Femring estradiol acetate .1 mg/d Ring — NDC 72495-202-10 (Billing 72495-0202-10)
This is a package of Femring estradiol acetate .1 mg/d Ring from Millicent US, Inc., marketed since Dec 2018 and currently FDA-listed; retail pharmacies pay about $925.63 per unit (NADAC). It is this product's only package size.
NDC database record
One package, one record: these facts belong to NDC 72495-202-10 alone.
- Record
- FDA NDC Directory package listing · Human prescription drug
- Code segments
- 72495 labeler · 202 product · 10 package
- Package marketed since
- Dec 10, 2018
- Sample package
- No — commercial package
- Listing certified through
- Dec 31, 2026
- Barcode (UPC-A, from the NDC)
- 3 7249520210 9
- Medicaid fills, this package
- 365 prescriptions in the last four reported quarters
- FDA record last changed
- Jul 24, 2026
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- GSN (GCN sequence number): 052094
- GCN: 19599
- GPI-14 (Medi-Span): 55350020109030
- HICL (First Databank): 025182
- AHFS class code: 68:16.04.00
- RxCUI (RxNorm): 848331
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Radioactive Diagnostic Agent class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
Estrogen vaginal may be used to treat the following, depending on the specific product being prescribed: vaginal dryness, itching, and burning; painful or difficult urination; and sudden need to urinate immediately in women who are experiencing or have experienced menopause (change of life; the end of monthly menstrual periods). hot flushes ('hot flashes'; sudden strong feelings of heat and sweating) in women who are experiencing or have experienced menopause (change of life; the end of monthly menstrual periods). kraurosis vulvae (a condition that may cause vaginal dryness and discomfort...
Read the full MedlinePlus article ↗- It's an estrogen used mainly for menopause symptoms like hot flashes and vaginal dryness. Some patches are also used for low estrogen from ovarian problems or to prevent osteoporos...
- That depends on the form. Patches go on the skin once or twice a week depending on the brand, and the injection goes into a muscle. Use the lowest dose that works for the shortest...
- Headache, breast tenderness, spotting or irregular bleeding, cold-like symptoms and skin irritation where a patch sits are the most common. Tell your doctor if they bother you or d...
- Get urgent help for chest pain, sudden weakness or trouble speaking, a swollen painful leg, sudden shortness of breath or sudden vision changes. These could be a stroke or blood cl...
Patient education
Supplement & herbal interactions
Estradiol may be associated with lower levels of 5 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 6, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $925.631 | $83,306.79 / 90 ds |
| Medicaid paysCMS SDUD · 12 mo | $851.92 | $76,673.16 / 90 ds |
| Medicare drug plans payPart D · Q2 2026 | $918.85 | $82,696.72 / 90 ds |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q4 2025
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 72495-0202-10 You're viewing this Main listing | 1 POUCH in 1 CARTON / 90 d in 1 POUCH | 2018-12-10 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Femring .1 mg/dthis 72495-0202-10 | Millicent | 1 pouch | $925.631 | — | Availability likely | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Oct 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
We did not find an FDA-approved generic match for this exact strength, form and route.
Where does this data come from?
- FDA Orange Book · refreshed Oct 3, 2026
Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
🧪 Avoiding an ingredient? See Estradiol inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 25BB7EKE2E
Barium sulfate is a white powder mineral compound used as a filler and opacifying agent in tablets and capsules. It adds bulk to the medicine and may be included in formulations for imaging purposes.
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UNII 2RF6EJ0M85
Diatomaceous earth is a fine powder made from fossilized remains of diatoms, tiny aquatic organisms. It acts as a glidant and anti-caking agent, helping medicine flow smoothly during manufacturing and preventing clumping in the final product.
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UNII 92RU3N3Y1O
Dimethicone is a silicone-based oil that acts as an anti-foaming agent and lubricant in medicines. It reduces gas bubbles in liquid formulations and helps coat and protect the stomach lining when ingested.
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UNII 519A78R12Y
A tin-based chemical compound used as a stabilizer and antioxidant in pharmaceutical formulations. It helps prevent degradation of active ingredients and maintains product stability during storage.
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UNII 4PE821G3GH
A silica-based compound used in pharmaceuticals as a binder and flow agent. It helps hold tablet or capsule ingredients together and improves powder flow during manufacturing.
5 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.- FDA label on DailyMed · label index refreshed Oct 6, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Manufacturer & labeler
More NDCs from Millicent US, Inc. labeler code 72495
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA Estrogen-Alone Therapy Endometrial Cancer 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 [see Warnings and Precautions (5.2) ] .
Cardiovascular Disorders and Probable Dementia Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1 , 5.3 ), and Clinical Studies (14.3 , 14.4 )] . The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT) in postmenopausal women (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg]-alone, relative to placebo [see Warnings and Precautions (5.1) , and Clinical Studies (14.3) ].
The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the WHI reported an increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 5.2 years of treatment with daily CE (0.625 mg)-alone, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions (5.3) , Use in Specific Populations (8.5) , and Clinical Studies (14.4) ]. In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and other dosage forms of estrogens.
Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. Estrogen Plus Progestin Therapy Cardiovascular Disorders and Probable Dementia Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia [see Warnings and Precautions (5.1 , 5.3 ) and Clinical Studies (14.3 , 14.4 )] . The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism (PE), stroke and myocardial infarction (MI) in postmenopausal women (50 to 79 years of age) during 5.6 years of treatment with daily oral CE (0.625 mg) combined with medroxyprogesterone acetate (MPA) [2.5 mg], relative to placebo [see Warnings and Precautions (5.1) , and Clinical Studies (14.3) ] .
The WHIMS estrogen plus progestin ancillary study of the WHI reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily CE (0.625 mg) combined with MPA (2.5 mg), relative to placebo. It is unknown whether this finding applies to younger postmenopausal women [see Warnings and Precautions (5.3) , Use in Specific Populations (8.5) and Clinical Studies (14.4) ] . Breast Cancer The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer [see Warnings and Precautions (5.3) , and Clinical Studies (14.3) ].
In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA and other combinations and dosage forms of estrogens and progestins. Estrogens with or without progestins should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER, AND PROBABLE DEMENTIA See full prescribing information for complete boxed warning.
Estrogen-Alone Therapy • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens ( 5.2 ) • Estrogen-alone therapy should not be used for… [Excerpted — this section continues on DailyMed.]
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Femring is an estrogen indicated for: • Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause ( 1.1 ) • Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause ( 1.2 )
1.1Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause.
1.2Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Generally, when estrogen is prescribed for a postmenopausal woman with a uterus, a progestin should also be considered to reduce the risk of endometrial cancer. A woman without a uterus does not need a progestin. In some cases, however, hysterectomized women with a history of endometriosis may need a progestin [see Warnings and Precautions (5.2 , 5.14 )].
Use of estrogen-alone, or in combination with a progestin, should be with the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman. Postmenopausal women should be re-evaluated periodically as clinically appropriate to determine if treatment is still necessary. • One ring inserted into the vagina for 3 months. Patients should be started at the lowest dose.
( 2.1 , 2.2 )
2.1Treatment of Moderate to Severe Vasomotor Symptoms due to Menopause Start therapy with 0.05 mg/day. Dosage adjustment should be guided by the clinical response. Therapy should be started at the lowest effective dose and the shortest duration consistent with treatment goals. Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals.
2.2Treatment of Moderate to Severe Vulvar and Vaginal Atrophy due to Menopause. Start therapy with 0.05 mg/day. Dosage adjustment should be guided by the clinical response. Therapy should be started at the lowest effective dose and the shortest duration consistent with treatment goals. Attempts to taper or discontinue the medication should be made at 3 to 6 month intervals.
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS The following two strengths of Femring are available: Femring (0.05 mg/day): Each off-white, soft, flexible ring has a central core that contains 12.4 mg of estradiol acetate, which releases at a rate equivalent to 0.05 mg of estradiol per day for 3 months. Femring (0.10 mg/day): Each off-white, soft, flexible ring has a central core that contains 24.8 mg of estradiol acetate, which releases at a rate equivalent to 0.10 mg of estradiol per day for 3 months. • Femring (0.05 mg/day): Each off-white, soft, flexible ring has a central core that contains 12.4 mg of estradiol acetate, which releases at a rate equivalent to 0.05 mg of estradiol per day for 3 months.
( 3 ) • Femring (0.10 mg/day): Each off-white, soft, flexible ring has a central core that contains 24.8 mg of estradiol acetate, which releases at a rate equivalent to 0.10 mg of estradiol per day for 3 months. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Femring 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 (for example, stroke and MI), or a history of these conditions • Known anaphylactic reaction or angioedema to Femring • Known liver impairment or disease • Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders • Known or suspected pregnancy • Undiagnosed abnormal genital bleeding ( 4 ) • Known, suspected, or history of breast cancer ( 4 , 5.2 ) • Known or suspected estrogen-dependent neoplasia ( 4 , 5.2 ) • Active DVT, PE, or history of these conditions ( 4 , 5.1 ) • Active arterial thromboembolic disease (for example, stroke and MI), or a history of these conditions ( 4 , 5.1 ) • Known anaphylactic reaction or angioedema to Femring ( 4 ) • Known liver impairment or disease ( 4 , 5.10 ) • Known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders ( 4 ) • Known or suspected pregnancy ( 4 , 8.1 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Femring is used only in the vagina, however, the risks associated with oral estrogens should be taken into account. • Estrogens increase the risk of gallbladder disease ( 5.4 ) • Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs ( 5.5 , 5.6 , 5.9 , 5.10 ) • Monitor thyroid function in women on thyroid replacement therapy ( 5.11 , 5.18 )
5.1Cardiovascular Disorders An increased risk of stroke and DVT has been reported with estrogen-alone therapy. An increased risk of PE, DVT, stroke, and MI has been reported with estrogen plus progestin therapy. Should any of these occur or be suspected, estrogen with or without progestin therapy should be discontinued immediately.
Risk factors for arterial vascular disease (for example, hypertension, diabetes mellitus, tobacco use, hypercholesterolemia, and obesity) and/or venous thromboembolism (VTE) (for example, personal history or family history of VTE, obesity, and systemic lupus erythematosus) should be managed appropriately. Stroke In the WHI estrogen-alone substudy, a statistically significant increased risk of stroke was reported in women 50 to 79 years of age receiving daily CE (0.625 mg)-alone compared to women in the same age group receiving placebo (45 versus 33 per 10,000 women-years).
The increase in risk was demonstrated in year 1 and persisted [see Clinical Studies (14.3) ] . Should a stroke occur or be suspected, estrogen-alone therapy should be discontinued immediately. Subgroup analyses of women 50 to 59 years of age suggest no increased risk of stroke for those women receiving CE (0.625 mg)-alone versus those receiving placebo (18 versus 21 per 10,000 women-years).
1 In the WHI estrogen plus progestin substudy, a statistically significant increased risk of stroke was reported in women 50 to 79 years of age receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women in the same age group receiving placebo (33 versus 25 per 10,000 women-years) [see Clinical Studies (14.3) ] . The increase in risk was demonstrated after the first year and persisted. 1 Should a stroke occur or be suspected, estrogen plus progestin therapy should be discontinued immediately.
Coronary Heart Disease In the WHI estrogen-alone substudy, no overall effect on coronary heart disease (CHD) events (defined as nonfatal MI, silent MI, or CHD death) was reported in women receiving estrogen-alone compared to placebo 2 [see Clinical Studies (14.3) ]. Subgroup analyses of women 50 to 59 years of age suggest a statistically non-significant reduction in CHD events (CE [0.625 mg]-alone compared to placebo) in women with less than 10 years since menopause (8 versus 16 per 10,000 woman-years). 1 In the WHI estrogen plus progestin substudy, there was a statistically non-significant increased risk of CHD events reported in women receiving daily CE (0.625 mg) plus MPA (2.5 mg) compared to women receiving placebo (41 versus 34 per 10,000 women-years).
1 An increase in relative risk was demonstrated in year 1, and a trend toward decreasing relative risk was reported in years 2 through 5 [see Clinical Studies (14.3) ]. In postmenopausal women with documented heart disease (n = 2,763, average 66.7 years of age), in a controlled clinical trial of secondary prevention of cardiovascular disease (Heart and Estrogen/Progestin Replacement Study; HERS) treatment with daily CE (0.625 mg) plus MPA (2.5 mg) demonstrated no cardiovascular benefit. During an average follow-up of 4.1 years, treatment with CE plus MPA did not reduce the overall rate of CHD events in postmenopausal women with established CHD.
There were more CHD events in the CE plus MPA-treated group than in the placebo group in year 1, but not during the subsequent years. Two thousand, three hundred and twenty-one (2,321) women from the original HERS trial agreed to participate in an open label extension of HERS, HERS II. Average follow-up in HERS II was an additi… [Excerpted — this section continues on DailyMed.]
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: • Cardiovascular Disorders [see Boxed Warning , Warnings and Precautions (5.1) ]. • Malignant Neoplasms [see Boxed Warning , Warnings and Precautions (5.2) ]. Most common adverse reactions (incidence > 5 percent) are vaginal bleeding and breast tenderness. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Millicent at 1-877-810-2101 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In a 13-week clinical trial that included 225 postmenopausal women treated with Femring and 108 women treated with placebo vaginal rings, adverse reactions that occurred at a rate of ≥ 2 percent are summarized in Table 1 . Table 1.
Incidence of Adverse Reactions Occurring in ≥ 2 Percent of Subjects Presented in Descending Frequency of Preferred Term AE = adverse event; NOS = not otherwise specified Adverse Event Placebo (n = 108) Estradiol 0.05 mg/day (n = 113) Estradiol 0.10 mg/day (n = 112) n (percent) n (percent) n (percent) Headache (NOS) 10 (9.3) 8 (7.1) 11 (9.8) Intermenstrual Bleeding 2 (1.9) 9 (8.0) 11 (9.8) Vaginal Candidiasis 3 (2.8) 7 (6.2) 12 (10.7) Breast Tenderness 2 (1.9) 7 (6.2) 12 (10.7) Back Pain 4 (3.7) 7 (6.2) 4 (3.6) Abdominal Distension 3 (2.8) 8 (7.1) 3 (2.7) Sinusitis (NOS) 2 (1.9) 2 (1.8) 4 (3.6) Uterine Pain 1 (0.9) 2 (1.8) 5 (4.5) Urinary Tract Infection (NOS) 2 (1.9) 1 (0.9) 4 (3.6)
6.2Postmarketing Experience 1. A few cases of toxic shock syndrome (TSS) have been reported in women using vaginal rings. TSS is a rare, but serious disease that may cause death.
Warning signs of TSS include fever, nausea, vomiting, diarrhea, muscle pain, dizziness, faintness, or a sunburn-rash on face and body. 2. Cases of ring adherence to the vaginal or bladder wall, making ring removal difficult, have been reported in women using vaginal rings and may require surgical removal of the device.
Women should be carefully evaluated for vaginal or bladder wall ulceration or erosion. Cases of vaginal erosion and vaginal ulceration have been reported with other estradiol vaginal rings. If an ulceration or erosion has occurred, consideration should be given to leaving the ring out and not replacing it until healing is complete to prevent the ring from adhering to the vaginal tissue.
3. A few cases of bowel obstruction associated with vaginal ring use have been reported. Persistent abdominal complaints consistent with obstruction should be carefully evaluated.
4. A few cases of inadvertent ring insertion into the urinary bladder, which may require surgical removal, have been reported for women using vaginal rings. Persistent unexplained urinary symptoms should be carefully evaluated.
The following additional adverse reactions have been identified during post-approval use of Femring. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Genitourinary system Uterine cancer, vaginal hemorrhage, ovarian cyst, irregular menstruation, metrorrhagia, menorrhagia, dysmenorrhea, uterine enlargement.
Breasts Breast cancer, fibrocystic breast disease, breast disorder, breast mass, breast enlargement, breast pain, nipple pain, breast discharge. Cardiovascular Chest pain, increased blood pressure, irregular heart rate, pulmonary embolism, cerebrovascular accident (stroke), hemiparesis, transient ischemic attack, thrombosis. Gastrointestinal Abdominal pain, pancreatitis, cholecystitis, cholelithiasis, vomiting.
Skin Generalized erythema, erythema multiforme, erythema nodosum, rash, hirsutism, pruritis. Eyes Blindness, contac… [Excerpted — this section continues on DailyMed.]
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS No drug interaction studies have been conducted for Femring. • Inducers and/or inhibitors of CYP3A4 may affect estrogen drug metabolism ( 7.1 )
7.1Metabolic Interactions In vitro and in vivo studies have shown that estrogens are metabolized partially by cytochrome P450 3A4 (CYP3A4). Therefore, inducers or inhibitors of CYP3A4 may affect estrogen drug metabolism. Inducers of CYP3A4 such as St.
John’s wort ( Hypericum perforatum ) preparations, phenobarbital, carbamazepine and rifampin may decrease the plasma concentration of estrogens, possibly resulting in a decrease in therapeutic effects and/or changes in the uterine bleeding profile. Inhibitors of CYP3A4 such as erythromycin, clarithromycin, ketoconazole, itraconazole, ritonavir and grapefruit juice may increase the plasma concentration of estrogens and may result in side effects.
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • Nursing Mothers: Estrogen administration to nursing women has been shown to decrease the quantity and quality of breast milk ( 8.3 ) • Geriatric Use: An increased risk of probable dementia in women over 65 years of age was reported in the Women’s Health Initiative Memory ancillary studies of the Women’s Health Initiative ( 5.3 , 8.5 )
8.1Pregnancy Femring should not be used during pregnancy [see Contraindications (4) ] . There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy.
8.3Nursing Mothers Femring should not be used during lactation. Estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. Detectable amounts of estrogens have been identified in the breast milk of women receiving estrogen-alone therapy. Caution should be exercised when Femring is administered to a nursing woman.
8.4Pediatric Use Femring is not indicated in children. Clinical studies have not been conducted in the pediatric population.
8.5Geriatric Use There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Femring to determine whether those over 65 years of age differ from younger subjects in their response to Femring. The Women’s Health Initiative Studies In the WHI estrogen-alone substudy (daily CE [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see Clinical Studies (14.2) ]. In the WHI estrogen plus progestin substudy (daily CE [0.625 mg] plus MPA [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see Clinical Studies (14.2) ] .
The Women’s Health Initiative Memory Study In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo [see Warnings and Precautions (5.3) , and Clinical Studies (14.4) ] . Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women 8 [see Warnings and Precautions (5.3) , and Clinical Studies (14.4) ] .
8.6Renal Impairment The effect of renal impairment on the pharmacokinetics of Femring has not been studied.
8.7Hepatic Impairment The effect of hepatic impairment on the pharmacokinetics of Femring has not been studied.
🤰 Pregnancy ▾
8.1Pregnancy Femring should not be used during pregnancy [see Contraindications (4) ] . There appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy.
🧒 Pediatric Use ▾
8.4Pediatric Use Femring is not indicated in children. Clinical studies have not been conducted in the pediatric population.
🧓 Geriatric Use ▾
8.5Geriatric Use There have not been sufficient numbers of geriatric women involved in clinical studies utilizing Femring to determine whether those over 65 years of age differ from younger subjects in their response to Femring. The Women’s Health Initiative Studies In the WHI estrogen-alone substudy (daily CE [0.625 mg]-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see Clinical Studies (14.2) ]. In the WHI estrogen plus progestin substudy (daily CE [0.625 mg] plus MPA [2.5 mg] versus placebo), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see Clinical Studies (14.2) ] .
The Women’s Health Initiative Memory Study In the WHIMS ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo [see Warnings and Precautions (5.3) , and Clinical Studies (14.4) ] . Since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women 8 [see Warnings and Precautions (5.3) , and Clinical Studies (14.4) ] .
🆘 Overdosage ▾
10 OVERDOSAGE Overdosage of estrogen may cause nausea, vomiting, breast tenderness, dizziness, abdominal pain, drowsiness and fatigue, and withdrawal bleeding may occur in women. Treatment of overdose consists of discontinuation of Femring with institution of appropriate symptomatic care.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites, estrone and estriol, at the receptor level. The primary source of estrogen in normally cycling adult women is the ovarian follicle, which secretes 70 to 500 mcg of estradiol daily, depending on the phase of the menstrual cycle.
After menopause, most endogenous estrogen is produced by conversion of androstenedione, which is secreted by the adrenal cortex, to estrone in the peripheral tissues. Thus, estrone and the sulfate conjugated form, estrone sulfate, are the most abundant circulating estrogens in postmenopausal women. Estrogens act through binding to nuclear receptors in estrogen-responsive tissues.
To date, two estrogen receptors have been identified. These vary in proportion from tissue to tissue. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and FSH through a negative feedback mechanism.
Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women.
12.2Pharmacodynamics There are no pharmacodynamic data for Femring.
12.3Pharmacokinetics Absorption Estradiol acetate is hydrolyzed to estradiol which is absorbed through the vaginal mucosa as evidenced by the mean time to maximum concentration (t max ) for estradiol of about 1 hour (range 0.25 to 1.5 hrs). After achieving the Cmax the estradiol concentration starts declining during the first 24 to 48 hours and then at a relatively constant rate for the remainder of the 3-month dosing interval (see Figure 1 for results from rings stored for 16 months). In vitro studies have shown that this initial release is higher as the rings age upon storage.
Figure 1. Mean serum estradiol concentrations following multiple dose administration of Femring (0.05 mg/day estradiol) (second dose administered at 13 weeks) (inset: mean (±SD) of serum concentration-time profile for dose 1 from 0-24 hours) Following administration of Femring (0.05 mg/day estradiol), average serum estradiol concentration was 40.6 pg/mL; the corresponding apparent in vivo estradiol delivery rate was 0.052 mg/day. Following administration of Femring (0.10 mg/day estradiol), average serum estradiol concentration was 76 pg/mL; apparent in vivo delivery rate was 0.097 mg/day.
Results are summarized in Table 2 below. Table 2. Summary of Mean (Percent RSD)* Pharmacokinetic Parameters for Femring Dose (as estradiol) Number of subjects C max (pg/mL) T max (hour) C avg (pg/mL) Estradiol 1 25 1129 (25) 0.9 (41) 40.6 (26) 0.05 mg/day Estrone 1 25 141 (25) 6.2 (84) 35.9 (21) Estrone sulfate 1 25 2365 (44) 9.3 (39) 494.6 (48) Estradiol 2 12 1665 (23) 0.7 (90) -- 4 0.10 mg/day Estradiol 3 11 -- -- 76.0 (24) Estrone 3 11 -- -- 45.7 (25) * Relative Standard Deviation, 1 Study 1, 2 Study 2, 3 Study 3, 4 -- Not determined Consistent with the avoidance of first pass metabolism achieved by vaginal estradiol administration, serum estradiol concentrations were slightly higher than estrone concentrations.
Distribution The distribution of exogenous estrogens is similar to that of endogenous estrogens. Estrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs. Estrogens circulate in the blood largely bound to SHBG and albumin.
Metabolism Exogenous estrogens are metabolized in the same manner as endogenous estrogens. Circulating estrogens exist in a dynamic equilibrium of metabolic interconversions. These transformations take place mainly in the liver.
Estradiol is converted reversibly to estrone, and both can be converted to estriol, which is a major urinary metabolite. Estrogens also unde… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
12.1Mechanism of Action Endogenous estrogens are largely responsible for the development and maintenance of the female reproductive system and secondary sexual characteristics. Although circulating estrogens exist in a dynamic equilibrium of metabolic interconversions, estradiol is the principal intracellular human estrogen and is substantially more potent than its metabolites, estrone and estriol, at the receptor level. The primary source of estrogen in normally cycling adult women is the ovarian follicle, which secretes 70 to 500 mcg of estradiol daily, depending on the phase of the menstrual cycle.
After menopause, most endogenous estrogen is produced by conversion of androstenedione, which is secreted by the adrenal cortex, to estrone in the peripheral tissues. Thus, estrone and the sulfate conjugated form, estrone sulfate, are the most abundant circulating estrogens in postmenopausal women. Estrogens act through binding to nuclear receptors in estrogen-responsive tissues.
To date, two estrogen receptors have been identified. These vary in proportion from tissue to tissue. Circulating estrogens modulate the pituitary secretion of the gonadotropins, luteinizing hormone (LH) and FSH through a negative feedback mechanism.
Estrogens act to reduce the elevated levels of these hormones seen in postmenopausal women.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING
16.1How Supplied Each Femring (estradiol acetate vaginal ring) is individually packaged in a pouch consisting of one side medical grade paper and the other side polyester/polyethylene laminate. N 72495-201-05 Femring 0.05 mg/day (estradiol acetate vaginal ring) is available in single units. N 72495-202-10 Femring 0.10 mg/day (estradiol acetate vaginal ring) is available in single units.
16.2Storage and Handling Store at 20º C to 25º C (68º F to 77º F); excursions permitted to -20º C to 40º C (-4º F to 104º F). Do not store unpouched. Insert immediately upon removal from the protective pouch.
16.1How Supplied Each Femring (estradiol acetate vaginal ring) is individually packaged in a pouch consisting of one side medical grade paper and the other side polyester/polyethylene laminate. N 72495-201-05 Femring 0.05 mg/day (estradiol acetate vaginal ring) is available in single units. N 72495-202-10 Femring 0.10 mg/day (estradiol acetate vaginal ring) is available in single units.
📦 Storage and Handling ▾
16.2Storage and Handling Store at 20º C to 25º C (68º F to 77º F); excursions permitted to -20º C to 40º C (-4º F to 104º F). Do not store unpouched. Insert immediately upon removal from the protective pouch.
📋 Description ▾
11 DESCRIPTION Femring (estradiol acetate vaginal ring) is an off-white, soft, flexible ring with a central core containing estradiol acetate. Femring is made of cured silicone elastomer composed of dimethyl polysiloxane silanol, silica (diatomaceous earth), normal propyl orthosilicate, stannous octoate; barium sulfate and estradiol acetate. The rings have the following dimensions: outer diameter 56 mm, cross-sectional diameter 7.6 mm, core diameter 2 mm.
Femring is available in two strengths: Femring 0.05 mg/day has a central core that contains 12.4 mg of estradiol acetate, which releases at a rate equivalent to 0.05 mg of estradiol per day for 3 months. Femring 0.10 mg/day has a central core that contains 24.8 mg of estradiol acetate, which releases at a rate equivalent to 0.10 mg of estradiol per day for 3 months. Estradiol acetate is chemically described as estra-1,3,5(10)-triene-3,17β-diol-3-acetate.
The molecular formula of estradiol acetate is C 20 H 26 O 3 and the molecular weight of estradiol acetate is 314.42. The Structural formula of Estradiol acetate is chemically described as estra-1,3,5(10)-triene-3,17b-diol-3-acetate
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling ( Patient Information and Instructions for Use ).
17.1Vaginal Bleeding Inform postmenopausal women of the importance of reporting abnormal vaginal bleeding to their healthcare provider as soon as possible [see Warnings and Precautions (5.2) ] .
17.2Possible Serious Adverse Reactions with Estrogen-Alone Therapy Inform postmenopausal women of possible serious adverse reactions of estrogen-alone therapy including Cardiovascular Disorders, Malignant Neoplasms, and Probable Dementia [see Warnings and Precautions (5.1 , 5.2 , 5.3 )] .
17.3Possible Less Serious but Common Adverse Reactions with Estrogen-Alone Therapy Inform postmenopausal women of possible less serious but common adverse reactions of estrogen-alone therapy such as headache, breast pain and tenderness, nausea and vomiting. Contact with blood may cause discoloration of Femring during use. This does not affect the release of the drug.
Inform postmenopausal women of the importance of reporting abnormal vaginal bleeding to their healthcare provider as soon as possible.
🍼 Nursing Mothers ▾
8.3Nursing Mothers Femring should not be used during lactation. Estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. Detectable amounts of estrogens have been identified in the breast milk of women receiving estrogen-alone therapy. Caution should be exercised when Femring is administered to a nursing woman.
🧬 Pharmacokinetics ▾
12.3Pharmacokinetics Absorption Estradiol acetate is hydrolyzed to estradiol which is absorbed through the vaginal mucosa as evidenced by the mean time to maximum concentration (t max ) for estradiol of about 1 hour (range 0.25 to 1.5 hrs). After achieving the Cmax the estradiol concentration starts declining during the first 24 to 48 hours and then at a relatively constant rate for the remainder of the 3-month dosing interval (see Figure 1 for results from rings stored for 16 months). In vitro studies have shown that this initial release is higher as the rings age upon storage.
Figure 1. Mean serum estradiol concentrations following multiple dose administration of Femring (0.05 mg/day estradiol) (second dose administered at 13 weeks) (inset: mean (±SD) of serum concentration-time profile for dose 1 from 0-24 hours) Following administration of Femring (0.05 mg/day estradiol), average serum estradiol concentration was 40.6 pg/mL; the corresponding apparent in vivo estradiol delivery rate was 0.052 mg/day. Following administration of Femring (0.10 mg/day estradiol), average serum estradiol concentration was 76 pg/mL; apparent in vivo delivery rate was 0.097 mg/day.
Results are summarized in Table 2 below. Table 2. Summary of Mean (Percent RSD)* Pharmacokinetic Parameters for Femring Dose (as estradiol) Number of subjects C max (pg/mL) T max (hour) C avg (pg/mL) Estradiol 1 25 1129 (25) 0.9 (41) 40.6 (26) 0.05 mg/day Estrone 1 25 141 (25) 6.2 (84) 35.9 (21) Estrone sulfate 1 25 2365 (44) 9.3 (39) 494.6 (48) Estradiol 2 12 1665 (23) 0.7 (90) -- 4 0.10 mg/day Estradiol 3 11 -- -- 76.0 (24) Estrone 3 11 -- -- 45.7 (25) * Relative Standard Deviation, 1 Study 1, 2 Study 2, 3 Study 3, 4 -- Not determined Consistent with the avoidance of first pass metabolism achieved by vaginal estradiol administration, serum estradiol concentrations were slightly higher than estrone concentrations.
Distribution The distribution of exogenous estrogens is similar to that of endogenous estrogens. Estrogens are widely distributed in the body and are generally found in higher concentrations in the sex hormone target organs. Estrogens circulate in the blood largely bound to SHBG and albumin.
Metabolism Exogenous estrogens are metabolized in the same manner as endogenous estrogens. Circulating estrogens exist in a dynamic equilibrium of metabolic interconversions. These transformations take place mainly in the liver.
Estradiol is converted reversibly to estrone, and both can be converted to estriol, which is a major urinary metabolite. Estrogens also undergo enterohepatic recirculation via sulfate and glucuronide conjugation in the liver, biliary secretion of conjugates into the intestine, and hydrolysis in the intestine followed by reabsorption. In postmenopausal women, a significant proportion of the circulating estrogens exist as sulfate conjugates, especially estrone sulfate, which serves as a circulating reservoir for the formation of more active estrogens.
Excretion Estradiol, estrone, and estriol are excreted in the urine along with glucuronide and sulfate conjugates. The estradiol apparent elimination half-life value is 21 to 26 hours. Use in Specific Populations No pharmacokinetic studies were conducted with Femring in specific populations, including women with renal or hepatic impairment.
Figure 1. Mean serum estradiol concentrations following multiple dose administration of Femring (0.05 mg/day estradiol) (second dose administered at 13 weeks) (inset: mean (±SD) of serum concentrati
🧬 Pharmacodynamics ▾
12.2Pharmacodynamics There are no pharmacodynamic data for Femring.
🔬 Clinical Studies ▾
14 CLINICAL STUDIES
14.1Effects on Vasomotor Symptoms A 13-week double-blind, placebo-controlled clinical trial was conducted to evaluate the efficacy of 2 doses of the vaginal ring in the treatment of moderate to severe vasomotor symptoms in 333 postmenopausal women between 29 and 85 years of age (mean age 51.7 years, 77 percent were Caucasian) who had at least 7 moderate to severe hot flushes daily or at least 56 moderate to severe hot flushes per week before randomization. Patients were randomized to receive either placebo, Femring 0.05 mg/day or Femring 0.10 mg/day.
Femring 0.05 mg/day and Femring 0.10 mg/day were shown to be statistically better than placebo at weeks 4 and 12 for relief of both the frequency and severity of moderate to severe vasomotor symptoms. Frequency results are shown in Table 3 . Severity results are shown in Table 4 .
Table 3. Mean Change from Baseline in the Number of Moderate to Severe Vasomotor Symptoms per Week – ITT Population, LOCF Visit Placebo (n = 105) Estradiol 0.05 mg/day (n = 111) Estradiol 0.10 mg/day (n = 109) Baseline [1] Mean (SD) 83.62 (60.42) 73.83 (24.53) 75.11 (25.44) Week 4 Mean (SD) 51.14 (51.19) 21.59* (27.76) 11.37* (19.43) Mean Change from Baseline (SD) -32.48 (46.25) -52.24* (32.92) -63.75* (26.68) p value vs. Placebo (95 percent CI) [2] - <0.001 (-30.7, -8.8) <0.001 (-42.2, -20.3) Week 12 Mean (SD) 42.21 (41.13) 15.48* (25.42) 8.25* (16.58) Mean Change from Baseline (SD) -41.41 (65.61) -58.36* (31.36) -66.87* (27.44) p value vs.
Placebo (95 percent CI) [2] - 0.006 (-30.5, -3.4) <0.001 (-39.1, -11.8) *Denotes statistical significance at the 0.050 level. [1] The baseline number of moderate to severe vasomotor symptoms (MSVS) is the weekly average number of MSVS during the two weeks between screening and randomization. [2] p values and confidence intervals are from a two-way ANOVA with factors for treatment and study center for the difference between treatment groups in the mean change from baseline. Confidence intervals are adjusted for multiple comparisons within each timepoint using Dunnett’s method.
ITT = intent to treat; LOCF = last observation carried forward; CI = confidence interval Table 4. Mean Change from Baseline in the Severity of Moderate to Severe Vasomotor Symptoms per Week – ITT Population, LOCF Visit Placebo (n = 105) Estradiol 0.05 mg/day (n = 111) Estradiol 0.10 mg/day (n = 109) Baseline [1] Mean (SD) 2.51 (0.26) 2.46 (0.23) 2.48 (0.24) Week 4 Mean (SD) 2.23 (0.71) 1.67* (1.07) 1.15* (1.14) Mean Change from Baseline (SD) -0.28 (0.69) - 0.79* (1.08) -1.33* (1.10) p value vs. Placebo (95 percent CI) [2] - <0.001 (-0.8, -0.2) <0.001 (-1.3, -0.8) Week 12 Mean (SD) 2.00 (0.96) 1.41* (1.17) 0.92* (1.09) Mean Change from Baseline (SD) -0.51 (0.94) -1.06* (1.16) -1.56* (1.06) p value vs.
Placebo (95 percent CI) [2] - <0.001 (-0.9, -0.2) <0.001 (-1.4, -0.7) *Denotes statistical significance at the 0.050 level. [1] The baseline severity of moderate to severe vasomotor symptoms (MSVS) is the average severity of MSVS during the two weeks between screening and randomization. [2] p values and confidence intervals are from a two-way ANOVA with factors for treatment and study center for the difference between treatment groups in the mean change from baseline. Confidence intervals are adjusted for multiple comparisons within each timepoint using Dunnett’s method.
ITT = intent to treat; LOCF = last observation carried forward; CI = confidence interval
14.2Effects on Vulvar and Vaginal Atrophy In the same 13-week clinical trial, vaginal superficial cells increased by a mean of 16.0 percent and 18.9 percent for Femring 0.05 mg/day and Femring 0.10 mg/day, respectively, as compared to 1.11 percent for placebo at week 13. A corresponding reduction in parabasal cells was observed at week 13. Vaginal pH decreased for Femring 0.05 mg/day and Femring 0.10 mg/day by a mean of 0.73 and 0.60, respectively, compared to a mean decrease of 0.25 in the placebo group.
14.3Women’s Healt… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
13 NONCLINICAL TOXICOLOGY
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver. Estradiol acetate was assayed for mutation in four histidine-requiring strains of Salmonella typhimurium and in one tryptophan-requiring strain of Escherichia coli . Estradiol acetate did not induce mutations in any of the bacterial strains tested under the conditions employed.
📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ▾
13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Long-term continuous administration of natural and synthetic estrogens in certain animal species increases the frequency of carcinomas of the breast, uterus, cervix, vagina, testis, and liver. Estradiol acetate was assayed for mutation in four histidine-requiring strains of Salmonella typhimurium and in one tryptophan-requiring strain of Escherichia coli . Estradiol acetate did not induce mutations in any of the bacterial strains tested under the conditions employed.
📚 References ▾
15 REFERENCES 1. Rossouw JE, et al. Postmenopausal Hormone Therapy and Risk of Cardiovascular Disease by Age and Years Since Menopause.
JAMA . 2007;297:1465-1477. 2.
Hsia J, et al. Conjugated Equine Estrogens and Coronary Heart Disease. Arch Int Med .
2006;166:357-365. 3. Curb JD, et al.
Venous Thrombosis and Conjugated Equine Estrogen in Women Without a Uterus. Arch Int Med . 2006;166:772-780.
4. Cushman M, et al. Estrogen Plus Progestin and Risk of Venous Thrombosis.
JAMA . 2004;292:1573-1580. 5.
Stefanick ML, et al. Effects of Conjugated Equine Estrogens on Breast Cancer and Mammography Screening in Postmenopausal Women With Hysterectomy. JAMA .
2006;295:1647-1657. 6. Chlebowski RT, et al.
Influence of Estrogen Plus Progestin on Breast Cancer and Mammography in Healthy Postmenopausal Women. JAMA . 2003;289:3234-3253.
7. Anderson GL, et al. Effects of Estrogen Plus Progestin on Gynecologic Cancers and Associated Diagnostic Procedures.
JAMA . 2003;290:1739-1748. 8.
Shumaker SA, et al. Conjugated Equine Estrogens and Incidence of Probable Dementia and Mild Cognitive Impairment in Postmenopausal Women. JAMA .
2004;291:2947-2958. 9. Jackson RD, et al.
Effects of Conjugated Equine Estrogen on Risk of Fractures and BMD in Postmenopausal Women With Hysterectomy: Results From the Women’s Health Initiative Randomized Trial. J Bone Miner Res . 2006;21:817-828.
10. Hendrix SL, et al. Effects of Conjugated Equine Estrogen on Stroke in the Women’s Health Initiative.
Circulation . 2006;113:2425-2434.
📄 Patient Package Insert ▾
Patient Information Femring (fem-ring) (estradiol acetate vaginal ring) Read this Patient Information before you start using Femring and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your menopausal symptoms or your treatment.
What is the most important information I should know about Femring (an estrogen hormone)? • Using estrogen-alone may increase your chance of getting cancer of the uterus (womb). Report any unusual vaginal bleeding right away while you are using Femring. Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb).
Your healthcare provider should check any unusual vaginal bleeding to find out the cause. • Do not use estrogen-alone to prevent heart disease, heart attacks, strokes or dementia (decline in brain function). • Using estrogen-alone may increase your chances of getting strokes or blood clots. • Using estrogen-alone may increase your chance of getting dementia, based on a study of women 65 years of age or older. • Do not use estrogens with progestins to prevent heart disease, heart attacks, strokes or dementia. • Using estrogens with progestins may increase your chances of getting heart attacks, strokes, breast cancer, or blood clots. • Using estrogens with progestins may increase your chance of getting dementia, based on a study of women 65 years of age or older. • You and your healthcare provider should talk regularly about whether you still need treatment with Femring.
What is Femring? Femring is a prescription vaginal ring that contains estradiol (an estrogen hormone). Femring should be removed after 90 days of continuous use.
If you and your healthcare provider decide you should continue using Femring, a new ring can be inserted in your vagina. What is Femring used for? Femring is used after menopause to: • reduce moderate to severe hot flushes Estrogens are hormones made by a woman’s ovaries.
The ovaries normally stop making estrogens when a woman is between 45 and 55 years old. This drop in body estrogen levels causes the “change of life” or menopause, the end of monthly menstrual periods. Sometimes both ovaries are removed during an operation before natural menopause takes place.
The sudden drop in estrogen levels causes “surgical menopause”. When estrogen levels begin dropping, some women get very uncomfortable symptoms, such as feelings of warmth in the face, neck, and chest, or sudden intense episodes of heat and sweating (“hot flashes” or “hot flushes”). In some women the symptoms are mild, and they will not need to take estrogens.
In other women, symptoms can be more severe. • treat moderate to severe menopausal changes in and around the vagina You and your healthcare provider should talk regularly about whether you still need treatment with Femring to control these problems. If you use Femring only to treat your menopausal changes in and around your vagina, talk with your healthcare provider about whether a topical vaginal product would be better for you. You and your healthcare provider should talk regularly about whether you still need treatment with Femring.
Who should not use Femring? Do not start using Femring if you: • have unusual vaginal bleeding Vaginal bleeding after menopause may be a warning sign of cancer of the uterus (womb). Your healthcare provider should check any unusual vaginal bleeding to find out the cause. • currently have or have had certain cancers Estrogens may increase the chances of getting certain types of cancers, including cancer of the breast and uterus.
If you have or have had cancer, talk with your healthcare provider about whether you should use Femring. • had a stroke or heart attack • currently have or have had blood clots • currently have or have had liver problems • have been diagnosed with a bleeding disorder • are allergic to Femring or any of its ingredients See the list of ingredients in Femring at the end of this leaflet… [Excerpted — this section continues on DailyMed.]
📄 Recent Major Changes ▾
Warnings and Precautions, Malignant Neoplasms ( 5.2 ) 11/2023
📄 Package Label / Principal Display Panel ▾
PRINCIPAL DISPLAY PANEL – 0.05 mg/day Carton Label NDC 72495-201-05 Femring ® (estradiol acetate vaginal ring) 0.05 mg/day Femring (estradiol acetate vaginal ring) 0.05 mg/day carton label
PRINCIPAL DISPLAY PANEL – 0.05 mg/day Pouch Label N 72495-201-05 PM00004 Femring ® (estradiol acetate vaginal ring) 0.05 mg/day (Contains 12.4 mg estradiol acetate to deliver the equivalent of 0.05 mg estradiol per day for three months.) Other ingredients: barium sulfate and cured elastomer. For intravaginal use only. CONTENTS: 1 VAGINAL RING Femring ® is a registered trademark of Millicent Pharma Limited Millicent TM Pharma Rx ONLY Femring (estradiol acetate vaginal ring) 0.05 mg/day pouch label
PRINCIPAL DISPLAY PANEL – 0.10 mg/day Carton Label NDC 72495-202-10 Femring ® (estradiol acetate vaginal ring) 0.10 mg/day Femring (estradiol acetate vaginal ring) 0.10 mg/day carton label
PRINCIPAL DISPLAY PANEL – 0.10 mg/day Pouch Label N 72495-202-10 PM00005 Femring ® (estradiol acetate vaginal ring) 0.10 mg/day (Contains 24.8 mg estradiol acetate to deliver the equivalent of 0.10 mg estradiol per day for three months.) Other ingredients: barium sulfate and cured elastomer. For intravaginal use only. CONTENTS: 1 VAGINAL RING Femring ® is a registered trademark of Millicent Pharma Limited Millicent TM Pharma Rx ONLY Femring (estradiol acetate vaginal ring) 0.10 mg/day pouch label