Fyavolv 1mg/5mcg Tablets

Manufacturer LUPIN PHARMACEUTICALS Active Ingredient Ethinyl Estradiol and Norethindrone (MHT)(ETH in il es tra DYE ole & nor eth IN drone) Pronunciation Fye-AH-volv (Ethinyl Estradiol: ETH-in-il es-tra-DYE-ole; Norethindrone: nor-ETH-in-drone)
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.
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Drug Class
Contraceptive
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Pharmacologic Class
Estrogen and Progestin Combination
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Pregnancy Category
Category X
FDA Approved
Sep 2019
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Fyavolv is a birth control pill that contains two female hormones, ethinyl estradiol (an estrogen) and norethindrone (a progestin). It works by preventing ovulation (the release of an egg from the ovary) and by changing the lining of the uterus and cervical mucus to prevent pregnancy. It is taken daily.
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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. Do not flush it down the toilet or pour it down the drain unless you're instructed to do so. Check with your pharmacist for guidance on the best way to dispose of your medication. 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. Do not take two doses at the same time or take extra doses. If you miss taking your medication for several days in a row, call your doctor before starting to take it again.
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Lifestyle & Tips

  • Do not smoke, especially if you are over 35 years old, as smoking significantly increases the risk of serious side effects like blood clots, heart attack, and stroke.
  • Take the pill at the same time every day to maximize effectiveness and reduce breakthrough bleeding.
  • If you miss a pill, follow the instructions in the package insert immediately. Missing pills increases the risk of pregnancy.
  • Use a backup method of birth control (like condoms) if you miss pills, have vomiting or severe diarrhea, or are taking certain medications that can reduce the pill's effectiveness.
  • This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs).
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: One tablet orally daily, taken at the same time each day, continuously (28 active tablets).
Dose Range: 1 - 1 mg

Condition-Specific Dosing:

contraception: One tablet daily, continuously, starting on the first day of menstruation or the first Sunday after menstruation begins. Use a non-hormonal backup method for the first 7 days of the first cycle.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Dosing is the same as for adults once menstruation has begun.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment required.
Moderate: No specific dose adjustment required.
Severe: Use with caution due to potential for fluid retention; monitor for adverse effects.
Dialysis: Not specifically studied; use with caution.

Hepatic Impairment:

Mild: Use with caution; monitor for adverse effects.
Moderate: Use with caution; monitor for adverse effects.
Severe: Contraindicated in women with severe liver disease or liver tumors.

Pharmacology

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Mechanism of Action

Combined oral contraceptives (COCs) like Fyavolv primarily act by suppressing gonadotropins. Although the primary mechanism is inhibition of ovulation, other alterations include changes in the cervical mucus (which increases the difficulty of sperm penetration) and changes in the endometrium (which reduce the likelihood of implantation).
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Pharmacokinetics

Absorption:

Bioavailability: Ethinyl Estradiol: ~40-60%; Norethindrone: ~60-80%
Tmax: Ethinyl Estradiol: ~1-2 hours; Norethindrone: ~1-2 hours
FoodEffect: Food may slightly decrease the rate but not the extent of absorption.

Distribution:

Vd: Ethinyl Estradiol: ~5-15 L/kg; Norethindrone: ~2-4 L/kg
ProteinBinding: Ethinyl Estradiol: ~98% (primarily to albumin); Norethindrone: ~96-98% (primarily to albumin and sex hormone-binding globulin [SHBG])
CnssPenetration: Limited

Elimination:

HalfLife: Ethinyl Estradiol: ~10-20 hours; Norethindrone: ~5-14 hours
Clearance: Ethinyl Estradiol: ~5-10 mL/min/kg; Norethindrone: ~0.5-1.5 mL/min/kg
ExcretionRoute: Renal (primarily as glucuronide and sulfate conjugates) and Fecal (primarily as unconjugated metabolites)
Unchanged: Minimal
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Pharmacodynamics

OnsetOfAction: Contraceptive efficacy typically achieved after 7 consecutive days of active pill use.
PeakEffect: Not directly applicable for contraceptive effect, but hormonal levels peak within hours of dosing.
DurationOfAction: Daily dosing maintains continuous contraceptive effect.

Safety & Warnings

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BLACK BOX WARNING

Cigarette smoking increases the risk of serious cardiovascular events from combined oral contraceptive (COC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, COCs, including Fyavolv, are contraindicated in women who are over 35 years of age and smoke.
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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, fainting, or changes in vision.
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 vision.
Depression or other mood changes.
A lump in the breast, breast pain or soreness, or nipple discharge.
Vaginal itching or discharge.
Changes in vision or loss of vision, bulging eyes, or changes in how contact lenses feel.
Severe or persistent vaginal bleeding or spotting.
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, fatigue, 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

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.
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Seek Immediate Medical Attention If You Experience:

  • A: Abdominal pain (severe)
  • C: Chest pain (severe), cough, shortness of breath
  • H: Headaches (severe, sudden, or migraine with aura)
  • E: Eye problems (sudden vision loss, blurred vision)
  • S: Severe leg pain (calf or thigh), swelling, or warmth
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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, heart disease, or abnormal heart rhythms like 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 endometrial cancer, cervical or vaginal cancer, or unexplained vaginal bleeding.
Hereditary angioedema, a condition characterized by recurring episodes of severe swelling.
Dark skin patches (chloasma) or increased sensitivity to the sun or radiation.
Previous removal of the uterus (hysterectomy).
Recent use (within the past 2 weeks) of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir).
Current use of glecaprevir and pibrentasvir.
Pregnancy or suspected pregnancy, as this medication is contraindicated during pregnancy.
Breastfeeding or plans to breastfeed, as the medication may pass into breast milk.
* A history of jaundice (yellowing of the skin and eyes) during pregnancy or with estrogen use, such as hormonal birth control.

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 to ensure safe use of this medication. Do not initiate, stop, or modify any medication without consulting your doctor.
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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 provide guidance 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. Follow your doctor's instructions for regular blood pressure checks.

Additionally, this drug may lead to increased cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor. Regularly undergo blood work and other laboratory tests as advised by your doctor.

It is crucial to maintain regular breast exams and gynecology check-ups, and 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, discuss this with your doctor.

This medication may interfere with certain laboratory tests. Inform all your healthcare providers and laboratory personnel that you are taking this drug.

For optimal effectiveness, this medication should be used in conjunction with calcium and vitamin D supplements, as well as weight-bearing exercises like walking or physical therapy. Adhere to the diet and exercise plan recommended by your doctor, limit your alcohol consumption, and avoid smoking, as it increases the risk of heart disease. Consult with your doctor for guidance on quitting smoking.

The risk of certain side effects, such as heart attack, stroke, breast cancer, ovarian cancer, and others, 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 is not intended for use in children. Consult with your doctor if you have any questions or concerns.
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Overdose Information

Overdose Symptoms:

  • Nausea
  • Vomiting
  • Withdrawal bleeding (in females)

What to Do:

There is no specific antidote. Treatment is symptomatic. Contact a poison control center or seek medical attention. Call 1-800-222-1222 for poison control.

Drug Interactions

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Contraindicated Interactions

  • Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (risk of ALT elevations)
  • Drugs that are strong inducers of CYP3A4 (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, topiramate, primidone, St. John's Wort) due to potential for reduced contraceptive efficacy and increased breakthrough bleeding.
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Major Interactions

  • Aromatase inhibitors (e.g., anastrozole, letrozole) - COCs may decrease efficacy of aromatase inhibitors.
  • Ospemifene - Concomitant use with estrogens is not recommended.
  • Tranexamic acid - Increased risk of thrombosis.
  • Certain anticonvulsants (e.g., oxcarbazepine, rufinamide) - May reduce COC efficacy.
  • HIV protease inhibitors (e.g., nelfinavir, ritonavir, indinavir) - May alter COC metabolism, requiring dose adjustment or alternative contraception.
  • Non-nucleoside reverse transcriptase inhibitors (e.g., efavirenz, nevirapine) - May reduce COC efficacy.
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Moderate Interactions

  • Lamotrigine - COCs may significantly decrease lamotrigine plasma concentrations, potentially leading to loss of seizure control.
  • Corticosteroids (e.g., prednisone) - COCs may increase plasma concentrations of corticosteroids.
  • Thyroid hormone replacement therapy (e.g., levothyroxine) - COCs may increase thyroid binding globulin, leading to increased thyroid hormone requirements.
  • Cyclosporine - COCs may increase cyclosporine plasma concentrations, increasing risk of toxicity.
  • Theophylline - COCs may increase theophylline plasma concentrations.
  • Griseofulvin - May reduce COC efficacy.
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Minor Interactions

  • Acetaminophen - May increase ethinyl estradiol levels.
  • Ascorbic acid (Vitamin C) - May increase ethinyl estradiol levels.

Monitoring

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Baseline Monitoring

Blood Pressure

Rationale: To establish baseline and identify hypertension, a contraindication or risk factor for COC use.

Timing: Prior to initiation

Complete Medical History (including family history)

Rationale: To identify risk factors for cardiovascular disease, thrombosis, liver disease, and certain cancers.

Timing: Prior to initiation

Physical Examination (including breast and pelvic exam, Pap test)

Rationale: To assess overall health and rule out contraindications or conditions that may be exacerbated by COCs.

Timing: Prior to initiation or as clinically indicated per guidelines

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Routine Monitoring

Blood Pressure

Frequency: Annually or more frequently if clinically indicated.

Target: <140/90 mmHg (ideally <120/80 mmHg)

Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may warrant discontinuation or change in contraceptive method.

Annual Physical Examination

Frequency: Annually

Target: N/A

Action Threshold: Identification of new risk factors or contraindications.

Weight/BMI

Frequency: Annually

Target: Healthy BMI (18.5-24.9 kg/m²)

Action Threshold: Significant weight gain or obesity may increase cardiovascular risk.

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Symptom Monitoring

  • Severe abdominal pain (especially right upper quadrant)
  • Severe chest pain, shortness of breath, or coughing up blood
  • Severe headaches (sudden, severe, or migraine with aura)
  • Eye problems (sudden partial or complete loss of vision, double vision)
  • Severe leg pain, swelling, or warmth in calf or thigh
  • Jaundice (yellowing of skin or eyes)
  • Mood changes, depression
  • Lump in breast

Special Patient Groups

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Pregnancy

Contraindicated during pregnancy. There is no indication for COC use in pregnancy, and there is no evidence of teratogenicity from inadvertent exposure to COCs during early pregnancy.

Trimester-Specific Risks:

First Trimester: Contraindicated. No evidence of increased risk of birth defects.
Second Trimester: Contraindicated.
Third Trimester: Contraindicated.
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Lactation

Not recommended during lactation. COCs can decrease the quantity and quality of breast milk and may pass small amounts of steroids into breast milk. Non-hormonal methods or progestin-only methods are generally preferred for breastfeeding women.

Infant Risk: Small amounts of hormones are excreted in breast milk. No adverse effects have been reported in breastfed infants, but long-term effects are unknown. May affect milk supply.
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Pediatric Use

Safety and efficacy are established for women of reproductive age. Use is not indicated before menarche. Dosing for post-menarcheal adolescents is the same as for adults.

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Geriatric Use

Not indicated for use in post-menopausal women. Risk of cardiovascular events increases with age.

Clinical Information

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Clinical Pearls

  • Fyavolv is a continuous regimen (28 active pills), meaning no placebo pills. This can be beneficial for women who experience symptoms during the hormone-free interval.
  • Emphasize strict adherence to the daily dosing schedule at the same time each day for optimal contraceptive efficacy.
  • Counsel patients on the importance of using a backup contraceptive method (e.g., condoms) if they miss pills, experience vomiting or severe diarrhea, or are taking medications that may interact with COCs.
  • Be vigilant for signs and symptoms of serious adverse events, particularly thromboembolic events (ACHES mnemonic).
  • This low-dose ethinyl estradiol formulation may be associated with less estrogen-related side effects but potentially more breakthrough bleeding, especially during the initial cycles.
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Alternative Therapies

  • Other combined oral contraceptives (higher dose estrogen, different progestins)
  • Progestin-only pills (POPs)
  • Contraceptive patch (Xulane)
  • Vaginal ring (NuvaRing, Annovera)
  • Contraceptive injection (Depo-Provera)
  • Contraceptive implant (Nexplanon)
  • Intrauterine devices (IUDs - hormonal and non-hormonal)
  • Barrier methods (condoms, diaphragm, cervical cap)
  • Spermicides
  • Sterilization (tubal ligation, vasectomy)
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Cost & Coverage

Average Cost: $25 - $100 per 28 tablets
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 2 (often covered with low or no co-pay under ACA)
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General Drug Facts

If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.

To ensure your safety and the effectiveness of your treatment, never share your medication with others or take medication prescribed to someone else.

You may find additional patient information leaflets for certain medications. If you have any questions or concerns, consult with your pharmacist for more information.

If you have any questions or concerns about this medication, it is crucial to discuss them with 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 detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred.