ZAFEMY: Package Insert and Label Information (Page 6 of 6)

INSTRUCTIONS FOR USE

ZAFEMY® (za fe ʹ my)

(n orelgestromin and ethinyl estradiol transdermal system)

ZAFEMY is for skin use only.

Do not cut, damage, or alter the ZAFEMY patch in any way.

How to start using your ZAFEMY patch:

Figure A

Figure A

  • If you are not currently using hormonal birth control, you have 2 ways to begin using your ZAFEMY patch. Choose the way that is best for you:
  • First day start: Apply your first ZAFEMY patch during the first 24 hours of your menstrual period.
  • Sunday start: Apply your first ZAFEMY patch on the first Sunday after your menstrual period begins. Use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. If your period starts on Sunday, apply your first ZAFEMY patch that day, and no back-up birth control is needed.
  • If you are changing from oral hormone birth control pills, a vaginal contraceptive ring or another contraceptive transdermal patch to the ZAFEMY patch:
  • Complete your current oral hormone birth control pill cycle, vaginal ring cycle or contraceptive transdermal patch cycle. Apply your first ZAFEMY patch on the day you would normally start your next oral birth control pill, patch or insert your next vaginal ring.
  • If you do not get your period within 1 week after taking your last active pill, removing your last vaginal ring or contraceptive transdermal patch, check with your healthcare provider to make sure you are not pregnant. You may still go ahead and start ZAFEMY patch for contraception.
  • If you apply your ZAFEMY patch more than 1 week after taking your last active oral hormone birth control pill, removing your last vaginal ring or contraceptive transdermal patch, use a non-hormonal contraceptive method, such as a condom and spermicide or diaphragm and spermicide, with the ZAFEMY patch for the first 7 days of patch use.
  • If you are starting ZAFEMY after childbirth:
  • If you are not breastfeeding, wait 4 weeks before using ZAFEMY and use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. If you have had sex since your baby was born, wait for your first period, or see your healthcare provider to make sure you are not pregnant before starting ZAFEMY.
  • If you are starting ZAFEMY after a miscarriage or abortion:
  • You may start ZAFEMY immediately after a miscarriage or abortion that occurs in the first 12 weeks (first trimester) of pregnancy. You do not need to use another contraceptive method.
  • If you do not start ZAFEMY within 5 days after a first trimester miscarriage or abortion, use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, while you wait for your period to start. You have 2 ways to begin using your ZAFEMY patch. Choose the way that is best for you:
  • First day start: Apply your first ZAFEMY patch during the first 24 hours of your menstrual period.
  • Sunday start: Apply your first ZAFEMY patch on the first Sunday after your menstrual period begins. Use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. If your period starts on Sunday, apply your first ZAFEMY patch that day, and no back-up birth control is needed.
  • If you are starting ZAFEMY after a miscarriage or abortion that occurs after the first 12 weeks of pregnancy (second trimester), wait 4 weeks before using ZAFEMY and use a non-hormonal contraceptive method of birth control, such as a condom and spermicide or diaphragm and spermicide, for the first 7 days of your first cycle only. If you have had sex since your miscarriage or abortion, wait for your first period, or see your healthcare provider to make sure you are not pregnant before starting ZAFEMY.

Figure B is a picture of the ZAFEMY patch.

Figure B

Figure B

Step 1. Choose a place on your body for your ZAFEMY patch

Where to put patch
(click image for full-size original)

  • The ZAFEMY patch may be placed on your upper outer arm, abdomen, buttock or back in a place where it will not be rubbed by tight clothing. Avoid the waistline because clothing and belts may cause your patch to be rubbed off.
  • Do not apply the patch to your breasts.
  • Apply the ZAFEMY patch only to skin that is clean, dry, and free of any powder, make-up, cream, oil, or lotion.
  • Do not apply the ZAFEMY patch to cut or irritated skin, or in the same location as the previous ZAFEMY patch.

Step 2: Apply your ZAFEMY patch

Usage Illustration 1
  • Tear open the pouch at the top edge. Peel open the foil pouch that contains the ZAFEMY patch and its clear plastic cover. Gently remove the ZAFEMY patch and its plastic cover together from the pouch, being careful not to separate the patch from the clear plastic cover.
Usage Illustration 2
  • Using a fingernail, peel away half of the clear plastic. Avoid touching the sticky surface with your fingers.
Usage Illustration 3
  • Apply the sticky side of the ZAFEMY patch to clean, dry skin. Remove the other half of the clear plastic and apply the entire patch to your skin.
Usage Illustration 4
  • Press firmly on the ZAFEMY patch with the palm of your hand for 10 seconds, making sure that the whole patch sticks to your skin.
  • Run your fingers over the entire surface area to smooth out any “wrinkles” around the outer edges of the ZAFEMY patch.
  • Check your ZAFEMY patch every day to make sure all edges are sticking correctly.

Step 3: Throwing away your ZAFEMY patch

  • To throw away the ZAFEMY patch, fold the sticky side of the patch together, place it in a sturdy child-proof container, and place the container in the trash.
  • Used ZAFEMY patches should not be flushed in the toilet.

Important notes:

  • Your ZAFEMY patch must stick securely to your skin to work properly.
  • Do not try to reapply a ZAFEMY 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. Do not tape or wrap the patch to your skin or reapply a patch that is partially adhered to clothing.
  • If your ZAFEMY patch edge lifts up:
  • Press down firmly on the patch with the palm of your hand for 10 seconds, making sure that the whole patch sticks to your skin. Run your fingers over the entire surface area to smooth out any “wrinkles” around the edges of the ZAFEMY patch.
  • If your ZAFEMY patch does not stick completely, remove it and apply a replacement ZAFEMY patch.
  • Do not tape or wrap the ZAFEMY patch to your skin or reapply a ZAFEMY patch that is partially stuck to clothing.
  • If your ZAFEMY patch has been off or partially off:
  • For less than 1 Day, try to reapply it. If the ZAFEMY patch does not stick completely, apply a new ZAFEMY patch immediately. No back-up contraception is needed and your “Patch Change Day” will stay the same.
  • For more than 1 Day or if you are not sure for how long, you could become pregnant. To reduce this chance, apply a new ZAFEMY patch and start a new 4 week cycle. You will now have a new “Patch Change Day.” Use a non-hormonal back-up contraception method such as a condom and spermicide or diaphragm and spermicide for the first week of your new 4 week ZAFEMY cycle.
  • Talk to your healthcare provider about a replacement ZAFEMY patch prescription so you will always have an extra ZAFEMY patch available if needed.
  • If you want to move your “Patch Change Day” to a different day of the week, finish your current cycle. Remove your third ZAFEMY patch on the correct day.
  • During week 4, the “Patch Free Week” (Day 22 through Day 28), you may choose an earlier “Patch Change Day” by applying a new patch on the day you prefer. You now have a new Day 1 and a new “Patch Change Day.”
  • If your ZAFEMY patch becomes uncomfortable or your application site is red, painful or swollen, change your ZAFEMY patch. Remove your ZAFEMY patch and apply a new patch to a new location until your next “Patch Change Day.”
  • If you forget to change or remove your ZAFEMY patch:
  • At the start of any patch cycle (Week 1, Day 1):
  • You could become pregnant. You must use a back-up contraception method for 7 days. Apply the first ZAFEMY patch of your new cycle as soon as you remember. You now have a new “Patch Change Day” and a new Day 1.
  • In the middle of your patch cycle (Week 2 or Week 3):
  • If you forget to change your ZAFEMY patch for 1 or 2 days, apply a new ZAFEMY patch as soon as you remember. Apply your next patch on your normal “Patch Change Day.” No back-up contraception method is needed.
  • If you forget to change your ZAFEMY patch for more than 2 days, you could become pregnant. Start a new 4 week cycle as soon as you remember by putting on a new ZAFEMY patch. You now have a different “Patch Change Day” and a new Day 1. You must use a back-up contraception method for the first 7 days of your new cycle.
  • At the end of your patch cycle (Week 4):
  • If you forget to remove your ZAFEMY patch, take it off as soon as you remember. Start your next cycle on your normal “Patch Change Day,” the day after Day 28. No back-up contraception method is needed.
  • If you forget to apply your ZAFEMY patch at the start of your next patch cycle, you could become pregnant. Apply the first ZAFEMY patch of your new cycle as soon as you remember. You now have a new “Patch Change Day” and a new Day 1. Use a non-hormonal back-up contraception method such as a condom and spermicide or diaphragm and spermicide for the first 7 days of your new 4 week ZAFEMY cycle.
  • If you have trouble remembering to change your ZAFEMY patch, talk to your healthcare provider about how to make patch changing easier or about using another method of contraception.
  • If you are not sure how to use your ZAFEMY patch:
  • Use a back-up contraception method such as a condom and spermicide or diaphragm and spermicide anytime you have sex. Make sure to have 1 of these non-hormonal contraception methods ready at all times.
  • Talk to your healthcare provider for instructions on using your ZAFEMY patch.

This Patient Information and Instructions for Use have been approved by the U.S. Food and Drug Administration.

Distributed by:
Amneal Pharmaceuticals LLC Bridgewater, NJ 08807

Rev. 04-2022-04

PRINCIPAL DISPLAY PANEL

Pouch
(click image for full-size original)

Carton
(click image for full-size original)

ZAFEMY norelgestromin and ethinly estradiol patch
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:65162-358
Route of Administration TRANSDERMAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NORELGESTROMIN (NORELGESTROMIN) NORELGESTROMIN 150 ug in 1 d
ETHINYL ESTRADIOL (ETHINYL ESTRADIOL) ETHINYL ESTRADIOL 35 ug in 1 d
Inactive Ingredients
Ingredient Name Strength
POLYBUTENE (1400 MW)
CROSPOVIDONE
OLEYL ALCOHOL
DIPROPYLENE GLYCOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65162-358-03 3 POUCH in 1 CARTON contains a POUCH (65162-358-01)
1 NDC:65162-358-01 1 PATCH in 1 POUCH This package is contained within the CARTON (65162-358-03) and contains a PATCH
1 7 d in 1 PATCH This package is contained within a POUCH (65162-358-01) and a CARTON (65162-358-03)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA213950 06/28/2020
Labeler — Amneal Pharmaceuticals LLC (123797875)
Establishment
Name Address ID/FEI Operations
Amneal Pharmaceuticals, LLC 053542455 analysis (65162-358), label (65162-358), manufacture (65162-358), pack (65162-358)

Revised: 04/2022 Amneal Pharmaceuticals LLC

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