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Activella(estradiol/norethindrone acetate)tablets
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HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use ACTIVELLA safely and effectively. See full prescribing information for ACTIVELLA.
Activella ® (estradiol/norethindrone acetate) tablets, for oral use
Initial U.S. Approval: 1998
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER AND PROBABLE DEMENTIA
See full prescribing information for complete boxed warning
Estrogen Plus Progestin Therapy
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•Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia (5.1, 5.3)
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•The Women’s Health Initiative (WHI) estrogen plus progestin substudy reported increased risks of deep vein
thrombosis (DVT), pulmonary embolism (PE), stroke and myocardial infarction (MI) (5.1)
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•The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer (5.2)
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•The WHI Memory Study (WHIMS) estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older (5.3)
Estrogen-Alone Therapy
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•There is an increased risk of endometrial cancer in a woman with a uterus who use unopposed estrogens (5.2)
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•Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia (5.2, 5.3)
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•The WHI estrogen-alone substudy reported increased risks of stroke and DVT (5.1)
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•The WHIMS estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older (5.3)
RECENT MAJOR CHANGES
Contraindications (4) 10/2013
Warnings and Precautions, Hereditary Angioedema (5.15) 10/2013
INDICATIONS AND USAGE
Activella is an estrogen and progestin combination indicated in a woman with a uterus for:
Activella 1 mg/0.5 mg and 0.5 mg/0.1 mg are indicated in a woman with a uterus for:
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•Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1)
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•Prevention of Postmenopausal Osteoporosis ( 1.3)
Activella 1 mg/0.5 mg is also indicated in a woman with a uterus for:
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•Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause ( 1.2)
DOSAGE AND ADMINISTRATION
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•One tablet to be taken once daily ( 2)
DOSAGE FORMS AND STRENGTHS
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•Activella (estradiol/norethindrone acetate) 1 mg/0.5 mg tablet (3)
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•Activella (estradiol/norethindrone acetate) 0.5 mg/0.1 mg tablet (3)
CONTRAINDICATIONS
•Undiagnosed abnormal genital bleeding ( 4)
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•Known, suspected, or history of breast cancer ( 4, 5.2)
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•Known or suspected estrogen-dependent neoplasia ( 4, 5.2)
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•Active DVT, PE, or history of these conditions ( 4, 5.1)
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•Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions ( 4, 5.1)
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•Known anaphylactic reaction or angioedema or hypersensitivity to Activella ( 4)
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•Known liver impairment or disease ( 4, 5.10)
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•Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders ( 4)
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•Known or suspected pregnancy ( 4, 8.1)
WARNINGS AND PRECAUTIONS
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•Estrogens increase the risk of gall bladder disease ( 5.4)
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•Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs ( 5.5, 5.6, 5.9, 5.10)
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•Monitor thyroid function in women on thyroid replacement therapy ( 5.11, 5.18)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 5 percent) are back pain, headache, pain in the extremity, nausea, diarrhea, gastroenteritis, insomnia, emotional lability, upper respiratory tract infection, sinusitis, nasopharyngitis, weight increase, breast pain, post-menopausal bleeding, uterine fibroid vaginal hemorrhage, ovarian cyst, endometrial thickening, viral infection, moniliasis genital, and accidental injury. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Novo Nordisk Inc. at 1-888-824-4336 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
DRUG INTERACTIONS
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•Inducers and/or inhibitors of CYP3A4 may affect estrogen drug metabolism ( 7.1)
USE IN SPECIFIC POPULATIONS
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•Nursing Mothers: Estrogen administration to nursing women has been shown to decrease the quantity and quality of breast milk ( 8.3)
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•Geriatric Use: An increase risk of probable dementia in women over 65 years of age was reported in the Women’s Health Initiative Memory ancillary studies of the Women’s Health Initiative ( 5.3, 8.5)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 11/2014
FULL PRESCRIBING INFORMATION: CONTENTS*
WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER, ENDOMETRIAL CANCER AND PROBABLE DEMENTIA
1 INDICATIONS AND USAGE
1.1 Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause
1.2 Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal Atrophy due to Menopause
Limitation of Use
When prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered.
1.3 Prevention of Postmenopausal Osteoporosis
Limitation of Use
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.
2 DOSAGE AND ADMINISTRATION
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