Choice of Dosing and Regimen Options

Dosing Regimens

CombiPatch^® offers the unique choice within menopause hormone therapy (HT) of two approved dosing regimens.

• Continuous Combined regimen—designed to help achieve amenorrhea
• Continuous Sequential regimen—designed for predictable monthly bleed

The two dosing regimens are available as two dosing options to meet the needs of your individual patients. Encourage your patients to talk to you about their personal preferences as well as any concerns they have—such as breakthrough bleeding.

Continuous Combined Regimen

A Continuous Combined regimen of CombiPatch is used to help provide symptom relief and to help achieve amenorrhea. CombiPatch provides therapeutic levels of estrogen that are equivalent to the normal ranges seen at early follicular development.

Patients should be educated about the possibility of breakthrough bleeding, including the following facts:

• As with any continuous combined HT, Irregular bleeding (“spotting”) may occur, but generally decreases over time
  • Irregular bleeding may occur particularly in the first six months, but generally decreases with time, and often to an amenorrheic state
• In a clinical study with CombiPatch, women usually characterized their breakthrough bleeding episodes as light (1.3 on a scale of 1 to 4, with 4 being the heaviest), lasting 4 to 6 days.

With the Continuous Combined regimen, amenorrhea increases over time

In a one-year study, the incidence of cumulative amenorrhea* increased over time

Incidence of Cumulative Amenorrhea by Cycle Over One Year

As with any continuous combined HT, irregular bleeding may occur, but generally decreases with time

*Cumulative amenorrhea is defined as the absence of bleeding for the duration of a 28-day cycle and sustained to the end of the study.

A dose of 0.05 mg estradiol/0.25 mg norethindrone acetate (NETA) (16 sq cm system) is available if a greater progestin dose is desired.

Continuous Sequential Regimen

As part of a Continuous Sequential regimen, CombiPatch is applied sequentially with Vivelle-Dot^® (estradiol transdermal system) to help provide symptom relief while maintaining a predictable monthly bleed.

• CombiPatch is applied following Vivelle-Dot during weeks 3 and 4 when prescribing a sequential regimen
• Patients should be educated that monthly withdrawal bleeding often occurs