Etonogestrel/Ethinyl Estradiol

ETONOGESTREL/ETHINYL ESTRADIOL- etonogestrel and ethinyl estradiol insert, extended release
Prasco Laboratories

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 Etonogestrel/Ethinyl Estradiol Vaginal Ring, should not be used by women who are over 35 years of age and smoke. [See Contraindications (4).]

1 INDICATIONS AND USAGE

FOR VAGINAL USE ONLY

Etonogestrel/Ethinyl Estradiol Vaginal Ring is indicated for use by females of reproductive age to prevent pregnancy.

2 DOSAGE AND ADMINISTRATION

2.1 How to Use Etonogestrel/Ethinyl Estradiol Vaginal Ring

To achieve maximum contraceptive effectiveness, Etonogestrel/Ethinyl Estradiol Vaginal Ring must be used as directed [see Dosage and Administration (2.2)]. One 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 Etonogestrel/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/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.

2.2 How to Start Using Etonogestrel/Ethinyl Estradiol Vaginal Ring

IMPORTANT: Consider the possibility of ovulation and conception prior to the first use of Etonogestrel/Ethinyl Estradiol Vaginal Ring.

No Hormonal Contraceptive Use in the Preceding Cycle:

The woman should insert Etonogestrel/Ethinyl Estradiol Vaginal Ring on the first day of her menstrual bleeding. 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 with spermicide, should be used for the first seven days of Etonogestrel/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/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/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/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.

Start Etonogestrel/Ethinyl Estradiol Vaginal Ring no earlier than four weeks after a second trimester abortion or miscarriage, due to the increased risk of thromboembolism. [See Contraindications (4) and Warnings and Precautions (5.1).]

Following Childbirth:

The use of Etonogestrel/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. [See Contraindications (4) and Warnings and Precautions (5.1).]

Advise women who are breastfeeding not to use Etonogestrel/Ethinyl Estradiol Vaginal Ring but to use other forms of contraception until the child is weaned.

If a woman begins using Etonogestrel/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/Ethinyl Estradiol Vaginal Ring.

2.3 Deviations from the Recommended Regimen

To prevent loss of contraceptive efficacy, advise women not to deviate from the recommended regimen. Etonogestrel/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/Ethinyl Estradiol Vaginal Ring in the vagina (for example, before and after intercourse).

Inadvertent Removal or Expulsion:

Etonogestrel/Ethinyl Estradiol Vaginal Ring can be accidentally expelled, for example, while removing a tampon, during intercourse, or with straining during a bowel movement. Etonogestrel/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/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/Ethinyl Estradiol Vaginal Ring is lost, a new vaginal ring should be inserted and the regimen should be continued without alteration.

If Etonogestrel/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/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/Ethinyl Estradiol Vaginal Ring has been used continuously for seven days.

Prolonged Use of Etonogestrel/Ethinyl Estradiol Vaginal Ring:

If 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. Etonogestrel/Ethinyl Estradiol Vaginal Ring should be removed and the woman should insert a new ring after a one-week ring-free interval.

If Etonogestrel/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/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/Ethinyl Estradiol Vaginal Ring has been used continuously for seven days.

Ring Breakage:

There have been reported cases of Etonogestrel/Ethinyl Estradiol Vaginal Ring disconnecting at the weld joint. This is not expected to affect the contraceptive effectiveness of Etonogestrel/Ethinyl Estradiol Vaginal Ring. In the event of a disconnected ring, vaginal discomfort or expulsion (slipping out) is more likely to occur. Vaginal injury associated with ring breakage has been reported [see Adverse Reactions (6.2)].

If a woman discovers that her Etonogestrel/Ethinyl Estradiol Vaginal Ring has disconnected, she should discard the ring and replace it with a new ring.

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