Nextstellis

• 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.

• 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.

• 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.

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 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 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.

• 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.

• 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.

• 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.

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.

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.

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.

• 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.