Junel Fe 24

JUNEL FE 24- norethindrone acetate and ethinyl estradiol and ferrous fumarate
Teva Pharmaceuticals USA, Inc.

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS

Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs should not be used by women who are over 35 years of age and smoke [see Contraindications (4)].

1 INDICATIONS AND USAGE

Junel® Fe 24 (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) is indicated for use by women to prevent pregnancy [see Clinical Studies (14)].

The efficacy of Junel Fe 24 in women with a body mass index (BMI) of > 35 kg/m2 has not been evaluated.

2 DOSAGE AND ADMINISTRATION

2.1 How to Start Junel Fe 24

Junel Fe 24 is dispensed in a blister card [see How Supplied/Storage and Handling (16)]. Junel Fe 24 may be started using either a Day 1 start or a Sunday start (see Table 1). For the first cycle of a Sunday Start regimen, an additional method of contraception must be used until after the first 7 consecutive days of administration.

2.2 How to Take Junel Fe 24

Table 1: Instructions for Administration of Junel Fe 24

Starting COCs in women not currently using hormonal contraception (Day 1 Start or Sunday Start)

Important:

Consider the possibility of ovulation and conception prior to initiation of this product.

Tablet Color:

  • Junel Fe 24 active tablets are light yellow (Day 1 to Day 24).
  • Junel Fe 24 inactive tablets are brown (Day 25 to Day 28).

Day 1 Start:

  • Take first light yellow active tablet without regard to meals on the first day of menses.
  • Take subsequent active tablets once daily at the same time each day for a total of 24 days.
  • Take one brown inactive tablet daily for 4 days and at the same time of day that active tablets were taken.
  • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the day after taking the last inactive tablet).

Sunday Start:

For each 28-day course, take in the following order:

  • Take the light yellow active tablet without regard to meals on the first Sunday after the onset of menses. Due to the potential risk of becoming pregnant, use additional non-hormonal contraception (such as condoms and spermicide) for the first 7 days of the patient’s first cycle pack of Junel Fe 24.
  • Take subsequent active tablets once daily at the same time each day for a total of 24 days.
  • Take one brown tablet (ferrous fumarate) daily for the following 4 days and at the same time of day that active tablets were taken. A scheduled period should occur during the 4 days that the brown tablets are taken.
  • Begin each subsequent pack on the same day of the week as the first cycle pack (i.e., on the Sunday after taking the last inactive tablet) and additional non-hormonal contraceptive is not needed.

Switching to Junel Fe 24 from another oral contraceptive

Start on the same day that a new pack of the previous oral contraceptive would have started.

Switching from another contraceptive method to Junel Fe 24

Start Junel Fe 24:

  • Transdermal patch
  • On the day when next application would have been scheduled.
  • Vaginal ring
  • On the day when next insertion would have been scheduled
  • Injection
  • On the day when next injection would have been scheduled
  • Intrauterine contraceptive
  • On the day of removal
  • If the IUD is not removed on first day of the patient’s menstrual cycle, additional non-hormonal contraceptive (such as condoms and spermicide) is needed for the first seven days of the first cycle pack.
  • Implant
  • On the day of removal

Complete instructions on proper tablet usage are located in the FDA-approved patient labeling.

Starting Junel Fe 24 after Abortion or Miscarriage

First-trimester

  • After a first-trimester abortion or miscarriage, Junel Fe 24 may be started immediately. An additional method of contraception is not needed if Junel Fe 24 is started immediately.
  • If Junel Fe 24 is not started within 5 days after termination of the pregnancy, the patient must use additional non-hormonal contraception (such as condoms and spermicide) for the first 7 days of her first 28-day course of Junel Fe 24.

Second-trimester

  • Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Junel Fe 24 following the instructions in Table 1 for Sunday start. Use additional non-hormonal contraception (such as condoms and spermicide) for the first 7 days of the patient’s first 28-day course of Junel Fe 24 [see Contraindications (4), Warnings and Precautions (5.1), and FDA-approved Patient Labeling].
  • Starting Junel Fe 24 after Childbirth
  • Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Junel Fe 24 following the instructions in Table 1 for women not currently using hormonal contraception.
  • If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Junel Fe 24 [see Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.3)].

2.3 Missed Tablets

Table 2: Instructions for Missed Junel Fe 24 Tablets

  • If one active tablet is missed in Weeks 1, 2 or 3

Take the tablet as soon as possible. Take the next pill at the regular time, and continue taking one tablet a day until the pack is finished. Back-up contraception is not needed.

  • If two consecutive active tablets are missed in Week 1 or Week 2

Take the two missed tablets as soon as possible and the next two active tablets the next day. Continue taking one tablet a day until the pack is finished. Additional non-hormonal contraception (such as condoms and spermicide) must be used as back-up if the patient has sex within 7 days after missing tablets.

  • If two consecutive active tablets are missed in Week 3 or Week 4 or three or more consecutive active tablets are missed at any time

Day 1 Start: Throw out the rest of the pack and start a new pack that same day.

Sunday Start: Continue taking one tablet a day until Sunday, then throw out the rest of the pack and start a new pack that same day.

Additional non-hormonal contraception (such as condoms and spermicide) must be used as back-up if the patient has sex within 7 days after missing 3 tablets.

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