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Climara Pro®—designed with your patients in mind

Climara Pro® (estradiol/levonorgestrel transdermal system) box and patches

Transdermal administration of Climara Pro® provides a nominal delivery rate (mg per day) of 0.045 estradiol and 0.015 levonorgestrel; Climara Pro® produces mean maximum estradiol concentrations in serum in about 2 to 2.5 days.

 

Estradiol concentrations equivalent to the normal ranges observed at the early follicular phase in premenopausal women are achieved within 12 to 24 hours after the first application.

Dosing and administration

Starting Climara Pro®

Dosing and administration

Starting Climara Pro®

  • Use of estrogen-alone therapy or in combination with a progestin should be given at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman
  • Postmenopausal women should be reevaluated periodically as clinically appropriate to determine if treatment is still necessary
  • One Climara Pro® transdermal system is available for use
Blue graphic image of woman with droplets on both sides of head indicating hot flushes and sweating

Treatment of moderate to severe vasomotor symptoms due to menopause:

Climara Pro® 0.045 mg per day/0.015 mg per day applied to the skin once weekly. Therapy should be started at the lowest effective dose and the shortest duration consistent with the treatment goals. Attempts to discontinue the medication should be made at 3 to 6 month intervals.

Blue graphic image of woman with droplets on both sides of head indicating hot flushes and sweating

Treatment of moderate to severe vasomotor symptoms due to menopause:

Climara Pro® 0.045 mg per day/0.015 mg per day applied to the skin once weekly. Therapy should be started at the lowest effective dose and the shortest duration consistent with the treatment goals. Attempts to discontinue the medication should be made at 3 to 6 month intervals.

Graphical image of hip bone in blue indicating postmenopausal osteoporosis

Prevention of postmenopausal osteoporosis:

Climara Pro® 0.045 mg per day/0.015 mg per day applied to the skin once weekly.

Graphical image of hip bone in blue indicating postmenopausal osteoporosis

Prevention of postmenopausal osteoporosis:

Climara Pro® 0.045 mg per day/0.015 mg per day applied to the skin once weekly.

Initiation of therapy

  • Initiation of therapy in women not currently using continuous estrogen-alone therapy or estrogen plus progestin therapy may start therapy with Climara Pro® at any time 
  • Women currently using continuous estrogen-alone therapy or estrogen plus progestin 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

 

Application of the transdermal system

Site selection

  • The adhesive side of Climara Pro® should be placed on a smooth (fold free), clean, dry area of the skin on the lower abdomen or the upper quadrant of the buttock
  • Climara Pro® should not be applied to or near the breasts
  • The area selected should not be oily (which can impair adherence of the system), damaged, or irritated
  • The waistline should be avoided, since tight clothing may rub Climara Pro® off or modify drug delivery
  • Application to areas where sitting would dislodge Climara Pro® should also be avoided
  • The sites of application must be rotated, with an interval of at least 1-week allowed between applications to the same site

 

Application

  • Climara Pro® should be applied immediately after opening the pouch and removing the protective lining
  • Climara Pro® should be pressed firmly in place with the fingers for at least 10 seconds, making sure there is good contact, especially around the edges
  • If the system lifts, apply pressure to maintain adhesion
  • In the event that a system should fall off, the same system may be reapplied 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
  • Only one system should be worn at any one time during 7-day dosing interval
  • Once in place, the transdermal system should not be exposed to the sun for prolonged periods of time
  • 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 transdermal system 

 

  • Removal of Climara Pro® should be done carefully and slowly to avoid irritation of the skin
  • Should any adhesive remain on the skin after removal of the system, allow the area to dry for 15 minutes
  • Then gently rubbing the area with an oil-based cream or lotion should remove the adhesive residue
  • Used patches still contain some active hormones. Each patch should be carefully folded in half so that it sticks to itself before throwing it away


 

Climara Pro® provides clinically acceptable adhesion

 

  • A study of the adhesion potential of Climara Pro® was conducted in 104 healthy women aged 45 to 75 years. Each woman applied a placebo patch, containing only the Climara Pro® adhesive without active ingredient, to the upper outer abdominal area weekly for 3 weeks. The adhesion assessment was visually assessed on days 2, 4, 5, 6, and 7 of each of the 3 weeks using a 4-point scale. The mean scores ranked in the highest category possible on the 0 to 4 scale, demonstrating clinically acceptable adhesion performance

Help your patients get started on Climara Pro® today with these step-by-step application instructions 

Application Guide

Hand holding Climara Pro patch

Help manage moderate to severe vasomotor symptoms due to menopause

Learn more

IMPORTANT SAFETY INFORMATION

MORE IMPORTANT SAFETY INFORMATION

WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, AND ENDOMETRIAL CANCER

Estrogen Plus Progestin Therapy 

Cardiovascular Disorders and Probable Dementia

WARNING: CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA, BREAST CANCER, AND ENDOMETRIAL CANCER

Estrogen Plus Progestin Therapy 

Cardiovascular Disorders and Probable Dementia

CONTRAINDICATIONS

Climara Pro is contraindicated in women with any of the following conditions: undiagnosed abnormal genital bleeding, Breast cancer or history of breast cancer, estrogen-dependent neoplasia, active deep vein thrombosis, pulmonary emboli or a history of these conditions, active arterial thromboembolic disease (e.g., stroke or myocardial infarction), or a history of these conditions, known anaphylactic reaction or angioedema, or hypersensitivity to Climara Pro,  hepatic impairment or disease, Protein C, protein S, or antithrombin deficiency, or other  thrombophilic disorders.

WARNINGS AND PRECAUTIONS

Cardiovascular Disorders: Increased risks of PE, DVT, stroke, and MI are reported with estrogen plus progestin therapy. Increased risks of stroke and DVT are reported with estrogen alone therapy. Immediately discontinue estrogen with or without progestogen therapy if any of these occur or are suspected. 

Manage appropriately any risk factors for arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (VTE) (for example, personal history or family history of VTE, obesity, and systemic lupus erythematosus).  If feasible, discontinue Climara Pro at least 4 to 6 weeks before surgery of the type associated with an increased risk of thromboembolism, or during periods of prolonged immobilization.

Malignant Neoplasia: A mean follow-up of 5.6 years, the estrogen plus progestin substudy reported an increased risk of invasive breast cancer in women who took daily CE plus MPA compared to placebo. One large meta-analysis of prospective cohort studies reported increased risks that were dependent upon duration of use and could last up to >10 years after discontinuation of estrogen plus progestin therapy and estrogen-alone therapy. The use of estrogen-alone and estrogen plus progestin has been reported to result in an increase in abnormal mammograms requiring further evaluation.  All women should receive yearly breast examinations by a healthcare provider and perform monthly breast self-examinations.  In addition, mammography examinations should be scheduled based on patient age, risk factors, and prior mammography results.  The use of unopposed estrogens in women with intact uteri has been associated with an increased risk of endometrial cancer.  The greatest risk appears to be associated with prolonged use and may persist for at least 8 to 15 years after discontinuation.  Adding a progestogen to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer.  Clinical surveillance of all women using estrogen-alone or estrogen plus progestogen therapy is important.  Adequate diagnostic measures, including directed or random endometrial sampling when indicated, to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding with unknown etiology. Estrogens with or without progestin may increase the risk of ovarian cancer.

Probable Dementia: Climara Pro should not be used for the prevention of dementia (see Boxed Warning).

Gallbladder Disease: An increased risk of gallbladder disease which may require surgery has been reported in postmenopausal women receiving estrogens.

Hypercalcemia: Estrogen administration may lead to severe hypercalcemia in women with breast cancer and bone metastases. Discontinue estrogens, including Climara Pro if hypercalcemia occurs, and take appropriate measures to reduce the serum calcium levels.

Visual Abnormalities: Retinal vascular thrombosis has been reported in women receiving estrogens. Discontinue Climara Pro pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine. Permanently discontinue estrogens, including Climara Pro, if examination reveals papilledema or retinal vascular lesions.

Addition of a Progestogen When a Woman Has Not Had a Hysterectomy

Studies of the addition of a progestogen for 10 or more days of a cycle of estrogen administration, or daily with estrogen in a continuous regimen, have reported a lowered incidence of endometrial hyperplasia than would be induced by estrogen treatment alone. Endometrial hyperplasia may be a precursor to endometrial cancer.

Elevated Blood Pressure: In a small number of case reports, increases in blood pressure have been attributed to idiosyncratic reactions to estrogens.

Exacerbation of Hypertriglyceridemia: Increased plasma triglycerides leading to pancreatitis may occur with estrogens in women with preexisting hypertriglyceridemia. Discontinue Climara Pro if pancreatitis occurs.

Liver Disease: Estrogens may be poorly metabolized in women with hepatic impairment. Discontinue Climara Pro if cholestatic jaundice occurs.

Exacerbation of Hypothyroidism: Increased thyroid-binding globulin levels may occur.  Monitor thyroid function in women on thyroid replacement therapy during treatment with Climara Pro.

Fluid retention: Estrogens plus progestogens may cause fluid retention; monitoring may be warranted. Discontinue estrogen plus progestogen therapy including Climara Pro, with evidence of medically concerning fluid retention.

Hypocalcemia: Estrogen induced hypocalcemia may occur in women with hypoparathyroidism. Consider whether the benefits of estrogen therapy, including Climara Pro, outweigh the risks in such women.

Exacerbation of Endometriosis: A few cases of malignant transformation of residual endometrial implants have been reported in women treated post-hysterectomy with estrogen-alone therapy.

Hereditary Angioedema:  Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema. Consider whether the benefits of estrogen therapy, including Climara Pro, outweigh the risks in such women.

Exacerbation of other conditions: Estrogen therapy, including Climara-Pro, may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas. Consider whether the benefits of estrogen therapy outweigh the risks in women with these conditions.

ADVERSE REACTIONS

The most common adverse reactions (≥5%) with Climara Pro, are: application site reaction, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, pain, headache, and flu syndrome.

INDICATIONS FOR CLIMARA PRO

In women with an intact uterus, Climara Pro® (estradiol/levonorgestrel transdermal system) is indicated for treatment of moderate to severe vasomotor symptoms due to menopause.  Climara Pro is also indicated for the prevention of postmenopausal osteoporosis.  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.

For important risk and use information about Climara Pro, including Boxed Warning, please see the accompanying Full Prescribing Information.

You are encouraged to report adverse side effects or quality complaints for Bayer’s prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088

BAYER, the Bayer Cross, and Climara Pro are registered trademarks of Bayer.

 

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