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Extended Regimen Oral Contraceptives—Practical Management

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MS MOORE: I agree. The extended regimen has become mainstream over the past couple of years—the only reason I can see for using 21/7 is if the patient demands it or if reimbursement drives the issue.

How important is breakthrough bleeding in OC product selection?

DR KAUNITZ: Breakthrough bleeding occurs with all OC products—it’s importance becomes a matter of how well you have prepared patients for it.

MS MOORE: I like to tell my patients that it is likely they will experience some breakthrough bleeding in the early cycles. Then they are prepared and those who do not have any are pleasantly surprised.

DR SULAK: It’s inevitable and it can be managed—to me, it’s more important to focus on eliminating hormone withdrawal symptoms.

Are all combined hormonal contraceptive products appropriate for use in extended regimens?

DR NELSON: At this time there are insufficient data regarding the safety and pharmacokinetics of extended regimen use of the transdermal patch. Until studies evaluating its use in multiple extended cycles become available, we cannot recommend its use in extended regimens.18

DR KAUNITZ: Traditional 21/7 pill packs can be used in extended regimens but I find this approach often poses challenges for the patient—from remembering not to take placebo pills to reimbursement to trips to the pharmacy every 3 weeks for a new pill pack.

DR LONDON: It seems intuitive that the multiphasic pills would not be optimal for use in extended regimens. Given the paucity of data supporting their use, I would not recommend initiating an extended regimen with a mutiphasic pill. I certainly would allow a patient who is using them successfully to continue.

What are practical options to manage breakthrough bleeding in patients taking extended regimen OCs?

DR SULAK: We find that patients usually don’t begin to have unscheduled bleeding until week 4 or later. In our prospective study, we found that women who had heavier daily flow ratings during the 21/7 lead-in cycle tended to have greater daily flow ratings and earlier occurrence of unscheduled bleeding when taking an extended regimen.13 We also showed that a 3-day pill holiday was helpful in managing breakthrough bleeding and/or spotting that had persisted for 7 consecutive days (TABLE 4).

MS MOORE: Essentially patients have 2 options: endure the bleeding or take a brief pill holiday. I let my patients decide—some are very bothered by even the slightest amount of breakthrough bleeding while others have no issue with it. The worse thing a patient can do is to stop taking pills without a back-up plan for contraception. It is critical that they take at least 3 weeks of active pills between drug holidays.

DR LONDON: It’s also important to remember that you cannot use a 3-day pill holiday to manage breakthrough bleeding/spotting with 21/7 regimens as the increased number of hormone-free days per cycle could lead to a greater chance of escape ovulation.

DR KAUNITZ: Let’s not forget the value of counseling. Just letting women know what to expect and what to do has certainly been proven to be valuable in improving continuation rates among women on other forms of long-term contraception19,20 and would without doubt be beneficial for women receiving extended regimens (SIDEBAR).

DR SULAK: With the low-dose OCs, it is especially important to let the patient know at the time you write the prescription that she has to take her pills at about the same time each day. I have had patients tell me that they experience bleeding if they take their pills even a few hours late.

DR NELSON: There will be patients with breakthrough bleeding/spotting who need to be examined, such as a long-term pill user who reports it for the first time. If you can establish a history of good pill taking with no illnesses or medication interaction which might alter hormone absorption, this woman should be evaluated for infection and anatomic changes like cervical or endometrial polyps.

TABLE 4

Recommendations for Initiating Extended Regimens

New starts: Begin your pack according to the directions provided by your clinician. You may be able to begin your pack on the same day or on the first day of menstruation.
Transition patients: Begin the extended pack as soon as the withdrawal bleeding from your prior cycle ends and you have a hormone free interval that lasts no more than 4 days.

Guidelines and Recommendations for Unscheduled Bleeding

Counseling Guidelines

• When prescribing, provide counseling regarding the possibility of unscheduled bleeding/spotting.
• When the patient complains of unscheduled bleeding ask about
  • pill-taking habits
    - Did you start the most recent pill pack on time?
    - Are you taking the pills at approximately the same time each day?
    - Have you skipped any pills recently?
    - Have you had any recent illnesses?
    - Are you using other medications?
  • Characteristics of the unscheduled bleeding episode
    - How long did you experience breakthrough bleeding?
    - How severe was the bleeding?
    - At what point in the cycle did it occur?
  • Any lifestyle changes or habits that might
    - Predispose her to sexually transmitted disease (change in partners)
    - Alter the metabolism of active hormone components (use of St. John’s Wort, smoking)

Management Recommendations

• With a 91-day regimen, bleeding may occur before the 7-day ethinyl estradiol period at the end of the pill pack.
• If bleeding/spotting is bothersome during the 84 combination pills, it is possible to take a 3-day hormone-free interval and immediately restart.
• Always take a minimum of 3 weeks of active pills before taking a 3-day break.
• Do not take a break during the first 3 weeks or during the last 3 weeks of the 84 combination active pills.

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