Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, consider addition of a progestogen to reduce the risk of endometrial cancer. Generally, a woman without a uterus, does not need to use a progestogen in addition to her estrogen therapy. In some cases, however, hysterectomized women who have a history of endometriosis may need a progestogen [see Warnings and Precautions (5.2, 5.14)].
Use estrogen-alone, or in combination with a progestogen, at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Reevaluate postmenopausal women periodically as clinically appropriate to determine if treatment is still necessary.
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
Start therapy with LYLLANA 0.0375 mg per day applied to the skin twice weekly. Make dosage adjustments based on clinical response. Attempt to taper or discontinue LYLLANA at 3 to 6 month intervals.
Prevention of Postmenopausal Osteoporosis due to Menopause
Application Instructions
Place the adhesive side of LYLLANA on a clean, dry area on the lower abdomen (below the umbilicus) or buttocks. Do not apply LYLLANA to the breasts.
Replace LYLLANA twice weekly (every 3 to 4 days).
Rotate the sites of application, with an interval of at least 1 week allowed between applications to a particular site.
Select an area for application that is not oily, damaged, or irritated. Avoid the waistline, since tight clothing may rub the system off. Apply the system immediately after opening the pouch and removing the protective liner. Press the system firmly in place with the palm of the hand for about 10 seconds, making sure there is good contact with the skin, especially around the edges. In the event that a system falls off, reapply the same system or apply a new system to another location. In either case, continue the original treatment schedule. If a woman has forgotten to apply LYLLANA, have her apply a new system as soon as possible. Apply the new system on the original treatment schedule. The interruption of treatment in women taking LYLLANA might increase the likelihood of breakthrough bleeding, spotting and recurrence of symptoms.
