Etonogestrel And Ethinyl Estradiol Vaginal

2 DOSAGE AND ADMINISTRATION One Etonogestrel and ethinyl estradiol vaginal ring is inserted in the vagina. The ring must remain in place continuously for three weeks, followed by a one-week ring-free interval. 2 )]. 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. An optional alternative is to insert the ring using the applicator for Etonogestrel and ethinyl estradiol vaginal ring [see Applicator for Etonogestrel and ethinyl estradiol vaginal ring Instructions for Use ].

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. 2 How to Start Using Etonogestrel and ethinyl estradiol vaginal ring IMPORTANT: 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 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. ” In the meantime, she should be advised to use a non-hormonal contraceptive method.

Start Etonogestrel and ethinyl estradiol vaginal ring no earlier than four weeks after a second trimester abortion or miscarriage, due to the increased risk of thromboembolism. ] 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.

] Advise women who are breastfeeding not to use Etonogestrel and ethinyl estradiol vaginal ring but to use other forms of contraception until the child is weaned. If a woman begins using Etonogestrel and ethinyl estradiol vaginal ring 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 Etonogestrel and ethinyl estradiol vaginal ring. 3 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. Advise women to regularly check for the presence of Etonogestrel and ethinyl estradiol vaginal ring in the vagina (for example, before and after intercourse).

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 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: 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 male condoms with spermicides must be used until the new ring has been used continuously for seven days. If Etonogestrel and ethinyl estradiol vaginal ring 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 Etonogestrel and ethinyl estradiol vaginal ring has been used continuously for seven days.

, 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.

2 )] . 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. 4 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.

5 Use with Other Vaginal Products Etonogestrel and ethinyl estradiol vaginal ring 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 Etonogestrel and ethinyl estradiol vaginal ring use.

Pharmacokinetic data show that the use of tampons has no effect on the systemic absorption of the hormones released by Etonogestrel and ethinyl estradiol vaginal ring .

6 ADVERSE REACTIONS The following serious adverse reactions with the use of CHCs are discussed elsewhere in the labeling. , expulsion/discomfort/foreign body sensation), nausea/vomiting, vaginal discharge, increased weight, vaginal discomfort, breast pain/discomfort/tenderness, dysmenorrhea, abdominal pain, acne, and decreased libido.

1 Clinical Trials Experience 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.

Trials with a duration of 6 to 13 28-day cycles provided safety data. In total, 2,501 women, aged 18 to 41 contributed 24,520 cycles of exposure. 0%). 2%). 1 ) ], anxiety, cholelithiasis, and vomiting. 12 (Figure 2). Three studies compared breast cancer risk between current or recent COC users (<6 months since last use) and never users of COCs (Figure 2).

One of these studies reported no association between breast cancer risk and COC use. 33 with current or recent use. 4 with more than 8-10 years of COC use.

Figure 2:

Relevant Studies of Risk of Breast Cancer with Combined Oral Contraceptives RR = relative risk; OR = odds ratio; HR = hazard ratio. “ever COC” are females with current or past COC use; “never COC use” are females that never used COCs.

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 reactions, including anaphylaxis and angioedema 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 : exacerbations of hereditary and acquired angioedema, urticaria, chloasma Reproductive system and breast disorders : penile disorders, including local reactions on penis (in male partners of women using Etonogestrel and ethinyl estradiol vaginal ring), galactorrhea General Disorders and Administration Site Conditions : device breakage (including with concomitant use of intravaginal antimycotic, antibiotic, and lubricant products) Injury, poisoning and procedural complications : vaginal injury (including associated pain, discomfort, and bleeding) associated with ring breakage enilloring-chart

5 WARNINGS AND PRECAUTIONS Vascular risks: Stop Etonogestrel and ethinyl estradiol vaginal ring use if a thrombotic event occurs. Stop Etonogestrel and ethinyl estradiol vaginal ring use at least 4 weeks before and through 2 weeks after major surgery.

Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. 1 ) Toxic Shock Syndrome (TSS): If patient exhibits signs or symptoms of TSS, consider the possibility of this diagnosis and initiate appropriate medical evaluation and treatment.

2 ) Liver disease: Discontinue Etonogestrel and ethinyl estradiol vaginal ring use if jaundice develops. 3 ) High blood pressure: If used in women with well-controlled hypertension, monitor blood pressure and stop Etonogestrel and ethinyl estradiol vaginal ring use if blood pressure rises significantly.

5 ) Carbohydrate and lipid metabolic effects: Monitor prediabetic and diabetic women. Consider an alternate contraceptive method for women with uncontrolled dyslipidemia. 9 ) Headache: Evaluate significant changes in headaches and discontinue Etonogestrel and ethinyl estradiol vaginal ring use if indicated.

10 ) Uterine bleeding: Evaluate irregular bleeding or amenorrhea. 1 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 [see Contraindications ( 4 )]. Two epidemiologic studies 1, 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 Combined Oral Contraceptives (COCs) users (see Table 1 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. 2 per 10,000 WY). 9 per 10,000 WY. 2 events per 10,000 WY. *Includes low-dose COCs containing the following progestins: norgestimate, norethindrone, or levonorgestrel. 0) * Includes low-dose COCs containing the following progestins: chlormadinone acetate, cyproterone acetate, desogestrel, dienogest, drospirenone, ethynodiol diacetate, gestodene, levonorgestrel, norethindrone, norgestimate, or norgestrel † Adjusted for age, BMI, duration of use, VTE history ‡Includes low-dose COCs containing the following progestins: norgestimate, norethindrone, or levonorgestrel §Adjusted for age, site, year of entry into study 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 1). 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.

Figure 1:

Likelihood of Developing a VTE *CHC=combination hormonal contraception **Pregnancy data based on actual duration of pregnancy in the reference studies. Based on a model assumption that pregnancy duration is nine months, the rate is 7 to 27 per 10,000 WY.

Several epidemiology studies indicate that third generation oral contraceptives, including those containing desogestrel (etonogestrel, the progestin in Etonogestrel and ethinyl estradiol vaginal ring, is the biologically active metabolite of desogestrel), may be associated with a higher risk of VTE than oral contraceptives containing other progestins.

Some of these studies indicate an approximate two-fold increased risk. However, data from other studies have not shown this two-fold increase in risk. Use of CHCs also increases the risk of arterial thromboses such as strokes and myocardial infarctions, especially in women with other risk factors for these events.

CHCs have been shown to increase both the relative and attributable risks of cerebrovascular events (thrombotic and hemorrhagic strokes). In general, the risk is greatest among older (>35 years of age), hypertensive women who also smoke.

Use Etonogestrel and ethinyl estradiol vaginal ring with caution in women with cardiovascular disease risk factors. 2 Toxic Shock Syndrome (TSS) Cases of TSS have been reported by Etonogestrel and ethinyl estradiol vaginal ring users.

TSS has been associated with tampons and certain barrier contraceptives, and, in some cases the Etonogestrel and ethinyl estradiol vaginal ring users were also using tampons. A causal relationship between the use of Etonogestrel and ethinyl estradiol vaginal ring and TSS has not been established.

If a patient exhibits signs or symptoms of TSS, consider the possibility of this diagnosis and initiate appropriate medical evaluation and treatment. 3 Liver Disease Impaired Liver Function Do not use Etonogestrel and ethinyl estradiol vaginal ring in women with liver disease such as acute viral hepatitis or severe (decompensated) cirrhosis of the liver [see Contraindications ( 4 )].

6 )]. Discontinue Etonogestrel and ethinyl estradiol vaginal ring use if jaundice develops. Liver Tumors Etonogestrel and ethinyl estradiol vaginal ring is contraindicated in women with benign and malignant liver tumors [see Contraindications ( 4 )].

Hepatic adenomas are associated with CHC use. 3 cases per 100,000 CHC users. Rupture of hepatic adenomas may cause death through intra-abdominal hemorrhage. Studies have shown an increased risk of developing hepatocellular carcinoma in long term (>8 years) CHC users.

However, the attributable risk of liver cancers in CHC users is less than one case per million users. 4 Risk of Liver Enzyme Elevations with Concomitant Hepatitis C Treatment CHCs, such as etonogestrel and ethinyl estradiol vaginal ring, are contraindicated for use with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir (with or without dasabuvir) [see Contraindications (4)].

Discontinue etonogestrel and ethinyl estradiol vaginal ring prior to starting therapy with the combination drug regimen ombitasvir/paritaprevir/ritonavir (with or without dasabuvir). Etonogestrel and ethinyl estradiol vaginal ring can be restarted approximately 2 weeks following completion of treatment with this hepatitis C combination drug regimen.

During clinical trials with some HCV combination drug regimens, ALT elevations were observed in women using ethinyl estradiol containing medications [see Drug Interactions (7)]. For example, the Hepatitis C combination drug regimen that contains ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, ALT elevations greater than 5 times the upper limit of normal (ULN), including some cases greater than 20 times the ULN, were significantly more frequent in women using ethinyl estradiol-containing medications, such as CHCs.

5 High Blood Pressure Etonogestrel and ethinyl estradiol vaginal ring is contraindicated in women with uncontrolled hypertension or hypertension with vascular disease [see Contraindications ( 4 )] . For women with well-controlled hypertension, monitor blood pressure and stop Etonogestrel and ethinyl estradiol vaginal ring use if blood pressure rises significantly.

An increase in blood pressure has been reported in women using CHCs and this increase is more likely in older women and with extended duration of use. The incidence of hypertension increases with increasing concentrations of progestin.

6 Hypersensitivity Reactions Hypersensitivity reactions of anaphylaxis and angioedema have been reported during use of Etonogestrel and ethinyl estradiol vaginal ring. If anaphylaxis and/or angioedema is suspected, Etonogestrel and ethinyl estradiol vaginal ring should be discontinued and appropriate treatment administered.

7 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.

, when the tissue had grown over the ring), removal was achieved by cutting the ring without incising the overlying vaginal tissue. 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.

8 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. 9 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.

10 Headache If a woman using Etonogestrel and ethinyl estradiol vaginal ring develops new headaches that are recurrent, persistent, or severe, evaluate the cause and discontinue Etonogestrel and ethinyl estradiol vaginal ring if indicated.

Consider discontinuation of Etonogestrel and ethinyl estradiol vaginal ring 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 )].

11 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. 7% during cycles 1-13. 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.

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.

12 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.

13 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. 14 Malignant Neoplasms Etonogestrel and ethinyl estradiol vaginal ring is contraindicated in females who currently have or have had breast cancer because breast cancer may be hormonally sensitive [see Contraindications ( 4 )].

Epidemiology studies have not found a consistent association between use of combined oral contraceptives (COCs) and breast cancer risk. Studies do not show an association between ever (current or past) use of COCs and risk of breast cancer.

2 )] . Cervical Cancer 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.

15 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.

16 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. 17 Hereditary Angioedema In women with hereditary angioedema, exogenous estrogens may induce or exacerbate symptoms of angioedema.

18 Chloasma Chloasma may occasionally occur, especially in women with a history of chloasma gravidarum. Women with a tendency to chloasma should avoid exposure to the sun or ultraviolet radiation while using Etonogestrel and ethinyl estradiol vaginal ring.

4 CONTRAINDICATIONS Etonogestrel and ethinyl estradiol vaginal ring is contraindicated in females who are known to have or develop the following conditions: A high risk of arterial or venous thrombotic diseases. 4 )]. A high risk of arterial or venous thrombotic diseases ( 4 ) Breast cancer ( 4 ) Liver tumors or liver disease ( 4 ) Undiagnosed abnormal uterine bleeding ( 4 ) Pregnancy ( 4 ) Hypersensitivity, including anaphylaxis and angioedema, to any of the components of Etonogestrel and ethinyl estradiol vaginal ring ( 4 ) Co-administration with Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir ( 4 )