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Reference ID: 4175326 FULL PRESCRIBING INFORMATION: CONTENTS *

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Reference ID: 4175326 FULL PRESCRIBING INFORMATION: CONTENTS * HIGHLIGHTS OF PRESCRIBING INFORMATION —————— DOSAGE FORMS AND STRENGTHS —————— These highlights do not include all the information needed to use PREMPRO Tablets: 0.3 mg CE plus 1.5 mg MPA, 0.45 mg CE plus 1.5 mg PREMPRO/PREMPHASE safely and effectively. See full prescribing MPA, 0.625 mg CE plus 2.5 mg MPA, 0.625 mg CE plus 5 mg MPA. information for PREMPRO/PREMPHASE. PREMPHASE Tablets: 0.625 mg CE, 0.625 mg CE plus 5 mg MPA. PREMPRO® (conjugated estrogens/medroxyprogesterone acetate tablets) PREMPHASE® (conjugated estrogens plus ————————— CONTRAINDICATIONS ———————— medroxyprogesterone acetate tablets) • Undiagnosed abnormal genital bleeding (4) Initial U.S. Approval: 1995 • Known, suspected, or history of breast cancer (4, 5.2) • Known or suspected estrogen-dependent neoplasia (4, 5.2) WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER and PROBABLE DEMENTIA • Active DVT, PE, or a history of these conditions (4, 5.1) See full prescribing information for complete boxed warning. • Active arterial thromboembolic disease (for example, stroke and MI), Estrogen Plus Progestin Therapy or a history of these conditions (4, 5.1) • Estrogen plus progestin therapy should not be used for the • Known anaphylactic reaction or angioedema to prevention of cardiovascular disease or dementia (5.1, 5.3) PREMPRO/PREMPHASE (5.15, 5.16) • The Women’s Health Initiative (WHI) estrogen plus progestin • Known liver dysfunction or disease (4, 5.10) substudy reported increased risks of stroke, deep vein thrombosis • Known protein C, protein S, or antithrombin deficiency, or other (DVT), pulmonary embolism (PE), and myocardial infarction (MI) known thrombophilic disorders (4) (5.1) • Known or suspected pregnancy (4, 8.1) • The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer (5.2) ——————— WARNINGS AND PRECAUTIONS —————— • The WHI Memory Study (WHIMS) estrogen plus progestin • Estrogens increase the risk of gallbladder disease (5.4) ancillary study of WHI reported an increased risk of probable • Discontinue estrogen if severe hypercalcemia, loss of vision, severe dementia in postmenopausal women 65 years of age and older (5.3) hypertriglyceridemia or cholestatic jaundice occurs (5.5, 5.6, 5.9, 5.10) Estrogen-Alone Therapy • Monitor thyroid function in women on thyroid replacement therapy • There is an increased risk of endometrial cancer in a woman with a (5.11, 5.19) uterus who uses unopposed estrogens (5.2) ————————— ADVERSE REACTIONS ————————— • Estrogen-alone therapy should not be used for the prevention of In two prospective, randomized clinical studies, the most common adverse cardiovascular disease or dementia (5.1, 5.3) reactions > 5 percent are abdominal pain, asthenia, back pain, headache, • The WHI estrogen-alone substudy reported increased risks of flatulence, nausea, depression, pruritus, breast pain, dysmenorrhea, and stroke and DVT (5.1) leukorrhea. (6.1) • The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. years of age and older (5.3) at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ------------------------ RECENT MAJOR CHANGES --------------------------­ Warnings and Precautions, Malignant Neoplasms (5.2) 11/2017 ————————— DRUG INTERACTIONS ————————— • Inducers and/or inhibitors of CYP3A4 may affect estrogen drug ———————— INDICATIONS AND USAGE ———————— metabolism (7.1) PREMPRO/PREMPHASE is an estrogen plus progestin indicated in a • Aminoglutethimide administered concomitantly with MPA may woman with a uterus for: significantly depress the bioavailability of medroxyprogesterone • Treatment of Moderate to Severe Vasomotor Symptoms due to acetate (7.1) Menopause (1.1) ——————— USE IN SPECIFIC POPULATIONS —————— • Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause (1.2) • Nursing Mothers: Estrogen administration to nursing women has been shown to decrease the quantity and quality of breast milk (8.3) • Prevention of Postmenopausal Osteoporosis (1.3) • Geriatric Use: An increased risk of probable dementia in women over ——————— DOSAGE AND ADMINISTRATION —————— 65 years of age was reported in the Women’s Health Initiative PREMPRO: one tablet containing conjugated estrogens (CE) plus Memory ancillary studies of the Women’s Health Initiative (5.3, 8.5) medroxyprogesterone acetate (MPA) taken orally once daily. (2) See 17 for PATIENT COUNSELING INFORMATION and PREMPHASE: one maroon tablet containing 0.625 mg CE taken orally on FDA-approved patient labeling days 1 through 14, and one light-blue tablet containing 0.625 mg CE plus Revised: 11/2017 5.0 mg MPA taken orally on days 15 through 28. (2) 1 Reference ID: 4175326 FULL PRESCRIBING INFORMATION: CONTENTS * WARNING: CARDIOVASCULAR DISORDERS, BREAST 7 DRUG INTERACTIONS CANCER, ENDOMETRIAL CANCER and PROBABLE 7.1 Metabolic Interactions DEMENTIA 8 USE IN SPECIFIC POPULATIONS 1 INDICATIONS AND USAGE 8.1 Pregnancy 1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to 8.3 Nursing Mothers Menopause 8.4 Pediatric Use 1.2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to 8.5 Geriatric Use Menopause 8.6 Renal Impairment 1.3 Prevention of Postmenopausal Osteoporosis 8.7 Hepatic Impairment 2 DOSAGE AND ADMINISTRATION 10 OVERDOSAGE 2.1 Treatment of Moderate to Severe Vasomotor Symptoms due to 11 DESCRIPTION Menopause 12 CLINICAL PHARMACOLOGY 2.2 Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to 12.1 Mechanism of Action Menopause 12.2 Pharmacodynamics 2.3 Prevention of Postmenopausal Osteoporosis 12.3 Pharmacokinetics 3 DOSAGE FORMS AND STRENGTHS 13 NONCLINICAL TOXICOLOGY 4 CONTRAINDICATIONS 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 5 WARNINGS AND PRECAUTIONS 14 CLINICAL STUDIES 5.1 Cardiovascular Disorders 14.1 Effects on Vasomotor Symptoms 5.2 Malignant Neoplasms 14.2 Effects on Vulvar and Vaginal Atrophy 5.3 Probable Dementia 14.3 Effects on the Endometrium 5.4 Gallbladder Disease 14.4 Effects on Uterine Bleeding or Spotting 5.5 Hypercalcemia 14.5 Effects on Bone Mineral Density 5.6 Visual Abnormalities 14.6 Women’s Health Initiative Studies 5.7 Addition of a Progestin When a Woman Has Not Had a Hysterectomy 14.7 Women’s Health Initiative Memory Study 5.8 Elevated Blood Pressure 15 REFERENCES 5.9 Hypertriglyceridemia 16 HOW SUPPLIED/STORAGE AND HANDLING 5.10 Hepatic Impairment and/or Past History of Cholestatic Jaundice 16.1 How Supplied 5.11 Hypothyroidism 16.2 Storage and Handling 5.12 Fluid Retention 17 PATIENT COUNSELING INFORMATION 5.13 Hypocalcemia 17.1 Abnormal Vaginal Bleeding 5.14 Exacerbation of Endometriosis 17.2 Possible Serious Adverse Reactions with Estrogen Plus Progestin 5.15 Anaphylactic Reaction and Angioedema Therapy 5.16 Hereditary Angioedema 17.3 Possible Less Serious but Common Adverse Reactions with Estrogen 5.17 Exacerbation of Other Conditions Plus Progestin Therapy 5.18 Laboratory Tests 5.19 Drug-Laboratory Test Interactions FDA-Approved Patient Labeling 6 ADVERSE REACTIONS 6.1 Clinical Trials Experience 6.2 Postmarketing Experience * Sections or subsections omitted from the full prescribing information are not listed 2 Reference ID: 4175326 FULL PRESCRIBING INFORMATION 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 (14.6, 14.7)]. 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 estrogen (CE) [0.625 mg] combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo [see Warnings and Precautions (5.1), and Clinical Studies (14.6)]. The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or 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 (5.3), Use in Specific Populations (8.5), and Clinical Studies (14.7)]. Breast Cancer The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer [see Warnings and Precautions (5.2), and Clinical Studies (14.6)]. In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins. Estrogens with or without progestins should be prescribed 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 progestin to estrogen therapy has been shown to reduce the risk of endometrial hyperplasia, which may be a precursor to endometrial cancer. Adequate diagnostic measures, including directed or random endometrial sampling when 3 Reference ID: 4175326 indicated, should be undertaken
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