Nextstellis
Nextstellis is a combination birth control pill that's used to help prevent pregnancy. It contains two hormones: drospirenone and estetrol. Nextstellis is the first birth control pill that contains estetrol, a new type of estrogen approved in over 60 years that's also made from a plant source. Each blister card has 24 pink active pills and 4 white inactive pills. Each pill is taken by mouth once daily in the order noted in the instructions. The active pills are monophasic, meaning they contain the same amount of hormones throughout the entire pack. Side effects include irregular vaginal bleeding and mood changes.
What is Nextstellis?
What is Nextstellis used for?
To prevent pregnancy
How Nextstellis works
Nextstellis contains a combination of two hormones: drospirenone (a progestin) and estetrol (an estrogen). These hormones work together to prevent pregnancy by:
Stopping your ovaries from releasing an egg (also known as ovulation)
Making it harder for sperm to move through to fertilize an egg
Making it harder for a fertilized egg to attach to the uterus and grow
Drug Facts
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What are the side effects of Nextstellis?
Common Side Effects
- Mood changes or mood swings (11%)
- Irregular vaginal bleeding (10%)
- Breast symptoms, like changes in color or size, breast pain, or swelling (5%)
- Headache (5%)
Other Side Effects
- Menstrual cramps
- Weight gain
- Acne
- Reduced sex drive
Serious Side Effects
- Heart attack: chest pain, arm pain, shortness of breath, cold sweat
- Stroke: sudden weakness on one side of the body, drooping face, headache, changes in your speech or vision, confusion
- Deep vein thrombosis (blood clot in the leg): leg cramp, swelling, pain, muscle tightness
- Pulmonary embolism (blood clot in the lung): cough, chest pain, trouble breathing, racing heart
- Retinal vein thrombosis (blood clot in the eyes): problems seeing, vision loss, eye pain
- Serious liver problems: yellowing of the skin or the whites of the eyes, tiredness, stomach pain
- High potassium levels: tiredness, fast heartbeat, muscle weakness, tingling or numbing sensation
- Depression: feeling sad, anxious, or hopeless
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Blood clot—pain, swelling, or warmth in the leg, shortness of breath, chest pain
- Gallbladder problems—severe stomach pain, nausea, vomiting, fever
- Heart attack—pain or tightness in the chest, shoulders, arms, or jaw, nausea, shortness of breath, cold or clammy skin, feeling faint or lightheaded
- High potassium level—muscle weakness, fast or irregular heartbeat
- Increase in blood pressure
- Liver injury—right upper belly pain, loss of appetite, nausea, light-colored stool, dark yellow or brown urine, yellowing skin or eyes, unusual weakness or fatigue
- New or worsening migraines or headaches
- Stroke—sudden numbness or weakness of the face, arm, or leg, trouble speaking, confusion, trouble walking, loss of balance or coordination, dizziness, severe headache, change in vision
- Worsening mood, feelings of depression
Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):
- Acne
- Breast pain or tenderness
- Dark patches of skin on the face or other sun-exposed areas
- Irregular menstrual cycles or spotting
- Nausea
- Weight gain
Pros and cons of Nextstellis
Pros
First birth control pill containing estetrol (a different type of estrogen than ethinyl estradiol)
Few people had breakthrough bleeding during studies
Cons
Must take every day around the same time to work well
No lower-cost generic available; brand name only
Pharmacist tips for Nextstellis
Carefully follow the directions on the blister card. This helps you take Nextstellis properly and lower your chances of getting pregnant.
Take 1 pill from the blister card every day. Swallow the pill whole with or without food. Take a pink pill each day for the first 24 days, then a white pill for the following 4 days. Start a new blister card of Nextstellis on the next day.
Set an alarm for the same time every day to help you remember to take Nextstellis. The chance of accidentally getting pregnant gets higher if you forget to take a pill and you're sexually active. This risk gets higher with the more pills you miss.
Refer to the instructions or ask your prescriber or pharmacist about what to do if you miss a dose. It depends on how many pills you've missed and where you are in your cycle. You might need to use a back-up method of contraception for a week while you continue to take Nextstellis.
You might have some spotting or light vaginal bleeding while you're taking the pink active pills of Nextstellis. This is normal, especially during the first 4 months of taking this birth control pill, but it should lessen over time. If the spotting doesn't improve as you continue the medication, talk to your prescriber. Switching to a different birth control might help.
Tell your prescriber ahead of time about any planned procedures or any situations where you can't walk for a long time. You're at risk for blood clots during this time and Nextstellis might put you at an even higher risk. Your prescriber will discuss with you about when to stop Nextstellis before and restart it afterwards to keep your risk for blood clots low.
Wear sunscreen and avoid tanning beds to protect your skin while you're taking Nextstellis. This medication can cause some areas of the face, such as the forehead, nose, and cheeks, to darken. Exposure to ultraviolet (UV) rays can darken these areas of skin even more.
Stop taking Nextstellis if you become pregnant while you're taking this birth control pill. You won't need birth control at that point.
Discuss with your prescriber about other birth control methods if you're breastfeeding. The hormones in Nextstellis can lower your milk supply.
Frequently asked questions about Nextstellis
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What are the risks and warnings for Nextstellis?
Nextstellis can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Cigarette smoking and risk for blood clots
Risk factors: Over age 35 and smoke cigarettes
Smoking cigarettes or using other nicotine-containing products while taking combined hormonal birth control pills like Nextstellis raises the risk for having a blood clot. Blood clots can sometimes lead to more serious problems, such as heart attack or stroke. This risk gets higher after the age of 35 and with the number of cigarettes you smoke. For this reason, you can't take Nextstellis if you're over 35 years of age and you smoke. Talk with your prescriber about other birth control options.
Blood clots and other complications
Risk factors: Personal or family history of blood clots | Age 40 years or older | Smoking | Age 35 or older and smoke | High blood pressure | High cholesterol | High blood sugar | People identified as obese | Not moving for a long period of time | Had a baby in the past 3 months
There's a small risk that taking combined hormonal birth control pills like Nextstellis can cause your blood to clump together and form blood clots. These clots can block blood from getting to other parts of your body, like your legs, lungs, eyes, heart, or brain. Some clots can lead to complications, such as heart attack or stroke.
Stop taking Nextstellis and call 911 right away if you have any symptoms of a blood clot or complications of a blood clot. These clots can occur anywhere in your body, including:
Leg: swelling, tenderness, or pain in the leg
Brain: sudden weakness on one side of your body, drooping face, bad headaches, trouble breathing, or changes in your speech or vision
Heart: arm pain, chest pain, or a cold sweat
Lung: shortness of breath
Eye: double vision, partial or complete vision loss, or trouble seeing
If you need to have surgery, tell your prescriber you're taking Nextstellis. They might have you stop taking it some time before and after your surgery to lower your risk of blood clots.
High potassium levels in the blood
Risk factors: Taking other medications that can raise potassium levels | Kidney or liver damage | Low adrenal hormone levels
Nextstellis contains drospirenone, a medication that can raise the potassium levels in your blood. You can't take this birth control pill if you have a condition that can cause high potassium levels, such as liver or kidney problems. And if you're taking other medications that can cause high potassium, you might need blood tests done during your first birth control cycle with Nextstellis to check your potassium levels.
Most people who took Nextstellis had mild elevations in potassium levels during studies. Sometimes, the potassium levels returned to normal while people were still taking the birth control pill. Call your care team if you have symptoms of high potassium levels, like muscle weakness or a tingling sensation, while you're taking Nextstellis.
High blood pressure
It's recommended that you check your blood pressure regularly while you're taking Nextstellis because the birth control pill might raise your blood pressure over time. Stop taking Nextstellis and let your care team know if your blood pressure is unusually high.
Stop taking if you have a migraine
Stop taking Nextstellis if you have migraines for the first time that keep coming back, don't go away, or are severe. Also stop taking this birth control pill if you have migraines more frequently or if you have migraines that are more severe than before. People who have migraines with aura are at higher risk for stroke while they're taking combined birth control pills. For this reason, people who have migraines with aura can't take Nextstellis.
Risk for breast and cervical cancer
Risk factors: Currently have or have had breast cancer
Based on studies, it's unclear whether there's a direct link between taking combined hormonal birth control pills like Nextstellis and the risk for breast cancer or cervical cancer. But it's possible that combined hormonal birth control pills can potentially affect the risk of developing these cancers.
Nextstellis contains estrogen and progestin hormones. Some cancers, such as breast and cervical cancers, can rely on hormones like estrogen to grow. Some studies suggest that there's a slightly higher risk of breast cancer or cervical cancer if you've been taking combined birth control pills for a longer period of time.
To be safe, don't take Nextstellis if you currently have or have had breast cancer. It's important to continue to get your breast scans (mammograms) and Pap smears regularly to screen for cancer. Talk with your prescriber about your birth control options if you're worried about your risk for breast cancer or cervical cancer.
Liver or gallbladder problems
Risk factors: History of liver damage or liver problems | History of gallbladder problems | Taking certain hepatitis C combination medications
Nextstellis can raise the liver enzyme levels in the blood, which can be a sign of liver damage. You shouldn't take this medication if you have any liver problems because of the risk for more liver damage.
Taking Nextstellis might also raise your risk for new or worsening gallbladder problems. Tell your prescriber if you've had gallbladder problems in the past.
Call your care team if you notice yellowing of your skin or eyes (jaundice), upper right-sided stomach pain, nausea, vomiting, dark urine, or light-colored stool. These can be signs of either liver or gallbladder problems.
High blood sugar
Risk factors: Prediabetes or diabetes (high blood sugar)
Nextstellis can raise your blood sugar levels, since the medication can affect how well your body processes sugar. Tell your prescriber if you have high blood sugar levels or diabetes. Your prescriber might recommend that you check your blood sugar often to make sure it doesn't get too high. Contact your prescriber if you seem a lot thirstier than usual or if you urinate more often than usual while you're taking Nextstellis. These might be signs that your blood sugar levels are too high.
High cholesterol levels
Risk factors: Personal or family history of high triglyceride (fat) levels
Taking Nextstellis can raise your cholesterol levels, including your triglyceride levels. Having higher triglyceride levels can put you at risk for swelling in the pancreas (pancreatitis). Let your prescriber know if you have high cholesterol so they can consider whether Nextstellis is safe for you to take. Contact your care team if you notice signs of pancreatic problems, like sudden pain around your upper stomach to your back, stomach tenderness or bloating, nausea, or vomiting.
Possible need for changes to thyroid hormone replacement therapy
Estetrol, the estrogen component of Nextstellis, can affect the way thyroid hormone replacement therapy works. If you have a thyroid condition, tell the healthcare professional who's managing your thyroid hormone replacement therapy that you're taking Nextstellis. They might need to adjust the dose of your thyroid medication.
Irregular bleeding
You might notice changes to your menstrual bleeding patterns after starting Nextstellis. It's normal to see some breakthrough bleeding and spotting while you're taking the active birth control pills, especially during the first 4 months of taking Nextstellis. Breakthrough bleeding and spotting typically lessens over time. But let your prescriber know if it doesn't get better. Your prescriber might consider changing to a different birth control.
It's also possible that you won't have your period at all during the 4 days that you take the white inactive placebo pills. Keep in mind that not having your period can be a sign that you might be pregnant. So consider whether pregnancy is a possibility and take a pregnancy test to check if you miss your period. This is especially important if you might've forgotten to take Nextstellis for a few days.
Depression
Let your prescriber know if you experience symptoms of depression or worsening depression while taking Nextstellis. In cases of serious depression, your prescriber might have you stop taking it.
Worsening of other health conditions
Risk factors: History of hereditary angioedema | History of chloasma gravidarum
If you have certain conditions, such as hereditary angioedema or chloasma (a skin condition that causes dark patches on the face), talk to your healthcare professional before taking Nextstellis because it might worsen your symptoms. If you have a history of chloasma, limit exposure to the sun or UV light while taking birth control pills like Nextstellis.
Nextstellis dosage forms
| Dosage | Quantity | Price as low as | Price per unit |
|---|---|---|---|
| 28 tablets of 3mg/14.2mg | 1 package | $65.00 | $65.00 |
Typical dosing for Nextstellis
The typical dose is 1 pill by mouth at the same time every day. During each cycle of birth control, take 1 pink active pill for the first 24 days, then 1 white inactive (placebo) pill for the following 4 days.
Each active pill contains 3 mg of drospirenone and 14.2 mg of estetrol. And each inactive (placebo) pill doesn't contain any hormones.
How much does Nextstellis cost?
Nextstellis contraindications
Over the age of 35 who smoke
Currently have or have had a blood clot
Blood-clotting condition
Coronary artery disease (CAD)
Certain heart rhythm problems, like atrial fibrillation (AFib)
Uncontrolled high blood pressure
Diabetes with high blood pressure or organ damage
Diabetes for over 20 years
Currently have or have had breast cancer
Liver tumors or liver disease
Kidney problems
Abnormal vaginal bleeding that your prescriber doesn’t know about or hasn't checked out yet
Take hepatitis C combination medications containing ombitasvir/paritaprevir/ritonavir
What are alternatives to Nextstellis?
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References
Best studies we foundAmerican Cancer Society. (2023). What is cervical cancer?
American College of Obstetricians and Gynecologists. (2023). Abnormal uterine bleeding.
Creinin, M. D., et al. (2021). Estetrol-drospirenone combination oral contraceptive: North American phase 3 efficacy and safety results. Contraception.
French, V. (2023). What you should know about breakthrough bleeding with birth control. The American College of Obstetricians and Gynecologists.
Fruzzetti, F., et al. (2021). Estetrol: A new choice for contraception. Journal of Clinical Medicine.
Ludmann, P. (2022). Melasma: Causes. American Academy of Dermatology Association.
Mayne Pharma. (2023). Nextstellis- drospirenone and estetrol kit [package insert]. DailyMed.
Mayne Pharma and Mithra Pharmaceuticals. (2021). Mayne Pharma and Mithra announce FDA approval of new oral contraceptive Nextstellis®.
National Cancer Institute. (2018). Oral contraceptives and cancer risk.
National Institute of Diabetes and Digestive and Kidney Diseases. (2018). Definition & facts of adrenal insufficiency & Addison's disease.
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