2, 3 that assessed the risk of VTE associated with the use of etonogestrel and ethinyl estradiol vaginal ring are described below.
  • In these studies, which were required or sponsored by regulatory agencies, etonogestrel and ethinyl estradiol vaginal ring users had a risk of VTE similar to COC users (see table below for adjusted hazard ratios). A large prospective, observational study, the Transatlantic Active Surveillance on Cardiovascular Safety of etonogestrel and ethinyl estradiol vaginal ring (TASC), investigated the risk of VTE for new users, and women who were switching to or restarting etonogestrel and ethinyl estradiol vaginal ring or COCs in a population that is representative of routine clinical users. The women were followed for 24 to 48 months. The results showed a similar risk of VTE among etonogestrel and ethinyl estradiol vaginal ring users (VTE incidence 8.3 per 10,000 WY) and women using COCs (VTE incidence 9.2 per 10,000 WY). For women using COCs that did not contain the progestins desogestrel (DSG) or gestodene (GSD), VTE incidence was 8.9 per 10,000 WY.
  • A retrospective cohort study using data from 4 health plans in the US (FDA-funded Study in Kaiser Permanente and Medicaid databases) showed the VTE incidence for new users of etonogestrel and ethinyl estradiol vaginal ring to be 11.4 events per 10,000 WY, for new users of a levonorgestrel (LNG)-containing COC 9.2 events per 10,000 WY, and for users of other COCs available during the course of the study1 8.2 events per 10,000 WY.
This image is provided by the National Library of Medicine.
  • An increased risk of thromboembolic and thrombotic disease associated with the use of CHCs is well-established. 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 below).
  • The frequency of VTE in women using CHCs has been estimated to be 3 to 12 cases per 10,000 women-years.
  • 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. The risk of VTE due to CHCs gradually disappears after use is discontinued.
  • 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. 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.
This image is provided by the National Library of Medicine.

1Includes low-dose COCs containing the following progestins: norgestimate, norethindrone, or levonorgestrel.

Toxic Shock Syndrome (TSS)
Liver Disease
Impaired Liver Function
Liver Tumors
High Blood Pressure
Vaginal Use
  • Etonogestrel and ethinyl estradiol vaginal ring may not be suitable for women with conditions that make the vagina more susceptible to vaginal irritation or ulceration. Vaginal/cervical erosion or ulceration in women using etonogestrel and ethinyl estradiol vaginal ring has been reported. In some cases, the ring adhered to vaginal tissue, necessitating removal by a healthcare provider.
  • Some women are aware of the ring on occasion during the 21 days of use or during intercourse, and sexual partners may feel etonogestrel and ethinyl estradiol vaginal ring in the vagina.
Gallbladder Disease
  • Studies suggest a small increased relative risk of developing gallbladder disease among CHC users. Use of CHCs may also worsen existing gallbladder disease.
  • A past history of CHC-related cholestasis predicts an increased risk with subsequent CHC use. Women with a history of pregnancy-related cholestasis may be at an increased risk for CHC-related cholestasis.
Carbohydrate and Lipid Metabolic Effects
  • Carefully monitor prediabetic and diabetic women who are using etonogestrel and ethinyl estradiol vaginal ring. CHCs may decrease glucose tolerance.
  • Consider alternative contraception for women with uncontrolled dyslipidemia. Some women will have adverse lipid changes while on CHCs.
  • Women with hypertriglyceridemia, or a family history thereof, may be at an increased risk of pancreatitis when using CHCs.
Headache
Bleeding Irregularities and Amenorrhea
Unscheduled Bleeding and Spotting
  • Unscheduled bleeding (breakthrough or intracyclic) bleeding and spotting sometimes occur in women using CHCs, especially during the first three months of use. If bleeding persists or occurs after previously regular cycles, check for causes such as pregnancy or malignancy. If pathology and pregnancy are excluded, bleeding irregularities may resolve over time or with a change to a different CHC.
  • Bleeding patterns were evaluated in three large clinical studies. In the North American study (US and Canada, N=1,177), the percentages of subjects with breakthrough bleeding/spotting ranged from 7.2% to 11.7% during cycles 1-13. In the two non-US studies, the percentages of subjects with breakthrough bleeding/spotting ranged from 2.6% to 6.4% (Europe, N=1,145) and from 2.0% to 8.7% (Europe, Brazil, Chile, N=512).
Amenorrhea and Oligomenorrhea
  • If scheduled (withdrawal) bleeding does not occur, consider the possibility of pregnancy. 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.
  • Occasional missed periods may occur with the appropriate use of etonogestrel and ethinyl estradiol vaginal ring. 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%.
  • 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.
Inadvertent Urinary Bladder Insertion

There have been reports of inadvertent insertions of etonogestrel and ethinyl estradiol vaginal ring into the urinary bladder, which required cystoscopic removal. Assess for ring insertion into the urinary bladder in etonogestrel and ethinyl estradiol vaginal ring users who present with persistent urinary symptoms and are unable to locate the ring.

CHC Use Before or During Early Pregnancy
  • Extensive epidemiological studies have revealed no increased risk of birth defects in women who have used oral contraceptives prior to pregnancy. 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. Discontinue etonogestrel and ethinyl estradiol vaginal ring if pregnancy is confirmed.
Depression
  • Carefully observe women with a history of depression and discontinue etonogestrel and ethinyl estradiol vaginal ring use if depression recurs to a serious degree.
Carcinoma of the Breasts and Cervix
  • Etonogestrel and ethinyl estradiol vaginal ring is contraindicated in women who currently have or have had breast cancer because breast cancer is a hormonally-sensitive tumor.
  • There is substantial evidence that CHCs do not increase the incidence of breast cancer. Although some past studies have suggested that CHCs might increase the incidence of breast cancer, more recent studies have not confirmed such findings.
  • Some studies suggest that CHCs are associated with an increase in the risk of cervical cancer or intraepithelial neoplasia. However, there is controversy about the extent to which these findings may be due to differences in sexual behavior and other factors.
Effect on Binding Globulins
  • The estrogen component of CHCs may raise the serum concentrations of thyroxine-binding globulin, sex hormone-binding globulin, and cortisol-binding globulin. The dose of replacement thyroid hormones or cortisol therapy may need to be increased.
Monitoring
  • A woman who is using etonogestrel and ethinyl estradiol vaginal ring should have a yearly visit with her healthcare provider for a blood pressure check and for other indicated healthcare.
Hereditary Angioedema
Chloasma

Adverse Reactions

Clinical Trials Experience

The following serious adverse reactions with the use of CHCs are discussed elsewhere.

  • Serious cardiovascular events and stroke (see Etonogestrel and Ethinyl Estradiol Vaginal Ring#Boxed Warning

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of etonogestrel and ethinyl estradiol vaginal ring. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Immune system disorders: hypersensitivity
  • Nervous system disorders: stroke/cerebrovascular accident
  • Vascular disorders: arterial events (including arterial thromboembolism and myocardial infarction), aggravation of varicose veins
  • Skin and subcutaneous tissue disorders: urticaria, chloasma
  • Reproductive system and breast disorders: penile disorders, including local reactions on penis (in male partners of women using NuvaRing), galactorrhea

Drug Interactions

Consult the labeling of all concurrently-used drugs to obtain further information about interactions with hormonal contraceptives or the potential for enzyme alterations.

Effects of Other Drugs on CHCs
Effects of CHCs on Other Drugs
Interference with Laboratory Tests
  • The use of contraceptive steroids may influence the results of certain laboratory tests, such as coagulation factors, lipids, glucose tolerance, and binding proteins.

Use in Specific Populations

Pregnancy

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Labor and Delivery

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Nursing Mothers

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Pediatric Use

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Geriatic Use

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Gender

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Race

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Renal Impairment

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Hepatic Impairment

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Females of Reproductive Potential and Males

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Immunocompromised Patients

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Others

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Administration and Monitoring

Administration

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Monitoring

Condition 1

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Condition 2

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Condition 3

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IV Compatibility

Solution

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Not Tested

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Variable

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Incompatible

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Y-Site

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Not Tested

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Variable

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Admixture

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Not Tested

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Variable

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Incompatible

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Syringe

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Not Tested

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Variable

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Incompatible

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TPN/TNA

Compatible

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Not Tested

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Variable

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Incompatible

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Overdosage

Acute Overdose

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Management

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Chronic Overdose

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Pharmacology

Etonogestrel and Ethinyl Estradiol Vaginal Ring
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Storage

There is limited information regarding Etonogestrel and Ethinyl Estradiol Vaginal Ring Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

(Patient Counseling Information)

Precautions with Alcohol

Alcohol-NuvaRing interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Etonogestrel and Ethinyl Estradiol Vaginal Ring Brand Names in the drug label.

Look-Alike Drug Names

  • (Paired Confused Name 1a) — (Paired Confused Name 1b)
  • (Paired Confused Name 2a) — (Paired Confused Name 2b)
  • (Paired Confused Name 3a) — (Paired Confused Name 3b)

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References

The contents of this FDA label are provided by the National Library of Medicine.