Dosage & Administration
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Climara Pro Prescribing Information
Estrogen Plus Progestin Therapy
Cardiovascular Disorders and Probable Dementia
The Women's Health Initiative (WHI) estrogen plus progestin substudy reported an increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo [see Warnings and Precautions , and Clinical Studies ].
The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions , and Clinical Studies ].
Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia [see Warnings and Precautions , and Clinical Studies ].
Breast Cancer
The WHI estrogen plus progestin substudy demonstrated an increased risk of invasive breast cancer [see Warnings and Precautions , and Clinical Studies ].
Only daily oral 0.625 mg CE and MPA were studied in the estrogen plus progestin substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia and breast cancer to lower CE plus other MPA doses, other routes of administration, or other estrogen plus progestogen products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen plus progestogen therapy, taking into account her individual risk profile.
Prescribe estrogens with or without progestogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Estrogen-Alone Therapy
Endometrial Cancer
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens. Adding a progestogen to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Perform adequate diagnostic measures, including directed or random endometrial sampling when indicated rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding [see Warnings and Precautions ].
Cardiovascular Disorders and Probable Dementia
The WHI estrogen-alone substudy reported increased risks of stroke and DVT in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral CE (0.625 mg)-alone, relative to placebo [see Warnings and Precautions , and Clinical Studies ].
The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age and older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions , Use in Specific Populations , and Clinical Studies ].
Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia [see Warnings and Precautions , and Clinical Studies ].
Only daily oral 0.625 mg CE was studied in the estrogen-alone substudy of the WHI. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events and dementia to lower CE doses, other routes of administration, or other estrogen-alone products is not known. Without such data, it is not possible to definitively exclude these risks or determine the extent of these risks for other products. Discuss with your patient the benefits and risks of estrogen-alone therapy, taking into account her individual risk profile.
Prescribe estrogens with or without progestogens at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman.
Climara Pro is indicated for:
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
Prevention of Postmenopausal Osteoporosis
Limitation of Use
When prescribing solely for the prevention of postmenopausal osteoporosis, first consider the use of non-estrogen medications. Consider estrogen therapy only for women at significant risk of osteoporosis.
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 women. Reevaluate postmenopausal women periodically as clinically appropriate to determine if treatment is still necessary.
One Climara Pro transdermal system is available for use.
Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
Start therapy with Climara Pro 0.045 mg per day/0.015 mg per day applied to the skin once weekly. Start therapy at the lowest effective dose and the shortest duration consistent with the treatment goals. Attempts to discontinue Climara Pro should be made at 3 to 6 month intervals.
Prevention of Postmenopausal Osteoporosis
Apply Climara Pro 0.045 mg per day/0.015 mg per day applied to the skin once weekly.
Application of the Climara Pro Transdermal System
Initiation of Therapy
Women not currently using continuous estrogen-alone therapy or estrogen plus progestogen therapy may start therapy with Climara Pro at any time. However, women currently using continuous estrogen-alone therapy or estrogen plus progestogen therapy should complete the current cycle of therapy before initiating Climara Pro therapy. Women often experience withdrawal bleeding at the completion of the cycle. The first day of this bleeding would be an appropriate time to begin Climara Pro therapy.
Site Selection
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- Place the adhesive side of Climara Pro on a smooth (fold free), clean, dry area of the skin on the lower abdomen or the upper quadrant of the buttock.
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- Do not apply Climara Pro to or near the breasts.
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- Select an area selected that is not oily (which can impair adherence of the system), damaged, or irritated.
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- Avoid the waistline; tight clothing may rub Climara Pro off or modify drug delivery.
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- Avoid application to areas where sitting would dislodge Climara Pro.
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- Rotate the sites of application, with an interval of at least 1-week allowed between applications to the same site.
Application
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- Apply Climara Pro immediately after opening the pouch and removing the protective lining.
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- Press Climara Pro firmly in place with the fingers for at least 10 seconds, making sure there is good contact, especially around the edges.
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- If the system lifts, apply pressure to maintain adhesion.
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- In the event that a system should fall off, reapply the same system to another area of the lower abdomen. If the system cannot be reapplied, a new system may be applied, in which case, the original treatment schedule should be continued.
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- Only one system should be worn at any one time during 7-day dosing interval.
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- Do not expose the applied transdermal system to the sun for prolonged periods of time.
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- Swimming, bathing, or using a sauna while using Climara Pro has not been studied, and these activities may decrease the adhesion of the system and the delivery of the estrogen and progestin.
Removal of the Climara Pro Transdermal System
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- Remove Climara Pro carefully and slowly to avoid irritation of the skin.
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- If any adhesive remain on the skin after removal of Climara Pro, allow the area to dry for 15 minutes and then gently rub the area with an oil-based cream or lotion should remove the adhesive residue.
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- Used patches still contain some active hormones. Carefully fold each patch in half so that it sticks to itself before throwing it away.
Climara Pro (estradiol/levonorgestrel transdermal system) 0.045 mg/day estradiol and 0.015 mg/day levonorgestrel – each 22 cm2 system contains 4.4 mg of estradiol and 1.39 mg of levonorgestrel.
Pregnancy
Risk Summary
Climara Pro is not indicated for use in pregnancy. There are no data with the use of Climara Pro in pregnant women; however, epidemiologic studies and meta-analyses have not found an increased risk of genital or nongenital birth defects (including cardiac anomalies and limb-reduction defects) following exposure to combined hormonal contraceptives (estrogens and progestins) before conception or during early pregnancy.
In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Lactation
Risk Summary
Estrogens plus progestogens are present in human milk and can reduce milk production in breast-feeding women. This reduction can occur at any time but is less likely to occur once breast-feeding is well-established. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Climara Pro and any potential adverse effects on the breastfed child from Climara Pro or from the underlying maternal condition.
Pediatric Use
Climara Pro is not indicated for use in pediatric patients. Clinical studies have not been conducted in the pediatric population.
Geriatric Use
There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Climara Pro to determine whether those over 65 years of age differ from younger subjects in their response to Climara Pro.
The Women’s Health Initiative Studies
In the WHI estrogen plus progestin substudy (daily CE [0.625 mg] plus MPA [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see Clinical Studies ].
In the WHI estrogen-alone substudy (daily CE [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see Clinical Studies ]
The Women’s Health Initiative Memory Study
In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen plus progestin or estrogen-alone when compared to placebo [see Warnings and Precautions , and Clinical Studies ].
Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8(see Warnings and Precautions , and Clinical Studies ].
Climara Pro is contraindicated in women with any of the following conditions:
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- Undiagnosed abnormal genital bleeding [see Warnings and Precautions ]
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- Breast cancer or history of breast cancer [see Warnings and Precautions ]
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- Estrogen-dependent neoplasia [see Warnings and Precautions ]
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- Active DVT, PE or a history of these conditions [see Warnings and Precautions ]
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- Active arterial thromboembolic disease (for example, stroke or MI), or a history of these conditions [ see Warnings and Precautions ]
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- Known anaphylactic reaction, or angioedema, or hypersensitivity to Climara Pro
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- Hepatic impairment or disease
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- Protein C, protein S, or antithrombin deficiency, or other thrombophilic disorders