Transdermal Patch (OrthoEvra®)

(Published September 2009)

Description. OrthoEvra is a beige-colored, transdermal patch applied once a week to the abdomen, buttock, upper outer arm, or upper torso (excluding breasts). The patch releases 150 mcg of norelgestromin and 20 mcg of ethinyl estradiol to the bloodstream daily to inhibit ovulation. Three consecutive 7-day patches (21 days) are applied, followed by 1 patch-free week per cycle. The patch contains 9 days of medication.

Use. Providers are encouraged to write an extra prescription for patients in case of detachment. The drug is mixed with the adhesive; therefore, patches that do not stick must be replaced to maintain therapeutic levels. Patients must change the patch once per week. The patch can be worn during exercise, showers, bathing, and swimming; adhesion is not affected by heat, humidity, or exercise.

Effectiveness. This method is very effective. The contraceptive efficacy of the transdermal patch is comparable to that of COCs.⁵¹ The failure rate is 0.3% with perfect use and 8% with typical use. There is some evidence that efficacy is slightly decreased in women who weigh more than 198 pounds; however the patch is still a very effective method for these women.⁵² In such cases, provider and patient will need to compare the benefits and drawbacks with those of other contraceptive options.

Risks and Side Effects. As described previously for all combined hormonal contraception. There is an increased exposure to estrogen with the patch, which may increase the risk of side effects, such as breast tenderness. The side effects usually dissipate within the first 2 months of use. Some women may experience skin irritation at the application site.

In 2005, the FDA created a bolded warning for OrthoEvra about increased risk of venous thromboembolism. In January 2008, the OrthoEvra label added new study results showing twice the VTE risk for the patch compared with COCs. Some key points to consider about VTE risk, hormonal contraception, and the patch:

• The risk of thromboembolism is significantly higher in pregnancy than from the patch.⁵³
• The overall risk of VTE is small, and it is a rare complication.

Advantages. As described previously for all combined hormonal contraception.

• Very effective
• Rapidly reversible
• Excellent cycle control by 3 months of use
• Easy to use, start, and stop
• Extra protection built in; if a women forgets to remove the patch after a week, serum hormone levels will remain in the contraceptive range for up to 2 additional days
• Potential for improved adherence

Disadvantages

• Requires a prescription
• Concern about visibility of patch for some women (may be considered an advantage to others)
• Possible skin reactions or detachment
• Slight increase in risk of VTE compared with COCs
• Lack of protection against STIs

Contraindications. As described previously for all combined hormonal contraception.

Counseling Messages. Educate patients on application and removal of patch. Apply to clean, dry skin. Place on abdomen, buttock, upper outer arm, or upper torso (excluding breasts). Avoid placing patch in areas that receive a lot of friction, such as bra straps. Patients must change patch weekly. Once patch is removed, fold it closed to reduce release of hormones. Do not flush in the waste system; dispose of in the garbage. Nonhormonal backup contraception is needed for first 7 days if patch is started any day other than day 1 of the menstrual cycle. Counsel women who use the patch to protect themselves against STIs.