Balcoltra 0.1/20 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. If you have been given this drug for some other reason, talk with your doctor for more information.
Drug Class
Contraceptive
Pharmacologic Class
Estrogen and Progestin Combination; Iron Supplement
Pregnancy Category
Category X
FDA Approved
Dec 2018
DEA Schedule
Not Controlled
Overview
What is this medicine?
Balcoltra is a birth control pill that contains two female hormones, ethinyl estradiol and levonorgestrel, which work together to prevent pregnancy. It also includes iron in the last 7 pills to help prevent iron deficiency that can occur with menstrual bleeding.
How to Use This Medicine
Taking Your Medication Correctly
To ensure the effectiveness of this medication, follow your doctor's instructions carefully. Read all the information provided and adhere to the guidelines.
Take this medication with or without food, but consider taking it with food if you experience stomach upset.
Establish a routine by taking this medication at the same time every day.
Do not skip doses, even if you do not engage in sexual activity frequently.
If you are also taking colesevelam, take it at least 4 hours before or after 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.
Managing Side Effects and Missed Doses
If you vomit or experience diarrhea, this medication may not be as effective in preventing 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 are unsure about what to do, call your doctor for guidance.
Pregnancy Testing
If your menstrual cycle is 28 days and you miss two consecutive periods, take a pregnancy test before starting a new dosing cycle. If your cycle is longer than 91 days and you miss one period, also take a pregnancy test before starting a new cycle.
Storage and Disposal
Store this medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom.
Missed Doses
If you miss a dose, refer to the package insert or consult your doctor for instructions. If you are 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 ensure the effectiveness of this medication, follow your doctor's instructions carefully. Read all the information provided and adhere to the guidelines.
Take this medication with or without food, but consider taking it with food if you experience stomach upset.
Establish a routine by taking this medication at the same time every day.
Do not skip doses, even if you do not engage in sexual activity frequently.
If you are also taking colesevelam, take it at least 4 hours before or after 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.
Managing Side Effects and Missed Doses
If you vomit or experience diarrhea, this medication may not be as effective in preventing 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 are unsure about what to do, call your doctor for guidance.
Pregnancy Testing
If your menstrual cycle is 28 days and you miss two consecutive periods, take a pregnancy test before starting a new dosing cycle. If your cycle is longer than 91 days and you miss one period, also take a pregnancy test before starting a new cycle.
Storage and Disposal
Store this medication at room temperature, protected from light, and in a dry place. Avoid storing it in a bathroom.
Missed Doses
If you miss a dose, refer to the package insert or consult your doctor for instructions. If you are 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
- 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.
- Use a backup method of birth control (like condoms) for the first 7 days when you start Balcoltra, or if you miss pills.
- Take the pill at the same time every day to maximize effectiveness.
- If you experience severe vomiting or diarrhea, the effectiveness of the pill may be reduced; use a backup method of birth control.
- Maintain regular follow-up appointments with your healthcare provider for blood pressure checks and annual exams.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
One active tablet (light pink, containing 0.1 mg levonorgestrel and 0.02 mg ethinyl estradiol) orally once daily for 21 consecutive days, followed by one inert tablet (dark pink, containing 35 mg ferrous bisglycinate) orally once daily for 7 consecutive days. Begin new pack on day 29.
Condition-Specific Dosing:
missedDose:
If one active tablet is missed, take as soon as remembered. If two or more active tablets are missed, refer to package insert for specific instructions, as backup contraception may be needed.
postpartum:
Do not start earlier than 4 weeks postpartum in non-breastfeeding women due to increased risk of thromboembolism. In breastfeeding women, use is generally not recommended.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Indicated only after menarche. Dosing is the same as for adults.
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed
Dialysis:
No specific data; use with caution due to potential fluid retention and cardiovascular risk.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
Use with caution; monitor for adverse effects.
Severe:
Contraindicated due to impaired steroid metabolism and increased risk of cholestasis.
Pharmacology
Mechanism of Action
Balcoltra prevents conception primarily by inhibiting ovulation through suppression of gonadotropins (FSH and LH). It also causes changes in the cervical mucus (making it less permeable to sperm) and the endometrium (making it less receptive to implantation). The ferrous bisglycinate component provides iron supplementation to help prevent iron deficiency anemia, which can be exacerbated by menstrual blood loss.
Pharmacokinetics
Absorption:
Bioavailability:
Ethinyl Estradiol: ~40-45% (due to first-pass metabolism); Levonorgestrel: ~100%; Ferrous Bisglycinate: Varies, generally good absorption for chelated iron.
Tmax:
Ethinyl Estradiol: ~1.5-2 hours; Levonorgestrel: ~1 hour; Ferrous Bisglycinate: Not directly applicable for Tmax of elemental iron.
FoodEffect:
Food may slightly decrease the rate but not the extent of absorption for ethinyl estradiol and levonorgestrel. Iron absorption can be affected by food components (e.g., phytates, tannins, calcium) but ferrous bisglycinate is designed for better absorption.
Distribution:
Vd:
Ethinyl Estradiol: ~5 L/kg; Levonorgestrel: ~1.8 L/kg; Ferrous Bisglycinate: Not applicable for distribution volume of elemental iron.
ProteinBinding:
Ethinyl Estradiol: >98% (primarily to albumin); Levonorgestrel: 97-99% (primarily to SHBG and albumin); Ferrous Bisglycinate: Iron binds to transferrin for transport.
CnssPenetration:
Limited
Elimination:
HalfLife:
Ethinyl Estradiol: ~18-24 hours; Levonorgestrel: ~24-45 hours; Ferrous Bisglycinate: Not applicable for half-life of elemental iron.
Clearance:
Ethinyl Estradiol: ~5-10 mL/min/kg; Levonorgestrel: ~1 mL/min/kg; Ferrous Bisglycinate: Not applicable for clearance of elemental iron.
ExcretionRoute:
Ethinyl Estradiol: Urine and feces (as metabolites); Levonorgestrel: Urine and feces (as metabolites); Ferrous Bisglycinate: Minimal excretion, primarily stored or recycled.
Unchanged:
Ethinyl Estradiol: <10%; Levonorgestrel: <1%
Pharmacodynamics
OnsetOfAction:
Contraceptive effect: Within 7 days if started on the first day of menstruation; otherwise, after 7 consecutive days of active pill use. Iron supplementation: Gradual, over weeks to months.
PeakEffect:
Contraceptive effect: Achieved after 7 consecutive days of active pill use. Iron supplementation: Peak effect on hemoglobin levels seen after several weeks of consistent use.
DurationOfAction:
Contraceptive effect: Maintained with continuous daily dosing. Iron supplementation: As long as supplementation continues and iron stores are replenished.
Safety & Warnings
BLACK BOX WARNING
Cigarette smoking increases the risk of serious cardiovascular events from combined 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 Balcoltra, 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 immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of gallbladder problems, such as:
+ Pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Change in stools
+ Dark urine or yellow skin or eyes
+ Fever with chills
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
New or worsening migraines
Depression or other mood changes
Breast lump, pain, or soreness, or nipple discharge
Vaginal itching or discharge
Severe or persistent spotting or vaginal bleeding
Changes in eyesight or loss of vision
Bulging eyes
Changes in how contact lenses feel
Swelling or fluid retention in the body (tell your doctor if you experience swelling, weight gain, or trouble breathing)
Signs of a blood clot, including:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, changes in color, or pain in a leg or arm
+ 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 only mild ones. If you notice any of the following side effects, contact your doctor if they bother you or do not go away:
Changes in appetite
Dizziness or headache
Weight gain or loss
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged or tender breasts
Changes in menstrual periods, including spotting or bleeding between cycles
Back pain
Dark patches of skin on the face (avoid sun exposure, use sunscreen, and wear protective clothing and eyewear)
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 immediately or seek emergency medical attention:
Signs of an allergic reaction, such as:
+ Rash or 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
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of liver problems, including:
+ Dark urine
+ Tiredness
+ Decreased appetite
+ Upset stomach or stomach pain
+ Light-colored stools
+ Vomiting
+ Yellow skin or eyes
Signs of gallbladder problems, such as:
+ Pain in the upper right belly area, right shoulder area, or between the shoulder blades
+ Change in stools
+ Dark urine or yellow skin or eyes
+ Fever with chills
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in eyesight
Signs of high blood sugar, such as:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Weakness on one side of the body
Trouble speaking or thinking
Changes in balance
Drooping on one side of the face
Blurred eyesight
New or worsening migraines
Depression or other mood changes
Breast lump, pain, or soreness, or nipple discharge
Vaginal itching or discharge
Severe or persistent spotting or vaginal bleeding
Changes in eyesight or loss of vision
Bulging eyes
Changes in how contact lenses feel
Swelling or fluid retention in the body (tell your doctor if you experience swelling, weight gain, or trouble breathing)
Signs of a blood clot, including:
+ Chest pain or pressure
+ Coughing up blood
+ Shortness of breath
+ Swelling, warmth, numbness, changes in color, or pain in a leg or arm
+ 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 only mild ones. If you notice any of the following side effects, contact your doctor if they bother you or do not go away:
Changes in appetite
Dizziness or headache
Weight gain or loss
Upset stomach or vomiting
Stomach cramps
Bloating
Enlarged or tender breasts
Changes in menstrual periods, including spotting or bleeding between cycles
Back pain
Dark patches of skin on the face (avoid sun exposure, use sunscreen, and wear protective clothing and eyewear)
Reporting Side Effects
If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- ACHES: Abdominal pain (severe)
- Chest pain (severe), shortness of breath, coughing blood
- Headaches (severe, sudden, or worse than usual), dizziness, weakness, numbness
- Eye problems (vision loss or blurring)
- Severe leg pain (calf or thigh), swelling, redness, warmth
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. Be sure to 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
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain)
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health conditions, including:
+ Endometrial cancer
+ Cancer of the cervix or vagina
+ Unexplained vaginal bleeding
If you have ever experienced jaundice (yellowing of the skin and eyes) during pregnancy or while taking estrogen-containing medications, such as hormonal birth control.
Recent use of certain medications, including:
+ Ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
+ Glecaprevir and pibrentasvir
Pregnancy or potential pregnancy: Do not take this medication if you are pregnant.
* Breastfeeding or plans to breastfeed.
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. Always check with your doctor before starting, stopping, or changing the dose of any medication 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. Be sure to 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
+ Abnormal heart rhythms, such as atrial fibrillation
+ Angina (chest pain)
+ Heart attack
+ Stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
A history of other specific health conditions, including:
+ Endometrial cancer
+ Cancer of the cervix or vagina
+ Unexplained vaginal bleeding
If you have ever experienced jaundice (yellowing of the skin and eyes) during pregnancy or while taking estrogen-containing medications, such as hormonal birth control.
Recent use of certain medications, including:
+ Ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks
+ Glecaprevir and pibrentasvir
Pregnancy or potential pregnancy: Do not take this medication if you are pregnant.
* Breastfeeding or plans to breastfeed.
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. Always check with your doctor before starting, stopping, or changing the dose of any medication 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.
Blood Clots, Stroke, and Heart Attack Risk
This medication may increase the risk of blood clots, stroke, or heart attack. Discuss this risk with your doctor. If you will be immobile for an extended period, such as during long trips, bedrest after surgery, or illness, talk to your doctor, as this may further increase your risk of blood clots.
Diabetes and Blood Sugar Monitoring
If you have high blood sugar (diabetes), consult your doctor, as this medication may raise your blood sugar levels. Monitor your blood sugar as directed by your doctor.
Blood Pressure Monitoring
Drugs like this one may cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor.
Lab Tests and Monitoring
Regularly have your blood work and other lab tests checked, as directed by your doctor. This medication may affect certain lab tests, so inform all your healthcare providers and lab workers that you are taking this drug.
Breast Health and Gynecology Check-ups
Regular breast exams and gynecology check-ups are crucial. Perform breast self-exams as instructed by your doctor.
Interactions with Other Medications and Health Problems
Certain medications, herbal products, or health problems may reduce the effectiveness of hormone-based birth control. Ensure your doctor is aware of all your medications and health problems. You may need to use a non-hormone form of birth control, such as condoms, in addition to this medication.
Tartrazine Allergy
If you are allergic to tartrazine (FD&C Yellow No. 5), consult your doctor, as some products contain this ingredient.
Cholesterol and Triglyceride Levels
This medication may cause high cholesterol and triglyceride levels. Discuss this risk with your doctor.
Sexually Transmitted Diseases
This medication does not protect against diseases like HIV or hepatitis that are transmitted through sex. Use a latex or polyurethane condom during sex to reduce the risk of transmission. If you have questions, consult your doctor.
Accidental Overdose and Child Safety
Accidental overdose of iron-containing medications is a leading cause of fatal poisoning in children under 6 years old. Keep this medication out of reach of children. If a child accidentally ingests this medication, call a doctor or poison control center immediately.
Cervical Cancer Risk
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, discuss this risk with your doctor.
Breast Cancer Risk
Some studies suggest that long-term use of hormone-based birth control may increase the risk of breast cancer, while others have not found this association. If you have questions, consult your doctor.
Pediatric Use
This medication should not be used in children who have not had their first menstrual period.
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.
Blood Clots, Stroke, and Heart Attack Risk
This medication may increase the risk of blood clots, stroke, or heart attack. Discuss this risk with your doctor. If you will be immobile for an extended period, such as during long trips, bedrest after surgery, or illness, talk to your doctor, as this may further increase your risk of blood clots.
Diabetes and Blood Sugar Monitoring
If you have high blood sugar (diabetes), consult your doctor, as this medication may raise your blood sugar levels. Monitor your blood sugar as directed by your doctor.
Blood Pressure Monitoring
Drugs like this one may cause high blood pressure. Have your blood pressure checked regularly, as advised by your doctor.
Lab Tests and Monitoring
Regularly have your blood work and other lab tests checked, as directed by your doctor. This medication may affect certain lab tests, so inform all your healthcare providers and lab workers that you are taking this drug.
Breast Health and Gynecology Check-ups
Regular breast exams and gynecology check-ups are crucial. Perform breast self-exams as instructed by your doctor.
Interactions with Other Medications and Health Problems
Certain medications, herbal products, or health problems may reduce the effectiveness of hormone-based birth control. Ensure your doctor is aware of all your medications and health problems. You may need to use a non-hormone form of birth control, such as condoms, in addition to this medication.
Tartrazine Allergy
If you are allergic to tartrazine (FD&C Yellow No. 5), consult your doctor, as some products contain this ingredient.
Cholesterol and Triglyceride Levels
This medication may cause high cholesterol and triglyceride levels. Discuss this risk with your doctor.
Sexually Transmitted Diseases
This medication does not protect against diseases like HIV or hepatitis that are transmitted through sex. Use a latex or polyurethane condom during sex to reduce the risk of transmission. If you have questions, consult your doctor.
Accidental Overdose and Child Safety
Accidental overdose of iron-containing medications is a leading cause of fatal poisoning in children under 6 years old. Keep this medication out of reach of children. If a child accidentally ingests this medication, call a doctor or poison control center immediately.
Cervical Cancer Risk
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, discuss this risk with your doctor.
Breast Cancer Risk
Some studies suggest that long-term use of hormone-based birth control may increase the risk of breast cancer, while others have not found this association. If you have questions, consult your doctor.
Pediatric Use
This medication should not be used in children who have not had their first menstrual period.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Vaginal bleeding (withdrawal bleeding may occur in females)
What to Do:
There is no specific antidote. Treatment is symptomatic and supportive. Call 911 or your local poison control center (1-800-222-1222) immediately.
Drug Interactions
Contraindicated Interactions
- Ombitasvir/Paritaprevir/Ritonavir with or without Dasabuvir
- Glecaprevir/Pibrentasvir
Major Interactions
- CYP3A4 inducers (e.g., Rifampin, Carbamazepine, Phenytoin, Phenobarbital, Topiramate, St. John's Wort) - may decrease contraceptive efficacy
- Lamotrigine - COCs can decrease lamotrigine levels, leading to loss of seizure control
- Tranexamic Acid - increased risk of thrombosis
- Griseofulvin - may decrease contraceptive efficacy
Moderate Interactions
- Certain broad-spectrum antibiotics (e.g., Tetracyclines, Ampicillin) - theoretical risk of decreased contraceptive efficacy due to altered enterohepatic recirculation (clinical significance debated)
- CYP3A4 inhibitors (e.g., Azole antifungals like Ketoconazole, Itraconazole; Macrolide antibiotics like Erythromycin, Clarithromycin) - may increase estrogen levels
- Grapefruit juice - may increase estrogen levels
- Thyroid hormones - COCs can increase thyroid-binding globulin, requiring increased thyroid hormone dose
- Warfarin - COCs may alter anticoagulant effects (monitor INR)
- Antacids, Proton Pump Inhibitors, H2 Blockers - may decrease iron absorption
- Fluoroquinolones, Tetracyclines - form insoluble complexes with iron, reducing absorption of both
Minor Interactions
- Vitamin C - may enhance iron absorption (generally beneficial)
- Calcium supplements - may inhibit iron absorption if taken concurrently
Monitoring
Baseline Monitoring
Complete Medical History (including family history of VTE, MI, stroke)
Rationale: To identify contraindications and risk factors for cardiovascular events, breast cancer, and other conditions.
Timing: Prior to initiation
Blood Pressure
Rationale: To identify hypertension, a risk factor for cardiovascular events.
Timing: Prior to initiation
Physical Examination (including breast and pelvic exam, Pap test)
Rationale: To rule out pregnancy, assess for contraindications, and establish baseline health status.
Timing: Prior to initiation (as clinically indicated)
Lipid Profile
Rationale: To assess baseline cardiovascular risk, as COCs can affect lipid levels.
Timing: Prior to initiation (as clinically indicated)
Routine Monitoring
Blood Pressure
Frequency: Annually or more frequently if risk factors present
Target: <120/80 mmHg
Action Threshold: Sustained elevation >140/90 mmHg may warrant discontinuation or alternative contraception.
Annual Physical Exam (including breast and pelvic exam, Pap test)
Frequency: Annually
Target: Normal findings
Action Threshold: Abnormal findings require further investigation.
Symptoms of Thromboembolism (e.g., DVT, PE, stroke, MI)
Frequency: Ongoing patient education and self-monitoring
Target: Absence of symptoms
Action Threshold: Immediate medical attention for new or worsening symptoms (e.g., severe leg pain, chest pain, sudden vision changes, severe headache).
Symptom Monitoring
- Severe abdominal pain (liver problems, blood clot)
- Chest pain, shortness of breath, coughing blood (pulmonary embolism, heart attack)
- Severe headache, weakness or numbness on one side of the body, speech problems, vision changes (stroke)
- Eye problems (vision loss, bulging eyes) (blood clot in eye)
- Severe leg pain, swelling, redness (deep vein thrombosis)
- Jaundice (liver problems)
- Depression or mood changes
- Unusual vaginal bleeding
- Signs of iron overload (if excessive iron intake from other sources)
Special Patient Groups
Pregnancy
Balcoltra is contraindicated during pregnancy. There is no indication for use in pregnancy, and studies have shown an association between in utero exposure to female sex hormones and congenital anomalies.
Trimester-Specific Risks:
First Trimester:
Contraindicated. Potential for increased risk of congenital anomalies (e.g., VACTERL association) if exposure occurs early in pregnancy, though data are inconsistent.
Second Trimester:
Contraindicated. No therapeutic indication.
Third Trimester:
Contraindicated. No therapeutic indication.
Lactation
Use is generally not recommended in breastfeeding women. Estrogens can decrease the quantity and quality of breast milk. Small amounts of contraceptive steroids and/or their metabolites are excreted in breast milk and may affect the infant.
Infant Risk:
Potential for adverse effects on the infant, including jaundice and breast enlargement. Long-term effects on breastfed infants are not fully known. Consider alternative contraception or delaying initiation until weaning.
Pediatric Use
Balcoltra is indicated only after menarche. Safety and efficacy are expected to be similar to adults post-menarche. Not for use in pre-menarcheal females.
Geriatric Use
Balcoltra is not indicated for use in postmenopausal women. The risk of cardiovascular events increases with age, and COCs are generally not recommended for women over 35 who smoke or for women over 40-50 due to increased cardiovascular risks.
Clinical Information
Clinical Pearls
- Emphasize the importance of taking the pill at the same time every day to maintain consistent hormone levels and maximize contraceptive efficacy.
- Counsel patients on the critical importance of not smoking while on COCs due to the significantly increased risk of serious cardiovascular events.
- Educate patients on the 'ACHES' warning signs of serious adverse events (Abdominal pain, Chest pain, Headaches, Eye problems, Severe leg pain) and when to seek immediate medical attention.
- Remind patients that Balcoltra does not protect against HIV infection or other sexually transmitted infections (STIs).
- Advise patients that breakthrough bleeding or spotting is common, especially during the first few months of use, and usually resolves over time. If persistent or heavy, it warrants evaluation.
- The iron component is for iron supplementation and does not contribute to contraception. It is typically included in the inactive pills.
Alternative Therapies
- Progestin-only pills (POPs)
- Contraceptive patch (Xulane)
- Vaginal ring (NuvaRing, Annovera)
- Contraceptive injection (Depo-Provera)
- Contraceptive implant (Nexplanon)
- Intrauterine devices (IUDs - hormonal or copper)
- Barrier methods (condoms, diaphragm, cervical cap)
- Surgical sterilization (tubal ligation, vasectomy)
- Emergency contraception
Cost & Coverage
Average Cost:
Typically $100 - $200+ per 28 tablets (1 cycle)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Brand name), Tier 1 (Generic)
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, so it is a good idea to consult with your pharmacist. If you have any questions or concerns about this medication, do not hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.