ZAFEMY- norelgestromin and ethinyl estradiol patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

NORELGESTROMIN (UNII: R0TAY3X631) (NORELGESTROMIN - UNII:R0TAY3X631), ETHINYL ESTRADIOL (UNII: 423D2T571U) (ETHINYL ESTRADIOL - UNII:423D2T571U)

Available from:

Amneal Pharmaceuticals LLC

Administration route:

TRANSDERMAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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)]. ZAFEMY is contraindicated in females who are known to have or develop the following conditions: - At high risk of arterial or venous thromboembolic events. Examples include women who: - Smoke, if over age 35 [see Boxed Warning, and Warnings and Precautions (5.1)] - Have deep vein thrombosis or pulmonary embolism, now or in the past [see Warnings and Precautions (5.1)] - Have inherited or acquired hypercoagulopathies [see Warnings and Precautions (5.1)] - Have cerebrovascular disease [see Warnings and Precautions (5.1)] - Have coronary artery disease [see Warnings and Precautions (5.1)]

Product summary:

ZAFEMY (norelgestromin and ethinyl estradiol transdermal system) is available in one strength of 150 mcg/day NGMN, USP and 35 mcg/day EE, USP. ZAFEMY is a 12.5 cm2 system with rounded corners with tan backing printed with “Norelgestromin and Ethinyl Estradiol 150/35 mcg per day” in brown ink, protected with a removable translucent oversized dimple slit-release liner. Each patch contains 3.15 mg of norelgestromin, USP and 0.289 mg of ethinyl estradiol, USP. Each transdermal system is packaged in a protective pouch. ZAFEMY is available in folding cartons of 1 cycle each (NDC 65162-358-03); each cycle contains 3 systems. Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Store patches in their protective pouches. Apply immediately upon removal from the protective pouch. Do not store in the refrigerator or freezer. Used patches still contain some active hormones. The sticky sides of the patch should be folded together and the folded patch placed in a sturdy container, preferably with a child-resistant cap, and the container thrown in the trash. Used patches should not be flushed down the toilet.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

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 birt

Summary of Product characteristics

ZAFEMY- NORELGESTROMIN AND ETHINLY ESTRADIOL PATCH
AMNEAL PHARMACEUTICALS LLC
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
ZAFEMY SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR ZAFEMY.
ZAFEMY (NORELGESTROMIN AND ETHINYL ESTRADIOL TRANSDERMAL SYSTEM)
INITIAL U.S. APPROVAL: 2001
WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS AND
CONTRAINDICATED IN WOMEN WITH A BMI ≥ 30 KG/M
_SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING._
ZAFEMY IS CONTRAINDICATED IN WOMEN OVER 35 YEARS OLD WHO SMOKE.
CIGARETTE
SMOKING INCREASES THE RISK OF SERIOUS CARDIOVASCULAR EVENTS FROM
COMBINATION
HORMONAL CONTRACEPTIVE (CHC) USE. (4, 5.1) ZAFEMY IS CONTRAINDICATED FOR USE IN WOMEN WITH A BMI ≥ 30 KG/M .
WOMEN WITH A
BMI ≥ 30 KG/M WHO USE ZAFEMY MAY HAVE A HIGHER RISK OF VENOUS
THROMBOEMBOLIC
EVENTS COMPARED WITH WOMEN WITH A LOWER BMI. (4, 5.1, 8.8)
RECENT MAJOR CHANGES
Warnings and Precautions (5.12) 11/2021
INDICATIONS AND USAGE
ZAFEMY is an estrogen/progestin combination hormonal contraceptive
(CHC), indicated for the
prevention of pregnancy in women with a BMI < 30 kg/m for whom a
combined hormonal contraceptive is
appropriate. (1)
Limitations of Use: ZAFEMY may be less effective in preventing
pregnancy in women at or above 198 lbs
(90 kg). (1, 4, 14)
DOSAGE AND ADMINISTRATION
ZAFEMY uses a 28-day (four-week) cycle. Apply a new patch to the upper
outer arm, abdomen, buttock
or back each week for three weeks (21 total days). Week Four is
patch-free. (2.1, 2.3)
Apply each new patch on the same day of the week. Wear only one patch
at a time. (2.1)
Do not cut or alter the patch in any way. (2.1)
DOSAGE FORMS AND STRENGTHS
Transdermal system: 150 mcg/day norelgestromin, USP and 35 mcg/day
ethinyl estradiol, USP. (3)
CONTRAINDICATIONS
At high risk of arterial or venous thromboembolic events (4)
BMI ≥ 30 kg/m (4)
Breast cancer or other estrogen- or progestin-sensitive cancer (4)
Liver tumors or liver disease (4)
Undiagnosed ab