NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Like oral contraceptives, NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) is highly effective if used as recommended in this label. In three large clinical trialsof 13 cycles of NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) use, pregnancy rates were between one and two per 100 women-years of use. Table III lists the pregnancy rates for users of various contraceptive methods.

TABLE III: PERCENTAGE OF WOMEN EXPERIENCING AN UNINTENDED PREGNANCY DURING THE FIRST YEAR OF TYPICAL USE AND THE FIRST YEAR OF PERFECT USE OF CONTRACEPTION AND THE PERCENTAGE CONTINUING USE AT THE END OF THE FIRST YEAR: UNITED STATES.

To achieve maximum contraceptive effectiveness, NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) must be used as directed (see When to Start NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) below). One NuvaRing® (etonogestrel, 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 NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) inside the vagina is not critical for its function. The vaginal ring must be inserted onthe appropriate day and left in place for three consecutive weeks. This means that the ring is removed three weeks later on the same day of the week as it was inserted an data bout the same time. NuvaRing® (etonogestrel, 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 awaste 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 one week after the previous one was removed even if menstrual bleeding has not finished.

When to Start NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring)

IMPORTANT: The possibility of ovulation and conception prior to the first use of NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) should be considered.

No hormonal contraceptive use in the preceding cycle

Insert NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) on the first day of the woman's natural cycle (i.e., the first day of her menstrual bleeding). NuvaRing® (etonogestrel, 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 or spermicide, is recommended for the first seven days of NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) use in the first cycle.

Changing from a combined hormonal contraceptive

The woman may switch from her previous combined hormonal contraceptive 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 progestagen-only method (minipill, implant, or injection) orfroma progestagen-releasing intrauterine system (IUS)

The woman may switch on any day from the minipill. 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 or spermicide, for the first seven days.

Following complete first trimester abortion

The woman may start using NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) within the first five days following a complete first trimester abortion and does not need to use an additional method of contraception. If use of NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) is not started within five days following a first trimester abortion, 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 delivery or second trimester abortion

The use of NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) for contraception may be initiated four weeks postpartum in women who elect not to breast-feed. Women who are breast-feeding should be advised not to use NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) but to use other forms of contraception until the child is weaned. NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) use may be initiated four weeks after a second trimester abortion. When NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) is used postpartum or postabortion, the increased risk of thromboembolic disease must be considered. (See CONTRAINDICATIONS and WARNINGS concerning thromboembolic disease. See PRECAUTIONS for “Nursing Mothers”.) If a woman begins using NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) postpartum, she should be instructed to use an additional method of contraception, such as male condoms or spermicide, for the first seven days. If she has not yet had a period, the possibility of ovulation and conception occurring prior to initiation of NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) should be considered.

Deviations from the Recommended Regimen

To prevent loss of contraceptive efficacy, women should not deviate from the recommended regimen. NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) should be left in the vagina for a continuous period of three weeks.

Inadvertent removal, expulsion, or prolonged ring-free interval

If the ring is accidentally expelled and is left outside of the vagina for less than three hours contraceptive efficacy is not reduced. N uvaRing® 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® (etonogestrel, ethinyl estradiol vaginal ring) is lost, a new vaginal ring should be inserted and the regimen should be continued without alteration. If NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) is out of the vagina for more than three hours, the directions listed under PRECAUTIONS, Expulsion should be followed.

If the ring-free interval has been extended beyond one week, the possibility of pregnancy should be considered, and an additional method of contraception, such as male condoms or spermicide, MUST be used until NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) has been used continuously for seven days.

Prolonged Use of NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring)

If NuvaRing® (etonogestrel, 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. NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) should be removed and the woman should insert a new ring after a one-week ring-free interval. The mean serum etonogestrel concentration during the fourth week of continuous use of NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) was 1272 ± 311 pg/mL compared to a mean concentration range of 1578 ± 408 to 1374 ± 328 pg/mL during weeks one to three. The mean serum ethinyl estradiol concentration during the fourth week of continuous use of NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) was 16.8 ± 4.6 pg/mL compared to a mean concentration range of 19.1 ± 4.5 to 17.6 ± 4.3 pg/mL during weeks one to three. If NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) has been left in place for longer than four weeks, pregnancy should be ruled out, and an additional method of contraception, such as male condoms or spermicide, MUST be used until a new N uvaRing® has been used continuously for seven days.

In the event of a missed menstrual period

1. If the woman has not adhered to the prescribed regimen (NuvaRing® (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) the possibility of pregnancy should be considered at the time of the first missed period and NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) use should be discontinued if pregnancy is confirmed.
2. If the woman has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out.
3. If the woman has retained one NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) for longer than four weeks, pregnancy should be ruled out.

Each NuvaRing® (etonogestrel/ethinyl estradiol vaginal ring) is individually packaged in a reclosable aluminum laminate sachet consisting of three layers, from outside to inside: polyester, aluminum foil, and low-density polyethylene. The ring should be replaced in this reclosable sachet after use for convenient disposal.

Box of 3 sachets..............NDC 0052-0273-03

Box of 1 sachet..............NDC 0052-0273-01

Storage

Prior to dispensing to the user, store refrigerated 2-8°C (36-46°F). After dispensing to the user, NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) can be stored for up to four months at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Avoid storing NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) in direct sunlight or at temperatures above 30°C (86°F). For the Dispenser: When NuvaRing® (etonogestrel, ethinyl estradiol vaginal ring) is dispensed to the user place an expiration date on the label. The date should not exceed either four months from the date of dispensing or the expiration date, whichever comes first.

REFERENCES FURNISHED UPON REQUEST

Manufactured for Organon USA Inc. Roseland, NJ 07068. by N.V. Organon, Oss, The Netherlands

Last reviewed on RxList: 7/10/2009
This monograph has been modified to include the generic and brand name in many instances.