Femring 0.1mg/day
Overview
What is this medicine?
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and read all the information provided.
Inserting the Vaginal Ring
1. Wash your hands before handling the ring.
2. Remove the ring from its pouch, making sure your hands are dry.
3. Fold the ring by pressing its sides between your thumb and index finger.
4. Gently insert the folded ring into your vagina.
5. Note that precise placement is not necessary for the ring to be effective, and it will not cause harm.
Removing the Vaginal Ring
1. To remove the ring, insert your index finger into the vagina and hook it around the rim of the ring, or hold the rim between your index and middle fingers.
2. Gently pull the ring out.
3. After removal, wash your hands thoroughly.
4. Do not dispose of the vaginal ring in the toilet.
Storage and Disposal
Store this medication at room temperature in a dry location, avoiding storage in a bathroom.
Missed Dose
If you miss a dose or have questions about using this medication, contact your doctor for guidance on what to do next.
Lifestyle & Tips
- Do not smoke, as smoking increases the risk of serious cardiovascular side effects (blood clots, stroke, heart attack) with estrogen use.
- Maintain a healthy diet and regular exercise to support overall cardiovascular health.
- Attend all scheduled doctor's appointments and screenings (e.g., mammograms, pelvic exams).
- Report any unusual or concerning symptoms to your doctor immediately.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Condition-Specific Dosing:
Pediatric Dosing
Dose Adjustments
Renal Impairment:
Hepatic Impairment:
Pharmacology
Mechanism of Action
Pharmacokinetics
Absorption:
Distribution:
Elimination:
Pharmacodynamics
Safety & Warnings
BLACK BOX WARNING
Side Effects
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems: dark urine, fatigue, decreased appetite, stomach pain or upset, light-colored stools, vomiting, or yellow skin and eyes.
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades, yellow skin and eyes, fever with chills, bloating, or severe stomach upset or vomiting.
Signs of pancreatitis (pancreas problem): severe stomach pain, severe back pain, or severe stomach upset or vomiting.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Weakness on one side of the body, difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Changes in eyesight or loss of eyesight, bulging eyes, or changes in how contact lenses feel.
Breast lump, breast pain or tenderness, or nipple discharge.
Vaginal itching or discharge.
Abnormal vaginal bleeding.
Depression or other mood changes.
Memory problems or loss.
Fever.
Difficulty urinating or changes in urine output.
Pain while urinating.
This medication may cause fluid retention or swelling in the body. Inform your doctor if you experience swelling, weight gain, or breathing difficulties.
Additional Urgent Side Effects:
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, or difficulty speaking or swallowing.
Signs of high calcium levels: weakness, confusion, fatigue, headache, stomach upset or vomiting, constipation, or bone pain.
Toxic shock syndrome (TSS): a rare but potentially life-threatening condition. Seek medical help immediately if you experience diarrhea, dizziness, fainting, fever, muscle pain, stomach upset, vomiting, or a sunburn-like rash.
Other Possible Side Effects:
Most medications can cause side effects, but many people experience none or only mild side effects. If you are concerned about any of the following side effects or if they persist, contact your doctor:
Dizziness or headache.
Hair loss.
Stomach upset or vomiting.
Constipation.
Stomach pain or cramps.
Bloating.
Breast enlargement or tenderness.
Vaginal bleeding or spotting.
Painful periods.
Common cold symptoms.
Nose or throat irritation.
Weight changes.
Joint pain.
Leg cramps.
Changes in sex drive.
Irritation at the application site.
This list is not exhaustive. If you have questions about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Sudden severe headache, dizziness, or fainting
- Sudden vision changes (e.g., partial or complete loss of vision)
- Numbness or weakness in an arm or leg, especially on one side of the body
- Trouble speaking or understanding speech
- Chest pain or pressure, pain spreading to your arm or shoulder, nausea, sweating, general ill feeling
- Sudden shortness of breath, coughing up blood
- Pain, swelling, or warmth in one or both legs (signs of a blood clot)
- Yellowing of your skin or eyes (jaundice)
- New breast lump or changes in your breasts
- Unusual vaginal bleeding (e.g., spotting, breakthrough bleeding, prolonged or heavy bleeding)
- Severe abdominal pain
Before Using This Medicine
It is essential to inform your doctor about the following conditions to ensure safe use of this medication:
Any allergies you have, including allergies to this drug, its components, or other substances. Be sure to describe the allergic reaction and its symptoms.
A history of certain health conditions, such as:
+ Bleeding disorders or blood clots
+ A higher risk of blood clots
+ Breast cancer
+ Liver problems or liver tumors
+ Heart attack or stroke
+ Tumors that are influenced by estrogen
Unexplained vaginal bleeding
Pregnancy or potential pregnancy. Note: This medication should not be taken during pregnancy.
* Certain vaginal problems, including:
+ Narrow vagina
+ Vaginal infection
+ Uterus not in its normal position
+ Other conditions that may increase the risk of vaginal irritation, ulcers, or cause the vaginal ring to be dislodged. If you are unsure about any of these conditions, consult your doctor.
This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health problems with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other drugs and health conditions. Never start, stop, or change the dosage of any medication without first consulting your doctor.
Precautions & Cautions
If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as prolonged inactivity may increase your risk of developing blood clots. Additionally, if you have diabetes, you will need to closely monitor your blood sugar levels.
Be aware that medications like this one can cause high blood pressure. Follow your doctor's instructions for regular blood pressure checks. You should also have your blood work and bone density checked as directed by your doctor.
Regular breast exams and gynecology check-ups are crucial, and you should also perform breast self-exams as instructed by your doctor. The risk of certain side effects, such as heart attack, stroke, breast cancer, and ovarian cancer, may vary depending on factors like the duration of estrogen use, whether it is taken with or without a progestin, and other individual factors. Discuss the benefits and risks of using this medication with your doctor.
This medication can cause elevated triglyceride levels. If you have a history of high triglyceride levels, inform your doctor. Prolonged use of this medication may lead to the development of dark skin patches on your face, so it is essential to avoid sun exposure, sunlamps, and tanning beds, and to use sunscreen and protective clothing and eyewear.
This medication may affect the results of certain laboratory tests, so be sure to inform all your healthcare providers and lab personnel that you are taking this medication. Smoking can increase the risk of heart disease, so it is recommended that you do not smoke. Limit your alcohol consumption, and if you regularly drink grapefruit juice or eat grapefruit, discuss this with your doctor.
If you experience difficulty removing the ring, inform your doctor, as it may become stuck to the vaginal wall and require surgical removal. Contact with blood during use may cause the ring to change color, but this will not affect its efficacy.
In rare cases, this medication may affect growth in children and teenagers, and they may require regular growth checks. If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you are breastfeeding, discuss the potential risks to your baby with your doctor.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Breast tenderness
- Abdominal pain
- Drowsiness/fatigue
- Withdrawal bleeding (in females)
What to Do:
Overdose with a vaginal ring is unlikely due to its controlled release. If symptoms occur, remove the ring and contact your doctor or poison control center immediately. Call 1-800-222-1222 for poison control assistance.
Drug Interactions
Major Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenobarbital, phenytoin, St. John's Wort) - may significantly decrease estrogen levels, reducing efficacy.
- Aromatase inhibitors (e.g., anastrozole, letrozole, exemestane) - concomitant use is generally not recommended as estrogens would counteract their effect.
Moderate Interactions
- CYP3A4 inhibitors (e.g., ketoconazole, erythromycin, ritonavir, grapefruit juice) - may increase estrogen levels, potentially increasing adverse effects.
- Thyroid hormone replacement therapy (e.g., levothyroxine) - estrogens can increase thyroid-binding globulin (TBG), potentially increasing the need for thyroid hormone.
- Corticosteroids (e.g., prednisone) - estrogens may decrease the clearance of corticosteroids, leading to increased effects.
- Oral anticoagulants (e.g., warfarin) - estrogens may reduce the anticoagulant effects of warfarin, requiring dose adjustments.
Minor Interactions
- Certain herbal supplements (e.g., black cohosh - theoretical interaction, but not well-established for vaginal rings).
Monitoring
Baseline Monitoring
Rationale: To identify contraindications, risk factors (e.g., cardiovascular disease, breast cancer), and establish baseline health status.
Timing: Prior to initiation of therapy.
Rationale: Estrogens can affect blood pressure.
Timing: Prior to initiation.
Rationale: To screen for breast cancer and establish baseline breast health, as estrogens can increase breast cancer risk.
Timing: Prior to initiation, as per age-appropriate guidelines.
Rationale: To screen for gynecological conditions and establish baseline reproductive health.
Timing: Prior to initiation, as per age-appropriate guidelines.
Rationale: Estrogens can affect lipid metabolism.
Timing: Prior to initiation.
Routine Monitoring
Frequency: Annually
Target: N/A
Action Threshold: Any significant changes or new symptoms warrant further investigation.
Frequency: Annually or more frequently if indicated
Target: <130/80 mmHg (general guideline)
Action Threshold: Sustained elevation (e.g., >140/90 mmHg) requires evaluation and management.
Frequency: Annually (breast exam); mammography as per age-appropriate guidelines (e.g., every 1-2 years)
Target: N/A
Action Threshold: New lumps, pain, nipple discharge, or abnormal mammogram findings require immediate investigation.
Frequency: Annually
Target: N/A
Action Threshold: Abnormal bleeding, pain, or other gynecological symptoms require investigation.
Symptom Monitoring
- Signs of blood clots (e.g., leg pain/swelling, chest pain, shortness of breath, sudden severe headache, vision changes)
- Signs of stroke (e.g., sudden numbness/weakness, confusion, trouble speaking, vision problems, dizziness, severe headache)
- Signs of heart attack (e.g., chest pain, discomfort in other areas of upper body, shortness of breath)
- Abnormal vaginal bleeding (e.g., spotting, breakthrough bleeding, prolonged or heavy bleeding)
- Breast lumps or changes
- Jaundice (yellowing of skin or eyes)
- Severe abdominal pain
Special Patient Groups
Pregnancy
Contraindicated. Femring is not indicated for use in pregnant women. Estrogen exposure during pregnancy has been associated with an increased risk of birth defects in the fetus.
Trimester-Specific Risks:
Lactation
Not recommended. Estrogens are excreted in human milk and may decrease the quantity and quality of breast milk. Potential adverse effects on the nursing infant have been reported (e.g., breast enlargement, vaginal bleeding).
Pediatric Use
Not indicated for use in pediatric patients. Safety and efficacy have not been established in this population.
Geriatric Use
Use with caution in women 65 years of age or older. The Women's Health Initiative Memory Study (WHIMS) reported an increased risk of probable dementia in postmenopausal women 65 years of age or older treated with CE alone or CE plus MPA. The overall risks of estrogen therapy, including cardiovascular events and breast cancer, may be higher in older women.
Clinical Information
Clinical Pearls
- Femring provides continuous, low-dose systemic estradiol, which can be beneficial for women who prefer a long-acting, non-oral estrogen therapy.
- Ensure proper insertion and removal technique is taught to the patient. The ring should be placed as high as possible in the vagina.
- Patients should be advised that the ring can be removed for short periods (e.g., during intercourse) but should be reinserted as soon as possible.
- Regular follow-up appointments are crucial to monitor for adverse effects and assess the continued need for therapy.
- Emphasize the importance of the Black Box Warning regarding cardiovascular risks, breast cancer, endometrial cancer, and dementia, especially for women with existing risk factors.
Alternative Therapies
- Other systemic estrogen therapies: oral tablets (e.g., estradiol, conjugated estrogens), transdermal patches (e.g., Estraderm, Vivelle-Dot), gels (e.g., EstroGel), sprays (e.g., Evamist).
- Other vaginal estrogen therapies (primarily for local symptoms): vaginal creams (e.g., Estrace, Premarin), vaginal tablets (e.g., Vagifem, Imvexxy), other vaginal rings (e.g., Estring - lower dose, primarily for local symptoms).
- Non-hormonal therapies for vasomotor symptoms: SSRIs/SNRIs (e.g., paroxetine, venlafaxine), gabapentin, clonidine.
- Non-hormonal therapies for vulvar and vaginal atrophy: vaginal moisturizers and lubricants.