• Nextstellis is a birth control pill (oral contraceptive) used by females to prevent pregnancy.
• Nextstellis does not protect against HIV infections (AIDS) and other sexually transmitted infections.
• Nextstellis may be less effective if you have a body mass index (BMI) of 30 or higher. In females with a BMI of 30 or higher, Nextstellis may become less effective as your BMI increases.
• It is not known if this medicine is safe and effective in females with a BMI of 35 or higher.

Do not use Nextstellis if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from birth control pills, including death from heart attack, blood clots or stroke. The risk increases with age and the number of cigarettes you  smoke.

How does Nextstellis work for contraception?

Your chance of getting pregnant depends on how well you follow the directions for taking your birth control pills. The better you follow the directions, the less chance you have of getting pregnant.
Based on the results of one clinical study of a regimen of drospirenone 3 mg and estetrol 14.2 mg tablets, about 2 out of 100 females may get pregnant within the first year they use Nextstellis.

Who should not take Nextstellis?

Do not take Nextstellis if you:

• smoke and are 35 years of age and older.
• have or have had blood clots in your arms, legs, lungs, or eyes.
• have a problem with your blood that makes it clot more than normal.
• have certain heart valve problems or an irregular heart beat that increases your risk of having blood clots.
• had a stroke.
• had a heart attack.
• have high blood pressure that cannot be controlled by medicine or have high blood pressure with blood vessel problems.
• have diabetes:
  
  • with high blood pressure or kidney, eye, nerve, or blood vessel damage, or
  • for more than 20 years.
• have certain kinds of severe migraine headaches with aura.
• have liver problems, including liver tumors.
• have any unexplained vaginal bleeding.
• have or have had breast cancer or any cancer that is sensitive to female hormones.
• have kidney disease or kidney failure.
• have reduced adrenal gland function (adrenal insufficiency).
• take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood.

If any of these conditions happen while you are taking Nextstellis, stop taking Nextstellis right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Nextstellis.

• Read the detailed Instructions for Use at the end of this Patient Information leaflet about the right way to take your Nextstellis.

Do not take Nextstellis if you:

• smoke and are 35 years of age and older.
• have or have had blood clots in your arms, legs, lungs, or eyes.
• have a problem with your blood that makes it clot more than normal.
• have certain heart valve problems or an irregular heart beat that increases your risk of having blood clots.
• had a stroke.
• had a heart attack.
• have high blood pressure that cannot be controlled by medicine or have high blood pressure with blood vessel problems.
• have diabetes:
  
  • with high blood pressure or kidney, eye, nerve, or blood vessel damage, or
  • for more than 20 years.
• have certain kinds of severe migraine headaches with aura.
• have liver problems, including liver tumors.
• have any unexplained vaginal bleeding.
• have or have had breast cancer or any cancer that is sensitive to female hormones.
• have kidney disease or kidney failure.
• have reduced adrenal gland function (adrenal insufficiency).
• take any Hepatitis C drug combination containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir. This may increase levels of the liver enzyme “alanine aminotransferase” (ALT) in the blood.

If any of these conditions happen while you are taking Nextstellis, stop taking Nextstellis right away and talk to your healthcare provider. Use non-hormonal contraception when you stop taking Nextstellis.

Before taking Nextstellis

Before taking Nextstellis, tell your healthcare provider about all of your medical conditions, including if you:

• are scheduled for surgery. Nextstellis may increase your risk of blood clots after surgery. Talk to your healthcare provider about taking Nextstellis before and after your surgery or if you are going to be unable to walk for an extended period of time (immobilized).
• are depressed now or have been depressed in the past.
• had yellowing of your skin or eyes (jaundice) caused by pregnancy (cholestasis of pregnancy).
• are pregnant or think you may be pregnant.
• are breastfeeding or plan to breastfeed. Nextstellis may decrease the amount of breast milk you make.
  Nextstellis may pass into your breast milk. Talk to your healthcare provider about the best birth control method for you while breastfeeding.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. If you are currently on daily, long-term treatment for a chronic condition with any of the following medicines, you should talk to your healthcare provider before taking Nextstellis:

• CYP inducers (aprepitant, barbituates, bosentan, carbamazepine, efavirenz, felbamate, griseofluvin, oxycarbazepine, phenytoin, rifamptin, ribatin, topiramate, products containing St. John’s wort, and others)
• CYP inhibitors (itraconazole, voriconazole, fluconazole, ketoconazole and others)
• HIV/hepatitis C virus protease inhibitors and non-nucleoside reverse transcriptase inhibitors (nelfinavir, ritonavir, boceprevir, telaprevir, indinavir, nevirapine, etravirine and others)
• Lamotrigine
• Potassium-sparing diuretics (spironolactone and others)
• Potassium supplementation
• Corticosteroids

Nextstellis may affect the way other medicines work, and other medicines may affect how well Nextstellis works.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new
medicine.

• Nextstellis may cause serious side effects including blood clots in your lungs, heart attack, or a stroke that may lead to death. Some other examples of serious blood clots include blood clots in the legs or eyes. Serious blood clots can happen especially if you smoke, are obese, have high blood pressure, have diabetes, have high cholesterol, or are older than 35 years of age. Serious blood clots are more likely to happen when you:
  • first start taking birth control pills
  • restart the same or different birth control pills after not using them for a month or more

Call your healthcare provider or go to a hospital emergency room right away if you have:

• • leg pain that will not go away
  • sudden severe shortness of breath
  • sudden change in vision or blindness
  • chest pain
  • a sudden, severe headache unlike your usual headaches
  • weakness or numbness in your arm or leg
  • trouble speaking

Other serious side effects include:

• high potassium levels in your blood (hyperkalemia). Certain medicines and conditions can also increase the potassium levels in your blood. Your healthcare provider may check the potassium levels in your blood during treatment with Nextstellis. Call your healthcare provider or go to a hospital emergency room right away if you have signs or symptoms of high potassium levels in your blood including:
  • weakness or numbness in an arm or leg
  • palpitations (feel like your heart is racing or fluttering) or irregular heartbeat
  • nausea
  • vomiting
  • severe pain in your chest
  • shortness of breath
• high blood pressure. You should see your healthcare provider to check your blood pressure regularly.
• new or worsening headaches including migraine headaches.
• possible cancer that is sensitive to female hormones, such as breast cancer, skin cancer (melanoma), lung cancer, and brain cancer.
• liver problems, including:
  • an increase in liver enzymes in the blood
  • rare liver tumors
  • jaundice. Call your healthcare provider if you have yellowing of your skin or eyes.
• changes in the sugar and fat (cholesterol and triglycerides) levels in your blood.
• gallbladder problems (cholestasis), especially if you previously had cholestasis of pregnancy.
• irregular or unusual vaginal bleeding or spotting between your menstrual periods, especially during the first 4 months of taking Nextstellis, or the absence of menstrual periods.
• Depression.
• possible cancer in your cervix.
• swelling of your skin especially around your mouth, eyes, and in your throat (angioedema). Call your healthcare provider right away if you have a swollen face, lips, mouth tongue or throat, which may lead to difficulty swallowing or breathing. Your chance of having angioedema is higher if you have a history of angioedema.
• dark patches of skin around your forehead, nose, cheeks and around your mouth, especially during pregnancy (chloasma). Females who tend to get chloasma should avoid spending a long time in sunlight, tanning booths, and under sun lamps while taking Nextstellis. Use sunscreen if you have to be in the sunlight.

The most common side effects include:

• irregular vaginal bleeding (including absence of period)
• mood changes
• headache
• breast tenderness, pain, and discomfort
• pain with your periods
• acne
• weight gain
• decreased sex drive

These are not all of the possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your current medicines. Many drugs can interact with drospirenone and estetrol, especially:

• aprepitant;

• bosentan;

• phenobarbital or other barbiturates;

• lamotrigine;

• St. John's wort;

• an antibiotic - clarithromycin, rifabutin, rifampin, rifapentine, telithromycin;

• antifungal medicine - fluconazole, griseofulvin, itraconazole, ketoconazole, voriconazole;

• antiviral medicine for HIV or hepatitis C - boceprevir, boceprevir, efavirenz, etravirine, indinavir, nelfinavir, nevirapine, ritonavir, telaprevir;

• cancer medicine - apalutamide, enzalutamide, mitotane;

• a diuretic or "water pill" - amiloride, eplerenone, Spironolactone;

• seizure medicine - carbamazepine, felbamate, oxcarbazepine, phenytoin, topiramate; or

• steroid medicine - dexamethasone, prednisone.

This list is not complete and many other drugs may interact with drospirenone and estetrol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.