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Quick Reference Guide for Clinicians
 
Choosing a Birth Control Method

(Published September 2011)

Transdermal Contraceptive Patch

Description

OrthoEvra® is a beige-colored, transdermal contraceptive patch applied once a week to a part of a woman's body, including the abdomen, buttock, upper outer arm, or upper torso (excluding breasts). The patch releases 150 mcg of a type of progestin called norelgestromin and 20 mcg of ethinyl estradiol. Three consecutive 7-day patches (21 days) are applied once a week, followed by 1 patch-free week per cycle. Although it is recommended that women put on a new patch after seven days, the patch contains up to 9 days' Transdermal patchworth of contraceptive hormones.

Use

Providers are encouraged to provide patients with an additional prescription for the contraceptive patch for use in case of detachment. The drug is mixed with the adhesive; therefore, patches that do not stick must be replaced to maintain therapeutic levels of hormone. 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.25
  • The failure rate is 0.3 percent with perfect use and 9 percent with typical use.18
  • Some evidence suggests 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.26 In such cases, provider and patient will need to compare the benefits and drawbacks with those of other contraceptive options.

Risks

Venous thromboembolism (see Dispelling Myths About the Contraceptive Patch and VTE box)

Side Effects

As described previously for all combined hormonal contraception. In addition, skin irritation at the application site may occur in some users.

Contraindications and Precautions

As described previously for all combined hormonal contraception.

Advantages

As described previously for all combined hormonal contraception, plus:

  • 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

As described previously for all combined hormonal contraception, plus:

  • Concern about visibility of patch for some women (may be considered an advantage to others)
  • Possible skin reactions or detachment
  • Possible slight increase in risk of VTE compared with COCs

Counseling Messages

  • The patch should be applied to clean, dry skin on the abdomen, buttock, upper outer arm, or upper torso (excluding breasts). It should not be placed in areas that receive a lot of friction, such as under bra straps.
  • The patch must be changed weekly.
  • When the patch is removed, it should be folded closed to reduce release of hormones and should be disposed of in the garbage. To avoid the release of hormones into the soil and water supply, a used patch should not be flushed down the toilet.
  • Non-hormonal back-up contraception is needed for first 7 days if the patch is started any day other than day 1 of the menstrual cycle.
  • If the patch falls off, a new patch should be applied immediately. If the patch was off for more than 24 hours, 7 days of back-up contraception is required.
  • This method does not protect against STIs.

Dispelling Myths About the Contraceptive Patch and VTE

  • Based on prior data, the FDA created a bolded warning for OrthoEvra about increased risk of venous thromboembolism
    in 2005.
  • In January 2008, the OrthoEvra label added new study results showing twice the VTE risk for the patch compared with COCs. However, this increase in relative risk of VTE should be viewed in context.
  • The overall risk of VTE is small, approximately 100 cases per 100,000 per year.27 For women 25 to 35 years old, the incidence is only 30 cases per 100,000 per year.
  • The risk of VTE is significantly higher in pregnancy than from the patch.28
  • Currently available evidence suggests that the risk of VTE with the contraceptive patch is similar to that observed with COCs.29
  • In a case control study of women with VTE, contraceptive patch use was associated with a similar incidence of VTE as COCs with norgestimate and 30 mcg of ethinyl estradiol.30 In this study, the incidence of VTE was 52.8 per 100,000 women-years among patch users and 41.8 per 100,000 women-years among COC users.
  • Post-marketing data demonstrate a similar risk of VTE among patch users and COC users who are ≤39 years of age; the data could not rule out an increased risk of VTE among patch users ≥40 years old.31
  • Health care providers should review with women their overall risk of VTE in light of the absolute and relative risk of VTE and the woman's individual situation.