Etonogestrel/Ethinyl Estradiol (Page 2 of 8)

2.4 In the Event of a Missed Menstrual Period

  1. If the woman has not adhered to the prescribed regimen (Etonogestrel/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/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/Ethinyl Estradiol Vaginal Ring for longer than four weeks, rule out pregnancy.

2.5 Use with Other Vaginal Products

Etonogestrel/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/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/Ethinyl Estradiol Vaginal Ring.

3 DOSAGE FORMS AND STRENGTHS

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. Etonogestrel/Ethinyl Estradiol Vaginal Ring is not made with natural rubber latex.

4 CONTRAINDICATIONS

Do not prescribe Etonogestrel/Ethinyl Estradiol Vaginal Ring to women who are known to have or use the following:

5 WARNINGS AND PRECAUTIONS

5.1 Thromboembolic Disorders and Other Vascular Problems

Stop Etonogestrel/Ethinyl Estradiol Vaginal Ring use if an arterial thrombotic or venous thromboembolic event (VTE) occurs. Stop Etonogestrel/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. [See Adverse Reactions (6).]

If feasible, stop Etonogestrel/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/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 studies1, 2, 3 that assessed the risk of VTE associated with the use of Etonogestrel/Ethinyl Estradiol Vaginal Ring are described below.

In these studies, which were required or sponsored by regulatory agencies, Etonogestrel/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/Ethinyl Estradiol Vaginal Ring (TASC), investigated the risk of VTE for new users, and women who were switching to or restarting Etonogestrel/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/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/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 study 1 8.2 events per 10,000 WY.

Table 1: Estimates (Hazard Ratios) of Venous Thromboembolism Risk in Users of Etonogestrel/Ethinyl Estradiol Vaginal Ring Compared to Users of Combined Oral Contraceptives (COCs)
Epidemiologic Study(Author, Year of Publication)Population StudiedComparator Product(s)Hazard Ratios (HR)(95% CI)
*
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
TASC(Dinger, 2012)
Initiators, including new users, switchers and restartersAll COCs available during the course of the study *HR : 0.8(0.5-1.5)
COCs available excluding DSG- or GSD -containing OCsHR : 0.8(0.4-1.7)
FDA-funded Study in Kaiser Permanente and Medicaid databases(Sidney, 2011)
First use of a combined hormonal contraceptive (CHC) during the study period COCs available during the course of the study HR §: 1.1(0.6-2.2)
LNG/0.03 mg ethinyl estradiolHR §: 1.0(0.5-2.0)

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.
Figure 1
(click image for full-size original)

Several epidemiology studies indicate that third generation oral contraceptives, including those containing desogestrel (etonogestrel, the progestin in Etonogestrel/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/Ethinyl Estradiol Vaginal Ring with caution in women with cardiovascular disease risk factors.

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