Uses
What is Nextstellis used for?
Nextstellis is a combination birth control pill (oral contraceptive) commonly used to prevent pregnancy. Nextstellis contains 2 types of hormones: drospirenone (a progestin) and estetrol (an estrogen).
Nextstellis may also be used for other conditions as determined by your healthcare provider.
How does Nextstellis work (mechanism of action)?
Nextstellis stops ovulation, which prevents your ovaries from releasing an egg.
How is Nextstellis supplied (dosage forms)?
Nextstellis is available in the following dosage form that is taken by mouth.
- drospirenone and estetrol oral tablets (3 mg/14.2 mg)
How should I store Nextstellis?
Nexstellis should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C), for shorter periods of time, such as when transporting it. Store in a cool, dry place.
Side Effects
What are the most common side effects of Nextstellis?
The most common side effects of Nextstellis are listed below. Tell your healthcare provider if you have any of these side effects that bother you.
- Bleeding between periods
- Changes in mood or behavior
- Headache
- Breast tenderness, pain, and discomfort
- Painful periods
- Acne
- Weight gain
- Decreased sex drive
There may be other side effects of Nextstellis that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Nextstellis?
While less common, the most serious side effects of Nextstellis are described below, along with what to do if they happen.
Severe Allergic Reactions. Nextellis may cause allergic reactions, which can be serious. Stop using Nextellis and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin called hives
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Blood Clots. Nextstellis may cause blood clots in your veins or arteries and could cause venous thromboembolism (VTE), stroke, heart attack, a blood clot in the lungs (pulmonary embolism), or blood clot in the eyes (retinal vein thrombosis). Stop taking Nextstellis and get emergency help right away if you have any of the following signs of blood clots.
- Chest pain or pressure
- Fast or abnormal heartbeat
- Trouble breathing
- Pain in your back, jaw, throat, or arm
- Sweating, upset stomach, vomiting, or dizziness
- Sudden weakness on one side of your body
- Sudden and severe headache
- Slurred speech, trouble understanding speech, or trouble speaking
- Pain, swelling, or tenderness in your arm or leg that will not go away
- Vision loss
- Bulging eyes
- Double vision
Increased Blood Pressure (Hypertension). Nextstellis may increase your blood pressure or make it worse if you have a history of high blood pressure. Stop taking Nextellis and call your healthcare provider if your blood pressure increases significantly while taking this medicine.
If you measure your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, stop taking Nextstellis and get medical attention right away. Increases in blood pressure may not be noticeable but look out for any of the following symptoms of severely high blood pressure.
- Sudden severe headache
- Chest pain
- Dizziness or confusion
- Trouble breathing
- Nausea/vomiting
- Blurry or other changes to vision
- Anxiety
- Buzzing in the ears
- Nosebleed
- Feeling of skipped heart beats
Migraine. Stop taking Nextstellis and call your healthcare provider right away if you develop new migraines that keep coming back or cause you a lot of pain. Talk to your healthcare provider right away if you develop migraine headaches with aura. Aura can cause vision or hearing changes, muscle weakness, tingling, or trouble speaking.
Cancer. Nextellis is a combination birth control pill that contains two hormones. Certain cancers, including breast cancer, cervical cancer, skin cancer, lung cancer, and brain cancer are types of cancers that may be sensitive to hormones. Make sure you keep all appointments with your doctor.
Liver Problems. Liver problems, including tumors on the liver and an increase in your liver enzymes, can happen when taking Nextellis. Call your healthcare provider right away if you have any of the following symptoms.
- Nausea or vomiting
- Stomach or belly pain
- Fever
- Weakness or unusual tiredness
- Itching
- Loss of appetite
- Light-colored poop
- Dark-colored urine
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
Depression. Nextstellis may cause changes in mood, including depression. Stop taking Nextstellis and call your healthcare provider right away if you have new or increased depression or other unusual changes in mood or behavior.
High Potassium Level (Hyperkalemia). Nextstellis can cause a high potassium level, which can be serious and may lead to death. Your healthcare provider will check your potassium levels, especially if you take certain other medicines. Call your healthcare provider if you have any of the following symptoms of a high potassium level.
- Weakness or numbness your arm or leg
- Feeling of skipped heart beats
- Nausea
- Vomiting
- Chest pain
- Shortness of breath
Gallbladder Problems. Nextstellis can cause gallbladder problems or cholestasis (slowed flow of bile from the liver). Call your healthcare provider right away if you have any of the following symptoms.
- Fever
- Your skin or the whites of your eyes turning yellowish in color (also called jaundice)
- Pain in your upper stomach area
- Stool (poop) that is clay-colored
Warnings & Precautions
Who should not use Nextstellis?
Allergies to Ingredients. People who are allergic to any of the following should not take Nextstellis.
- Nextstellis
- Drospirenone
- Estetrol
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Nextstellis
Drug Interactions. Nextstellis should not be taken while you are using certain other medicines. Before taking Nextstellis, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.
Smoking. Nextstellis should not be taken if you smoke and are 35 years of age or older.
Blood Clots. Nextstellis should not be taken if you currently have or have had blood clots, such as deep vein thrombosis (DVT), pulmonary embolism (PE), stroke, heart attack, or have had blood clots/blood vessel damage from diabetes.
Blood and Blood Vessel Problems. Nexstellis should not be taken if you have a condition that makes you more likely to get blood clots (hypercoagulation). Nextstellis should not be taken if you have plaque buildup in the blood vessels of your heart (coronary artery disease) or if you have a condition that affects the blood flow to your brain (cerebrovascular disease).
bNextstellis should not be taken if you have heart rhythm problems (such as atrial fibrillation) or heart valve problems, as these may increase your chances of having a blood clot.
Increased Blood Pressure (Hypertension). Nextstellis should not be taken if you have high blood pressure that is not controlled or high blood pressure with a condition that affects your blood vessels (vascular disease).
Diabetes. Nextstellis should not be taken if you have diabetes with high blood pressure or diabetes with kidney, eye, nerve, or blood vessel damage. Nextstellis should not be taken if you have had diabetes for more than 20 years.
Migraines. Nextstellis should not be taken if you have migraines with vision or hearing changes, muscle weakness, tingling, or trouble speaking (aura), as this can increase your risk of having a stroke.
Breast Cancer. Nextstellis should not be taken if you have or have had breast cancer.
Liver Tumors or Problems. Nextstellis should not be used if you have hepatic adenoma (a non-cancerous tumor on your liver), hepatocellular carcinoma (cancerous tumor on the liver), acute hepatitis (inflammation of the liver), or decompensated cirrhosis (scar tissue on your liver).
Spotting. Nextstellis should not be taken if you are bleeding between your monthly periods without a known cause. Tell your healthcare provider if you are bleeding between your monthly periods while on Nextstellis. Your healthcare provider will find out why this is happening and may do tests to determine if you are able to take this medicine.
Kidney Problems. Nextstellis should not be taken if your kidneys are not working as well as they should be. If there is a concern about the health of your kidneys, your healthcare provider may do tests to determine if they are working well enough to take this medicine.
Reduced Adrenal Function. Nextstellis should not be taken if you have adrenal insufficiency, which is when your adrenal glands do not make enough cortisol (the stress hormone).
What should I know about Nextstellis before using it?
Read the Instructions for Use when taking Nextstellis for the first time and for instructions on how to take Nextellis if you have missed a dose.
Do not take Nextstellis if you smoke and are 35 years of age or older. Smoking while taking Nextstellis can increase your chances of having heart and blood vessel problems, which can include blood clots, heart attack, or stroke. Your risk increases as you get older and the number of cigarettes you smoke.
Nextellis does not protect against human immunodeficiency virus (HIV), acquired immunodeficiency syndrome (AIDS), or other sexually transmitted infections (STIs).
Nextellis comes in a blister pack with 28 tablets that are separated into different colors. Take tablets in order (from left to right) at the same time every day until the pack is finished. Swallow the tablets whole. After taking the last tablet in the blister pack, start with the first tablet in a new blister pack. Talk to your healthcare provider about backup contraception options (condoms, spermicide).
Your periods may be irregular, lighter, and/or shorter than usual while you are taking Nextellis. If you miss your period and have not taken Nextellis as directed, call your healthcare provider right away.
You may also have spotting or light bleeding between your periods, which can last a few months. Call your healthcare provider if this does not go away after a few months.
Do not take Nextstellis unless it has been prescribed to you by a healthcare provider. Take it as prescribed.
Do not share Nextstellis with other people, even if they have the same condition as you. It may harm them.
Keep Nextstellis out of the reach of children.
What should I tell my healthcare provider before using Nextstellis?
Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Nextstellis is right for you.
In particular, make sure that you discuss any of the following.
Immobilization. Talk to your healthcare provider if you are unable to walk for an extended period of time (immobile). Taking Nextellis while you are immobile may increase your risk of having blood clots.
Major Surgeries. Talk to your healthcare provider about any upcoming surgeries. Taking Nextellis may increase your risk of blood clots after surgery. Your healthcare provider may stop Nextellis if you are about to have major surgery and may not start you on it right away after your surgery. If your healthcare provider decides to stop Nextellis because of an upcoming surgery, your healthcare provider will talk to you about other forms of contraception to use during that time.
Skin Issues. Talk to your healthcare provider if you have had a condition that led to dark patches of skin around your forehead, nose, cheeks, and around your mouth, especially during pregnancy (chloasma) as this may increase your chances of having chloasma while taking Nextellis. Tell your healthcare provider if you have sensitivity to the sun or to ultraviolet (UV) rays from tanning booths or sun lamps.
Angioedema. Talk to your healthcare provider if you have a condition called hereditary angioedema that leads to swelling in different parts of your body including your lips, face, tongue, or throat. Taking Nextellis may increase your chances of having angioedema or make your angioedema symptoms worse if you have a history of angioedema.
Depression. Talk to your healthcare provider if you have a history of depression. Taking Nextstellis may worsen depression.
Diabetes. Tell your healthcare provider if you have prediabetes or diabetes. Nextellis may increase your blood sugar.
High Triglycerides. Tell your healthcare provider if you have high triglyceride levels or you have a family history of high triglyceride levels. Netxtellis may increase your triglyceride levels, which may increase your chances of having pancreatitis. Your healthcare provider will decide if you should take Nextellis.
Gallbladder or Liver Problems. Tell your healthcare provider if you have gallbladder or liver problems, including jaundice, cholestasis (slowed flow of bile from the liver), or a history of cholestasis, especially during pregnancy. Taking Nextellis can increase your chances of having cholestasis and can worsen your gallbladder problems.
Pregnancy. Nextellis may cause harm to an unborn baby. Tell your healthcare provider if you are or plan to become pregnant. If you become pregnant, stop taking Nextellis right away and contact your healthcare provider.
Breastfeeding. Nextellis passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Nextellis may decrease the amount of breastmilk you make. Your healthcare provider will advise you if you should take Nextellis while breastfeeding.
How can I get more information about Nextstellis?
For more information about Nextstellis, you can visit the manufacturer’s website at https://www.nextstellis.com/ or call them at 844-825-8500.
Interactions
Does Nextstellis interact with foods or drinks?
There are no known interactions between Nextstellis and foods or drinks.
There are no known interactions between Nextstellis and alcohol.
Does Nextstellis interact with other medicines (drug interactions)?
Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
In particular, make sure that you discuss if you are using any of the following before using Nextellis.
- A combination of ombitasvir, paritaprevir, ritonavir, and/or dasabuvir, which are medicines used for hepatitis C
- A protease inhibitor and non-nucleoside reverse transcriptase inhibitor (nelfinavir, ritonavir, boceprevir, telaprevir, indinavir, nevirapine, etravirine), which are used for HIV and hepatitis C
- A medicine for diabetes
- A medicine that can increase the level of potassium in the blood (potassium supplements, spironolactone, amiloride, triamterene, eplerenone)
- A medicine used to control seizures
- A corticosteroid, which is a medicine for certain inflammatory conditions
- A thyroid medicine, such as levothyroxine, which is used to raise thyroid hormone levels
- A bile acid sequestrant, which is a medicine used to lower cholesterol
Some other medicines may alter the blood levels of Nextellis, and vice versa. Tell your healthcare provider about all medicines that you take or have recently taken.
This may not be a complete list of medicines that can interact with Nextellis. Always check with your healthcare provider.
Overdose/Missed Dose
What should I do if I accidentally use too much Nextstellis?
If you or someone else has used too much Nextstellis, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Nextstellis?
Nextstellis may not work as it should if you miss tablets. Follow the Instructions for Use on how to take Nextstellis when you miss a dose, as this can change depending on how many tablets you have missed and which weeks they were missed. Follow the Instructions for Use if you vomit or have diarrhea after taking Nextellis. Talk to your healthcare provider about back up contraception options.
Are you currently using Nextstellis (drospirenone/estetrol)?
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