Blisovi 24 FE Tablets 28s
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 is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Contraceptive, Oral; Iron Supplement
Pharmacologic Class
Estrogen/Progestin Combination; Iron Preparation
Pregnancy Category
Category X
FDA Approved
Feb 2006
DEA Schedule
Not Controlled
Overview
What is this medicine?
Blisovi 24 Fe is a birth control pill that contains two female hormones, estrogen (ethinyl estradiol) and progestin (norethindrone), to prevent pregnancy. It works by stopping your body from releasing an egg (ovulation) and by changing your cervical mucus and uterine lining. It also contains iron (ferrous fumarate) to help prevent or treat iron deficiency anemia, which can be common due to menstrual bleeding.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication effectively, follow your doctor's instructions and read all the information provided. 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, for a period of time to prevent pregnancy. Follow your doctor's guidance on using non-hormone birth control.
It's essential to take your medication as directed, even if you don't 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're 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.
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.
Missing a Dose
If you miss a dose, refer to the package insert or call your doctor for instructions on what to do. If you're using this medication for birth control, you may need to use a non-hormone form of birth control, such as condoms, for a period of time to prevent pregnancy.
To use this medication effectively, follow your doctor's instructions and read all the information provided. 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, for a period of time to prevent pregnancy. Follow your doctor's guidance on using non-hormone birth control.
It's essential to take your medication as directed, even if you don't 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're 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.
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.
Missing a Dose
If you miss a dose, refer to the package insert or call your doctor for instructions on what to do. If you're using this medication for birth control, you may need to use a non-hormone form of birth control, such as condoms, for a period of time to prevent pregnancy.
Lifestyle & Tips
- Take one pill at the same time every day, in the order directed on the blister pack. Consistency is key for effectiveness.
- Do not smoke, especially if you are over 35 years old, as this significantly increases your risk of serious side effects like blood clots, heart attack, and stroke.
- This medication does not protect against HIV/AIDS or other sexually transmitted infections (STIs). Use condoms to protect against STIs.
- If you miss a pill, follow the specific instructions in the package insert or consult your healthcare provider. A backup method of birth control (like condoms) may be needed.
- Be aware of potential drug interactions, especially with certain antibiotics, seizure medications, and St. John's Wort, which can reduce the effectiveness of the birth control. Always inform your doctor and pharmacist about all medications and supplements you are taking.
- The iron pills (brown) are taken during the 4 days you are not taking the active hormone pills. They are for iron supplementation and do not prevent pregnancy.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One active tablet (light pink) daily for 24 consecutive days, followed by one ferrous fumarate tablet (brown) daily for 4 consecutive days. Tablets must be taken in the order directed on the blister pack, at the same time each day.
Condition-Specific Dosing:
missed_dose_1_active:
Take as soon as remembered, then next pill at usual time. No backup needed.
missed_dose_2_active_in_row_weeks_1_2:
Take 2 pills on the day remembered and 2 pills the next day. Use backup contraception for 7 days. Continue taking 1 pill daily until pack is finished.
missed_dose_2_active_in_row_week_3_4:
Discard the rest of the pack and start a new pack on the same day (Sunday start) or discard the rest of the pack and start a new pack immediately (Day 1 start). Use backup contraception for 7 days.
missed_dose_3_or_more_active:
Discard the rest of the pack and start a new pack immediately. Use backup contraception for 7 days.
missed_dose_ferrous_fumarate:
Discard the missed pill(s) and continue taking one pill daily until the pack is finished. No backup contraception needed.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Not established (indicated for post-menarcheal females for contraception)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
Use with caution; monitor for fluid retention. No specific dose adjustment provided.
Dialysis:
Use with caution; monitor for fluid retention. No specific dose adjustment provided.
Hepatic Impairment:
Mild:
Use with caution.
Moderate:
Use with caution; monitor closely.
Severe:
Contraindicated due to impaired steroid metabolism.
Confidence:
Medium
Pharmacology
Mechanism of Action
Ethinyl Estradiol and Norethindrone: Primarily inhibits ovulation by suppressing gonadotropin-releasing hormones (GnRH) from the hypothalamus, which in turn suppresses the release of luteinizing hormone (LH) and follicle-stimulating hormone (FSH) from the pituitary gland. This prevents follicular development and ovulation. Secondary mechanisms include changes in cervical mucus (making it thicker and less permeable to sperm) and endometrial changes (making it less receptive to implantation). Ferrous Fumarate: Provides elemental iron, an essential component in the formation of hemoglobin and myoglobin, and is necessary for effective erythropoiesis. It replenishes iron stores, preventing or treating iron deficiency anemia, which can be exacerbated by menstrual blood loss.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: ~40-60%; Norethindrone: ~60-100%; Ferrous Fumarate: Variable, typically 5-15% of dietary iron, but can be higher in iron-deficient states.
Tmax:
Ethinyl Estradiol: 1-2 hours; Norethindrone: 1-2 hours; Ferrous Fumarate: Not applicable for Tmax in the same way as hormones, absorption is continuous.
FoodEffect:
Ethinyl Estradiol/Norethindrone: Minimal effect. Ferrous Fumarate: Absorption is decreased by food, especially dairy products, tea, coffee, and whole grains. Best taken on an empty stomach, but can be taken with food to reduce GI upset.
Distribution:
Vd:
Ethinyl Estradiol: 5-15 L/kg; Norethindrone: ~4 L/kg; Ferrous Fumarate: Distributed to bone marrow, liver, spleen, and muscle.
ProteinBinding:
Ethinyl Estradiol: >95% (primarily to albumin and sex hormone-binding globulin [SHBG]); Norethindrone: >95% (primarily to albumin and SHBG); Ferrous Fumarate: Iron is transported in the plasma bound to transferrin.
CnssPenetration:
Ethinyl Estradiol/Norethindrone: Limited; Ferrous Fumarate: Limited (does not cross blood-brain barrier significantly).
Elimination:
HalfLife:
Ethinyl Estradiol: 10-20 hours; Norethindrone: 5-14 hours; Ferrous Fumarate: Iron is conserved in the body; minimal excretion.
Clearance:
Ethinyl Estradiol: ~5-10 mL/min/kg; Norethindrone: ~0.4 mL/min/kg; Ferrous Fumarate: Not applicable (body conserves iron).
ExcretionRoute:
Ethinyl Estradiol/Norethindrone: Renal and fecal (as metabolites); Ferrous Fumarate: Primarily through shedding of GI mucosal cells, sweat, urine, and menstrual blood.
Unchanged:
Ethinyl Estradiol: <5%; Norethindrone: <1%; Ferrous Fumarate: Minimal.
Pharmacodynamics
OnsetOfAction:
Contraceptive effect: Typically within 7 days if started on Day 1 of menses or Sunday after menses begins. Full protection after 7 consecutive active pills. Iron effect: Gradual, improvement in anemia symptoms typically within weeks, full correction of iron stores takes months.
PeakEffect:
Contraceptive effect: Maintained with continuous use; Iron effect: Hemoglobin levels begin to rise in 1-2 weeks, peak effect on hemoglobin in 4-6 weeks.
DurationOfAction:
Contraceptive effect: Maintained as long as pills are taken correctly; Iron effect: As long as iron is supplemented and underlying cause of deficiency is addressed.
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
Cigarette smoking increases the risk of serious cardiovascular events from combination 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, combination oral contraceptives, including Blisovi 24 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 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, 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
Vision changes or loss, bulging eyes, or changes in contact lens comfort
Severe or persistent vaginal bleeding or spotting
Fluid retention, swelling, weight gain, or difficulty breathing
Additionally, be aware of the following serious condition:
Blood clots: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, or difficulty speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention 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
This list is not exhaustive, and you may experience other 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, 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
Vision changes or loss, bulging eyes, or changes in contact lens comfort
Severe or persistent vaginal bleeding or spotting
Fluid retention, swelling, weight gain, or difficulty breathing
Additionally, be aware of the following serious condition:
Blood clots: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, or difficulty speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention 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
This list is not exhaustive, and you may experience other 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, sudden), Headaches (severe, sudden, or worse than usual), Eye problems (sudden vision loss or blurring), Severe leg pain (calf or thigh, with or without swelling, warmth, redness). These could be signs of serious blood clots.
- Jaundice (yellowing of skin or eyes), dark urine, light-colored stools, severe abdominal pain (signs of liver problems).
- Sudden shortness of breath or coughing up blood (signs of pulmonary embolism).
- Sudden numbness or weakness on one side of the body, trouble speaking or understanding speech (signs of stroke).
- Severe depression or mood changes.
- Lump in the breast.
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. Describe the allergic reaction and its symptoms.
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 (angina) or heart attack
+ Stroke or 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 sunlight or radiation.
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.
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. Describe the allergic reaction and its symptoms.
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 (angina) or heart attack
+ Stroke or 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 sunlight or radiation.
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
Important Warnings and 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 surgeries, and will instruct you on when to resume taking it after the procedure.
If you will be immobile for an extended period, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor. 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 medication may increase cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor. Regularly check your blood work and other lab tests as instructed by your doctor.
It is crucial to have regular breast exams and gynecology check-ups. You should also perform breast self-exams as directed 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 consume grapefruit juice or eat grapefruit frequently, 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 medication.
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. 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 sex. If you have questions, consult your doctor.
This medication may increase the 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 using this medication and when restarting hormone-based birth control after a break of 4 weeks or more.
Some studies suggest that taking hormone-based birth control for an extended period may increase the risk of cervical cancer, although this may be due to other factors. If you have questions, consult your doctor. Additionally, some studies have shown a potential increased risk of breast cancer with long-term use of hormone-based birth control, while others have not. If you have concerns, discuss them with 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 suspect you are pregnant or have a positive pregnancy test, contact your doctor immediately.
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 surgeries, and will instruct you on when to resume taking it after the procedure.
If you will be immobile for an extended period, such as during long trips, bedrest after surgery, or illness, discuss this with your doctor. 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 medication may increase cholesterol and triglyceride levels. If you have high cholesterol or triglycerides, discuss this with your doctor. Regularly check your blood work and other lab tests as instructed by your doctor.
It is crucial to have regular breast exams and gynecology check-ups. You should also perform breast self-exams as directed 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 consume grapefruit juice or eat grapefruit frequently, 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 medication.
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. 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 sex. If you have questions, consult your doctor.
This medication may increase the 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 using this medication and when restarting hormone-based birth control after a break of 4 weeks or more.
Some studies suggest that taking hormone-based birth control for an extended period may increase the risk of cervical cancer, although this may be due to other factors. If you have questions, consult your doctor. Additionally, some studies have shown a potential increased risk of breast cancer with long-term use of hormone-based birth control, while others have not. If you have concerns, discuss them with 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 suspect you are pregnant or have a positive pregnancy test, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Withdrawal bleeding (in females)
- For iron overdose: abdominal pain, diarrhea, vomiting (may be bloody), lethargy, pallor, cyanosis, shock, metabolic acidosis, liver damage (delayed).
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). For iron overdose, specific treatments like chelation therapy may be required.
Drug Interactions
Contraindicated Interactions
- Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (increased ALT levels)
- Aromatase inhibitors (e.g., anastrozole, letrozole) - theoretical interaction, not typically co-administered
Major Interactions
- CYP3A4 inducers (e.g., carbamazepine, phenytoin, phenobarbital, rifampin, topiramate, St. John's Wort, bosentan, felbamate, griseofulvin, oxcarbazepine, rufinamide) - may decrease contraceptive efficacy and increase breakthrough bleeding.
- Lamotrigine (oral contraceptive may decrease lamotrigine plasma concentrations, leading to loss of seizure control).
- Thyroid hormones (oral contraceptives may increase thyroid-binding globulin, leading to increased thyroid hormone requirements).
Moderate Interactions
- Antibiotics (e.g., ampicillin, tetracycline) - controversial, but some evidence suggests reduced efficacy; backup method often recommended.
- Ascorbic acid (Vitamin C) - may increase ethinyl estradiol levels.
- Acetaminophen - may increase ethinyl estradiol levels.
- Atorvastatin - may increase AUC of ethinyl estradiol.
- Cyclosporine - oral contraceptives may increase cyclosporine plasma concentrations.
- Theophylline - oral contraceptives may increase theophylline plasma concentrations.
- Iron absorption inhibitors (e.g., antacids, proton pump inhibitors, H2 blockers, calcium supplements, dairy products, coffee, tea, whole grains, fiber) - may decrease iron absorption.
- Tetracyclines, Fluoroquinolones (e.g., ciprofloxacin, levofloxacin) - iron may decrease absorption of these antibiotics; separate administration by at least 2 hours.
- Levothyroxine - iron may decrease absorption of levothyroxine; separate administration by at least 4 hours.
Minor Interactions
- Corticosteroids (oral contraceptives may increase plasma concentrations of corticosteroids).
- Benzodiazepines metabolized by oxidation (e.g., diazepam) - oral contraceptives may increase plasma concentrations.
Monitoring
Baseline Monitoring
Complete medical history and physical examination (including blood pressure, breast exam, pelvic exam, Pap test)
Rationale: To identify contraindications, risk factors for adverse events (e.g., VTE, cardiovascular disease, liver disease), and establish baseline health status.
Timing: Prior to initiation of therapy.
Lipid profile (total cholesterol, HDL, LDL, triglycerides)
Rationale: To assess cardiovascular risk, especially if patient has risk factors for dyslipidemia.
Timing: Prior to initiation, if indicated by patient history.
Blood glucose
Rationale: To assess for pre-existing glucose intolerance or diabetes, especially if patient has risk factors.
Timing: Prior to initiation, if indicated by patient history.
Hemoglobin and Hematocrit
Rationale: To assess for baseline anemia or polycythemia, and to monitor the effectiveness of the iron component if used for iron deficiency.
Timing: Prior to initiation, if indicated.
Routine Monitoring
Blood pressure
Frequency: Annually, or more frequently if clinically indicated.
Target: <140/90 mmHg (or individualized target)
Action Threshold: Sustained elevation >140/90 mmHg or significant increase from baseline; consider discontinuation or alternative contraception.
Physical examination (including breast and pelvic exam)
Frequency: Annually, or as clinically indicated.
Target: Normal findings
Action Threshold: Abnormal findings requiring further investigation.
Lipid profile and Blood glucose
Frequency: Periodically, if patient has risk factors for dyslipidemia or diabetes, or if clinically indicated.
Target: Within normal limits or individualized targets
Action Threshold: Significant worsening or development of new abnormalities.
Hemoglobin and Hematocrit
Frequency: Every 3-6 months if treating iron deficiency anemia, then annually for maintenance.
Target: Within normal limits for age/sex
Action Threshold: Failure to improve or worsening anemia.
Symptom Monitoring
- Signs and symptoms of venous thromboembolism (VTE): severe leg pain, swelling, warmth, redness; sudden shortness of breath, chest pain, coughing up blood.
- Signs and symptoms of arterial thromboembolism (stroke, myocardial infarction): sudden severe headache, vision changes, slurred speech, weakness/numbness on one side of body; chest pain, arm pain, jaw pain, sweating, nausea.
- Signs and symptoms of liver problems: severe abdominal pain, dark urine, yellowing of skin/eyes (jaundice).
- Signs and symptoms of severe hypertension: severe headache, blurred vision.
- Signs and symptoms of depression or mood changes.
- Changes in menstrual bleeding patterns (e.g., prolonged or heavy bleeding, amenorrhea).
- Signs of iron overload (rare with therapeutic doses, but important if patient has hemochromatosis).
Special Patient Groups
Pregnancy
Contraindicated in pregnancy. There is no indication for use of Blisovi 24 Fe in pregnancy, and there is evidence of fetal harm. Discontinue if pregnancy is confirmed.
Trimester-Specific Risks:
First Trimester:
Increased risk of birth defects (e.g., limb reduction defects, cardiovascular defects) if exposure occurs during early pregnancy, though data are conflicting and risks are generally considered low. However, due to potential for virilization of female fetus with progestins, and general contraindication, use is avoided.
Second Trimester:
Not applicable, as use is contraindicated.
Third Trimester:
Not applicable, as use is contraindicated.
Lactation
Not recommended during lactation. Estrogen-containing oral contraceptives can decrease the quantity and quality of breast milk and may be excreted in breast milk, potentially affecting the infant. Non-hormonal or progestin-only methods are generally preferred during breastfeeding.
Infant Risk:
Potential for decreased milk supply, and small amounts of hormones may be transferred to the infant, though adverse effects on the infant are generally not well-established but cannot be ruled out. Iron is naturally present in breast milk and is not a concern.
Pediatric Use
Not indicated for use in pre-menarcheal females. Safety and efficacy for contraception have been established in females of reproductive age. The iron component is not specifically dosed for pediatric iron deficiency, which would require different considerations.
Geriatric Use
Not indicated for use in post-menopausal women. Contraception is not required, and the risks of estrogen-containing products generally outweigh benefits in this population.
Clinical Information
Clinical Pearls
- Always take the pills in the correct order as indicated on the blister pack to ensure proper hormone sequencing.
- The ferrous fumarate tablets (brown) are inert regarding contraception; they are for iron supplementation during the hormone-free interval.
- Breakthrough bleeding or spotting is common, especially during the first few cycles, and usually resolves. If it persists or is heavy, consult a healthcare provider.
- This formulation is a 24/4 regimen, meaning 24 active pills and 4 inactive (iron) pills, which may lead to a shorter, lighter period or even amenorrhea for some users.
- Consider a backup method of contraception if experiencing severe vomiting or diarrhea, as absorption of hormones may be compromised.
- Inform all healthcare providers (including dentists) that you are taking oral contraceptives, as they can interact with other medications or affect certain lab tests.
Alternative Therapies
- Progestin-only pills (POPs)
- Contraceptive patch (e.g., Xulane)
- Contraceptive vaginal ring (e.g., NuvaRing, Annovera)
- Contraceptive injection (e.g., Depo-Provera)
- Contraceptive implant (e.g., Nexplanon)
- Intrauterine devices (IUDs - hormonal or copper)
- Barrier methods (condoms, diaphragm, cervical cap)
- Spermicides
- Sterilization (tubal ligation, vasectomy)
- Emergency contraception
Cost & Coverage
Average Cost:
$15 - $50 per 28 tablets (1 cycle)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (for generic formulations) under most commercial and Medicaid plans. Often covered without cost-sharing under the Affordable Care Act.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet; consult your pharmacist for more information. If you have any questions or concerns about this medication, 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 details about the overdose, including the medication taken, the amount, and the time it occurred.