What is the recommended protocol for using Xulane (ethinyl estradiol and norelgestromin) for an extended birth control regimen?

Extended Regimen Protocol for Xulane (Ethinyl Estradiol and Norelgestromin) Transdermal Patch

For extended regimen contraception with Xulane, apply a new patch weekly for 12 consecutive weeks (skipping the patch-free week), followed by a 7-day patch-free interval, then resume the extended regimen. 1

Standard vs. Extended Regimen

Standard Regimen

• Apply one patch weekly for 3 consecutive weeks
• Have a patch-free week during the 4th week
• Resume with a new patch after the 7-day break

Extended Regimen

• Apply one patch weekly for 12 consecutive weeks (3 months)
• Have a 7-day patch-free interval
• Resume with a new patch after the 7-day break
• This reduces the number of withdrawal bleeding episodes to once every 3 months

Application Instructions

1. Apply a new patch immediately upon removal from the pouch 2
2. Each patch should be worn for exactly 7 days
3. Apply to clean, dry, intact skin on the buttock, abdomen, upper outer arm, or upper torso (excluding breasts)
4. Change the patch on the same day of the week (your "Patch Change Day")
5. Do not place on red, irritated, or cut skin
6. Do not apply makeup, creams, lotions, powders, or other topical products to the skin area where the patch will be placed

Managing Delayed Application or Detachment

If patch detachment or delayed application is <48 hours:

• Apply a new patch as soon as possible
• Keep the same patch change day
• No additional contraceptive protection needed 3

If patch detachment or delayed application is ≥48 hours:

• Apply a new patch immediately
• Establish a new Patch Change Day
• Use backup contraception (e.g., condoms) for 7 consecutive days
• If this occurs during week 3 of patch use, omit the hormone-free week and start a new patch immediately 3

Managing Unscheduled Bleeding

Breakthrough bleeding is common during the first 3-6 months of extended regimen use and typically decreases over time 3, 4. If unscheduled bleeding becomes problematic:

1. Rule out underlying gynecological problems (STIs, pregnancy, uterine pathology) 3
2. If no underlying condition is found and bleeding is bothersome:
   • Consider a short hormone-free interval (3-4 consecutive days)
   • Do not implement a hormone-free interval during the first 21 days of use
   • Do not use hormone-free intervals more than once per month as this may reduce contraceptive effectiveness 3

Benefits of Extended Regimen

• Fewer bleeding days (median 6 days vs. 14 days with standard regimen) 1
• Fewer bleeding episodes (median 1 vs. 3 with standard regimen) 1
• Delayed menses (median 54 days vs. 25 days with standard regimen) 1
• Potential improvement in conditions exacerbated by hormonal fluctuations (migraines, epilepsy, irritable bowel syndrome, certain psychiatric symptoms) 3
• Optimized ovarian suppression with potentially increased contraceptive effectiveness 3

Important Considerations

Safety

• Do not exceed 12 weeks of continuous use without a hormone-free interval, as EE2 levels may slowly accumulate over time 5
• Women weighing >90 kg (198 pounds) may experience reduced contraceptive efficacy 6

Adherence Tips

• Partial or total detachment occurs at a rate of 3.8% but is not affected by climate, exercise, or water exposure 6
• Set a weekly reminder for patch change day
• Keep replacement patches available in case of detachment

Counseling Points

• Extended regimen does not increase risk of serious adverse events compared to standard regimen 1
• Efficacy is similar to oral contraceptives, with perfect use failure rate of 0.70 pregnancies per 100 woman-years 6
• Transdermal delivery eliminates variability in gastrointestinal absorption and avoids hepatic first-pass metabolism 7

By following this protocol, patients can effectively use Xulane in an extended regimen to reduce the frequency of withdrawal bleeding while maintaining contraceptive efficacy.