Femring

(Estradiol Acetate)

The active ingredient in Femring is estradiol, a form of estrogen. In postmenopausal women, hormone replacement therapy (HRT) supplements are used to increase estrogen hormone levels to relieve symptoms such as vaginal dryness, night sweats, or hot flashes.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide before using Femring. However, the following is a synopsis of the general guidelines for the use of Femring:

1. Wash and dry your hands.

2. Open the pouch and remove Femring.

3. Find a comfortable position, such as lying down or standing with one leg up.

4. Using your thumb and index finger, press the sides of the ring together.

5. Use your index finger to insert the folded ring into your vagina as far as you can.

6. In three months, you will need to remove it and re-insert another ring.

7. To remove it, wash and dry your hands, and find a comfortable position. Put your finger into your vagina and loop it through the ring, then pull it out. Wrap the ring in tissue or toilet paper and put it into the trash.

7. You may need to stop using estradiol for 4-6 weeks before surgery or if you’re on bed rest.

8. If you have a uterus, you may also need a progestin to lower your risk of uterine cancer.

9. Do not drink grapefruit juice while taking this medication.

10. Have a breast exam and mammogram yearly, as this medication may increase your risk of breast cancer.

Some mild or common side effects of Femring seen in clinical trials as compared to placebo include:

• Breast tenderness/ breast pain.
• Abnormal vaginal bleeding.
• Headache.

Estradiol can put you at an increased risk of serious side effects. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Severe allergic reaction or angioedema presenting with swelling of the face, lips, tongue, or throat, hives, and trouble breathing.
• Signs of toxic shock syndrome such as fever, diarrhea, muscle pain, dizziness, or a sunburn-rash on the face/ body.
• Signs of a vaginal yeast infection such as abnormal discharge, itching, or redness in the genital area.
• Signs of a urinary tract infection such as painful urination, blood in the urine, or lower back pain.
• Signs of a heart attack include chest pain, shortness of breath, and pain radiating to your shoulder, neck, or jaw.
• Signs of a stroke include numbness on one side of your body, a severe headache, or trouble speaking.
• Signs of a blood clot/ thromboembolism (deep vein thrombosis or pulmonary embolism), including severe leg cramps, swelling or redness, chest pain, or fast heart rate.
• Signs of cancer include breast lumps/ pain, swollen lymph nodes, or unusual vaginal bleeding.
• Signs of gallbladder disease such as pain or tenderness in your stomach.

These are not all of the possible side effects of Femring. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Femring, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical history, including whether you have:

High triglyceride levels (hypertriglyceridemia).

High blood pressure.

Reduced liver function or liver disease.

Kidney disease.

Low thyroid levels (hypothyroidism).

Fluid retention/ edema.

Asthma.

Migraine headaches.

Systemic lupus erythematosus.

Epilepsy.

Heart disease.

High cholesterol

High calcium levels (hypercalcemia).

Endometriosis.

Diabetes.

Undiagnosed vaginal bleeding - endometrial cancer must be ruled out before you can start this medication.

Active blood clot (DVT or PE).

Porphyria.

Breastfeeding.

Hereditary angioedema.

Active or recent stroke or heart attack.

Liver dysfunction.

History of serious hypersensitivity reaction to estrogens.

Known or suspected pregnancy.

It takes 1-2 weeks to notice a benefit from the estrogen vaginal ring.

When Femring is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

Strong liver enzyme inducers such as St. John’s Wort, phenobarbital, carbamazepine, and rifampin may reduce levels of estrogen in your body and make it less effective.

Strong liver enzyme inhibitors, such as itraconazole, clarithromycin, ritonavir, and grapefruit juice, increase levels of estrogen and cause more side effects.

Brand-name Femring contains either 0.05mg/day or 0.10mg/day of estradiol acetate.

It should be stored at room temperature out of the reach of children or pets.

It is manufactured by Millicent Pharma.

No, there is no generic version of this dosage form, but there are generic versions of estradiol cream, tablets, and patches.

Barring any serious side effects as listed above, or under the direction of a physician, you should not stop using estradiol suddenly.

Estradiol should not be used during pregnancy.

Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

This medication may reduce the quantity and quality of breast milk and pass into breast milk. It should not be used during lactation.

Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.