ZAFEMY

ZAFEMY- norelgestromin and ethinyl estradiol patch
Amneal Pharmaceuticals LLC

WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS and CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30 kg/m2

  • Cigarette Smoking and Serious Cardiovascular Events

    Cigarette smoking increases the risk of serious cardiovascular events from hormonal contraceptive 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 ZAFEMY, are contraindicated in women who are over 35 years of age and smoke [see Contraindications (4) and Warnings and Precautions (5.1)].

  • Contraindicated in Women with a BMI ≥ 30 kg/m2

ZAFEMY is contraindicated in women with a BMI ≥ 30 kg/m2. The risk of VTE may be greater with ZAFEMY in women with a BMI > 30 kg/m2 compared to women with a lower BMI [see Contraindications (4) and Warnings and Precautions (5.1)] .

1 INDICATIONS AND USAGE

ZAFEMY® is indicated for the prevention of pregnancy in women with a body mass index (BMI) < 30 kg/m2 for whom a combined hormonal contraceptive is appropriate.

Limitations of Use:

ZAFEMY may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more. ZAFEMY is contraindicated for use in women with BMI ≥ 30 kg/m2 [see Contraindications (4), Warnings and Precautions (5.1) and Clinical Studies (14)].

2 DOSAGE AND ADMINISTRATION

To achieve maximum contraceptive effectiveness, ZAFEMY must be used exactly as directed.

Complete instructions to facilitate patient counseling on proper system usage may be found in the FDA-Approved Patient Labeling.

2.1 How to Use ZAFEMY

The ZAFEMY transdermal system uses a 28-day (four-week) cycle. A new patch is applied each week for three weeks (21 total days). Week Four is patch-free. Withdrawal bleeding is expected during this time.

Every new patch should be applied on the same day of the week. This day is known as the “Patch Change Day.” For example, if the first patch is applied on a Monday, all subsequent patches should be applied on a Monday. Only one patch should be worn at a time.

Do not cut, damage or alter the ZAFEMY patch in any way. If the ZAFEMY patch is cut, damaged or altered in size, contraceptive efficacy may be impaired.

On the day after Week Four ends, a new four-week cycle is started by applying a new patch. Under no circumstances should there be more than a seven-day patch-free interval between dosing cycles.

2.2 How to Start Using ZAFEMY

There are multiple options for starting the ZAFEMY patch, and the woman should choose the option that is most appropriate (see Table 1):

Table 1: Instructions for Administration

Starting ZAFEMY patch in women with no current use of hormonal contraception

The woman has two options for starting the patch and she should choose the option that is right for her:

First Day Start

  • The woman should apply her first patch during the first 24 hours of her menstrual period. If a patch is applied after the first 24 hours of menstruation, non-hormonal back-up contraception (such as condoms and spermicide, or diaphragm and spermicide) is needed for the first 7 days of the first cycle only.
  • The woman should apply a new patch each week for three weeks (21 total days). Every new patch should be applied on the same day of the week. This day is known as the “Patch Change Day.” For example, if the first patch is applied on a Monday, all subsequent patches should be applied on a Monday. Only one patch should be worn at a time.
  • No patch is worn during Week Four (the “Patch-Free Week”). Withdrawal bleeding is expected during this time.
  • On the day after Week 4 ends, a new 4-week cycle is started by applying a new patch. Under no circumstances should there be more than a 7-day patch-free interval between dosing cycles.

Sunday Start

  • The woman should apply her first patch on the first Sunday after her menstrual period begins.
  • With this option, a non-hormonal backup method of birth control, such as a condom and spermicide or diaphragm and spermicide, is needed for the first 7 days of the first cycle only.
  • If her period starts on a Sunday, the first patch should be applied that day, and no backup contraception is needed.

Switching from another contraceptive method

Oral combination hormonal contraception (oral CHC)

  • If the woman is switching from the pill to ZAFEMY patch, she should complete her current pill cycle and apply the first ZAFEMY patch on the day she would normally start her next pill
  • If she does not get her period within a week after taking the last active pill, she should check with her healthcare professional to be sure that she is not pregnant, but she may go ahead and start ZAFEMY patch for contraception.
  • If the patch is applied more than a week after taking the last active pill, she should use a non-hormonal back-up contraception (such as condoms and spermicide, or diaphragm and spermicide) concurrently for the first 7 days of patch use.

Transdermal system

  • If the woman is switching from another contraceptive transdermal system to ZAFEMY patch, she should complete the current transdermal system cycle and apply the first ZAFEMY patch on the day the next transdermal system cycle would normally start.
  • If she does not get her period within a week after removing the last transdermal system, she should check with her healthcare professional to be sure that she is not pregnant, but she may go ahead and start ZAFEMY patch for contraception. If ZAFEMY patch is applied more than a week after removal of the last patch, non-hormonal back-up contraception (such as condoms and spermicide, or diaphragm and spermicide) should be used concurrently for the first 7 days of patch use.

Vaginal ring

  • If the woman is switching from the vaginal ring to ZAFEMY patch, she should complete her current vaginal ring cycle and apply the first ZAFEMY patch on the day she would normally insert her next vaginal ring.
  • If she does not get her period within a week after removing the last vaginal ring, she should check with her healthcare professional to be sure that she is not pregnant, but she may go ahead and start ZAFEMY patch for contraception.
  • If the patch is applied more than a week after removal of the last vaginal ring, she should use a non-hormonal back-up contraception (such as condoms and spermicide, or diaphragm and spermicide) concurrently for the first 7 days of patch use.

Injection

  • If the woman is switching from an injection contraceptive to ZAFEMY patch, she should apply the first ZAFEMY patch on the day the next injection would normally occur.

Intrauterine system (IUS)

  • If the woman is switching from an intrauterine system to ZAFEMY patch, she should apply the first ZAFEMY patch on the day of IUS removal. If the IUS is not removed on the first day of the menstrual cycle, non-hormonal backup contraception (such as condoms and spermicide, or diaphragm and spermicide) should be used concurrently for the first 7 days of patch use.

Implant

  • If the woman is switching from an implant to ZAFEMY patch, she should apply the first ZAFEMY patch on the day of implant removal.

Progestin-only pill

  • If the woman is switching from a progestin-only pill to ZAFEMY patch, she should apply the first ZAFEMY patch on the day the next progestin-only pill cycle would normally start.

Use after Childbirth

Start contraceptive therapy with ZAFEMY in women who elect not to breastfeed no sooner than 4 weeks after childbirth due to increased risk of thromboembolism. If a woman begins using ZAFEMY postpartum, and has not yet had a period, consider the possibility of ovulation and conception occurring prior to use of ZAFEMY, and instruct her to use an additional method of contraception, such as a condom and spermicide or diaphragm and spermicide, for the first seven days [see Warnings and Precautions (5.1) and Pregnancy (8.1)].

Use after Abortion or Miscarriage

After an abortion or miscarriage that occurs in the first trimester, ZAFEMY may be started immediately. An additional method of contraception is not needed if ZAFEMY is started immediately. If use of ZAFEMY is not started within 5 days following a first trimester abortion, the woman should follow the instructions for a woman starting ZAFEMY for the first time. In the meantime she should be advised to use a non-hormonal contraceptive method. Ovulation may occur within 10 days of an abortion or miscarriage.

Start ZAFEMY no earlier than 4 weeks after a second trimester abortion or miscarriage, due to the increased risk of thromboembolic disease [see Contraindications (4) and Warnings and Precautions (5.1)].

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