Blisovi FE 1.5/30 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, Hormonal; Iron Supplement
Pharmacologic Class
Estrogen; Progestin; Iron
Pregnancy Category
Category X
FDA Approved
Jun 2014
DEA Schedule
Not Controlled
Overview
What is this medicine?
Blisovi FE 1.5/30 is a birth control pill that contains two female hormones, estrogen (ethinyl estradiol) and progestin (norethindrone), and also includes iron (ferrous fumarate) tablets. It works by preventing ovulation (the release of an egg from the ovary) and by changing the cervical mucus and uterine lining to prevent pregnancy. The iron tablets help prevent or treat iron deficiency anemia, which can sometimes occur with 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, to prevent pregnancy for a certain period. 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. If you vomit or have diarrhea, the medication may not work as well to prevent pregnancy. 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. If you're 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 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, to prevent pregnancy for a certain period. 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. If you vomit or have diarrhea, the medication may not work as well to prevent pregnancy. 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. If you're 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
- Take one pill at the same time every day to maximize effectiveness and reduce the risk of breakthrough bleeding.
- Do not smoke, especially if you are over 35, as smoking significantly increases the 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 prevent STIs.
- If you miss a pill, follow the instructions in the patient information leaflet carefully, as missing pills can increase your risk of pregnancy.
- Be aware of symptoms of serious side effects like blood clots (e.g., severe leg pain, chest pain, sudden shortness of breath, sudden severe headache, vision changes) and seek immediate medical attention if they occur.
- Maintain regular check-ups with your doctor, including blood pressure monitoring.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet daily, taken at the same time each day. Active tablets (light blue) are taken for 21 days, followed by inactive tablets (brown, containing ferrous fumarate) for 7 days. Begin new pack on day 29.
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
contraception:
One active tablet daily for 21 days, followed by one inactive tablet daily for 7 days. Start new pack immediately after the last inactive tablet.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Same as adult dosing for post-menarcheal adolescents requiring contraception.
Dose Adjustments
Renal Impairment:
Mild:
No specific dose adjustment required for hormonal components. Iron absorption may be altered in chronic kidney disease, but specific dose adjustments for ferrous fumarate in this combination are not typically provided.
Moderate:
No specific dose adjustment required for hormonal components. Iron absorption may be altered in chronic kidney disease, but specific dose adjustments for ferrous fumarate in this combination are not typically provided.
Severe:
Use with caution. No specific dose adjustment for hormonal components, but iron supplementation should be carefully monitored in severe renal impairment due to risk of iron overload or altered absorption.
Dialysis:
Use with caution. Not specifically studied. Iron supplementation should be managed by a specialist.
Hepatic Impairment:
Mild:
Use with caution. Hormonal contraceptives are extensively metabolized by the liver.
Moderate:
Contraindicated due to impaired steroid metabolism.
Severe:
Contraindicated due to impaired steroid metabolism.
Pharmacology
Mechanism of Action
Ethinyl Estradiol and Norethindrone primarily act by suppressing gonadotropins, thereby inhibiting ovulation. They also induce changes in the cervical mucus (increasing viscosity to impede sperm penetration) and the endometrium (making it unfavorable for implantation). Ferrous Fumarate provides elemental iron, which is an essential component in the formation of hemoglobin and is used to prevent or treat iron deficiency anemia.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: ~40-45%; Norethindrone: ~60-90%; Ferrous Fumarate: Variable, depends on iron stores and dietary factors (typically 10-30% of elemental iron).
Tmax:
Ethinyl Estradiol: 1-2 hours; Norethindrone: 1-2 hours; Ferrous Fumarate: Not directly applicable as absorption is continuous.
FoodEffect:
Food may slightly decrease the rate but not the extent of absorption for hormonal components. Food can decrease iron absorption but is often recommended to reduce GI upset.
Distribution:
Vd:
Ethinyl Estradiol: ~4.3 L/kg; Norethindrone: ~4 L/kg; Ferrous Fumarate: Iron is distributed throughout the body, primarily bound to transferrin.
ProteinBinding:
Ethinyl Estradiol: ~98% (to albumin and sex hormone-binding globulin [SHBG]); Norethindrone: ~96% (to albumin and SHBG); Ferrous Fumarate: Iron is transported by transferrin.
CnssPenetration:
Limited for hormonal components; Iron does not readily cross the blood-brain barrier in significant amounts.
Elimination:
HalfLife:
Ethinyl Estradiol: Biphasic, terminal half-life ~10-20 hours; Norethindrone: ~5-14 hours; Ferrous Fumarate: Iron is primarily excreted via feces (unabsorbed iron) and small amounts via urine, sweat, and desquamation of cells. No true half-life for elemental iron.
Clearance:
Ethinyl Estradiol: ~5 L/hr/kg; Norethindrone: ~0.4 L/hr/kg; Ferrous Fumarate: Not applicable.
ExcretionRoute:
Ethinyl Estradiol: Renal (40%) and Fecal (60%); Norethindrone: Renal (50%) and Fecal (50%); Ferrous Fumarate: Primarily fecal (unabsorbed iron), minimal renal.
Unchanged:
Ethinyl Estradiol: <5%; Norethindrone: <1%; Ferrous Fumarate: Not applicable (absorbed iron is utilized, not excreted unchanged).
Pharmacodynamics
OnsetOfAction:
Contraceptive effect: Not immediate; typically after 7 consecutive days of active pill use. Iron supplementation: Gradual, improvement in anemia symptoms may take weeks.
PeakEffect:
Contraceptive effect: Achieved after consistent use over several cycles. Iron supplementation: Hemoglobin levels begin to rise after 2-4 weeks.
DurationOfAction:
Contraceptive effect: Maintained with continuous daily dosing. Iron supplementation: As long as supplementation continues and iron stores are replenished.
Confidence:
Medium
Safety & Warnings
BLACK BOX WARNING
Cigarette smoking increases the risk of serious cardiovascular events from combination 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 Blisovi FE 1.5/30, are contraindicated in women who are over 35 years of age and smoke. Postmarketing reports of serious adverse events, including significant elevations in alanine aminotransferase (ALT) levels, have been reported in patients receiving ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, or glecaprevir/pibrentasvir regimens, while concomitantly using ethinyl estradiol-containing products such as Blisovi FE 1.5/30. Discontinue Blisovi FE 1.5/30 prior to starting therapy with these combination drug regimens.
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, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, 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 yellowing of the 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 abdomen, right shoulder, or between the shoulder blades, yellowing of the skin or eyes, fever with chills, bloating, or severe stomach upset or vomiting.
Weakness on one side of the body, difficulty speaking or thinking, balance problems, 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.
Fluid retention, swelling, weight gain, or difficulty breathing.
Blood Clots: Seek Immediate Medical Attention
If you experience any of the following symptoms, call your doctor right away, as they may indicate a blood clot:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color change, 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
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)
* Changes in menstrual periods, 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, redness, swelling, blistering, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or speaking, 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 yellowing of the 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 abdomen, right shoulder, or between the shoulder blades, yellowing of the skin or eyes, fever with chills, bloating, or severe stomach upset or vomiting.
Weakness on one side of the body, difficulty speaking or thinking, balance problems, 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.
Fluid retention, swelling, weight gain, or difficulty breathing.
Blood Clots: Seek Immediate Medical Attention
If you experience any of the following symptoms, call your doctor right away, as they may indicate a blood clot:
Chest pain or pressure
Coughing up blood
Shortness of breath
Swelling, warmth, numbness, color change, 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
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)
* Changes in menstrual periods, 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:
- Sudden severe headache or migraine with aura
- Sudden vision changes (e.g., partial or complete loss of vision, double vision)
- Sudden numbness or weakness on one side of the body
- Slurred speech or difficulty speaking
- Severe chest pain, pressure, or heaviness
- Sudden shortness of breath or coughing up blood
- Severe pain, swelling, or warmth in one leg
- Yellowing of the skin or eyes (jaundice)
- Severe abdominal pain
- Dark urine or light-colored stools
- 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 and situations 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 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, heart disease, or abnormal heart rhythms like atrial fibrillation
+ Angina (chest pain), 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 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
Previous experiences of jaundice (yellowing of the skin) during pregnancy or while using estrogen-containing products like 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 conditions with your doctor and pharmacist to ensure safe use of this medication. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
It is essential to inform your doctor about the following conditions and situations 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 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, heart disease, or abnormal heart rhythms like atrial fibrillation
+ Angina (chest pain), 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 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
Previous experiences of jaundice (yellowing of the skin) during pregnancy or while using estrogen-containing products like 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 conditions with your doctor and pharmacist to ensure safe use of this medication. Do not initiate, stop, or adjust the dosage of any medication without consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is crucial 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. If you need to stop taking this medication, your doctor will instruct you on when to resume taking it after your 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. 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 essential 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 sexual activity. 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 the risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be due to other factors. If you have questions, consult your doctor.
Long-term use of hormone-based birth control may be associated with an increased risk of breast cancer, although not all studies have confirmed this. If you have questions, discuss this 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 experience any signs of pregnancy or have a positive pregnancy test, contact your doctor immediately.
It is crucial 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. If you need to stop taking this medication, your doctor will instruct you on when to resume taking it after your 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. 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 essential 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 sexual activity. 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 the risk of cervical cancer may be higher in individuals taking hormone-based birth control, although this may be due to other factors. If you have questions, consult your doctor.
Long-term use of hormone-based birth control may be associated with an increased risk of breast cancer, although not all studies have confirmed this. If you have questions, discuss this 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 experience any signs of pregnancy or have a positive pregnancy test, contact your doctor immediately.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Breast tenderness
- Dizziness
- Abdominal pain
- Drowsiness/fatigue
- Vaginal bleeding (especially in females)
What to Do:
There is no specific antidote for overdose. Treatment is symptomatic and supportive. In case of suspected overdose, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention.
Drug Interactions
Contraindicated Interactions
- Ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (Viekira Pak, Technivie) - risk of ALT elevations
- Glecaprevir/pibrentasvir (Mavyret) - risk of ALT elevations
Major Interactions
- Strong CYP3A4 inducers (e.g., Rifampin, Phenytoin, Carbamazepine, Barbiturates, Primidone, Topiramate, Oxcarbazepine, Felbamate, Griseofulvin, St. John's Wort) - may decrease contraceptive efficacy and increase breakthrough bleeding.
- Lamotrigine - decreased lamotrigine plasma concentrations, potentially leading to loss of seizure control.
- Cyclosporine - increased cyclosporine plasma concentrations, leading to toxicity.
- Theophylline - increased theophylline plasma concentrations.
- Tizanidine - increased tizanidine plasma concentrations, leading to hypotension and somnolence.
- Warfarin and other oral anticoagulants - altered anticoagulant effect (monitor INR).
Moderate Interactions
- Broad-spectrum antibiotics (e.g., Ampicillin, Tetracyclines) - theoretical reduction in contraceptive efficacy due to altered enterohepatic recirculation (though clinical significance is debated, backup contraception often advised).
- Colesevelam - decreased absorption of ethinyl estradiol (administer COCs at least 4 hours before colesevelam).
- Thyroid hormones (e.g., Levothyroxine) - decreased absorption of thyroid hormones due to iron (separate administration by at least 4 hours).
- Quinolone antibiotics (e.g., Ciprofloxacin, Levofloxacin) - decreased absorption of quinolones due to iron (separate administration by at least 2 hours).
- Bisphosphonates (e.g., Alendronate) - decreased absorption of bisphosphonates due to iron (separate administration by at least 30 minutes, preferably longer).
- Antacids containing calcium, magnesium, aluminum - decreased iron absorption (separate administration by at least 2 hours).
- Proton pump inhibitors (PPIs) and H2 blockers - may decrease iron absorption due to reduced gastric acidity.
Minor Interactions
- Ascorbic acid (Vitamin C) - may enhance iron absorption.
- Grapefruit juice - may increase ethinyl estradiol levels (minor effect).
Monitoring
Baseline Monitoring
Complete medical history (including family history)
Rationale: To identify contraindications, risk factors for cardiovascular disease, thromboembolic events, and other conditions.
Timing: Prior to initiation of therapy
Physical examination (including blood pressure, breast exam, pelvic exam, Pap test)
Rationale: To establish baseline health status and rule out existing conditions.
Timing: Prior to initiation of therapy
Lipid profile
Rationale: To assess cardiovascular risk factors.
Timing: Prior to initiation of therapy (optional, based on risk factors)
Routine Monitoring
Blood pressure
Frequency: Annually, or more frequently if clinically indicated
Target: <140/90 mmHg
Action Threshold: Sustained elevation >140/90 mmHg requires re-evaluation and potential discontinuation.
Annual physical examination (including breast exam, pelvic exam, Pap test as per guidelines)
Frequency: Annually
Target: Normal findings
Action Threshold: Abnormal findings require further investigation.
Symptoms of thromboembolism, stroke, MI, liver dysfunction
Frequency: Ongoing patient education and self-monitoring
Target: Absence of symptoms
Action Threshold: Presence of symptoms requires immediate medical attention.
Hemoglobin/Hematocrit (if iron deficiency suspected or monitored)
Frequency: As clinically indicated
Target: Normal range for age/sex
Action Threshold: Persistent low levels or signs of iron overload require investigation.
Symptom Monitoring
- Severe abdominal pain (liver tumor, pancreatitis, DVT)
- Chest pain (MI, PE)
- Headaches (severe, sudden, or unusual, with focal neurological symptoms - stroke, migraine with aura)
- Eye problems (blurred vision, loss of vision - stroke, retinal thrombosis)
- Severe leg pain (DVT, PE)
- Jaundice or dark urine (liver dysfunction)
- Unusual vaginal bleeding or spotting
- Mood changes, depression
Special Patient Groups
Pregnancy
Contraindicated in pregnancy. There is no indication for Blisovi FE 1.5/30 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 the absolute risk is low.
Second Trimester:
Not applicable, as contraception is not indicated.
Third Trimester:
Not applicable, as contraception is not indicated.
Lactation
Not recommended during breastfeeding. Estrogens can decrease the quantity and quality of breast milk and may be excreted in small amounts into breast milk. Progestins may also be excreted into breast milk. Consider progestin-only methods if contraception is needed during lactation.
Infant Risk:
L3 (Moderate risk). Potential for decreased milk supply and possible adverse effects on the infant (e.g., jaundice, breast enlargement), though generally considered low risk for healthy, full-term infants.
Pediatric Use
Blisovi FE 1.5/30 is indicated for use in females of reproductive age. Safety and efficacy are established for post-menarcheal adolescents. Use in prepubertal children is not indicated.
Geriatric Use
Not indicated for use in post-menopausal women. The safety and efficacy have not been established in geriatric populations.
Clinical Information
Clinical Pearls
- Counsel patients on the importance of taking the pill at the same time every day to maintain contraceptive efficacy and minimize breakthrough bleeding.
- Emphasize the 'missed pill' instructions from the package insert, as they vary based on the number of pills missed and the week of the cycle.
- Advise patients that breakthrough bleeding and spotting are common, especially during the first few cycles, and usually resolve with continued use.
- Remind patients that this medication does not protect against STIs.
- Be vigilant for signs and symptoms of serious adverse events, particularly thromboembolic events, and educate patients on when to seek immediate medical attention.
- For patients taking medications that interact with COCs (e.g., enzyme inducers), advise on the need for alternative or backup contraception.
- The ferrous fumarate component is for iron supplementation; it does not contribute to the contraceptive effect. Advise patients to separate administration from other medications that interact with iron (e.g., antacids, thyroid hormones, certain antibiotics).
Alternative Therapies
- Progestin-only pills (POPs)
- Contraceptive patch (e.g., Xulane)
- Vaginal ring (e.g., NuvaRing, Annovera)
- Contraceptive implant (e.g., Nexplanon)
- Intrauterine devices (IUDs - hormonal or copper)
- Contraceptive injection (e.g., Depo-Provera)
- Barrier methods (e.g., condoms, diaphragm, cervical cap)
- Spermicides
- Surgical sterilization (vasectomy, tubal ligation)
Cost & Coverage
Average Cost:
$20 - $60 per 28 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (often preferred generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.