Nextstellis 3-14.2mg 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
Pregnancy Category
Contraindicated
FDA Approved
Apr 2021
DEA Schedule
Not Controlled
Overview
What is this medicine?
Nextstellis is a birth control pill that contains two hormones, drospirenone and estetrol. It works by preventing your body from releasing an egg (ovulation) and by changing the lining of your womb and the mucus in your cervix to prevent pregnancy. Estetrol is a new type of estrogen that is naturally produced in the body during pregnancy.
How to Use This Medicine
Taking Your Medication Correctly
To use this medication effectively, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the guidelines.
Take this medication at the same time every day.
You can take it with or without food.
Make sure you understand when to start taking this medication. If you're unsure, consult your doctor.
After starting this medication, you may need to use a non-hormonal form of birth control, such as condoms, to prevent pregnancy for a certain period. Follow your doctor's advice on using non-hormonal birth control.
Do not skip doses, even if you don't have sex frequently.
If you vomit or have diarrhea, this 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 the symptoms persist for more than a day, use an additional form of birth control and contact your doctor. If you're unsure what to do, call your doctor.
Important Warnings and Precautions
If you miss two periods in a row, take a pregnancy test before starting a new dosing cycle.
If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor.
If you have high blood sugar (diabetes), inform your doctor, as this medication may increase blood sugar levels.
Monitor your blood sugar levels as advised by your doctor.
If you're taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding the bathroom.
Missing a Dose
If you miss a dose, refer to the package insert or contact your doctor for guidance.
If you're using this medication to prevent pregnancy and miss a dose, you may need to use a non-hormonal form of birth control, such as condoms, for a certain period to prevent pregnancy.
To use this medication effectively, follow your doctor's instructions carefully. Read all the information provided to you and adhere to the guidelines.
Take this medication at the same time every day.
You can take it with or without food.
Make sure you understand when to start taking this medication. If you're unsure, consult your doctor.
After starting this medication, you may need to use a non-hormonal form of birth control, such as condoms, to prevent pregnancy for a certain period. Follow your doctor's advice on using non-hormonal birth control.
Do not skip doses, even if you don't have sex frequently.
If you vomit or have diarrhea, this 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 the symptoms persist for more than a day, use an additional form of birth control and contact your doctor. If you're unsure what to do, call your doctor.
Important Warnings and Precautions
If you miss two periods in a row, take a pregnancy test before starting a new dosing cycle.
If you regularly consume grapefruit juice or eat grapefruit, discuss this with your doctor.
If you have high blood sugar (diabetes), inform your doctor, as this medication may increase blood sugar levels.
Monitor your blood sugar levels as advised by your doctor.
If you're taking a salt substitute containing potassium, a potassium-sparing diuretic, or a potassium product, consult your doctor.
Storing and Disposing of Your Medication
Store this medication at room temperature in a dry place, avoiding the bathroom.
Missing a Dose
If you miss a dose, refer to the package insert or contact your doctor for guidance.
If you're using this medication to prevent pregnancy and miss a dose, you may need to use a non-hormonal form of birth control, such as condoms, for a certain period to prevent pregnancy.
Lifestyle & Tips
- Do not smoke, especially if you are over 35 years old, as this significantly increases your risk of serious side effects like blood clots, heart attack, and stroke.
- Take one tablet every day at the same time to ensure maximum effectiveness.
- Use a backup method of birth control (like condoms) for the first 7 days of your first pack, or if you miss pills.
- Be aware of the signs 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.
- Inform your healthcare provider about all medications, supplements, and herbal products you are taking, as they can interact with Nextstellis.
Available Forms & Alternatives
Available Strengths:
Dosing & Administration
Adult Dosing
Standard Dose:
One tablet orally once daily at the same time each day, starting with the first tablet on the first day of menstruation.
Dose Range:
3 - 14.2 mg
Condition-Specific Dosing:
missedDose:
If one active tablet is missed, take it as soon as possible and continue with the next tablet at the regular time. If two or more active tablets are missed, refer to package insert for specific instructions and consider backup contraception.
postpartum:
Do not use earlier than 4 weeks postpartum in non-breastfeeding women. In breastfeeding women, not recommended until weaning or at least 6 months postpartum.
Pediatric Dosing
Neonatal:
Not established
Infant:
Not established
Child:
Not established
Adolescent:
Indicated for use in females of reproductive potential; safety and efficacy established in women aged 16 years and older. Not indicated before menarche.
Dose Adjustments
Renal Impairment:
Mild:
Contraindicated
Moderate:
Contraindicated
Severe:
Contraindicated
Dialysis:
Contraindicated
Hepatic Impairment:
Mild:
Contraindicated
Moderate:
Contraindicated
Severe:
Contraindicated
Pharmacology
Mechanism of Action
Nextstellis works primarily by inhibiting ovulation through suppression of gonadotropins (follicle-stimulating hormone and luteinizing hormone). It also causes changes in the cervical mucus, making it more difficult for sperm to penetrate the uterus, and alters the endometrium, reducing the likelihood of implantation. Estetrol (E4) is a novel, native estrogen that acts as a selective estrogen receptor modulator (SERM) in some tissues and a full agonist in others, contributing to ovulation inhibition and cycle control. Drospirenone (DRSP) is a synthetic progestin with anti-mineralocorticoid and anti-androgenic activity.
Pharmacokinetics
Absorption:
Bioavailability:
Estetrol: ~60-70%; Drospirenone: ~76%
Tmax:
Estetrol: 0.5-2 hours; Drospirenone: 1-3 hours
FoodEffect:
Food does not significantly affect the extent of absorption of estetrol or drospirenone.
Distribution:
Vd:
Estetrol: ~40 L; Drospirenone: ~4 L/kg
ProteinBinding:
Estetrol: ~50% (primarily to albumin); Drospirenone: ~97% (primarily to albumin, not to SHBG or CBG)
CnssPenetration:
Limited
Elimination:
HalfLife:
Estetrol: ~24-28 hours; Drospirenone: ~30-34 hours
Clearance:
Estetrol: ~10.5 L/h; Drospirenone: ~1.4 mL/min/kg
ExcretionRoute:
Estetrol: Primarily renal (69% as glucuronide conjugates), some fecal; Drospirenone: Primarily fecal (60%), some renal (40%)
Unchanged:
Estetrol: <1% (urine); Drospirenone: <1% (urine)
Pharmacodynamics
OnsetOfAction:
Contraceptive efficacy begins after 7 consecutive days of active tablet use, assuming proper initiation on Day 1 of menses.
PeakEffect:
Ovulation inhibition is achieved within the first cycle of proper use.
DurationOfAction:
24 hours (requires daily dosing)
Safety & Warnings
BLACK BOX WARNING
Cigarette smoking increases the risk of serious cardiovascular events from combined hormonal contraceptive (CHC) use. This risk increases with age, particularly in women over 35 years of age, and with the number of cigarettes smoked. For this reason, CHCs, including Nextstellis, 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 potassium levels: abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, feeling like passing out, numbness or tingling, or shortness of breath.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
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.
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Weakness on one side of the body, trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Depression or other mood changes.
Breast lump, breast pain or tenderness, or nipple discharge.
Vaginal itching or discharge, severe or persistent vaginal bleeding, or spotting.
Changes in vision, bulging eyes, or changes in how contact lenses feel.
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, 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 help:
Weight gain
Headache
Menstrual changes, including spotting or bleeding between cycles
Painful periods
Breast tenderness
Acne
* Decreased interest in sex
This is not an exhaustive list of all possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
Signs of an allergic reaction: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, 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 potassium levels: abnormal heartbeat, confusion, weakness, lightheadedness, dizziness, feeling like passing out, numbness or tingling, or shortness of breath.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
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.
Signs of high blood sugar: confusion, drowsiness, unusual thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Weakness on one side of the body, trouble speaking or thinking, balance changes, drooping on one side of the face, or blurred vision.
Depression or other mood changes.
Breast lump, breast pain or tenderness, or nipple discharge.
Vaginal itching or discharge, severe or persistent vaginal bleeding, or spotting.
Changes in vision, bulging eyes, or changes in how contact lenses feel.
Signs of a blood clot: chest pain or pressure, coughing up blood, shortness of breath, swelling, warmth, numbness, color changes, or pain in a leg or arm, 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 help:
Weight gain
Headache
Menstrual changes, including spotting or bleeding between cycles
Painful periods
Breast tenderness
Acne
* Decreased interest in sex
This is not an exhaustive list of all possible 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
- Blurred vision or loss of vision
- Sudden numbness or weakness on one side of the body
- Severe chest pain 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
- Depressed mood or thoughts of self-harm
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 you experienced, including any symptoms.
A history of angioedema, a severe and potentially life-threatening reaction characterized by swelling of the hands, face, lips, eyes, tongue, or throat, difficulty breathing, swallowing problems, or unusual hoarseness.
Kidney problems or adrenal gland issues.
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
+ Angina (chest pain) or a history of heart attack or stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
Unexplained vaginal bleeding.
A history of jaundice (turning yellow) during pregnancy or while using estrogen-containing medications, such as hormonal birth control.
Recent use of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks.
Pregnancy or suspected pregnancy. Do not take this medication if you are pregnant.
Additionally, inform your doctor and pharmacist about all medications you are taking, including:
Prescription and over-the-counter medications
Natural products
* Vitamins
It is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or change the dose of any medication without consulting 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 you experienced, including any symptoms.
A history of angioedema, a severe and potentially life-threatening reaction characterized by swelling of the hands, face, lips, eyes, tongue, or throat, difficulty breathing, swallowing problems, or unusual hoarseness.
Kidney problems or adrenal gland issues.
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
+ Angina (chest pain) or a history of heart attack or stroke
+ High blood pressure
+ Liver tumors or other liver problems
+ Severe headaches or migraines
+ Diabetes
Unexplained vaginal bleeding.
A history of jaundice (turning yellow) during pregnancy or while using estrogen-containing medications, such as hormonal birth control.
Recent use of ombitasvir, paritaprevir, and ritonavir (with or without dasabuvir) within the past 2 weeks.
Pregnancy or suspected pregnancy. Do not take this medication if you are pregnant.
Additionally, inform your doctor and pharmacist about all medications you are taking, including:
Prescription and over-the-counter medications
Natural products
* Vitamins
It is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Do not start, stop, or change the dose of any medication without consulting your doctor.
Precautions & Cautions
Important Warnings and Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Your doctor may advise you to stop taking this medication 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 Clot Risk
This medication may increase the risk of blood clots, stroke, or heart attack. Discuss this risk with your doctor. The hormone drospirenone in this medication may further increase the risk of blood clots compared to other birth control pills. Talk to your doctor about this risk.
If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, inform your doctor. Prolonged immobility may increase your risk of blood clots.
High Blood Pressure and Triglyceride Levels
This medication may cause high blood pressure. Monitor your blood pressure as directed by your doctor. Additionally, this medication may lead to high triglyceride levels. If you have a history of high triglyceride levels, inform your doctor.
Regular Health Check-Ups
Regular breast exams and gynecology check-ups are crucial while taking this medication. Perform breast self-exams as instructed by your doctor. Also, have blood work done as directed by your doctor and discuss the results with your doctor.
Lab Tests and Interactions
This medication may affect 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 interact with this medication, reducing its effectiveness. Ensure your doctor is aware of all your medications and health conditions. You may need to use a non-hormone form of birth control, such as condoms, in addition to this medication.
Cancer Risks
Some studies suggest that taking hormone-based birth control, like this medication, for an extended period may increase the risk of breast cancer. However, other studies have not confirmed this risk. Discuss any concerns with your doctor. Additionally, 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, talk to your doctor.
Skin Darkening
This medication may cause dark patches of skin on your face. Avoid sun exposure, sunlamps, and tanning beds. Use sunscreen and protective clothing and eyewear to minimize sun exposure.
Sexually Transmitted Diseases
This medication does not protect against diseases like HIV or hepatitis that are transmitted through sexual contact. Use latex or polyurethane condoms to reduce the risk of transmission. If you have questions, discuss them with your doctor.
Body Mass Index (BMI)
Know your BMI, as this medication may be less effective if your BMI is 30 or higher. If you are unsure about your BMI, consult your doctor.
Contraindications
Do not use this medication 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.
Breastfeeding
If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.
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 medication 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 Clot Risk
This medication may increase the risk of blood clots, stroke, or heart attack. Discuss this risk with your doctor. The hormone drospirenone in this medication may further increase the risk of blood clots compared to other birth control pills. Talk to your doctor about this risk.
If you will be immobile for extended periods, such as during long trips, bedrest after surgery, or illness, inform your doctor. Prolonged immobility may increase your risk of blood clots.
High Blood Pressure and Triglyceride Levels
This medication may cause high blood pressure. Monitor your blood pressure as directed by your doctor. Additionally, this medication may lead to high triglyceride levels. If you have a history of high triglyceride levels, inform your doctor.
Regular Health Check-Ups
Regular breast exams and gynecology check-ups are crucial while taking this medication. Perform breast self-exams as instructed by your doctor. Also, have blood work done as directed by your doctor and discuss the results with your doctor.
Lab Tests and Interactions
This medication may affect 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 interact with this medication, reducing its effectiveness. Ensure your doctor is aware of all your medications and health conditions. You may need to use a non-hormone form of birth control, such as condoms, in addition to this medication.
Cancer Risks
Some studies suggest that taking hormone-based birth control, like this medication, for an extended period may increase the risk of breast cancer. However, other studies have not confirmed this risk. Discuss any concerns with your doctor. Additionally, 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, talk to your doctor.
Skin Darkening
This medication may cause dark patches of skin on your face. Avoid sun exposure, sunlamps, and tanning beds. Use sunscreen and protective clothing and eyewear to minimize sun exposure.
Sexually Transmitted Diseases
This medication does not protect against diseases like HIV or hepatitis that are transmitted through sexual contact. Use latex or polyurethane condoms to reduce the risk of transmission. If you have questions, discuss them with your doctor.
Body Mass Index (BMI)
Know your BMI, as this medication may be less effective if your BMI is 30 or higher. If you are unsure about your BMI, consult your doctor.
Contraindications
Do not use this medication 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.
Breastfeeding
If you are breastfeeding, inform your doctor, as you will need to discuss the potential risks to your baby.
Overdose Information
Overdose Symptoms:
- Nausea
- Vomiting
- Vaginal bleeding (especially in females)
What to Do:
Overdose is generally not life-threatening. Treatment is symptomatic. Call 1-800-222-1222 (Poison Control Center) for advice.
Drug Interactions
Contraindicated Interactions
- Drugs that increase serum potassium (e.g., potassium-sparing diuretics, potassium supplementation, ACE inhibitors, ARBs, aldosterone antagonists, NSAIDs, heparin) in patients with renal or hepatic impairment
- Hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir (risk of ALT elevations)
Major Interactions
- Strong CYP3A4 inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's Wort, topiramate, barbiturates, efavirenz, nevirapine) - may decrease contraceptive efficacy and increase breakthrough bleeding.
- Lamotrigine (estrogens can decrease lamotrigine plasma concentrations, potentially leading to loss of seizure control).
- Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, voriconazole, clarithromycin, erythromycin, diltiazem, verapamil, grapefruit juice) - may increase drospirenone exposure and risk of hyperkalemia.
Moderate Interactions
- Moderate CYP3A4 inducers/inhibitors
- Thyroid hormone replacement therapy (may require increased thyroid hormone dose as estrogens can increase thyroid-binding globulin).
Minor Interactions
- Ascorbic acid (may increase estrogen levels slightly)
- Acetaminophen (may increase estrogen levels slightly)
Monitoring
Baseline Monitoring
Blood Pressure
Rationale: To identify pre-existing hypertension and monitor for potential increases.
Timing: Prior to initiation
Physical Examination (including breast and pelvic exam)
Rationale: To assess overall health and rule out contraindications.
Timing: Prior to initiation
Serum Potassium
Rationale: Drospirenone has anti-mineralocorticoid activity; monitor in patients at risk for hyperkalemia (e.g., renal impairment, concomitant use of potassium-sparing drugs).
Timing: Prior to initiation and during the first cycle in at-risk patients
Routine Monitoring
Blood Pressure
Frequency: Annually or as clinically indicated
Target: <140/90 mmHg
Action Threshold: Sustained elevation requiring intervention or discontinuation.
Annual Physical Examination
Frequency: Annually
Target: N/A
Action Threshold: Development of new contraindications or risk factors.
Serum Potassium
Frequency: Periodically, especially during the first cycle or with changes in concomitant medications, in at-risk patients.
Target: 3.5-5.0 mEq/L
Action Threshold: Potassium >5.5 mEq/L or symptomatic hyperkalemia.
Symptom Monitoring
- Signs/symptoms of venous thromboembolism (VTE) such as leg pain, swelling, chest pain, shortness of breath
- Signs/symptoms of arterial thromboembolism (e.g., stroke, myocardial infarction) such as sudden severe headache, vision changes, weakness/numbness, chest pain
- Signs/symptoms of liver dysfunction (e.g., jaundice, severe abdominal pain, dark urine)
- Severe or persistent headache
- Changes in vision
- Mood changes or depression
- Unusual vaginal bleeding
Special Patient Groups
Pregnancy
Contraindicated. Nextstellis is intended to prevent pregnancy and should not be used during pregnancy. Discontinue if pregnancy is confirmed.
Trimester-Specific Risks:
First Trimester:
No increased risk of birth defects reported with inadvertent exposure to oral contraceptives early in pregnancy.
Second Trimester:
Not applicable, as use is contraindicated.
Third Trimester:
Not applicable, as use is contraindicated.
Lactation
Not recommended. Estrogens can decrease the quantity and quality of breast milk. Both drospirenone and estetrol are excreted into breast milk. Consider alternative contraceptive methods or discontinue breastfeeding.
Infant Risk:
Potential for adverse effects on the breastfed infant (e.g., jaundice, breast enlargement) and reduction in milk supply.
Pediatric Use
Safety and efficacy have been established in women of reproductive age. Not indicated for use before menarche. Use in adolescents (post-menarche) is similar to adults.
Geriatric Use
Not indicated for use in postmenopausal women. Safety and efficacy have not been established in geriatric populations.
Clinical Information
Clinical Pearls
- Nextstellis contains estetrol (E4), a novel, native estrogen, which is the first new estrogen introduced in a combined oral contraceptive in over 50 years. It has a distinct pharmacological profile compared to ethinyl estradiol.
- Due to drospirenone's anti-mineralocorticoid activity, monitor serum potassium in patients at risk for hyperkalemia, especially during the first cycle or with concomitant use of potassium-sparing drugs.
- This product has a Boxed Warning regarding the increased risk of serious cardiovascular events in women over 35 who smoke.
- Nextstellis has been shown to have a favorable bleeding profile and may be associated with less impact on lipid parameters compared to some other COCs.
- Counsel patients on the importance of consistent daily dosing for contraceptive efficacy and the use of backup contraception if pills are missed.
Alternative Therapies
- Progestin-only pills (POPs)
- Progestin injections (e.g., Depo-Provera)
- Progestin implants (e.g., Nexplanon)
- Intrauterine devices (IUDs - hormonal and non-hormonal)
- Barrier methods (e.g., condoms, diaphragm)
- Spermicides
- Natural family planning methods
- Sterilization (tubal ligation, vasectomy)
Cost & Coverage
Average Cost:
$150 - $250 per 28 tablets
Insurance Coverage:
Tier 2 or Tier 3 (preferred brand or non-preferred brand)
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 emergency medical attention. When seeking help, be prepared to provide details about the medication taken, the amount, and the time it happened.