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).
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 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 with PREMARIN; liver impairment 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.
Most common adverse reactions (≥ 5 percent) are abdominal pain, asthenia, pain, back pain, headache, flatulence, nausea, depression, insomnia, breast pain, endometrial hyperplasia, leucorrhea, vaginal hemorrhage, and vaginitis.
PREMARIN is indicated in the treatment of moderate to severe vasomotor symptoms due to menopause, treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, and the prevention of postmenopausal osteoporosis.
When prescribing solely for the symptoms of vulvar and vaginal atrophy, topical vaginal products should be considered.
When prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medications should be carefully considered.
Please see Full Prescribing Information, including BOXED WARNING and Patient Information.
By using this PREMARIN® (conjugated estrogens tablets, USP) Co-pay Card, you acknowledge that you currently meet the eligibility criteria and will comply with the terms and conditions described below:
- Patients are not eligible to use this card if they are enrolled in a state or federally funded insurance program, including but not limited to Medicare, Medicaid, TRICARE, Veteran Affairs health care, a state prescription drug assistance program, or the Government Health Insurance Plan available in Puerto Rico (formerly known as “La Reforma de Salud”).
- Patient must have private insurance. Offer is not valid for cash paying patients. The value of this co-pay card is limited to $55 per use or the amount of your co-pay, whichever is less.
- 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.
- Eligible patients will pay a minimum of $15 with a savings of up to $55 per prescription fill. Limit 12 offers per calendar year.
- If your out-of-pocket cost is $70 or less, you will pay $15 and save up to $55.
- If your out-of-pocket cost is more than $70, you will save up to $55 with this co-pay card and you must cover the remaining expenses.
- Maximum savings of $660 per calendar year. After you have reached the limit of $660, you will pay monthly out-of-pocket costs.
- You are responsible for reporting use of the 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 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 co-pay card is not valid where prohibited by law.
- Co-pay card cannot be combined with any other savings, free trial or similar offer for the specified prescription.
- Co-pay card will be accepted only at participating pharmacies.
- If your pharmacy does not participate, you may be able to submit a request for a rebate in connection with this offer.
- This co-pay card is not health insurance.
- Offer good only in the U.S. and Puerto Rico.
- Co-pay card is limited to 1 per person during this offering period and is not transferable.
- A co-pay card may not be redeemed more than once per month 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.
Pay for PREMARIN prescription and mail copy of original pharmacy receipt (cash register receipt NOT valid) with product name, date, and amount circled to: PREMARIN Co-pay Card, P.O. Box 4939, Warren, NJ 07059-6600. Be sure to include a copy of the front of your co-pay card, your name, and mailing address.
Visit www.PREMARIN.com for more information about PREMARIN. For help with the PREMARIN Co-pay Card, call 1-866-410-3700.
Utian et al: HOPE trial. Data from the Women’s Health, Osteoporosis, Progestin, Estrogen (HOPE) study: a 2-year trial of 2673 healthy, postmenopausal women (average age 53.3 years) with a uterus. This study reflects the results from the first year of the trial in the efficacy-evaluable population (n=241), which examined the effects of 3 dosage combinations of conjugated equine estrogen (CEE) therapy (including 2 lower dosages) with and without medroxyprogesterone (MPA) on vulvovaginal atrophy (VVA) and vasomotor symptoms. Within each treatment group, the number of patients included in the analyses ranged from 25 to 34 during weeks 1 through 12.2
Lindsay et al: HOPE trial substudy. Data from the Health, Osteoporosis, Progestin, Estrogen (HOPE) study: a 2-year trial of 2673 healthy, postmenopausal women (average age 53.3 years +/- 4.9 years). This study reflects the results from the second half of the study, which examined the effects of 3 dosage combinations of conjugated equine estrogen (CEE) therapy (including 2 lower dosages) with and without medroxyprogesterone acetate (MPA) on bone density and biochemical markers of bone turnover in 695 postmenopausal women. In addition to estrogen, all patients received 600 mg of calcium carbonate daily.4
- Premarin [prescribing information]. New York, NY: Pfizer Inc; 2018.
- Utian WH, Shoupe D, Bachmann G, Pinkerton JV, Pickar JH. Relief of vasomotor symptoms and vaginal atrophy with lower doses of conjugated equine estrogens and medroxyprogesterone acetate. Fertil Steril. 2001;75(6):1065-1079.
- Data on file. Pfizer Inc; New York, NY.
- Lindsay R, Gallagher J, Kleerekoper M, Pickar JH. Effect of lower doses of conjugated equine estrogens with and without medroxyprogesterone acetate on bone in early postmenopausal women. JAMA. 2002;287(20):2668-2676.