ZAFEMY- norelgestromin and ethinly estradiol patch 
Amneal Pharmaceuticals LLC

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Patient Information

ZAFEMY™ (za feʹ my)
(norelgestromin and ethinyl estradiol transdermal system)

What is the most important information I should know about ZAFEMY?

Do not use ZAFEMY if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from hormonal birth control methods, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.

Do not use ZAFEMY if you have an increased risk for blood clots.

Do not use ZAFEMY if your Body Mass Index (BMI) is 30 kg/m2 or more. Women with a BMI of 30 kg/m2 or more who use ZAFEMY may be at a higher risk for developing blood clots compared to women with a BMI lower than 30 kg/m2.

Hormonal birth control methods help to lower the chances of becoming pregnant. They do not protect against HIV infection (AIDS) and other sexually transmitted infections.

What is ZAFEMY?

ZAFEMY is a birth control patch for women with a BMI less than 30 kg/m2. It contains two female hormones, an estrogen called ethinyl estradiol, and a progestin called norelgestromin.

Hormones from ZAFEMY get into the blood stream and are processed by the body differently than hormones from birth control pills. You will be exposed to about 60% more estrogen if you use ZAFEMY than if you use a typical birth control pill containing 35 micrograms of estrogen. In general, increased estrogen may increase the risk of side effects.

How well does ZAFEMY work?

Your chance of getting pregnant depends on how well you follow the directions for using ZAFEMY. The better you follow the directions, the less chance you have of getting pregnant.

In clinical studies, 1 to 2 out of 100 women got pregnant during the first year that they used ZAFEMY.

ZAFEMY may not be as effective in women weighing more than 198 lbs. (90 kg). If you weigh more than 198 lbs. (90 kg), talk to your healthcare provider about which method of birth control is right for you.

The following chart shows the chance of getting pregnant for women who use different methods of birth control. Each box on the chart contains a list of birth control methods that are similar in effectiveness. The most effective methods are at the top of the chart. The box on the bottom of the chart shows the chance of getting pregnant for women who do not use birth control and are trying to get pregnant.

Flow Chart

 

Do not use ZAFEMY if you:

Hormonal birth control methods may not be a good choice for you if you have ever had jaundice (yellowing of the skin or eyes) caused by pregnancy or related to previous use of hormonal birth control.

Tell your healthcare provider if you have ever had any of the above conditions. Your healthcare provider may recommend another method of birth control.

 

Before you use ZAFEMY, tell your healthcare provider:

Tell your healthcare provider about all medicines and herbal products that you take.

Some medicines and herbal products may make hormonal birth control less effective, including, but not limited to:

Use another birth control method (such as a condom and spermicide or diaphragm and spermicide) when you take medicines that may make the ZAFEMY patch less effective.

Some medicines and grapefruit juice may increase your level of the hormone ethinyl estradiol if used together, including:

Hormonal birth control methods may interact with lamotrigine, an anti-seizure medicine used for epilepsy. This may increase the risk of seizures, so your healthcare provider may need to adjust the dose of lamotrigine.

Women on thyroid replacement therapy may need increased doses of thyroid hormone.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

How should I use ZAFEMY?

Calendar
Patient Information Graph

*CHC=combination hormonal contraception

**Pregnancy data based on actual duration of pregnancy in the reference studies. Based on a model assumption that pregnancy duration is nine months, the rate is 7 to 27 per 10,000 WY.

Call your healthcare provider right away if you have:

Other serious risks include

The most common side effects of ZAFEMY are:

Some women have spotting or light bleeding, breast tenderness, or feel sick to their stomach during ZAFEMY use. If these symptoms occur, do not stop using the ZAFEMY patch. The problem will usually go away. If it doesn't go away, check with your healthcare provider.

Less common side effects are:

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of ZAFEMY. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store and throw away used ZAFEMY patches?

Keep ZAFEMY and all medicines out of the reach of children.

General information about the safe and effective use of  ZAFEMY

Medicines are sometimes prescribed for purposes other than those listed in Patient Information. Do not use ZAFEMY for a condition for which it was not prescribed. Do not give ZAFEMY to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your pharmacist or healthcare provider for information about ZAFEMY that is written for health professionals.

For more information, go to www.amneal.com or call 1-877-835-5472.

What are the ingredients in ZAFEMY?

Active ingredient: norelgestromin, USP and ethinyl estradiol, USP

Inactive ingredient: pigmented polyethylene and polyester backing, polyisobutylene/polybutene adhesive, polybutene, crospovidone, oleyl alcohol, dipropylene glycol, polyethylene terephthalate (PET) film with a silicone coating.

Do hormonal birth control methods cause cancer?

Hormonal birth control methods do not seem to cause breast cancer. However, if you have breast cancer now, or have had it in the past, do not use hormonal birth control methods because some breast cancers are sensitive to hormones.

Women who use hormonal birth control methods may have a slightly higher chance of getting cervical cancer. However, this may be due to other reasons such as having more sexual partners.

What should I know about my period when using ZAFEMY?

When you use ZAFEMY you may have bleeding and spotting between periods, called unplanned bleeding. Unplanned bleeding may vary from slight staining between menstrual periods to breakthrough bleeding which is a flow much like a regular period. Unplanned bleeding occurs most often during the first few months of ZAFEMY use, but may also occur after you have been using the patch for some time. Such bleeding may be temporary and usually does not indicate any serious problems. It is important to continue using the patch on schedule. If the unplanned bleeding or spotting is heavy or lasts for more than a few days, you should discuss this with your healthcare provider.

What if I miss my scheduled period when using ZAFEMY?

Some women miss periods on hormonal birth control, even when they are not pregnant. However, if you go 2 or more months in a row without a period, or you miss your period after a month where you did not use all of your patches correctly, or you have symptoms associated with pregnancy, such as morning sickness or unusual breast tenderness, call your healthcare provider because you may be pregnant. Stop taking ZAFEMY if you are pregnant.

What if I want to become pregnant?

You may stop using ZAFEMY whenever you wish. Consider a visit with your healthcare provider for a pre-pregnancy checkup before you stop using the patch.

Distributed by:
Amneal Pharmaceuticals LLC
Bridgewater, NJ 08807

Rev. 02-2021-03

Revised: 2/2021
Amneal Pharmaceuticals LLC