WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER AND PROBABLE DEMENTIA: Estrogen Plus Progestin Therapy. Cardiovascular Disorders and Probable Dementia - Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1, 5.3), and Clinical Studies (14.5, 14.6)]. 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 (5.1), and Clinical Studies (14.5)]. Continue reading below for additional important risk information, including Boxed Warning, for Climara Pro.

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Once a week.1

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Indications for Climara Pro® (estradiol/levonorgestrel transdermal system)

In women with an intact uterus:

  • Climara Pro is indicated for treatment of moderate to severe vasomotor symptoms due to menopause.1
  • Climara Pro is also indicated for the prevention of postmenopausal osteoporosis. When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.1

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  • Applied to the skin once weekly1
    • 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.
  • Provides a nominal delivery rate (mg per day) of 0.045 estradiol and 0.015 levonorgestrel1
  • In a clinical study, Climara Pro provided clinically acceptable adhesion1
    • A study of the adhesion potential of Climara Pro was conducted in 104 healthy women of 45–75 years of age. Each woman applied a placebo patch, containing only the Climara Pro adhesive without active ingredient, to the upper outer abdominal areas weekly for three weeks. The adhesion assessment was done visually on Days 2, 4, 5, 6 and 7 of each of the three weeks using a four-point scale. The mean scores ranked in the highest category possible on the 0 to 4 scale demonstrating clinically acceptable adhesion performance.

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Demonstrated Efficacy in Clinical Trials

Fewer and less severe hot flushes compared to placebo at 4 weeks

The efficacy of 0.045 mg estradiol(E2)/0.03 mg levonorgestrel(LNG) administered weekly versus placebo in the relief of moderate to severe vasomotor symptoms in postmenopausal women was studied in one 12-week clinical trial (n=183, average age 52.1 ± 4.93 percent Caucasian). The 0.045 mg estradiol/0.03 mg levonorgestrel dosage strength was shown to be statistically better than placebo at weeks 4 and 12 for relief of both the number and severity of moderate to severe hot flushes.1

Summary of Mean Daily Number of Moderate to Severe Hot Flushes-ITTa

  • At baseline, the mean number of moderate to severe hot flushes was 10.13 per day for the treatment group (nb=92) and 10.8 for placebo (nb=88).
  • At week 4, the mean number of moderate to severe hot flushes was 2.69 per day for the treatment group (nb=88) and 6.13 for placebo (nb=82) (p<0.001).c
  • At week 8, the mean number of moderate to severe hot flushes was 1.22 per day for the treatment group (nb=80) and 5.35 for placebo (nb=73).
  • At week 12, the mean number of moderate to severe hot flushes was 1.06 per day for the treatment group (nb=73) and 5.59 for placebo (nb=69) (p<0.001).c
ITT=Intent-to-Treat population n=Number of subjects in a treatment group in a cycle; number of subjects varied from cycle to cycle due to missing data p<0.025. p-value for comparison to placebo, adjusted by the method of Bonferroni. Climara Pro and the 0.045 mg estradiol/0.03 mg levonorgestrel dosage strength are bioequivalent in terms of estradiol delivery.

Summary of Mean Severityd of Moderate to Severe Hot Flushes-ITTa

  • At baseline, the mean severity of moderate to severe hot flushes was 2.48 per day for the treatment group (nb=92) and 2.42 for placebo (nb=89).
  • At week 4, the mean severity of moderate to severe hot flushes was 1.1 per day for the treatment group (nb=83) and 1.99 for placebo (nb=76) (p<0.001).c
  • At week 8, the mean severity of moderate to severe hot flushes was 0.82 per day for the treatment group (nb=72) and 1.93 for placebo (nb=68).
  • At week 12, the mean severity of moderate to severe hot flushes was 0.44 per day for the treatment group (nb=55) and 1.8 for placebo (nb=57) (p<0.001).c
ITT=Intent-to-Treat population n=Number of subjects in a treatment group in a cycle; number of subjects varied from cycle to cycle due to missing data p<0.025. p-value for comparison to placebo, adjusted by the method of Bonferroni. Severity scores are: 1 = Mild, 2 = Moderate, 3 = Severe. Mean severity of hot flushes by day is [(2X number of moderate hot flushes) + (3X number of severe hot flushes)] / total number of moderate to severe hot flushes on that day. If no moderate to severe hot flush was indicated, the mean severity was 0. Climara Pro and the 0.045 mg estradiol/0.03 mg levonorgestrel dosage strength are bioequivalent in terms of estradiol delivery.

ADVERSE REACTIONS

The most common adverse reactions (≥5%) in clinical trials were: application site reaction, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, pain, and headache.

All treatment emergent reactions regardless of relationship reported at a frequency of >3% with Climara Pro in the 1-year endometrial hyperplasia study with Climara Pro 0.045 / 0.015 (N = 212)

Adverse Reactions: Application site reaction (40.6%), Vaginal bleeding (36.8%), Breast pain (18.9%), Upper respiratory infection (13.2%), Back pain (6.1%), Depression (5.7%), Headache (5.2%), Pain (5.2%), Flu syndrome (4.7%), Abdominal pain (4.2%), Arthralgia (4.2%), Bronchitis (4.2%), Edema (3.8%), Flatulence (3.8%), Sinusitis (3.8%), Accidental injury (3.3%), Hypertension (3.3%), Infection (3.3%), Urinary tract infection (3.3%).

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, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered.

CONTRAINDICATIONS

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

WARNINGS AND PRECAUTIONS

Cardiovascular Disorders: An increased risk of cardiovascular events such as MI, PE, DVT, VTE, and stroke has been associated with estrogen and estrogen plus progestin therapy. Should any of these occur or be suspected, estrogen with or without progestin therapy should be discontinued immediately. 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) should be managed appropriately. If feasible, Climara Pro should be discontinued 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: The use of estrogens and progestins by postmenopausal women has been reported to increase the risk of breast cancer. After 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. 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 progestin 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 progestin therapy is important. Adequate diagnostic measures, including directed or random endometrial sampling when indicated, should be undertaken to rule out malignancy in postmenopausal women with undiagnosed persistent or recurring abnormal genital bleeding. 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. If hypercalcemia occurs, use of the drug should be stopped and appropriate measures taken to reduce the serum calcium levels.

Visual Abnormalities: Retinal vascular thrombosis has been reported in women receiving estrogens. Discontinue medication pending examination if there is sudden partial or complete loss of vision, or a sudden onset of proptosis, diplopia, or migraine. Estrogens should be permanently discontinued if papilledema or retinal lesions are detected.

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

Studies of the addition of a progestin 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.

Hypertriglyceridemia: Increased plasma triglycerides leading to pancreatitis may occur with estrogens in women with preexisting hypertriglyceridemia. Consider discontinuation of treatment if pancreatitis occurs.

Liver Disease: Discontinue Climara Pro if cholestatic jaundice occurs.

Hypothyroidism: Increased thyroid-binding globulin levels may occur. Monitor thyroid function in women on thyroid replacement therapy.

Fluid retention: Estrogens plus progestins may cause fluid retention; monitoring may be warranted

Hypocalcemia: Use Climara Pro with caution in women with hypoparathyroidism as estrogen-induced hypocalcemia may occur.

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. For women known to have residual endometriosis post-hysterectomy, the addition of progestin should be considered.

Hereditary Angioedema: Exogenous estrogens may exacerbate symptoms of angioedema in women with hereditary angioedema.

Exacerbation of other conditions: Estrogen therapy may cause an exacerbation of asthma, diabetes mellitus, epilepsy, migraine or porphyria, systemic lupus erythematosus, and hepatic hemangiomas. Estrogens should be used with caution in women with these conditions.

ADVERSE REACTIONS

The most common adverse reactions (≥5%) in clinical trials were: application site reaction, vaginal bleeding, breast pain, upper respiratory infection, back pain, depression, pain, and headache.

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