Blisovi FE 1/20 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 is used to treat pimples (acne).It may be given to you for other reasons. Talk with the doctor.
Drug Class
Contraceptive
Pharmacologic Class
Estrogen and Progestin Combination; Iron Supplement
Pregnancy Category
Category X
FDA Approved
Feb 1999
DEA Schedule
Not Controlled
Overview
What is this medicine?
Blisovi FE 1/20 is a birth control pill that contains two female hormones, estrogen (ethinyl estradiol) and progestin (norethindrone), plus iron. It works by preventing ovulation (the release of an egg from the ovary) and by changing the lining of the uterus and cervical mucus to prevent pregnancy. The iron tablets are taken during the inactive week to help prevent iron deficiency.
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.
If you are also taking colesevelam, 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 as directed by your doctor. Do not skip doses, even if you do not have frequent sexual activity.
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. 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.
If you miss two consecutive periods, 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. Do not store it in a bathroom.
Missing a Dose
If you miss a dose, refer to the package insert or consult your doctor for guidance. If you are using this medication for pregnancy prevention, 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.
If you are also taking colesevelam, 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 as directed by your doctor. Do not skip doses, even if you do not have frequent sexual activity.
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. 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.
If you miss two consecutive periods, 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. Do not store it in a bathroom.
Missing a Dose
If you miss a dose, refer to the package insert or consult your doctor for guidance. If you are using this medication for pregnancy prevention, 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 tablet at the same time every day, without missing any doses, to ensure maximum effectiveness.
- Do not smoke, especially if you are over 35 years old, as this 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 for STI protection.
- If you experience severe vomiting or diarrhea, the effectiveness of the pill may be reduced; use a backup method of contraception.
- Discuss all other medications, including over-the-counter drugs, herbal supplements (especially St. John's Wort), and vitamins, with your doctor or pharmacist, as they can interact with birth control pills.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One active tablet (light yellow) daily for 21 consecutive days, followed by one inactive tablet (brown, containing ferrous fumarate) daily for 7 consecutive days. Begin new pack on day 29.
Dose Range:
1 - 1 mg
Condition-Specific Dosing:
missedDose:
If 1 active tablet is missed, take as soon as remembered and continue daily. If 2 active tablets are missed in Week 1 or 2, take 2 tablets daily for 2 days and use back-up contraception for 7 days. If 2 active tablets are missed in Week 3 or 3+ active tablets are missed anytime, discard pack and start new pack immediately (Day 1 start) or discard pack and start new pack on Sunday (Sunday start) and use back-up contraception for 7 days. Consult package insert for full instructions.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Indicated for post-menarcheal females for contraception. Dosing is the same as adults.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific recommendations; use with caution and monitor for adverse effects.
Hepatic Impairment:
Mild:
Use with caution; monitor for adverse effects.
Moderate:
Contraindicated due to impaired steroid metabolism.
Severe:
Contraindicated due to impaired steroid metabolism.
Pharmacology
Mechanism of Action
Combined oral contraceptives (COCs) like Blisovi FE 1/20 primarily act by suppressing gonadotropins, which in turn inhibits ovulation. They also induce changes in the cervical mucus, making it less permeable to sperm, and alter the endometrium, reducing the likelihood of implantation. Norethindrone contributes to the progestational effects, while ethinyl estradiol provides the estrogenic component. Ferrous fumarate is included in the inactive tablets to provide iron supplementation, addressing potential iron deficiency anemia, particularly during withdrawal bleeding.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: ~40-45%; Norethindrone: ~60-100%; Ferrous Fumarate: Variable (10-30% of elemental iron)
Tmax:
Ethinyl Estradiol: ~1-2 hours; Norethindrone: ~0.5-4 hours; Ferrous Fumarate: ~2-4 hours (for iron absorption)
FoodEffect:
Ethinyl Estradiol/Norethindrone: Minor effect on absorption; Ferrous Fumarate: Food decreases iron absorption, but may reduce GI upset.
Distribution:
Vd:
Ethinyl Estradiol: ~4-5 L/kg; Norethindrone: ~2-4 L/kg; Ferrous Fumarate: Not applicable (iron distributed via transferrin)
ProteinBinding:
Ethinyl Estradiol: >95% (to albumin and sex hormone-binding globulin [SHBG]); Norethindrone: ~80% (to albumin and SHBG); Ferrous Fumarate: Iron binds to transferrin in plasma.
CnssPenetration:
Limited for hormonal components; Not applicable for iron.
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 (as glucuronide and sulfate conjugates); Norethindrone: Renal and fecal (as metabolites); Ferrous Fumarate: Primarily fecal (unabsorbed iron), minor amounts lost via desquamation of cells, sweat, urine, and menses.
Unchanged:
Ethinyl Estradiol: <5%; Norethindrone: <10%; Ferrous Fumarate: Not applicable (absorbed iron is utilized)
Pharmacodynamics
OnsetOfAction:
Contraceptive efficacy begins after 7 consecutive days of active tablet use, if started on the first day of menstruation or the first Sunday after menstruation begins.
PeakEffect:
Steady-state concentrations of hormones are typically reached within 3-4 days of continuous dosing.
DurationOfAction:
Daily dosing is required to maintain contraceptive efficacy.
Safety & Warnings
BLACK BOX WARNING
Cigarette smoking increases the risk of serious cardiovascular events from combined 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, combined oral contraceptives, including Blisovi FE 1/20, 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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or severe upset stomach or vomiting
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight
Depression or other mood changes
A lump in the breast, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Changes in eyesight or loss of vision, bulging eyes, or changes in how contact lenses feel
Severe or persistent spotting or vaginal bleeding
Swelling or fluid retention in the body, which may cause weight gain or trouble breathing
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, changes in color, or pain in a leg or arm; or trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Changes in appetite
Weight gain or loss
Dizziness or headache
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged or tender breasts
Dark patches of skin on the face (to minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear)
* Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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, trouble breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems: dark urine, tiredness, decreased appetite, upset stomach or stomach pain, light-colored stools, vomiting, or yellow skin or eyes
Signs of high blood pressure: severe headache or dizziness, passing out, or changes in eyesight
Signs of gallbladder problems: pain in the upper right belly area, right shoulder area, or between the shoulder blades; yellow skin or eyes; fever with chills; bloating; or severe upset stomach or vomiting
Weakness on one side of the body, trouble speaking or thinking, changes in balance, drooping on one side of the face, or blurred eyesight
Depression or other mood changes
A lump in the breast, breast pain or soreness, or nipple discharge
Vaginal itching or discharge
Changes in eyesight or loss of vision, bulging eyes, or changes in how contact lenses feel
Severe or persistent spotting or vaginal bleeding
Swelling or fluid retention in the body, which may cause weight gain or trouble breathing
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, changes in color, or pain in a leg or arm; or trouble speaking or swallowing
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people may not experience any side effects or may only have mild ones. If you notice any of the following side effects or any other symptoms that bother you or do not go away, contact your doctor or seek medical attention:
Changes in appetite
Weight gain or loss
Dizziness or headache
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged or tender breasts
Dark patches of skin on the face (to minimize this risk, avoid sun exposure, sunlamps, and tanning beds, and use sunscreen and protective clothing and eyewear)
* Changes in menstrual periods, including heavy bleeding, spotting, or bleeding between cycles
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- A: Abdominal pain (severe)
- C: Chest pain (severe), cough, shortness of breath
- H: Headaches (severe, sudden, or worse than usual), dizziness, weakness, numbness
- E: Eye problems (sudden vision loss, blurred vision, bulging eyes)
- S: Severe leg pain (calf or thigh), swelling, redness, warmth
- Jaundice (yellowing of skin or eyes)
- Lump in breast
- Severe mood changes or depression
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 (angina) or heart attack
+ Stroke or high blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health conditions, including:
+ Endometrial cancer, cervical cancer, or vaginal cancer
+ Unexplained vaginal bleeding
+ Hereditary angioedema (a genetic condition that causes swelling)
If you have experienced dark skin patches (chloasma) or increased sensitivity to the sun or radiation
If you have taken certain medications, such as ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir), within the past 2 weeks
If you are currently taking glecaprevir and pibrentasvir
If you are pregnant or think you may be pregnant (do not take this medication if you are pregnant)
If you are breastfeeding or plan to breastfeed
* If you experienced jaundice (yellowing of the skin) during pregnancy or while using estrogen-containing products, such as hormonal birth control
This is not an exhaustive list of all potential interactions. 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 you have. 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 (angina) or heart attack
+ Stroke or high blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health conditions, including:
+ Endometrial cancer, cervical cancer, or vaginal cancer
+ Unexplained vaginal bleeding
+ Hereditary angioedema (a genetic condition that causes swelling)
If you have experienced dark skin patches (chloasma) or increased sensitivity to the sun or radiation
If you have taken certain medications, such as ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir), within the past 2 weeks
If you are currently taking glecaprevir and pibrentasvir
If you are pregnant or think you may be pregnant (do not take this medication if you are pregnant)
If you are breastfeeding or plan to breastfeed
* If you experienced jaundice (yellowing of the skin) during pregnancy or while using estrogen-containing products, such as hormonal birth control
This is not an exhaustive list of all potential interactions. 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 you have. Do not start, stop, or change the dose of any medication without consulting your doctor to ensure safe treatment.
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 surgical procedures. If you need to stop taking this medication, your doctor will provide guidance 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.
High cholesterol and triglyceride levels have been associated with this medication. If you have high cholesterol or triglycerides, discuss this with your doctor. Regularly check your blood work and other lab tests as directed by your doctor.
It is crucial to have regular breast exams and gynecology check-ups. Additionally, perform breast self-exams as instructed by your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. Also, if you 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.
Taking 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 using this medication and when restarting hormone-based birth control after a break of 4 weeks or more. Consult your doctor about this risk.
Some studies suggest that long-term use of 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.
Research on the link between hormone-based birth control and breast cancer risk has yielded conflicting results. If you have concerns, talk to 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 surgical procedures. If you need to stop taking this medication, your doctor will provide guidance 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.
High cholesterol and triglyceride levels have been associated with this medication. If you have high cholesterol or triglycerides, discuss this with your doctor. Regularly check your blood work and other lab tests as directed by your doctor.
It is crucial to have regular breast exams and gynecology check-ups. Additionally, perform breast self-exams as instructed by your doctor.
If you are allergic to tartrazine (FD&C Yellow No. 5), inform your doctor, as some products contain this ingredient. Also, if you 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.
Taking 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 using this medication and when restarting hormone-based birth control after a break of 4 weeks or more. Consult your doctor about this risk.
Some studies suggest that long-term use of 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.
Research on the link between hormone-based birth control and breast cancer risk has yielded conflicting results. If you have concerns, talk to 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 (from ferrous fumarate): abdominal pain, diarrhea, vomiting (possibly bloody), lethargy, pallor, cyanosis, shock, metabolic acidosis, liver damage.
What to Do:
Seek immediate medical attention. For iron overdose, call a poison control center (1-800-222-1222) or emergency services. Treatment may involve gastric lavage, chelation therapy (e.g., deferoxamine), and supportive care.
Drug Interactions
Contraindicated Interactions
- Ombitasvir/Paritaprevir/Ritonavir, Dasabuvir (used for Hepatitis C): May increase ALT levels significantly.
- Tranexamic acid: Increased risk of thrombosis.
Major Interactions
- CYP3A4 inducers (e.g., Carbamazepine, Phenytoin, Rifampin, Barbiturates, Topiramate, Griseofulvin, St. John's Wort): May decrease contraceptive efficacy and increase breakthrough bleeding.
- Lamotrigine: COCs may decrease lamotrigine plasma concentrations, potentially leading to loss of seizure control.
- Certain antibiotics (e.g., Rifampin): May reduce efficacy. While less evidence for broad-spectrum antibiotics, caution is advised.
- Bosentan: May decrease contraceptive efficacy.
Moderate Interactions
- Ascorbic acid (Vitamin C): May increase ethinyl estradiol levels.
- Acetaminophen: May increase ethinyl estradiol levels.
- Atorvastatin: May increase ethinyl estradiol levels.
- Thyroid hormones (e.g., Levothyroxine): COCs may increase thyroid-binding globulin, leading to increased thyroid hormone requirements.
- Warfarin and other anticoagulants: COCs may affect anticoagulant response; monitor INR/PT.
- Theophylline: COCs may increase theophylline levels.
- Cyclosporine: COCs may increase cyclosporine levels.
Minor Interactions
- Not typically listed as minor for COCs, as most interactions are significant due to efficacy or safety concerns.
Monitoring
Baseline Monitoring
Blood Pressure
Rationale: To establish baseline and identify hypertension, a risk factor for COC use.
Timing: Prior to initiation
Physical Examination (including breast and pelvic exam)
Rationale: To assess overall health and rule out contraindications.
Timing: Prior to initiation
Pregnancy Test
Rationale: To ensure patient is not pregnant before starting.
Timing: Prior to initiation
Lipid Profile (optional)
Rationale: To assess cardiovascular risk factors.
Timing: Prior to initiation
Liver Function Tests (optional)
Rationale: To assess liver health, especially if history of liver disease.
Timing: Prior to initiation
Routine Monitoring
Blood Pressure
Frequency: Annually or as clinically indicated
Target: <140/90 mmHg
Action Threshold: Sustained elevation (e.g., >140/90 mmHg) may require discontinuation or alternative contraception.
Annual Physical Examination
Frequency: Annually
Target: N/A
Action Threshold: Identification of new contraindications or risk factors.
Iron Status (e.g., Hemoglobin, Ferritin)
Frequency: As clinically indicated, especially if symptoms of anemia or risk factors.
Target: Normal ranges for age/sex
Action Threshold: Persistent low levels despite iron supplementation may require further investigation.
Symptom Monitoring
- Severe abdominal pain (especially sudden or radiating)
- Severe chest pain (sudden, crushing, or radiating to arm/jaw)
- Sudden or severe headache (especially with visual changes or weakness)
- Eye problems (sudden partial or complete loss of vision, double vision)
- Severe leg pain (sudden, swelling, warmth, redness, especially in one leg)
- Jaundice (yellowing of skin or eyes)
- Dark urine or light-colored stools
- Unusual vaginal bleeding or spotting
- Mood changes, depression
- Lump in breast
Special Patient Groups
Pregnancy
Contraindicated. Blisovi FE 1/20 should not be used during pregnancy. If pregnancy occurs while taking this medication, discontinue use immediately.
Trimester-Specific Risks:
First Trimester:
No evidence of teratogenicity or fetal harm from inadvertent exposure during early pregnancy.
Second Trimester:
Not applicable, as use is contraindicated.
Third Trimester:
Not applicable, as use is contraindicated.
Lactation
Not recommended. Estrogens and progestins can decrease the quantity and quality of breast milk and are excreted in breast milk. Consider progestin-only methods or non-hormonal contraception if breastfeeding.
Infant Risk:
Small amounts of steroids are excreted in breast milk. Potential for adverse effects on the infant, including jaundice and breast enlargement, though generally considered low risk. Long-term effects on breastfed infants have not been established.
Pediatric Use
Indicated for contraception in post-menarcheal females. Safety and efficacy are expected to be similar to adults. Not indicated before menarche.
Geriatric Use
Not indicated for post-menopausal women. This medication is for contraception and is not used in the geriatric population.
Clinical Information
Clinical Pearls
- Consistent daily use at the same time is crucial for contraceptive efficacy. Missing pills, especially active ones, increases the risk of pregnancy.
- Breakthrough bleeding or spotting is common, especially during the first few cycles, and usually resolves. If persistent or heavy, consult a healthcare provider.
- Non-contraceptive benefits include regulation of menstrual cycles, reduction of menstrual pain and blood loss, and potential reduction in risk of ovarian and endometrial cancers.
- The ferrous fumarate tablets are for iron supplementation during the placebo week and do not contribute to contraception.
- Always advise patients to use a backup method of contraception (e.g., condoms) for the first 7 days of the first pack, or after missing multiple pills, or when taking interacting medications.
Alternative Therapies
- Progestin-only pills (mini-pill)
- Contraceptive patch (e.g., Xulane)
- Vaginal ring (e.g., NuvaRing, Annovera)
- Contraceptive implant (e.g., Nexplanon)
- Intrauterine devices (IUDs) (hormonal or non-hormonal)
- Contraceptive injection (e.g., Depo-Provera)
- Barrier methods (condoms, diaphragm, cervical cap)
- Spermicides
- Surgical sterilization (tubal ligation, vasectomy)
Cost & Coverage
Average Cost:
Varies widely, typically $20-$60 per 28 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (often covered with no or low co-pay under ACA)
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 your 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 medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.