Get to know NEXTSTELLIS

You have more choices for birth control pills than ever before. While the options vary in the progestin they use, the type of estrogen available has been the same—until now.

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E4: The estrogen
that changed it all

NEXTSTELLIS is the only birth control pill made with E4 or estetrol, a different type of estrogen.

  • E4 is selective and doesn't have the same impact on the rest of your body
  • It is identical to the estetrol that can be made by the body. It’s the first and only naturally occurring estrogen in a birth control pill proven to prevent pregnancies
  • It is produced from a plant source. Even though it occurs naturally in the body, it can easily be produced from plants for contraceptive use

So when we say it’s the NEXT generation of birth control, we really mean it.

Proven to work

NEXTSTELLIS combines 2 hormones—estetrol (a type of estrogen), and a progestin called drospirenone (DRSP).

The main role of DRSP is to prevent pregnancies while estetrol works with DRSP to prevent unwanted changes in your menstrual cycle like breakthrough bleeding.

When taken every day as prescribed, NEXTSTELLIS is 98% effective at preventing pregnancy.

estrogen
(estetrol)

+

progestin
(drospirenone)

=

Nextstellis tablet icon

(NEXTSTELLIS)

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And the benefits
keep adding up

Less than 2% experienced breakthrough bleeding. This was most common in the first month and became even less frequent over time.

  • When studied, 85% of women taking NEXTSTELLIS experienced predictable monthly bleeding, just like a natural period.
  • It's normal to have some bleeding or spotting* between periods when starting the pill.

On average, breakthrough bleeding or spotting lasted less than 1 day*

*Spotting is any light bleeding that doesn’t require the use of sanitary protection (even pantyliners).

Side effects of
NEXTSTELLIS

In a trial of NEXTSTELLIS, users reported low rates of side effects

The estrogens found in other birth control pills affect cells throughout the body—even the parts you might not expect, such as your breasts, liver, and blood vessels. Estetrol is unique because, it has selective effects on the body.

Here’s what that looks like:

  • After 6 months on NEXTSTELLIS, the average change in weight was less than 1.1 lb
  • Low rates of acne (4%) and lowered sex drive (2%)
  • The rate of blood clots—one of the most serious side effects of combined hormonal birth control pills—was 3.66 per 10,000 women-years. In non-pregnant, non-combined pill users, the rate ranges from 1 to 5 per 10,000 women-years.

Additionally, in clinical trials, NEXTSTELLIS also had a low impact on:

  • Cholesterol
  • Triglycerides
  • Glucose
*The trial did not include women with complications from diabetes, women with diabetes diagnosed ≥20 years ago, or women taking lipid-lowering medications.
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Taking
NEXTSTELLIS

Adding NEXTSTELLIS to your daily routine is easy with just 1 pill, once daily.

  • Start on the first day of your natural menstrual period
    • If you start taking NEXTSTELLIS on any day other than the first day of your natural menstrual period, use a backup nonhormonal birth control method (such as condoms or spermicide) until you have taken 1 active (pink) pill every day for 7 days
    • For more information on the right time to start NEXTSTELLIS, please refer to the Prescribing Information for guidance
  • Continue taking the pills in order every day, including the white pills at the end of your pack

Pro Tip: It’s best to take your pills at the same time every day. Set an alarm on your phone to help you remember.

If you miss 1 of the pink active pills, take the next pill as soon as you can. Continue taking 1 pill per day—about 24 hours apart—until you finish the month.

  • Please refer to the Prescribing Information for guidance if you miss more than 1 pill. The next steps you need to take may depend on whether you missed doses in the first or second half of the 28-day dosing period

IMPORTANT SAFETY INFORMATION

What is NEXTSTELLIS?

NEXTSTELLIS is a prescription combination oral birth control pill used for the prevention of pregnancy. NEXTSTELLIS does not protect against HIV infections (AIDS) and other sexually transmitted diseases. NEXTSTELLIS may be less effective if you have a body mass index (BMI) of 30 or higher. It is not known if NEXTSTELLIS is safe and effective in females with a body mass index (BMI) of 35 or higher. If you are moderately obese, discuss with your healthcare provider whether NEXTSTELLIS is appropriate for you.

WARNING TO FEMALES WHO SMOKE

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. This risk increases with age and the number of cigarettes you smoke.

What is NEXTSTELLIS?

NEXTSTELLIS is a prescription combination oral birth control pill used for the prevention of pregnancy. NEXTSTELLIS does not protect against HIV infections (AIDS) and other sexually transmitted diseases. NEXTSTELLIS may be less effective if you have a body mass index (BMI) of 30 or higher. It is not known if NEXTSTELLIS is safe and effective in females with a body mass index (BMI) of 35 or higher. If you are moderately obese, discuss with your healthcare provider whether NEXTSTELLIS is appropriate for you.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT NEXTSTELLIS?

WARNING TO FEMALES WHO SMOKE

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. This risk increases with age and the number of cigarettes you smoke.

Who should not take NEXTSTELLIS?

Do not use NEXTSTELLIS if you smoke and are 35 years of age or older. Do not use NEXTSTELLIS if you have or have had blood clots, history of heart attack, stroke or certain heart valve problems, high blood pressure that medicine cannot control, diabetes for more than 20 years, severe migraine headaches with aura, breast cancer or any cancer that is sensitive to female hormones, liver disease or liver tumors, unexplained bleeding from the vagina, have kidney disease or kidney failure, have reduced adrenal gland function, or if you take Hepatitis C drugs containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir, as this may increase levels of liver enzymes in the blood.

What else should I know about 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 risks 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.
  • are depressed now or have been depressed in the past.
  • had yellowing of your skin or eyes caused by 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 breastmilk. 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. NEXTSTELLIS may affect the way other medicines work, and other medicines may affect how well NEXTSTELLIS works.

What are the most serious risks of taking NEXTSTELLIS?

NEXTSTELLIS may cause serious side effects that may lead to death including blood clots in your lungs, heart attack, or a stroke. Some other examples of serious blood clots include blood clots in the legs or eyes. Other serious risks include high potassium levels in your blood, high blood pressure, new or worsening headaches including migraine headaches, possible cancer that is sensitive to female hormones, liver problems, changes in the sugar and fat blood levels, gallbladder problems, irregular or unusual vaginal bleeding, spotting, or absence of menstrual periods, depression, possible cancer of the cervix, swelling of the skin especially around the mouth, eyes, and in the throat, and dark patches of skin around your forehead, nose, cheeks, and around your mouth, especially during pregnancy.

What are the possible side effects of NEXTSTELLIS?

The most common side effects reported by females taking NEXTSTELLIS in a study were spotting or bleeding between menstrual periods, mood changes, headache, breast tenderness, pain and discomfort, painful periods, acne, weight gain, and decreased sex drive.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see the full Prescribing Information, including Boxed Warning, and Patient Information.

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NEXTSTELLIS is a registered trademark of a third party. All other brands are trademarks of their respective owners. © 2022 Mayne Pharma. 1240 Sugg Parkway, Greenville, NC 27834. All rights reserved.PM-US-NEX-0193 5/22