Fyavolv 0.5-2.5mcg Tablets 28s
WARNING: Do not use this drug to prevent heart disease or dementia. A study of women taking an estrogen with a progestin showed a raised chance of heart attack, stroke, blood clot, breast cancer, and dementia. The chance of stroke, blood clot, and dementia was also raised when the estrogen was taken alone. Not all products and doses were studied. It is not known if the same effects may happen with this drug.The chance of endometrial cancer may be raised with the use of estrogen alone in patients with a uterus. Use of a progestin along with estrogen may lower the risk. Call your doctor right away if you have unexplained or long-lasting vaginal bleeding.Use this drug for the shortest time needed at the lowest useful dose. Your doctor will talk with you on a regular basis to see if you need to keep taking this drug. @ COMMON USES: It is used to prevent soft, brittle bones (osteoporosis) after menopause.It is used to treat signs caused by menopause.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Hormone Replacement Therapy (HRT)
Pharmacologic Class
Estrogen; Progestin
Pregnancy Category
Category X
FDA Approved
Oct 2019
DEA Schedule
Not Controlled
Overview
What is this medicine?
Fyavolv is a medication containing two female hormones, estrogen (ethinyl estradiol) and progestin (norethindrone). It's used by women after menopause to help with symptoms like hot flashes and to prevent bone thinning (osteoporosis). The progestin helps protect the lining of the uterus from changes that estrogen can cause.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication at the same time every day. You can take it with or without food, but if it causes stomach upset, take it with food.
If you are also taking colesevelam, be sure to take it at least 4 hours before or after taking this medication.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Keep all medications out of the reach of children and pets.
When you're finished with your medication or it's expired, dispose of it properly. Don't flush it down the toilet or pour it down the drain unless you're instructed to do so. If you're unsure about how to dispose of your medication, ask your pharmacist for guidance. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and go back to your regular schedule. Don't take two doses at the same time or take extra doses. If you miss taking your medication for several days in a row, contact your doctor before starting again.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Take your medication at the same time every day. You can take it with or without food, but if it causes stomach upset, take it with food.
If you are also taking colesevelam, be sure to take it at least 4 hours before or after taking this medication.
Storing and Disposing of Your Medication
Store your medication at room temperature, away from light and moisture. Keep it in a dry place, such as a closet or drawer, and avoid storing it in the bathroom. Keep all medications out of the reach of children and pets.
When you're finished with your medication or it's expired, dispose of it properly. Don't flush it down the toilet or pour it down the drain unless you're instructed to do so. If you're unsure about how to dispose of your medication, ask your pharmacist for guidance. You may also want to check if there are any drug take-back programs in your area.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next dose, skip the missed dose and go back to your regular schedule. Don't take two doses at the same time or take extra doses. If you miss taking your medication for several days in a row, contact your doctor before starting again.
Lifestyle & Tips
- Do not smoke, as smoking increases the risk of blood clots, stroke, and heart attack, especially when taking hormones.
- Maintain a healthy diet and engage in regular weight-bearing exercise to support bone health.
- Discuss any new or worsening symptoms with your doctor promptly.
- Attend all scheduled follow-up appointments and screenings (e.g., mammograms, blood pressure checks).
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet (0.5 mg norethindrone and 2.5 mcg ethinyl estradiol) orally once daily.
Dose Range:
0.5 - 2.5 mg
Condition-Specific Dosing:
postmenopausal_symptoms:
For the treatment of moderate to severe vasomotor symptoms due to menopause and for the prevention of postmenopausal osteoporosis.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment recommended.
Moderate:
No specific dose adjustment recommended.
Severe:
Use with caution; close monitoring is advised due to potential for fluid retention and electrolyte imbalance.
Dialysis:
Not specifically studied; use with caution and monitor for adverse effects.
Hepatic Impairment:
Mild:
Use with caution; monitor for adverse effects.
Moderate:
Use with caution; monitor for adverse effects. Estrogens and progestins are extensively metabolized by the liver.
Severe:
Contraindicated in patients with severe liver dysfunction or disease.
Pharmacology
Mechanism of Action
Ethinyl Estradiol is a synthetic estrogen that replaces the declining endogenous estrogen levels in postmenopausal women, alleviating vasomotor symptoms and preventing bone loss. Norethindrone is a synthetic progestin that counteracts the proliferative effects of estrogen on the endometrium, reducing the risk of endometrial hyperplasia and carcinoma associated with unopposed estrogen therapy.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: Approximately 40-50%; Norethindrone: Approximately 60-100%
Tmax:
Ethinyl Estradiol: 1-2 hours; Norethindrone: 0.5-4 hours
FoodEffect:
Food may slightly decrease the rate but not the extent of absorption for both components.
Distribution:
Vd:
Ethinyl Estradiol: 1-4 L/kg; Norethindrone: Approximately 4 L/kg
ProteinBinding:
Ethinyl Estradiol: >95% (primarily to albumin and sex hormone-binding globulin [SHBG]); Norethindrone: Approximately 80% (primarily to albumin and SHBG)
CnssPenetration:
Limited
Elimination:
HalfLife:
Ethinyl Estradiol: 13-20 hours; Norethindrone: 5-14 hours
Clearance:
Not readily available for combination product, but both are cleared hepatically.
ExcretionRoute:
Urine (primarily as glucuronide and sulfate conjugates) and feces (biliary excretion).
Unchanged:
Minimal
Pharmacodynamics
OnsetOfAction:
Symptomatic relief of vasomotor symptoms typically begins within a few weeks.
PeakEffect:
Maximal symptomatic relief may take 2-3 months.
DurationOfAction:
Continuous daily administration provides sustained hormonal levels.
Safety & Warnings
BLACK BOX WARNING
Estrogens and progestins should not be used for the prevention of cardiovascular disease or dementia. The Women's Health Initiative (WHI) study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50-79 years of age) during 5.6 years of treatment with daily oral conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo. The WHI Memory Study (WHIMS) reported an increased risk of probable dementia in postmenopausal women 65 years of age or older during 4 years of treatment with daily oral conjugated estrogens plus medroxyprogesterone acetate relative to placebo. Other doses of conjugated estrogens and medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestins, were not studied in the WHI and, in the absence of comparable data, these risks should be assumed to be similar. 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.
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
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 or seek medical attention immediately:
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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or severe upset stomach or vomiting
Signs of low calcium levels: muscle cramps or spasms, numbness and tingling, or seizures
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight
Depression or other mood changes
A lump in the breast, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel
Severe or persistent spotting or vaginal bleeding
Swelling or fluid retention in the body, which may cause weight gain or trouble breathing
Additional Serious Side Effects
Blood clots: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, changes in color, or pain in a leg or arm, or trouble speaking or swallowing
High calcium levels (more common in people with cancer): weakness, confusion, feeling tired, headache, upset stomach or vomiting, constipation, or bone pain
Other Possible Side Effects
Not everyone experiences side effects, and many people have only minor or no side effects at all. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Changes in appetite
Weight gain or loss
Dizziness or headache
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged or tender breasts
Dark patches of skin on the face (to minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear)
Diarrhea
Vaginal bleeding or spotting
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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 or seek medical attention immediately:
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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or severe upset stomach or vomiting
Signs of low calcium levels: muscle cramps or spasms, numbness and tingling, or seizures
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight
Depression or other mood changes
A lump in the breast, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Eyesight changes or loss, bulging eyes, or changes in how contact lenses feel
Severe or persistent spotting or vaginal bleeding
Swelling or fluid retention in the body, which may cause weight gain or trouble breathing
Additional Serious Side Effects
Blood clots: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, changes in color, or pain in a leg or arm, or trouble speaking or swallowing
High calcium levels (more common in people with cancer): weakness, confusion, feeling tired, headache, upset stomach or vomiting, constipation, or bone pain
Other Possible Side Effects
Not everyone experiences side effects, and many people have only minor or no side effects at all. However, if you notice any of the following side effects, contact your doctor or seek medical attention if they bother you or persist:
Changes in appetite
Weight gain or loss
Dizziness or headache
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged or tender breasts
Dark patches of skin on the face (to minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear)
Diarrhea
Vaginal bleeding or spotting
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact 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 or migraine
- Sudden vision changes (e.g., partial or complete loss of vision)
- Sudden chest pain or shortness of breath
- Pain, swelling, or tenderness in one leg
- Sudden weakness or numbness on one side of the body
- Slurred speech or difficulty speaking
- Yellowing of the skin or eyes (jaundice)
- Dark urine or light-colored stools
- Unusual vaginal bleeding or spotting after menopause
- New breast lump or nipple discharge
- Severe abdominal pain
Before Using This Medicine
Before Taking This Medication: Important Information to Share with Your Doctor
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, and describe the symptoms you experienced.
A history of certain health problems, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems or heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Chest pain caused by angina
+ Heart attack or stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health problems, including:
+ Endometrial cancer, cervical cancer, or vaginal cancer
+ Unexplained vaginal bleeding
+ Hereditary angioedema
+ Dark skin patches (chloasma) or increased sensitivity to the sun or radiation
+ Previous removal of the uterus (hysterectomy)
Recent use of certain medications, including:
+ Ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
+ Glecaprevir and pibrentasvir
Pregnancy or potential pregnancy, as this medication is contraindicated during pregnancy
Breastfeeding or plans to breastfeed
* A history of jaundice or yellowing of the skin during pregnancy or with estrogen use (e.g., hormonal birth control)
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Do not start, stop, or change the dose of any medication without consulting your doctor to ensure safe use of this medication.
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, and describe the symptoms you experienced.
A history of certain health problems, including:
+ Blood clots or blood clotting disorders
+ Breast cancer or other hormone-sensitive cancers
+ Diseased blood vessels in the brain or heart
+ Heart valve problems or heart disease
+ Abnormal heart rhythms, such as atrial fibrillation
+ Chest pain caused by angina
+ Heart attack or stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health problems, including:
+ Endometrial cancer, cervical cancer, or vaginal cancer
+ Unexplained vaginal bleeding
+ Hereditary angioedema
+ Dark skin patches (chloasma) or increased sensitivity to the sun or radiation
+ Previous removal of the uterus (hysterectomy)
Recent use of certain medications, including:
+ Ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
+ Glecaprevir and pibrentasvir
Pregnancy or potential pregnancy, as this medication is contraindicated during pregnancy
Breastfeeding or plans to breastfeed
* A history of jaundice or yellowing of the skin during pregnancy or with estrogen use (e.g., hormonal birth control)
This list is not exhaustive, and it is crucial to inform your doctor and pharmacist about all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you have. Do not start, stop, or change the dose of any medication without consulting your doctor to ensure safe use of this medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this drug before certain surgical procedures, and will instruct you on when to resume taking it after the surgery or procedure.
If you anticipate being immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as prolonged immobility may increase your risk of developing blood clots.
If you have diabetes (high blood sugar), consult with your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as directed by your doctor.
This medication may cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor.
Additionally, this drug may lead to increased cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor. Regularly have your blood work and other lab tests checked, as recommended by your doctor.
It is crucial to maintain regular breast exams and gynecology check-ups, and to perform breast self-exams as instructed by your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. Also, if you frequently consume grapefruit juice or eat grapefruit, consult with your doctor.
This medication may interfere with certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this drug.
To maximize the effectiveness of this medication, use it in conjunction with calcium and vitamin D supplements, and engage in weight-bearing exercises, such as walking or physical therapy, as recommended by your doctor. Adhere to the diet and exercise plan outlined by your doctor, limit your alcohol consumption, and avoid smoking, as it increases the risk of heart disease. Discuss the risks associated with smoking with your doctor.
The risk of certain side effects, including heart attack, stroke, breast cancer, ovarian cancer, and others, may vary depending on factors such as 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 is not intended for use in children. Consult with your doctor if you have any questions or concerns.
If you anticipate being immobile for extended periods, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor, as prolonged immobility may increase your risk of developing blood clots.
If you have diabetes (high blood sugar), consult with your doctor, as this medication may affect your blood sugar levels. Monitor your blood sugar as directed by your doctor.
This medication may cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor.
Additionally, this drug may lead to increased cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor. Regularly have your blood work and other lab tests checked, as recommended by your doctor.
It is crucial to maintain regular breast exams and gynecology check-ups, and to perform breast self-exams as instructed by your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. Also, if you frequently consume grapefruit juice or eat grapefruit, consult with your doctor.
This medication may interfere with certain lab tests. Inform all your healthcare providers and lab personnel that you are taking this drug.
To maximize the effectiveness of this medication, use it in conjunction with calcium and vitamin D supplements, and engage in weight-bearing exercises, such as walking or physical therapy, as recommended by your doctor. Adhere to the diet and exercise plan outlined by your doctor, limit your alcohol consumption, and avoid smoking, as it increases the risk of heart disease. Discuss the risks associated with smoking with your doctor.
The risk of certain side effects, including heart attack, stroke, breast cancer, ovarian cancer, and others, may vary depending on factors such as 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 is not intended for use in children. Consult with your doctor if you have any questions or concerns.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Breast tenderness
- Dizziness
- Abdominal pain
- Drowsiness/fatigue
- Withdrawal bleeding (in females)
What to Do:
There is no specific antidote. Treatment is symptomatic and supportive. In case of suspected overdose, contact a poison control center (1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Aromatase inhibitors (e.g., anastrozole, letrozole)
- Ombitasvir/paritaprevir/ritonavir with or without dasabuvir (increased ALT elevations)
Major Interactions
- CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, St. John's Wort) - may decrease estrogen/progestin levels and efficacy.
- CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, clarithromycin, ritonavir) - may increase estrogen/progestin levels and adverse effects.
- Thyroid hormone replacement (e.g., levothyroxine) - may require increased thyroid hormone dose due to increased thyroid binding globulin.
- Corticosteroids (e.g., prednisone) - estrogen may decrease corticosteroid clearance, leading to increased effects.
Moderate Interactions
- Anticoagulants (e.g., warfarin) - estrogen may alter coagulation factors, requiring INR monitoring.
- Antidiabetic agents (e.g., insulin, metformin) - estrogen may decrease glucose tolerance, requiring dose adjustment.
- Lamotrigine - estrogen may decrease lamotrigine levels, leading to loss of seizure control.
- Cyclosporine - estrogen may inhibit cyclosporine metabolism, increasing its levels.
Minor Interactions
- Ascorbic acid (Vitamin C) - may increase ethinyl estradiol levels.
- Acetaminophen - may increase ethinyl estradiol levels.
Monitoring
Baseline Monitoring
Complete medical history and physical examination
Rationale: To identify contraindications, risk factors (e.g., cardiovascular disease, breast cancer), and establish baseline health status.
Timing: Prior to initiation of therapy.
Blood pressure
Rationale: Estrogens can cause fluid retention and may affect blood pressure.
Timing: Prior to initiation.
Breast examination and mammography
Rationale: To screen for breast cancer, as HRT may increase risk.
Timing: Prior to initiation, according to age-appropriate guidelines.
Pelvic examination and Pap test
Rationale: To screen for gynecological conditions and cervical cancer.
Timing: Prior to initiation, according to age-appropriate guidelines.
Lipid profile
Rationale: Estrogens can affect lipid metabolism.
Timing: Prior to initiation, if clinically indicated.
Liver function tests
Rationale: Estrogens and progestins are metabolized by the liver; to assess baseline liver health.
Timing: Prior to initiation, if clinically indicated.
Routine Monitoring
Annual physical examination
Frequency: Annually
Target: N/A
Action Threshold: N/A
Blood pressure
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.
Breast examination and mammography
Frequency: Annually for breast exam; mammography according to age-appropriate guidelines (e.g., every 1-2 years).
Target: N/A
Action Threshold: New breast lump, nipple discharge, or abnormal mammogram requires immediate investigation.
Pelvic examination and Pap test
Frequency: Annually for pelvic exam; Pap test according to current screening guidelines.
Target: N/A
Action Threshold: Abnormal bleeding, pelvic pain, or abnormal Pap test requires investigation.
Assessment of symptoms and continued need for therapy
Frequency: Annually
Target: N/A
Action Threshold: If symptoms are well-controlled, consider tapering or discontinuing therapy, especially after 2-5 years of use, or if risks outweigh benefits.
Symptom Monitoring
- Unusual vaginal bleeding or spotting (especially after menopause)
- Breast lumps or changes
- Severe headache or migraine
- Sudden partial or complete loss of vision
- Sudden onset of proptosis, diplopia, or migraine
- Signs of blood clot: severe pain or swelling in the leg, sudden chest pain, shortness of breath, sudden weakness or numbness on one side of the body, slurred speech
- Signs of liver problems: yellowing of skin or eyes (jaundice), dark urine, light-colored stools, nausea, vomiting, severe abdominal pain
- Symptoms of depression or mood changes
- Fluid retention or swelling
Special Patient Groups
Pregnancy
Contraindicated. Fyavolv is not indicated for use in pregnant women. There is no indication for estrogen-progestin combination in pregnancy, and there is evidence of fetal harm.
Trimester-Specific Risks:
First Trimester:
Potential for adverse effects on fetal development, including genital abnormalities in female fetuses and cardiac defects.
Second Trimester:
Not applicable, as use is contraindicated.
Third Trimester:
Not applicable, as use is contraindicated.
Lactation
Not recommended. Estrogens and progestins are excreted in human milk and may decrease the quantity and quality of breast milk. Potential adverse effects on the infant are unknown but possible.
Infant Risk:
L4 (Possibly Hazardous). Potential for decreased milk production and excretion of hormones into breast milk. Observe infant for potential effects.
Pediatric Use
Not indicated for use in pediatric patients. Safety and effectiveness have not been established.
Geriatric Use
Use with caution in women 65 years of age or older. The WHIMS study showed an increased risk of probable dementia in women 65 years of age or older receiving conjugated estrogens plus medroxyprogesterone acetate. Consider the lowest effective dose for the shortest duration. Close monitoring for adverse events is recommended.
Clinical Information
Clinical Pearls
- Fyavolv is a continuous combined hormone therapy, meaning both estrogen and progestin are taken daily, which typically results in amenorrhea (no menstrual-like bleeding) in most women after several months of use.
- It is crucial to discuss the risks and benefits of HRT with patients, especially the Black Box Warnings regarding cardiovascular events, breast cancer, and dementia.
- HRT should be used at the lowest effective dose for the shortest duration consistent with treatment goals.
- Regular follow-up and monitoring, including breast exams and mammograms, are essential.
- Patients should be advised to report any unusual vaginal bleeding immediately, as it may indicate endometrial pathology.
- Smoking is a major contraindication due to significantly increased cardiovascular risks when combined with HRT.
Alternative Therapies
- Selective Serotonin Reuptake Inhibitors (SSRIs) / Serotonin-Norepinephrine Reuptake Inhibitors (SNRIs) (e.g., paroxetine, venlafaxine) for vasomotor symptoms.
- Gabapentin for vasomotor symptoms.
- Clonidine for vasomotor symptoms.
- Non-hormonal therapies for osteoporosis (e.g., bisphosphonates, denosumab, teriparatide).
- Lifestyle modifications (e.g., diet, exercise, avoiding triggers for hot flashes).
Cost & Coverage
Average Cost:
$150 - $250 per 28 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (preferred or non-preferred brand, or generic equivalent may be Tier 1)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.