Ortho Evra is a prescription medication used to prevent pregnancy. It contains two medications, norelgestromin and ethinyl estradiol, which belong to a group of drugs called hormonal contraceptives. These hormones prevent pregnancy by stopping ovulation and by altering cervical mucus and the lining of the uterus.
This medication comes in the form of a skin patch to be placed on the skin each week for the first 3 weeks of the menstrual cycle.
Common side effects include nausea, breast discomfort, and headache.
WARNINGS: 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 norelgestromin/ethinyl estradiol, 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 15–44 who used the norelgestromin/ethinyl estradiol patch compared to women who used oral contraceptives containing 30–35 mcg of ethinyl estradiol (EE) and either levonorgestrel or norgestimate was assessed in four U.S. case-control studies using electronic healthcare claims data. The odds ratios ranged from 1.2 to 2.2; one of the studies found a statistically significant increased risk of VTE for current users of norelgestromin/ethinyl estradiol.
Pharmacokinetic Profile of Ethinyl Estradiol
The pharmacokinetic (PK) profile for the norelgestromin/ethinyl estradiol patch is different from the PK profile for oral contraceptives in that it has higher steady state concentrations and lower peak concentrations. Area under the time-concentration curve (AUC) and average concentration at steady state for ethinyl estradiol (EE) are approximately 60% higher in women using norelgestromin/ethinyl estradiol compared with women using an oral contraceptive containing 35 mcg of EE. In contrast, peak concentrations for EE are approximately 25% lower in women using norelgestromin/ethinyl estradiol. 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/ethinyl estradiol compared with women using oral contraceptives containing 30–35 mcg of EE. Increased estrogen exposure may increase the risk of adverse events, including venous thromboembolism.
