Femynor

FEMYNOR- norgestimate and ethinyl estradiol
Amneal Pharmaceuticals NY LLC

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 are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4) ].

1 INDICATIONS AND USAGE

Femynor Tablets are indicated for use by females of reproductive potential to prevent pregnancy [see Clinical Studies (14) ].

2 DOSAGE AND ADMINISTRATION

2.1 How to Start Femynor

Femynor is dispensed in a blister pack [see How Supplied/Storage and Handling (16) ]. Femynor 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 should be used until after the first 7 consecutive days of administration.

2.2 How to Take Femynor

Table 1: Instructions for Administration of Femynor

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:

  • Femynor active tablets are red (Day 1 to Day 21).
  • Femynor has white inactive tablets (Day 22 to Day 28).

Day 1 Start:

  • Take first red “active” tablet without regard to meals on the first day of menses.
  • Take subsequent red “active” tablets once daily at the same time each day for a total of 21 days.
  • Take one white “inactive” tablet daily for 7 days and at the same time of day that red “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 white “inactive” tablet)

Sunday Start:

  • Take first red “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 seven days of the patient’s first cycle pack of Femynor.
  • Take subsequent red “active” tablets once daily at the same time each day for a total of 21 days.
  • Take one white “inactive” tablet daily for the following 7 days and at the same time of day that red “active” tablets were 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 white “inactive” tablet) and additional non-hormonal contraceptive is not needed.

Switching to Femynor 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 Femynor

Start Femynor :

  • 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 to facilitate patient counseling on proper tablet usage are located in the FDA-approved Patient Labeling.

Starting Femynor after Abortion or Miscarriage

First-trimester

  • After a first-trimester abortion or miscarriage, Femynor may be started immediately. An additional method of contraception is not needed if Femynor is started immediately.
  • If Femynor is not started within 5 days after termination of the pregnancy, the patient should use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of her first cycle pack of Femynor.

Second-trimester

  • Do not start until 4 weeks after a second-trimester abortion or miscarriage, due to the increased risk of thromboembolic disease. Start Femynor, following the instructions in Table 1 for Day 1 or Sunday start, as desired. If using Sunday start, use additional non-hormonal contraception (such as condoms and spermicide) for the first seven days of the patient’s first cycle pack of Femynor. [See Contraindications (4), Warnings and Precautions (5.1), and FDA-Approved Patient Labeling.]

Starting Femynor after Childbirth

  • Do not start until 4 weeks after delivery, due to the increased risk of thromboembolic disease. Start contraceptive therapy with Femynor following the instructions in Table 1 for women not currently using hormonal contraception.
  • Femynor is not recommended for use in lactating women [see Use in Specific Populations (8.3) ].
  • If the woman has not yet had a period postpartum, consider the possibility of ovulation and conception occurring prior to use of Femynor. [See Contraindications (4), Warnings and Precautions (5.1), Use in Specific Populations (8.1 and 8.3), and FDA-Approved Patient Labeling].
blister for inserts
(click image for full-size original)

SET THE DAY:

 □ Day 1 Start: Take the first pill of the first blister pack during the first 24 hours of your period.

 □ Sunday Start: Take the first pill of the first blister pack on the Sunday after your period starts, even if you are still bleeding. If your period begins on Sunday, start the blister pack that same day.

2.3 Missed Tablets

Table 2: Instructions for Missed Femynor Tablets

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

Take the tablet as soon as possible. Continue taking one tablet a day until the pack is finished.

  • If two red “active” tablets are missed in Week 1 or Week 2

Take the two missed tablets as soon as possible and the next two red “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) should be used as back-up if the patient has sex within 7 days after missing tablets.

  • If two red “active” tablets are missed in the third week or three or more red “active” tablets are missed in a row in Weeks 1, 2, or 3

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) should be used as back-up if the patient has sex within 7 days after missing tablets.


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