Femring

Femring is a prescription medication used to treat symptoms of menopause including hot flashes and vaginal dryness. 

Femring contains estradiol, which is a form of the hormone estrogen, and it replaces estrogen that is not naturally produced by the ovaries.

This medication is available as a vaginal ring and is usually inserted for a 3 month period (90 days).

Common side effects of Femring include headache and vaginal discharge. 

Femring is a prescription medication used to treat symptoms of menopause including hot flashes and vaginal dryness. 

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Warner Chilcott (US), LLC

Serious side effects have been reported with Femring. See the “Femring Precautions” section.

Common side effects of Femring include the following:

• headache
• breast pain or tenderness
• nausea
• vomiting
• constipation
• gas
• heartburn
• weight gain or loss
• hair loss
• swelling, redness, burning, irritation or itching of the vagina
• vaginal discharge
• painful menstrual periods
• anxiety
• depression
• changes in mood
• change in sexual desire
• back, neck, or muscle pain
• runny nose or congestion
• cough
• unwanted hair growth

This is not a complete list of Femring side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• Amiodarone (Cordarone, Pacerone)
• Antifungals such as itraconazole (Sporanox) and ketoconazole (Nizoral)
• Aprepitant (Emend)
• Carbamazepine (Carbatrol, Epitol, Tegretol)
• Cimetidine (Tagamet)
• Clarithromycin (Biaxin)
• Cyclosporine (Neoral, Sandimmune)
• Dexamethasone (Decadron, Dexpak)
• Diltiazem (Cardizem, Dilacor, Tiazac, others)
• Erythromycin (E.E.S, Erythrocin)
• Fluoxetine (Prozac, Sarafem)
• Fluvoxamine (Luvox)
• Griseofulvin (Fulvicin, Grifulvin, Gris-PEG)
• Lovastatin (Altocor, Mevacor)
• Medications for human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) such as atazanavir (Reyataz), delaviridine (Rescriptor), efavirenz (Sustiva), indinavir (Crixivan), lopinavir (in Kaletra),nelfinavir (Viracept), nevirapine (Viramune), ritonavir (Norvir, in Kaletra), and saquinavir (Fortovase, Invirase)
• Medications for thyroid disease
• Nefazodone
• Other medications that contain estrogen
• Phenobarbital
• Phenytoin (Dilantin, Phenytek); rifabutin (Mycobutin)
• Rifampin (Rifadin, Rimactane, in Rifamate)
• Sertraline (Zoloft)
• Troleandomycin (TAO)
• Verapamil (Calan, Covera, Isoptin, Verelan)
• Zafirlukast (Accolate)
• St. John's Wort

This is not a complete list of Femring drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Femring including the following:

• bulging eyes
• yellowing of the skin or eyes
• itching
• loss of appetite
• fever
• joint pain
• stomach tenderness, pain, or swelling
• movements that are difficult to control
• hives
• rash or blisters on the skin
• swelling, of the eyes, face, lips, tongue, throat, hands, feet, ankles, or lower legs
• hoarseness
• wheezing
• difficulty breathing or swallowing

Do not take Femring if you:

• are allergic to Femring or to any of its ingredients
• have abnormal vaginal bleeding
• have a known or suspected history of breast cancer
• have a known or suspected estrogen-dependent cancer
• have a history of blood clots
• have blood clots
• have or had stroke
• have or had a heart attack
• have liver disease
• are pregnant or possibly pregnant

Grapefruit and grapefruit juice may interact with Femring and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before using Femring, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Femring or to any of its ingredients
• have or have ever had asthma
• have seizures
• have migraine headaches
• have a history of blood clots
• have blood clots
• have or had stroke
• have or had a heart attack
• have endometriosis (a condition in which the type of tissue that lines the uterus [womb] grows in other areas of the body)
• have uterine fibroids (growths in the uterus that are not cancer)
• have or have had yellowing of the skin or eyes, especially during pregnancy or while you were using an estrogen product
• have very high or very low levels of calcium in your blood
• have porphyria (condition in which abnormal substances build up in the blood and cause problems with the skin or nervous system) or gallbladder, thyroid, pancreas, liver or kidney disease
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

Femring should not be used during pregnancy. 

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.

Tell your doctor if you are breastfeeding or plan to breastfeed.

Femring should not be used during lactation. Estrogen administration to nursing mothers has been shown to decrease the quantity and quality of the breast milk. Detectable amounts of estrogens have been identified in the milk of mothers receiving estrogens.

Use Femring exactly as prescribed.

This medication is available as a vaginal ring and is usually inserted for a 3 month period (90 days).

Instructions for Use

Hands should be thoroughly washed before and after ring insertion.

Femring Insertion

Insert upon removal from the protective pouch.

The opposite sides of the vaginal ring should be pressed together and inserted into the vagina. The exact position is not critical to its function. When Femring is in place, the patient should not feel anything. If the patient feels discomfort, the vaginal ring is probably not far enough inside the vagina. Gently push Femring further into the vagina.

Femring Use

Femring should remain in place for 3 months and then be replaced by a new Femring.

The patient should not feel Femring when it is in place and it should not interfere with sexual intercourse. Straining upon bowel movement may make Femring move down in the lower part of the vagina. If so, it may be repositioned with a finger.

If Femring is expelled totally from the vagina, it should be rinsed in lukewarm water and reinserted by the patient (or healthcare provider if necessary).

Femring Removal

Femring may be removed by looping a finger through the ring and pulling it out.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication

The recommended dose is 1 ring (0.05mg or 0.10 mg) inserted into the vagina every 3 months.

Your doctor will start you on the lowest dose.

If you insert too many Femrings, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

• Store Femring at 25˚ C (77˚ F).
• Keep this and all medicines out of the reach of children.

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS AND PROBABLE DEMENTIA FOR 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. 

CARDIOVASCULAR DISORDERS AND PROBABLE DEMENTIA

Estrogen-alone therapy 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 (50 to 79 years of age) during 7.1 years of treatment with daily oral conjugated estrogens (CE) [0.625 mg], relative to placebo.

The Women’s Health Initiative Memory Study (WHIMS) estrogen-alone ancillary study of the WHI reported 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. 

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.

WARNING: CARDIOVASCULAR DISORDERS, BREAST CANCER AND PROBABLE DEMENTIA FOR ESTROGEN PLUS PROGESTIN THERAPY

Estrogens plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia. 

The WHI estrogen plus progestin substudy reported increased risks of DVT, pulmonary embolism, stroke, and myocardial infarction 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. 

The WHI estrogen plus progestin substudy also demonstrated an increased risk of invasive breast cancer. 

The WHIMS estrogen plus progestin ancillary study of the WHI reported an 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. 

In the absence of comparable data, these risks should be assumed to be similar for other doses of CE and MPA therapy 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.