RX ITEM-Ortho Evra 150 35 24H Patch 6X3 By J O M Pharma

XULANE- norelgestromin and ethinyl estradiol patch
Mylan Pharmaceuticals Inc.
WARNING: CARDIOVASCULAR RISK ASSOCIATED WITH SMOKING, RISK OF VENOUS THROMBOEMBOLISM, AND PHARMACOKINETIC PROFILE OF ETHINYL ESTRADIOL

Cigarette Smoking and Serious Cardiovascular Risks

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, hormonal contraceptives, including Xulane, should not be used by women who are over 35 years of age and smoke.



Risk of Venous Thromboembolism

The risk of venous thromboembolism (VTE) among women aged 15 to 44 who used the norelgestromin and ethinyl estradiol transdermal system compared to women who used several different oral contraceptives was assessed in five U.S. epidemiologic studies using electronic healthcare claims data. The relative risk estimates ranged from 1.2 to 2.2; one of the studies found a statistically significant increased relative risk of VTE for current users of norelgestromin and ethinyl estradiol transdermal system [ see Warnings and Precautions (5.1)].

Pharmacokinetic (PK) Profile of Ethinyl Estradiol (EE)

The PK profile for the norelgestromin and ethinyl estradiol transdermal system is different from the PK profile for oral contraceptives in that it has a higher steady state concentrations and a lower peak concentration. Area under the time-concentration curve (AUC) and average concentration at steady state (Css ) for EE are approximately 60% higher in women using norelgestromin and ethinyl estradiol transdermal system compared with women using an oral contraceptive containing 35 mcg of EE. In contrast, the peak concentration (Cmax ) for EE is approximately 25% lower in women using norelgestromin and ethinyl estradiol transdermal system. It is not known whether there are changes in the risk of serious adverse events based on the differences in PK profiles of EE in women using norelgestromin and ethinyl estradiol transdermal system compared with women using oral contraceptives containing 30 mcg to 35 mcg of EE. Increased estrogen exposure may increase the risk of adverse events, including VTE [ see Warnings and Precautions (5.2) and Clinical Pharmacology (12.3)].

1 INDICATIONS AND USAGE

Xulane is indicated for the prevention of pregnancy in women who elect to use a transdermal patch as a method of contraception.

Limitation of Use:

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Xulane may be less effective in preventing pregnancy in women who weigh 198 lbs (90 kg) or more.
2 DOSAGE AND ADMINISTRATION

To achieve maximum contraceptive effectiveness, Xulane 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 Xulane
The Xulane transdermal system uses a 28-day (4-week) cycle. A new patch is applied each week for 3 weeks (21 total days). Week 4 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 Xulane patch in any way. If the Xulane patch is cut, damaged or altered in size, contraceptive efficacy may be impaired.

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.

DOSAGE FORMS AND STRENGTHS
Transdermal system: 150 mcg/day norelgestromin and 35 mcg/day ethinyl estradiol.

RX ITEM-Ortho Evra 150 35 24H Patch 6X3
NDC 50458-0192-15 UPC/GTIN No.3-50458-19215-5 Mfg.Part No.19215

Ortho Evra 150 35 24H Patch 6X3 By J O M
BRAND: ORTHO-EVRA NDC: 50458-0192-15,50458019215 UPC: 3-50458-19215-5,350458192155

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