Premarin-indication

Important Safety Information and Indications

IMPORTANT SAFETY INFORMATION AND INDICATIONS

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 (eg, stroke, myocardial infarction), or a history of these conditions; anaphylactic reaction or angioedema to Premarin Vaginal Cream; liver dysfunction or disease; thrombophilic disorders; pregnancy.

Estrogens increase the risk of gallbladder disease. Discontinue estrogen if 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.

In a prospective, randomized, placebo-controlled, double-blind study, the most common adverse reactions (≥2%) were headache, pelvic pain, vasodilation, breast pain, leucorrhea, metrorrhagia, vaginitis, and vulvovaginal disorder.

INDICATIONS

Premarin Vaginal Cream is indicated for the treatment of atrophic vaginitis and kraurosis vulvae; and for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.

Terms and Conditions

  • By participating in the PREMARIN® (conjugated estrogens) Vaginal Cream Pay As Little As $15 Co-pay Card program, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:
  • The Card is not valid for prescriptions that are eligible to be reimbursed, in whole or in part, by Medicaid, Medicare, or other federal or state healthcare programs including any state prescription drug assistance programs and the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”)
  • The Card is not valid for prescriptions that are eligible to be reimbursed by private insurance plans or other health or pharmacy benefit programs, which reimburse you for the entire cost of your prescription drugs
  • Insureds must be 18 or older
  • You must deduct the savings received under this program from any reimbursement request submitted to your insurance plan, either directly by you or on your behalf
  • Eligible patients will pay as little as $15 with a savings of up to $150 per prescription fill. Limit 2 offers per calendar year. Maximum savings of $300 per calendar year. After you have reached the limit of $300, you will pay monthly out-of-pocket costs
  • The Card will be accepted only at participating pharmacies
  • The Card is not health insurance
  • No membership fees
  • This offer is good only in the U.S. and Puerto Rico
  • The Card is limited to one per person during this offering period and is not transferable
  • Pfizer reserves the right to rescind, revoke, or amend this offer without notice at any time
  • Offer cannot be combined with any other rebate/coupon, free trial, or similar offer for the specified prescription
  • The Card and Program expire on 12/31/18

For reimbursement when using a nonparticipating pharmacy/mail order:

  • Pay for Premarin Vaginal Cream prescription as you normally would
  • Mail copy of original pharmacy receipt (cash register receipt NOT valid) with product name, date, and amount circled to:
    Premarin Vaginal Cream Co-pay Card
    2250 Perimeter Park Drive, Suite 300,
    Morrisville, NC 27560

Be sure to include a copy of the front of your Co-pay Card, your name, and mailing address.

Please see Full Prescribing Information, including BOXED WARNING.

References

  1. Premarin Vaginal Cream [prescribing information]. New York, NY: Pfizer Inc; 2015.
  2. Bachmann G, Bouchard C, Hoppe D, et al. Efficacy and safety of low-dose regimens of conjugated estrogens cream administered vaginally. Menopause. 2009;16(4):719-727.
  3. Data on file. Pfizer Inc, New York, NY.
  4. Reimer A, Johnson L. Atrophic vaginitis: signs, symptoms, and better outcomes. Nurse Pract. 2011;36(1):22-28.
  5. Lynch C. Vaginal estrogen therapy for the treatment of atrophic vaginitis. J Womens Health. 2009;18(10):1595-1606.
  6. Dorr MB, Nelson AL, Mayer P, et al. Plasma estrogen concentrations after oral and vaginal estrogen administration in women with atrophic vaginitis. Fertil Steril. 2010;94(6):2365-2368.