Clinical Information
Gen. Code and Des.
62587 estradiol/norethindrone acet ORAL TABLET 0.5-0.1 MG
GCN and Des.
98362 estradiol/norethindrone acet ORAL TABLET 0.5-0.1 MG
Strength
0.5/0.1MG
Dose Form
TABLET
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family
AHFS Class
68160400 ESTROGENS
68320000 PROGESTINS
Active Ingredients
1265 estradiol 50282
1299 norethindrone acetate 51989
Inactive Ingredients
2432 lactose 64044515
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)
?
The WHI estrogen plus progestin substudy reported increased risks
of invasive breast cancer
?
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
?
There is an increased risk of endometrial cancer in woman with
uterus who use unopposed estrogens
?
Estrogen-alone therapy should not be used for the prevention of
cardiovascular disease or dementia (5.2, 5.3)
?
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:
?
Treatment of Moderate to Severe Vasomotor Symptoms due to
Menopause
?
Prevention of Postmenopausal Osteoporosis
Activella mg/0.5 mg is also indicat
ed in woman with uterus for:
?
Treatment of Moderate to Severe Symptoms of Vulvar and Vaginal
Atrophy due to Menopause --DOSAGE AND ADMINISTRATION
?
One tablet to be taken once daily -DOSAGE FORMS AND STRENGTHS --
?
Activella (estradiol/norethindrone acetate) mg/0.5 mg tablet
?
Activella (estradiol/norethindrone acet
ate) 0.5 mg/0.1 mg tablet -CONTRAINDICATIONS
?
Undiagnosed abnormal genital bleeding
?
Known, suspected, or history of breast cancer (4, 5.2)
?
Known or suspected estrogen-de
pendent neoplasia (4, 5.2)
?
Active DVT, PE, or history of
these conditions (4, 5.1)
?
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
?
Estrogens increase the risk of gall bladder disease
?
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 -
?
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)
