WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, PROBABLE DEMENTIA and BREAST CANCER
See full prescribing information for complete boxed warning.
There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens
The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT)
The WHI Memory Study (WHIMS) estrogen-alone ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older
Do not use estrogen-alone therapy for the prevention of cardiovascular disease or dementia
Estrogen Plus Progestin Therapy
The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE) and myocardial infarction (MI)
The WHI estrogen plus progestin substudy reported increased risks of invasive breast cancer
The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older
Do not use estrogen plus progestogen therapy for the prevention of cardiovascular disease or dementia
The WHI estrogen-alone and estrogen plus progestin substudies evaluated only daily oral conjugated estrogens (CE) [0.625 mg] and medroxyprogesterone acetate (MPA) [2.5 mg]. Therefore, the relevance of the WHI findings regarding adverse cardiovascular events, dementia, and breast cancer to lower CE and MPA doses, other routes of administration, or other estrogen-alone or estrogen plus progestogen products is not known, and cannot be definitively excluded or determined.
IMVEXXY (estradiol vaginal inserts) is contraindicated in women with any of the following conditions: undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active DVT, PE, or history of these conditions; active arterial thromboembolic disease or a history of these conditions; known anaphylactic reaction or angioedema to IMVEXXY; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders.
Warning and Precautions
Risks from systemic absorption. IMVEXXY is intended only for vaginal administration. Systemic absorption may occur with the use of IMVEXXY.
Cardiovascular disorders, malignant neoplasms, and probable dementia. Please refer to Boxed Warning for endometrial cancer, cardiovascular disorders, probable dementia, and breast cancer.
The use of estrogen-alone and estrogen plus progestin therapy has been reported to result in an increase in abnormal mammograms requiring further evaluation.
The WHI estrogen plus progestin substudy 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.
Other warnings include: gallbladder disease; severe hypercalcemia, loss of vision, elevated blood pressure, severe hypertriglyceridemia, cholestatic jaundice, fluid retention, and hypocalcemia in women with hypoparathyroidism.
Estrogen therapy may exacerbate: hypothyroidism, endometriosis, hereditary angioedema, asthma, diabetes mellitus, epilepsy, migraine, porphyria, systemic lupus erythematosus, and hepatic hemangiomas, and should be used with caution in women with these conditions.
Women on thyroid replacement therapy should have their thyroid function monitored.
The most common adverse reaction with IMVEXXY (≥3%) was headache.
IMVEXXY (estradiol vaginal inserts) is an estrogen indicated for the treatment of moderate to severe dyspareunia, a symptom of vulvar and vaginal atrophy, due to menopause.
Please note that this information is not comprehensive. Please click here for the Full Prescribing Information, including BOXED WARNING.
For healthcare professionals
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Program Terms, Conditions, and Eligibility Criteria
THIS IS NOT HEALTH INSURANCE. Eligible patients must have a commercial medical or prescription insurance plan, be uninsured, or have an insurance plan that does not cover the prescription.
Deductible and Prior Authorization requirements may apply. Patients must meet applicable commercial insurance deductible requirements and Prior Authorization submission requirements as determined by their commercial insurers.
This offer is valid only for eligible patients and is good for use only with a valid prescription for IMVEXXY at the time the prescription is filled by the pharmacist and dispensed to the patient.
Depending on insurance coverage, most covered, insured, eligible patients will pay $15 for their IMVEXXY prescription.
Insured, eligible patients may incur out-of-pocket costs. Maximum reimbursement limits apply; patient out-of-pocket expenses may vary.
This Copay Savings offer is not valid for use by patients enrolled in TRICARE, Medicare, Medicaid, Medicare Advantage, Medicare Part D, Medigap, VHA, DOD, IHS any other federal or state-funded programs (including any state pharmaceutical assistance programs), or private indemnity or HMO Insurance plans that reimburse the patient for the entire cost of the prescription drugs. Patients may not use this offer if they are Medicare-eligible and enrolled in an employer-sponsored health plan or prescription drug benefit program for retirees.
Patients who move from commercial to federally funded or state-funded insurance will no longer be eligible for the Program.
This Copay Savings Card offer is not transferable. Selling, purchasing, trading, or counterfeiting this Copay Savings Card offer is prohibited by law.
Patients may not seek reimbursement for the value received from the Copay Savings Card from any third-party payers, including flexible spending accounts (“FSAs”) or healthcare savings accounts (“HSAs”).
All prescriptions must be filled before the program expires on 12/31/24.
Mayne Pharma reserves the right to rescind, revoke, or amend this offer without notice.
Offer good only in the USA at participating retail pharmacies.
Void if prohibited by law, taxed, or restricted.
Restrictions and limitations apply. Out-of-pocket cost may vary. Pricing is subject to change.
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