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)] .
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)].
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.
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.
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
Switching from another contraceptive method
Oral combination hormonal contraception (oral CHC)
Intrauterine system (IUS)
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)].
CHOOSING A PLACE ON THE BODY TO PUT THE PATCH
- The patch may be placed on the upper outer arm, abdomen, buttock or back in a place where it won’t be rubbed by tight clothing. For example, it should not be placed under the waistband of clothing.
- The patch should not be placed on the breasts, on cut or irritated skin, or on the same location as the previous patch.
Before applying the patch:
- The woman should make sure the skin is clean and dry.
- She should not use lotions, creams, oils, powders, or make-up at the patch site. It may cause the patch to fail to stick properly or to become loose.
HOW TO APPLY THE PATCH
- The woman should check her patch every day to make sure all edges are sticking correctly.
WHEN TO CHANGE THE ZAFEMY PATCH
- The patch works for seven days (one week). The woman should apply a new patch on the same day each week (her Patch Change Day) for 3 weeks in a row. She must make sure she has removed her old patch prior to applying the new patch.
- During Week 4, she DOES NOT wear a patch. She must make sure she removes her old patch. (Her period should begin during this week.)
- Following Week 4, she repeats the cycle of three weekly applications followed by a patch-free week.
WHAT IF THE PATCH BECOMES LOOSE OR FALLS OFF?
The patch must stick securely to the skin to work properly. If the ZAFEMY patch becomes partially or completely detached and remains detached, insufficient drug delivery occurs. The woman should not try to reapply a patch if it is no longer sticky, if it has become stuck to itself or another surface, or if it has other material stuck to it.
If a patch edge lifts up:
- The woman should press down firmly on the patch with the palm of her hand for 10 seconds, making sure that the whole patch adheres to her skin. She should run her fingers over the entire surface area to smooth out any “wrinkles” around the edges of the patch.
- If her patch does not stick completely, she should remove it and apply a replacement patch.
- She should not tape or wrap the patch to her skin or reapply a patch that is partially adhered to clothing.
If the patch has been off or partially off:
- For less than 1 Day, she should try to reapply it. If the patch does not adhere completely, she should apply a new patch immediately. (No backup contraception is needed and her Patch Change Day will stay the same).
- For more than 1 Day or if she is not sure for how long, she may not be protected from pregnancy. To reduce this risk, she should apply a new patch and start a new 4-week cycle. She will now have a new Patch Change Day and MUST USE NON-HORMONAL BACKUP CONTRACEPTION (such as a condom and spermicide or diaphragm and spermicide) for the first week of her new cycle.
IF THE WOMAN FORGETS TO CHANGE HER PATCH
- at the start of any patch cycle (Week One/Day 1): SHE MAY NOT BE PROTECTED FROM PREGNANCY. She should apply the first patch of her new cycle as soon as she remembers. There is now a new “Patch Change Day” and a new “Day 1.” The woman must use back-up contraception, such as a condom and spermicide or diaphragm and spermicide, for the first week of the new cycle.
- in the middle of the patch cycle (Week Two/Day 8 or Week Three/Day 15),
- for one or two days (up to 48 hours), she should apply a new patch immediately. The next patch should be applied on the usual “Patch Change Day.” No back-up contraception is needed.
- for more than two days (48 hours or more), SHE MAY NOT BE PROTECTED FROM PREGNANCY. She should stop the current contraceptive cycle and start a new four-week cycle immediately by putting on a new patch. There is now a new “Patch Change Day” and a new “Day 1.” The woman must use back-up contraception for one week.
- at the end of the patch cycle (Week Four/Day 22),
- If the woman forgets to remove her patch, she should take it off as soon as she remembers. The next cycle should be started on the usual “Patch Change Day,” which is the day after Day 28. No back-up contraception is needed.
Under no circumstances should there be more than a seven-day patch-free interval between cycles. If there are more than seven patch-free days, THE WOMAN MAY NOT BE PROTECTED FROM PREGNANCY and back-up contraception, such as a condom and spermicide or diaphragm and spermicide, must be used for seven days. As with combined oral contraceptives, the risk of ovulation increases with each day beyond the recommended drug-free period. If she has had intercourse during such an extended patch-free interval, consider the possibility of pregnancy.
Change Day Adjustment
If the woman wishes to change her Patch Change Day, she should complete her current cycle, removing the third ZAFEMY patch on the correct day. During the patch-free week, she may select an earlier Patch Day Change by applying a new ZAFEMY patch on the desired day. In no case should there be more than 7 consecutive patch-free days.
Breakthrough Bleeding or Spotting
In the event of unscheduled or breakthrough bleeding or spotting (bleeding that occurs on the days that ZAFEMY is worn), treatment should be continued. If unscheduled bleeding persists longer than a few cycles, consider causes other than ZAFEMY.
If the woman does not have scheduled or withdrawal bleeding (bleeding that should occur during the patch-free week), she should resume treatment on the next scheduled Change Day. If ZAFEMY has been used correctly, the absence of withdrawal bleeding is not necessarily an indication of pregnancy. Nevertheless, consider the possibility of pregnancy, especially if absence of withdrawal bleeding occurs in 2 consecutive cycles. Discontinue ZAFEMY if pregnancy is confirmed.
In Case of Skin Irritation
If patch use results in uncomfortable irritation, the patch may be removed and a new patch may be applied to a different location until the next Change Day. Only one patch should be worn at a time.
Additional Instructions for Dosing
Unscheduled bleeding, spotting, and amenorrhea are frequent reasons for patients discontinuing hormonal contraceptives. In case of breakthrough bleeding, as in all cases of irregular bleeding from the vagina, consider nonfunctional causes. In case of undiagnosed persistent or recurrent abnormal bleeding from the vagina, take adequate diagnostic measures to rule out pregnancy or malignancy. If pathology has been excluded, time or a change to another method of contraception may solve the problem.
Use of Hormonal Contraceptives in the Event of a Missed Menstrual Period
- If the woman has not adhered to the prescribed schedule, consider the possibility of pregnancy at the time of the first missed period. Discontinue use of ZAFEMY if pregnancy is confirmed.
- If the woman has adhered to the prescribed regimen and misses one period, she should continue using her contraceptive patches. However, if she has adhered to the prescribed regimen, misses one period and has symptoms associated with pregnancy, rule out pregnancy. Discontinue ZAFEMY use if pregnancy is confirmed.
- If the woman has adhered to the prescribed regimen and misses two consecutive periods, rule out pregnancy. Discontinue ZAFEMY use if pregnancy is confirmed.
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