2.1 Important Instructions Including Administration with a Progestin

• Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, consider addition of a progestin to reduce the risk of endometrial cancer. A woman who takes estrogen but does not have a uterus, generally does not need a progestin. In some cases, however, hysterectomized women who have a history of endometriosis may need a progestin [see Warnings and Precautions (5.2, 5.14)].
  
• Use estrogen-alone, or in combination with a progestin at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Re-evaluate postmenopausal women periodically as clinically appropriate to determine if treatment is still necessary.

2.2 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause

Start therapy with 0.05 mg per day applied to the skin twice weekly. Start therapy at the lowest effective dose and for the shortest duration consistent with treatment goals. Attempt to taper or discontinue the medication at 3 to 6-month intervals.

2.3 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause

Start therapy with 0.05 mg per day applied to the skin twice weekly. Start therapy at the lowest effective dose and for the shortest duration consistent with treatment goals. Attempt to taper or discontinue the medication at 3 to 6-month intervals.

2.4 Treatment of Hypoestrogenism due to Hypogonadism, Castration, or Primary Ovarian Failure

Start therapy with 0.05 mg per day applied to the skin twice weekly. Adjust the dose as necessary to control symptoms. Use the clinical responses (relief of symptoms) at the lowest effective dose to guide administration of the Alora transdermal system, especially in women with an intact uterus.

2.5 Prevention of Postmenopausal Osteoporosis

Start therapy with 0.025 mg per day applied to the skin twice weekly. Use bone mineral density measurements to monitor treatment efficacy. Increase the dosage as necessary, depending on bone mineral density and adverse events. No studies have been conducted using an intermittent regimen for the prevention of postmenopausal osteoporosis.

2.6 Application of the Alora Transdermal System

Site Selection

• Place the adhesive side of Alora on a clean, dry area of skin that is not oily, damaged or irritated.
  
• Apply Alora to the lower abdomen or the upper quadrant of the buttocks or the outer aspect of the hip.
  
• Never apply Alora to the breast.
  
• Do not apply Alora to the waistline since tight clothing may rub Alora off.

Application

• Apply Alora immediately after opening the pouch and remove the protective liner.
  
• Press Alora firmly in place with the palm of the hand for about 10 seconds. Make sure there is good contact with the skin, especially around the edges of Alora.
  
• If Alora falls off soon after application, the same Alora may be reapplied to a different site. If the original Alora cannot be reapplied, a new Alora may be applied to another site maintaining the same treatment schedule.
  
• Rotate the application sites with at least 1 week between applications to the same site.

2.7 Switching from Other Hormonal Therapies and Dosing Regimens

• In women who are not currently taking oral estrogens or in women switching from topical therapy or another transdermal estradiol therapy, treatment with Alora can be initiated at once. In women who are currently taking oral estrogens, initiate treatment with Alora one week after withdrawal of oral therapy or sooner if menopausal symptoms reappear in less than one week
  
• Administer Alora twice weekly, as instructed.
  
• Administer Alora in a continuous regimen in women who do not possess an intact uterus. In a woman with an intact uterus who is not using concomitant progestin therapy, Alora can be administered on a cycle schedule (for example, three weeks of therapy followed by one week without therapy) for the treatment of postmenopausal symptoms. However, no studies have been conducted using this intermittent regimen for the prevention of postmenopausal osteoporosis.