Layolis FE Chew Tablets
WARNING: Smoking cigarettes while using this drug raises the chance of severe heart and blood-related side effects. This chance is raised with age (mainly older than 35 years of age). It is also raised with the number of cigarettes smoked. It is strongly advised not to smoke. Do not use this drug if you smoke and are older than 35 years of age. @ COMMON USES: It is used to prevent pregnancy.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Oral Contraceptive; Iron Supplement
Pharmacologic Class
Estrogen; Progestin; Iron Salt
Pregnancy Category
Category X
FDA Approved
Jan 1970
DEA Schedule
Not Controlled
Overview
What is this medicine?
Layolis FE is a chewable birth control pill that contains two female hormones (estrogen and progestin) to prevent pregnancy. It also includes iron tablets to help prevent iron deficiency anemia, which can be common in women who menstruate.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. Take your medication at the same time every day, with or without food. If you experience stomach upset, take it with food to help alleviate discomfort.
If you are also taking colesevelam, be sure to take it at least 4 hours before or after taking this medication. After starting this medication, you may need to use a non-hormone form of birth control, such as condoms, to prevent pregnancy for a certain period. Follow your doctor's guidance on using non-hormone birth control.
It is essential to take your medication as directed, even if you do not have sex frequently. Do not skip doses, as this can reduce the medication's effectiveness in preventing pregnancy. If you vomit or have diarrhea, the medication may not work as well. If this occurs within 3 to 4 hours after taking an active tablet, take another tablet as soon as possible. If vomiting or diarrhea persists for more than a day, use an additional form of birth control and consult your doctor. If you are unsure what to do, call your doctor for guidance.
If you miss two periods in a row, take a pregnancy test before starting a new cycle of medication. When taking your medication, chew it well before swallowing, unless your brand can be swallowed whole. Check with your pharmacist to determine if your specific brand can be taken whole. Some brands require a full glass of water, while others should be taken without water. Consult your pharmacist to confirm the correct administration for your medication.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. If you have any questions about storing or disposing of your medication, consult your pharmacist or doctor.
What to Do If You Miss a Dose
If you miss a dose, refer to the package insert or call your doctor for instructions on what to do. If you are using this medication to prevent pregnancy, you may need to use a non-hormone form of birth control, such as condoms, for a certain period to prevent pregnancy.
To use this medication effectively, follow your doctor's instructions and read all accompanying information carefully. Take your medication at the same time every day, with or without food. If you experience stomach upset, take it with food to help alleviate discomfort.
If you are also taking colesevelam, be sure to take it at least 4 hours before or after taking this medication. After starting this medication, you may need to use a non-hormone form of birth control, such as condoms, to prevent pregnancy for a certain period. Follow your doctor's guidance on using non-hormone birth control.
It is essential to take your medication as directed, even if you do not have sex frequently. Do not skip doses, as this can reduce the medication's effectiveness in preventing pregnancy. If you vomit or have diarrhea, the medication may not work as well. If this occurs within 3 to 4 hours after taking an active tablet, take another tablet as soon as possible. If vomiting or diarrhea persists for more than a day, use an additional form of birth control and consult your doctor. If you are unsure what to do, call your doctor for guidance.
If you miss two periods in a row, take a pregnancy test before starting a new cycle of medication. When taking your medication, chew it well before swallowing, unless your brand can be swallowed whole. Check with your pharmacist to determine if your specific brand can be taken whole. Some brands require a full glass of water, while others should be taken without water. Consult your pharmacist to confirm the correct administration for your medication.
Storing and Disposing of Your Medication
Store your medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom. If you have any questions about storing or disposing of your medication, consult your pharmacist or doctor.
What to Do If You Miss a Dose
If you miss a dose, refer to the package insert or call your doctor for instructions on what to do. If you are using this medication to prevent pregnancy, you may need to use a non-hormone form of birth control, such as condoms, for a certain period to prevent pregnancy.
Lifestyle & Tips
- Do not smoke, especially if you are over 35 years old, as this significantly increases the risk of serious side effects like blood clots and heart attack.
- Take the tablet at the same time every day to maximize effectiveness and reduce breakthrough bleeding.
- Use a backup method of birth control (like condoms) for the first 7 days of your first pack, or if you miss pills.
- This medication does not protect against sexually transmitted infections (STIs). Use condoms to prevent STIs.
- Chew the tablet completely before swallowing.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One chewable tablet daily for 28 consecutive days, starting on the first day of menstruation or the first Sunday after menstruation begins. The first 21 tablets contain hormones, and the last 7 tablets contain ferrous fumarate.
Condition-Specific Dosing:
missed_dose:
Refer to package insert for specific instructions based on number of missed pills and week in cycle. Generally, take missed pill as soon as remembered, and if multiple pills are missed, use backup contraception.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not indicated before menarche. Once menarche occurs, adult dosing applies for contraception.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for hormonal components.
Moderate:
No specific adjustment needed for hormonal components.
Severe:
No specific adjustment needed for hormonal components. Use iron with caution in severe renal impairment due to risk of iron accumulation.
Dialysis:
No specific adjustment needed for hormonal components. Use iron with caution; monitor iron levels.
Hepatic Impairment:
Mild:
Use with caution.
Moderate:
Use with caution; monitor for adverse effects.
Severe:
Contraindicated due to impaired steroid metabolism and risk of cholestasis. (For hormonal components)
Pharmacology
Mechanism of Action
Ethinyl Estradiol and Norethindrone act primarily by suppressing gonadotropins (luteinizing hormone and follicle-stimulating hormone), thereby inhibiting ovulation. They also induce changes in the cervical mucus, making it less permeable to sperm, and alter the endometrium, making it less receptive to implantation. Ferrous Fumarate provides elemental iron, which is an essential component of hemoglobin, myoglobin, and various enzymes, necessary for oxygen transport and cellular respiration. It helps prevent or treat iron deficiency anemia.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: ~40-45%; Norethindrone: ~60-100%; Ferrous Fumarate: Variable, typically 10-30% of dietary iron, increased in iron deficiency.
Tmax:
Ethinyl Estradiol: ~1-2 hours; Norethindrone: ~0.5-4 hours; Ferrous Fumarate: Not applicable (slow absorption, peak serum iron levels 2-4 hours post-dose).
FoodEffect:
Ethinyl Estradiol/Norethindrone: Minimal effect. Ferrous Fumarate: Absorption decreased by food, especially dairy, tea, coffee, and whole grains; enhanced by Vitamin C.
Distribution:
Vd:
Ethinyl Estradiol: ~4-5 L/kg; Norethindrone: ~2-4 L/kg; Ferrous Fumarate: Iron binds to transferrin for distribution.
ProteinBinding:
Ethinyl Estradiol: ~98% (to albumin and sex hormone-binding globulin [SHBG]); Norethindrone: ~61% (to albumin and SHBG); Ferrous Fumarate: Iron binds to transferrin.
CnssPenetration:
Limited for hormonal components.
Elimination:
HalfLife:
Ethinyl Estradiol: ~18-24 hours; Norethindrone: ~5-14 hours; Ferrous Fumarate: Not applicable (iron is conserved in the body).
Clearance:
Ethinyl Estradiol: ~5-13 mL/min/kg; Norethindrone: ~0.4-1.2 L/hr/kg.
ExcretionRoute:
Ethinyl Estradiol: Renal and fecal (enterohepatic recirculation); Norethindrone: Renal and fecal; Ferrous Fumarate: Minimal excretion (shedding of cells, sweat, menses).
Unchanged:
Ethinyl Estradiol: <5%; Norethindrone: <1%.
Pharmacodynamics
OnsetOfAction:
Contraceptive efficacy typically achieved after 7 consecutive days of active pill use.
PeakEffect:
Steady-state plasma concentrations of hormones are generally reached within 5-7 days of continuous dosing.
DurationOfAction:
Daily dosing maintains contraceptive effect.
Safety & Warnings
BLACK BOX WARNING
Cigarette smoking increases the risk of serious cardiovascular events from oral contraceptive use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, oral contraceptives, including Layolis FE, are contraindicated in women who are over 35 years of age and smoke.
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 immediate 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 high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of gallbladder problems: pain in the upper right abdomen, right shoulder, or between the shoulder blades, yellow skin and eyes, fever with chills, bloating, or severe stomach upset or vomiting.
Weakness on one side of the body, difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Depression or other mood changes.
Breast lump, breast pain or tenderness, 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 breathing difficulties.
Blood Clot Warning
If you experience any of the following symptoms, seek immediate medical attention, as they may indicate 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
Difficulty speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical help if they bother you or persist:
Changes in appetite
Weight gain or loss
Dizziness or headache
Stomach upset or vomiting
Stomach cramps
Bloating
Breast enlargement or tenderness
Dark skin patches on the face (avoid sun exposure, use sunscreen, and protective clothing)
* Menstrual changes, including heavy bleeding, spotting, or bleeding between cycles
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.
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 immediate 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 high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of gallbladder problems: pain in the upper right abdomen, right shoulder, or between the shoulder blades, yellow skin and eyes, fever with chills, bloating, or severe stomach upset or vomiting.
Weakness on one side of the body, difficulty speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Depression or other mood changes.
Breast lump, breast pain or tenderness, 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 breathing difficulties.
Blood Clot Warning
If you experience any of the following symptoms, seek immediate medical attention, as they may indicate 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
Difficulty speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, contact your doctor or seek medical help if they bother you or persist:
Changes in appetite
Weight gain or loss
Dizziness or headache
Stomach upset or vomiting
Stomach cramps
Bloating
Breast enlargement or tenderness
Dark skin patches on the face (avoid sun exposure, use sunscreen, and protective clothing)
* Menstrual changes, including heavy bleeding, spotting, or bleeding between cycles
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:
- ACHES: Abdominal pain (severe), Chest pain (severe), Headaches (severe, sudden, or worse than usual), Eye problems (blurred vision, loss of vision), Severe leg pain (calf or thigh). These can be signs of serious blood clots.
- Jaundice (yellowing of skin or eyes), dark urine, light-colored stools (signs of liver problems).
- Sudden shortness of breath or coughing up blood.
- Sudden numbness or weakness on one side of the body.
- Severe depression or mood changes.
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 treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
A history of certain health conditions, 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 conditions, including:
+ Endometrial cancer
+ Cancer of the cervix or vagina
+ 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
Recent use of certain medications, such as ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir), within the past 2 weeks
Current use of glecaprevir and pibrentasvir
Pregnancy or suspected pregnancy, as this medication is contraindicated during pregnancy
Breastfeeding or plans to breastfeed
A history of jaundice (yellowing of the skin) during pregnancy or with estrogen use, such as 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. Do not start, stop, or change the dose of any medication without consulting your doctor to ensure safe treatment.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances. Describe the allergic reaction and its symptoms.
A history of certain health conditions, 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 conditions, including:
+ Endometrial cancer
+ Cancer of the cervix or vagina
+ 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
Recent use of certain medications, such as ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir), within the past 2 weeks
Current use of glecaprevir and pibrentasvir
Pregnancy or suspected pregnancy, as this medication is contraindicated during pregnancy
Breastfeeding or plans to breastfeed
A history of jaundice (yellowing of the skin) during pregnancy or with estrogen use, such as 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. Do not start, stop, or change the dose of any medication without consulting your doctor to ensure safe treatment.
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 will be 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 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 increase 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. Also, 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. Furthermore, if you frequently consume grapefruit juice or eat grapefruit, discuss this 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.
Certain medications, herbal products, or health conditions may reduce the effectiveness of hormone-based birth control. Ensure your doctor is aware of all your medications and health issues, as you may need to use a non-hormone form of birth control, such as condoms, in addition to this medication.
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. Always use a latex or polyurethane condom during sexual activity. If you have questions, consult your doctor.
Using this medication may increase your risk of blood clots, stroke, or heart attack. Discuss this with your doctor.
The risk of blood clots is highest during the first year of taking this medication and when restarting hormone-based birth control after a break of 4 weeks or more. Consult your doctor to discuss this risk.
Some studies suggest that taking hormone-based birth control may increase the risk of cervical cancer, although this may be due to other factors. If you have questions, discuss this with your doctor.
Additionally, some studies have shown a potential increased risk of breast cancer associated with long-term use of hormone-based birth control, while other studies have not found this association. If you have questions, consult your doctor.
If you are taking this medication for acne, you must be at least 15 years old. This medication should not be used in children who have not had their first menstrual period.
If you experience any signs of pregnancy or have a positive pregnancy test, contact your doctor immediately.
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 immobility may increase your risk of developing blood clots.
If you have diabetes (high blood sugar), consult 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 increase 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. Also, 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. Furthermore, if you frequently consume grapefruit juice or eat grapefruit, discuss this 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.
Certain medications, herbal products, or health conditions may reduce the effectiveness of hormone-based birth control. Ensure your doctor is aware of all your medications and health issues, as you may need to use a non-hormone form of birth control, such as condoms, in addition to this medication.
This medication does not protect against sexually transmitted diseases like HIV or hepatitis. Always use a latex or polyurethane condom during sexual activity. If you have questions, consult your doctor.
Using this medication may increase your risk of blood clots, stroke, or heart attack. Discuss this with your doctor.
The risk of blood clots is highest during the first year of taking this medication and when restarting hormone-based birth control after a break of 4 weeks or more. Consult your doctor to discuss this risk.
Some studies suggest that taking hormone-based birth control may increase the risk of cervical cancer, although this may be due to other factors. If you have questions, discuss this with your doctor.
Additionally, some studies have shown a potential increased risk of breast cancer associated with long-term use of hormone-based birth control, while other studies have not found this association. If you have questions, consult your doctor.
If you are taking this medication for acne, you must be at least 15 years old. This medication should not be used in children who have not had their first menstrual period.
If you experience any signs of pregnancy or have a positive pregnancy test, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Hormonal component: Nausea, vomiting, withdrawal bleeding (in females).
- Iron component: Abdominal pain, vomiting, diarrhea, lethargy, metabolic acidosis, shock, coma (especially in children).
- In children, even a small overdose of iron can be fatal.
What to Do:
Seek immediate medical attention or call Poison Control (1-800-222-1222). For iron overdose, gastric lavage, emesis, and chelation therapy (e.g., deferoxamine) may be necessary.
Drug Interactions
Contraindicated Interactions
- Ombitasvir/paritaprevir/ritonavir, dasabuvir (risk of ALT elevations)
- Glecaprevir/pibrentasvir (risk of ALT elevations)
Major Interactions
- Strong CYP3A4 inducers (e.g., rifampin, carbamazepine, phenytoin, phenobarbital, topiramate, St. John's Wort): May decrease contraceptive efficacy and increase breakthrough bleeding.
- Certain HIV protease inhibitors (e.g., nelfinavir, ritonavir) and NNRTIs (e.g., nevirapine, efavirenz): May alter hormone levels, reducing efficacy.
- Griseofulvin: May reduce contraceptive efficacy.
Moderate Interactions
- Lamotrigine: Oral contraceptives may decrease lamotrigine plasma concentrations, potentially leading to loss of seizure control.
- Thyroid hormones (e.g., levothyroxine): Oral contraceptives may increase thyroid-binding globulin, leading to decreased free thyroid hormone levels and increased thyroid hormone requirements.
- Tetracyclines, Fluoroquinolones: May chelate iron, reducing absorption of both.
- Antacids, Proton Pump Inhibitors, H2-receptor antagonists: May reduce iron absorption by increasing gastric pH.
- Bisphosphonates: Iron may interfere with absorption.
- Levodopa: Iron may reduce levodopa absorption.
Minor Interactions
- Vitamin C: Enhances iron absorption.
- Calcium supplements: May decrease iron absorption.
Monitoring
Baseline Monitoring
Blood Pressure
Rationale: To establish baseline and identify hypertension, a contraindication or risk factor for COC use.
Timing: Prior to initiation.
Physical Examination (including breast and pelvic exam)
Rationale: To assess overall health, identify contraindications, and provide preventative care.
Timing: Prior to initiation.
Lipid Profile
Rationale: To assess cardiovascular risk factors.
Timing: Prior to initiation, especially if risk factors present.
Liver Function Tests (LFTs)
Rationale: To assess liver health, as COCs are metabolized hepatically and contraindicated in severe liver disease.
Timing: Prior to initiation, especially if history of liver disease.
Complete Blood Count (CBC) and Ferritin
Rationale: To assess for iron deficiency anemia if indicated, and monitor iron status.
Timing: Prior to initiation if anemia suspected or for baseline.
Routine Monitoring
Blood Pressure
Frequency: Annually
Target: <140/90 mmHg
Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may require discontinuation or change in contraception.
Physical Examination
Frequency: Annually
Target: N/A
Action Threshold: Identification of new contraindications or significant health changes.
Lipid Profile
Frequency: Periodically, based on individual risk factors.
Target: N/A
Action Threshold: Significant adverse changes may warrant re-evaluation of COC use.
CBC and Ferritin
Frequency: Periodically, if on iron for anemia or if symptoms of iron deficiency recur.
Target: Hemoglobin and ferritin within normal limits.
Action Threshold: Persistent anemia or iron deficiency may require further investigation or dose adjustment.
Symptom Monitoring
- Signs of venous thromboembolism (VTE): severe leg pain, chest pain, shortness of breath, sudden vision changes.
- Signs of stroke: sudden severe headache, weakness or numbness on one side of the body, speech difficulties.
- Signs of myocardial infarction: chest pain, arm pain, shortness of breath, sweating.
- Signs of liver problems: jaundice (yellowing of skin/eyes), dark urine, light-colored stools, severe abdominal pain.
- Severe headaches or migraines with aura.
- Unexplained breakthrough bleeding or spotting.
- Mood changes, depression.
- Changes in vision (e.g., blurred vision, loss of vision).
Special Patient Groups
Pregnancy
Contraindicated during pregnancy (Category X). There is no indication for oral contraceptives in pregnancy, and there is evidence of fetal risk.
Trimester-Specific Risks:
First Trimester:
Contraindicated. Studies suggest a possible association between in utero exposure to female sex hormones and congenital anomalies, though data are conflicting.
Second Trimester:
Contraindicated.
Third Trimester:
Contraindicated.
Lactation
Not recommended during lactation. Estrogens can decrease the quantity and quality of breast milk. Small amounts of hormonal steroids and/or their metabolites may be excreted in breast milk, potentially affecting the infant.
Infant Risk:
L4 (Possibly Hazardous). Potential for decreased milk supply, altered milk composition, and potential adverse effects on the infant (e.g., jaundice, breast enlargement). Iron component is generally safe in lactation.
Pediatric Use
Not indicated for contraception before menarche. Safety and efficacy have not been established in pediatric patients for contraception prior to menarche. The iron component is not specifically dosed for pediatric iron deficiency in this formulation.
Geriatric Use
Not indicated for contraception in postmenopausal women. Risk of cardiovascular events increases with age. Not typically used in this population.
Clinical Information
Clinical Pearls
- Layolis FE is a chewable tablet; ensure patients understand it must be chewed completely before swallowing.
- Emphasize the importance of taking the pill at the same time every day to maintain efficacy.
- Counsel patients on the 'ACHES' warning signs for serious adverse events and when to seek immediate medical attention.
- Remind patients that the iron-containing tablets are taken during the last 7 days of the cycle to help prevent iron deficiency anemia.
- This formulation is particularly useful for patients who have difficulty swallowing pills or prefer a chewable option.
- Counsel on potential drug interactions, especially with antibiotics, anticonvulsants, and St. John's Wort, which can reduce contraceptive efficacy.
Alternative Therapies
- Progestin-only pills (mini-pill)
- Progestin injections (Depo-Provera)
- Contraceptive implants (Nexplanon)
- Intrauterine devices (IUDs - hormonal or copper)
- Barrier methods (condoms, diaphragm, cervical cap)
- Spermicides
- Natural family planning methods
- Permanent sterilization (tubal ligation, vasectomy)
Cost & Coverage
Average Cost:
Variable, typically $20-$50 per 28-tablet pack
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (preferred generic) on most insurance formularies.
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate 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 reporting the incident, be prepared to provide details about the medication taken, the amount, and the time it occurred.