Item info.
These highlights do not include a
ll the info. needed to use
ACTIVELLA safely and effectively. Se
e full prescribing info. 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 info. for complete boxed warning
Estrogen Plus Progestin Therapy
?
Estrogen plus progestin therapy should not be used for the
prevention of cardiovascular di
sease or dementia (5.1, 5.3)
?
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)
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The WHI estrogen plus progestin substudy reported increased risks
of invasive breast cancer
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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
Estrogen-Alone Therapy
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There is an increased risk of endometrial cancer in woman with
uterus who use unopposed estrogens
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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
?
The WHIMS estrogen-alone ancillary study of WHI reported an
increased risk of probable dementia in postmenopausal women 65
years of age and older RECENT MAJOR CHANGES
Contraindications 10/2013
Warnings and Precautions, Heredita
ry Angioedema (5.15)
10/2013 -INDICATIONS AND USAGE --
Activella
is an estrogen and progestin combination indicated in woman with
a uterus for:
Activella mg/0.5 mg and 0.5 mg/0.1 mg are indicated in woman with
uterus for:
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Treatment of Moderate to Severe Vasomotor Symptoms due to
Menopause
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Prevention of Postmenopausal Osteoporosis
Activella mg/0.5 mg is also indicat
ed in woman with uterus for:
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Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal
Atrophy due to Menopause --DOSAGE AND ADMINISTRATION
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One tablet to be taken once daily -DOSAGE FORMS AND STRENGTHS --
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Activella (estradiol/norethindrone acetate) mg/0.5 mg tablet
?
Activella (estradiol/norethindrone acet
ate) 0.5 mg/0.1 mg tablet -CONTRAINDICATIONS
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Undiagnosed abnormal genital bleeding
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Known, suspected, or history of breast cancer (4, 5.2)
?
Known or suspected estrogen-de
pendent 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)
?
Known anaphylactic reaction or a
ngioedema or hypersensitivity to
Activella
?
Known liver impairment or disease (4, 5.10)
?
Known protein C, protei
n S, or antithrombin deficiency, or other known
thrombophilic disorders
?
Known or suspected pregnancy(4, 8.1) -WARNINGS AND PRECAUTIONS
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Estrogens increase the risk of gall bladder disease
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Discontinue estrogen if severe hype
rcalcemia, loss of vision, severe
hypertriglyceridemia or cholestatic jaundice occurs (5.5, 5.6, 5.9, 5.10)
?
Monitor thyroid function in women on thyroid replacement therapy
(5.11, 5.18) ADVERSE REACTIONS -
Most common adverse reactions (incidence
?
percent) are back pain,
headache, pain in the extremity, naus
ea, 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 thicke
ning, viral infection,
moniliasis genital, and accidental injury.
To report SUSPECTED ADVERSE RE
ACTIONS, 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 -USE IN SPECIFIC POPULATIONS
?
Nursing Mothers: Estrogen administration to nursing women has been
shown to decrease the quantity a
nd quality of breast milk
?
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)