Important Safety Information and Indication
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.
ESTRING 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 DVT, pulmonary embolism, or a history of these conditions; active arterial thromboembolic disease (eg, stroke, myocardial infarction), or a history of these known conditions; anaphylactic reaction or known hypersensitivity to ESTRING; liver dysfunction or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders; known or suspected 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.
The most frequently reported adverse events associated with ESTRING were headache, leukorrhea, back pain, genital moniliasis, upper respiratory tract infection, vaginitis, and vaginal discomfort/pain.
ESTRING is indicated for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause.
By using the ESTRING Co-Pay Card, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:
- This Co-Pay Card is not valid for prescriptions that are reimbursed, in whole or in part, by Medicaid, Medicare, Tricare, Veterans Affairs health care, 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”).
- Eligible patients may pay as little as $15 by using the Co-Pay Card. The value of this Co-Pay Card is limited to $100 per use or the amount of your Co-Pay, whichever is less for each of the 4 uses, up to a maximum annual savings of $400.
- This Co-Pay Card is not valid when the entire cost of your prescription drug is eligible to be reimbursed by your private insurance plan or other private health or pharmacy benefit programs.
- You must deduct the value of this Co-Pay Card from any reimbursement request submitted to your private insurance plan, either directly by you or on your behalf.
- Patients who are enrolled in Medicare, Medicaid, or another state or federal health care program may use the Co-Pay Card if paying for the prescription covered by the Co-Pay Card is outside of their government insurance benefit, and no claim is submitted to Medicare, Medicaid or any federal or state health care program. Such patients must not apply any out-of-pocket expenses incurred using the Co-Pay Card toward any government insurance benefit out-of-pocket spending calculations, such as Medicare Part D true out-of-pocket (TrOOP) costs.
- You are responsible for reporting use of this Co-Pay Card to any private insurer, health plan, or other third party who pays for or reimburses any part of the prescription filled using the Co-Pay Card, as may be required. You should not use the Co-Pay Card [coupon/Co-Pay Card/debit card] if your insurer or health plan prohibits use of manufacturer Co-Pay Cards.
- You must be 18 years of age or older to redeem the Co-Pay Card.
- This card is not valid where prohibited by law.
- Card cannot be combined with any other savings, free trial or similar offer for the specified prescription.
- Card will be accepted only at participating pharmacies.
- This card is not health insurance.
- Offer good only in the U.S. and Puerto Rico.
- Card is limited to 1 per person during this offering period and is not transferable.
- The card may not be redeemed more than once per 90 days per patient.
- No other purchase is necessary.
- Data related to your redemption of the Co-Pay Card may be collected, analyzed, and shared with Pfizer, for market research and other purposes related to assessing Pfizer’s programs. Data shared with Pfizer will be aggregated and de-identified; it will be combined with data related to other Co-Pay Card redemptions and will not identify you.
- Pfizer reserves the right to rescind, revoke or amend this offer without notice.
- Offer expires 12/31/19.
No membership fees apply. For help with the ESTRING Co-Pay Card, call 1-800-631-1181, or write: Pfizer Inc, 235 East 42nd Street, New York, NY 10017 www.pfizer.com