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Prescribing Information, including BOXED WARNINGPatient
InformationIndicationPatient Site
Safety Profile

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 indicated, should be undertaken to rule out malignancy
in postmenopausal women with undiagnosed persistent or recurring abnormal
genital bleeding.

Estrogens with or without progestins should not be used for the prevention of
cardiovascular disease or dementia.

The Women's Health Initiative (WHI) estrogen-alone substudy reported increased
risks of stroke and deep vein thrombosis (DVT) in postmenopausal women with
daily oral conjugated estrogens (CE) alone. The WHI estrogen plus progestin
substudy reported increased risks of DVT, pulmonary embolism, stroke, and
myocardial infarction in postmenopausal women with daily oral CE combined with
medroxyprogesterone acetate (MPA). In the absence of comparable data, these
risks should be assumed to be similar for other dosage forms of estrogens.

The WHI Memory Study (WHIMS) reported an increased risk of developing probable
dementia in postmenopausal women 65 years of age or older, in both the estrogen
alone and estrogen plus progestin arms. It is unknown whether these findings
apply to younger postmenopausal women.

The WHI estrogen plus progestin substudy demonstrated an increased risk of
invasive breast cancer.

Estrogens with or without progestins should be prescribed at the lowest
effective dose and for the shortest duration consistent with treatment goals and
risks for the individual woman.

In a 12-week, double-blind phase,

Common adverse reactions occurring in ≥2% of subjects1
Premarin Vaginal Cream therapy should not be used in women with any of the
following conditions1:
 * Undiagnosed abnormal genital bleeding
 * Known, suspected, or history of breast cancer
 * Known or suspected estrogen-dependent neoplasia
 * Active DVT, PE, or a history of these conditions
 * Active arterial thromboembolic disease (for example, stroke and MI), or a
   history of these conditions
 * Known anaphylactic reaction or angioedema to Premarin Vaginal Cream
 * Known liver dysfunction or disease
 * Known protein C, protein S or antithrombin deficiency or other known
   thrombophilic disorders
 * Known or suspected pregnancy

In a 12-week, double-blind, placebo-controlled study with a 40-week open-label
extension phase,

 
No cases of endometrial hyperplasia or carcinoma at 1 year1
 * Endometrial safety was assessed by endometrial biopsy for all randomly
   assigned subjects at week 52

The safety of Premarin Vaginal Cream beyond 52 weeks at any dose is not well
known. The data on this page are not intended to minimize the risk of
endometrial hyperplasia and associated neoplasms included as part of the Women's
Health Initiative (WHI) BOXED warning for all estrogen therapies. The decision
as to whether or not to add a progestin to the unopposed estrogen in Premarin
Vaginal Cream should be left up to the physician’s clinical judgment based on
the individual patient’s risks.

Study Description

Results from a 12-week, randomized, double-blind, placebo-controlled trial that
evaluated the efficacy and safety of Premarin Vaginal Cream in generally healthy
postmenopausal women aged 44 to 77 years (N=423), who at baseline had ≤5%
superficial cells on a vaginal smear, a vaginal pH ≥5.0, and who identified a
most bothersome moderate to severe symptom of vulvar and vaginal atrophy.
Premarin Vaginal Cream was administered using 2 dosing regimens: 0.5 g twice
weekly and 0.5 g once daily (21 days on/7 days off). The study consisted of an
initial 12-week trial followed by an open-label extension to assess endometrial
safety through week 52.

Primary end points were the changes from baseline in Vaginal Maturation Index,
vaginal pH, and severity of patient-reported most bothersome symptom at week 12.
Participants defined the severity of their most bothersome symptom on the
following scale: 1=mild, 2=moderate, 3=severe. For most women, dyspareunia was
identified as the most bothersome symptom at baseline. Weekly severity score is
an average of the daily scores.1,2

References:Premarin Vaginal Cream. Prescribing information. Pfizer; 2018.Data on
file. Pfizer Inc., New York, NY.Efficacy & Safety Data
 * Efficacy
 * Safety Profile

To report an adverse event, please call 1-800-438-1985

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Pfizer. PP-MCL-USA-0367


INDICATION Premarin® (conjugated estrogens) Vaginal Cream is indicated for the
treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal
atrophy, due to menopause.
Important Safety Information

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 indicated, should be undertaken to rule out malignancy
in postmenopausal women with undiagnosed persistent or recurring abnormal
genital bleeding.

Estrogens with or without progestins should not be used for the prevention of
cardiovascular disease or dementia.

The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased
risks of stroke and deep vein thrombosis (DVT) in postmenopausal women with
daily oral conjugated estrogens (CE) alone. The WHI estrogen plus progestin
substudy reported increased risks of DVT, pulmonary embolism, stroke, and
myocardial infarction in postmenopausal women with daily oral CE combined with
medroxyprogesterone acetate (MPA). In the absence of comparable data, these
risks should be assumed to be similar for other dosage forms of estrogens.

The WHI Memory Study (WHIMS) reported an increased risk of developing probable
dementia in postmenopausal women 65 years of age or older, in both the estrogen
alone and estrogen plus progestin arms. It is unknown whether these findings
apply to younger postmenopausal women.

The WHI estrogen plus progestin substudy demonstrated an increased risk of
invasive breast cancer.

Estrogens with or without progestins should be prescribed at the lowest
effective dose and for the shortest duration consistent with treatment goals and
risks for the individual woman.

Premarin Vaginal Cream should not be used in women with any of the following
conditions: undiagnosed abnormal genital bleeding; known, suspected, or a
history of breast cancer; known or suspected estrogen-dependent neoplasia;
active deep vein thrombosis, pulmonary embolism, or a history of these
conditions; active arterial thromboembolic disease (e.g., stroke, myocardial
infarction), or a history of these conditions; anaphylactic reaction or
angioedema with Premarin Vaginal Cream; liver dysfunction or disease;
thrombophilic disorders; pregnancy.

The WHI estrogen plus progestin sub-study reported a statistically
non-significant increased risk of ovarian cancer. A meta-analysis of 17
prospective and 35 retrospective epidemiology studies found that women who used
hormonal therapy for menopausal symptoms had an increased risk for ovarian
cancer. The exact duration of hormone therapy use associated with an increased
risk of ovarian cancer, however, is unknown.

Estrogens increase the risk of gallbladder disease. Discontinue estrogen if
severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic
jaundice occurs. Monitor thyroid function in women on thyroid replacement
therapy, because estrogens may be associated with increased thyroid binding
globulin (TBG) levels.

The most common adverse reactions (≥2%) were headache, pelvic pain,
vasodilation, breast pain, leucorrhea, metrorrhagia, vaginitis, and vulvovaginal
disorder.

Indication Premarin Vaginal Cream is indicated for the treatment of moderate to
severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

Please see full Prescribing Information, including BOXED WARNING and Patient
Information.

In a prespecified secondary endpoint,

Overall vaginal health was assessed at baseline and week 122

 * Total composite scores‡ increased with Premarin Vaginal Cream from 10.78 to
   16.31 (n=139) vs 10.09 to 11.76 with placebo (n=68)
   
   - A total score of ≤15 is consistent with moderate to severe vaginal atrophy 

 

Overall vaginal health was a total composite score of:

 * Moisture
 * Epithelial mucosa
 * Fluid secretion
 * Vaginal rugosity
 * Vaginal pH
 * Mucosa color 

No conclusions can be made regarding significance or the individual components
comprising the total composite score.
 

‡Genital Health Clinical Evaluation is a tool used to measure overall vaginal
health by using a total composite score of the parameters listed above.
Individual components were not analyzed separately. 

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