Nuvaring (Etonogestrel / Ethinyl Estradiol Vaginal Ring) - Indications and Dosage

INDICATIONS AND USAGE

NuvaRing® is indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception. Like oral contraceptives, NuvaRing® is highly effective if used as recommended in this label.

In three large clinical trials of 13 cycles of NuvaRing® 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.

	% of Women Experiencing an Unintended Pregnancy within the First Year of Use		% of Women Continuing Use at One Year 1
Method (1)	Typical Use 2 (2)	Perfect Use 3 (3)	(4)
Emergency Contraceptive Pills: Treatment initiated within 72 hours after unprotected intercourse reduces the risk of pregnancy by at least 75%. 4
Lactation Amenorrhea Method: LAM is a highly effective, temporary method of contraception. 5
Adapted from Hatcher et al., Contraceptive Technology, 17th Revised Edition. New York, NY: Irvington Publishers, 1998.
Chance 6	85	85
Spermicides 7	26	6	40
Periodic abstinence	25		63
Calendar		9
Ovulation Method		3
Sympto-Thermal 8		2
Post-Ovulation		1
Cap 9
Parous Women	40	26	42
Nulliparous Women	20	9	56
Sponge
Parous Women	40	20	42
Nulliparous Women	20	9	56
Diaphragm	20	6	56
Withdrawal	19	4
Condom 10
Female (Reality)	21	5	56
Male	14	3	61
Pill
Progestin Only		0.5
Combined		0.1
IUD
Progesterone T	2.0	1.5	81
Copper T 380A	0.8	0.6	78
LNg 20	0.1	0.1	81
Depo-Provera	0.3	0.3	70
Norplant and Norplant-2	0.05	0.05	88
Female sterilization	0.5	0.5	100
Male sterilization	0.15	0.10	100

DOSAGE AND ADMINISTRATION

To achieve maximum contraceptive effectiveness, NuvaRing® must be used as directed (see When to Start NuvaRing® below). 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 is 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 one week after the previous one was removed even if menstrual bleeding has not finished.

When to Start NuvaRing®

IMPORTANT: The possibility of ovulation and conception prior to the first use of NuvaRing® should be considered.

No hormonal contraceptive use in the preceding cycle

Insert NuvaRing® on the first day of the woman’s natural cycle (i.e., 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 or spermicide, is recommended for the first seven days of NuvaRing® 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) or from a 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® 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® 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® 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® but to use other forms of contraception until the child is weaned. NuvaRing® use may be initiated four weeks after a second trimester abortion. When NuvaRing® 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® 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® should be considered.

Deviations from the Recommended Regimen

To prevent loss of contraceptive efficacy, women should not deviate from the recommended regimen. NuvaRing® 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. 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 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® 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. The mean serum etonogestrel concentration during the fourth week of continuous use of NuvaRing® 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® 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® 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 NuvaRing® has been used continuously for seven days.

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) the possibility of pregnancy should be considered at the time of the first missed period and NuvaRing® use should be discontinued if pregnancy is confirmed.If the woman has adhered to the prescribed regimen and misses two consecutive periods, pregnancy should be ruled out.If the woman has retained one NuvaRing® for longer than four weeks, pregnancy should be ruled out.

HOW SUPPLIED

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® 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® in direct sunlight or at temperatures above 30°C (86°F). For the Dispenser: When NuvaRing® 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.

Rx only