Fyavolv 1mg/5mcg Tablets
Overview
What is this medicine?
How to Use This Medicine
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.
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).
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 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.
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
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, 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.
Precautions & Cautions
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.
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
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.
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.
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.
Minor Interactions
- Acetaminophen - May increase ethinyl estradiol levels.
- Ascorbic acid (Vitamin C) - May increase ethinyl estradiol levels.
Monitoring
Baseline Monitoring
Rationale: To establish baseline and identify hypertension, a contraindication or risk factor for COC use.
Timing: Prior to initiation
Rationale: To identify risk factors for cardiovascular disease, thrombosis, liver disease, and certain cancers.
Timing: Prior to initiation
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
Routine Monitoring
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.
Frequency: Annually
Target: N/A
Action Threshold: Identification of new risk factors or contraindications.
Frequency: Annually
Target: Healthy BMI (18.5-24.9 kg/m²)
Action Threshold: Significant weight gain or obesity may increase cardiovascular risk.
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
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:
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.
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.
Geriatric Use
Not indicated for use in post-menopausal women. Risk of cardiovascular events increases with age.
Clinical Information
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.
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)
Cost & Coverage
General Drug Facts
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.