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About NEXTSTELLIS

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Why Settle?
About NEXTSTELLIS
- The NEXTSTELLIS Difference
- E4
- Proven to Work
- Side Effects
Taking NEXTSTELLIS
How to Get It
FAQs
$ Savings
Healthcare Professionals
Full Prescribing Information

The NEXTSTELLIS Difference

E4

Proven to Work

Side Effects

The NEXTSTELLIS Difference

The next generation of
birth control pills has arrived

You know it's important to take
the time and learn what works for
you and what doesn't. So, when it
comes to birth control, how does the
first human estrogen, now made
from a plant source, paired with a
progestin sound?

The NEXTSTELLIS Difference

The next generation of
birth control pills has arrived

Your response might be, “What
does that mean?”
Which is why we broke down
how NEXTSTELLIS works.

NEXTSTELLIS combines 2 hormones—an estrogen called estetrol (E4)
and a progestin called drospirenone (DRSP).

Estrogen

[estetrol]

Progestin

[drospirenone]

DRSP works very similarly to a hormone found naturally in
the body. It is used to prevent pregnancies. E4 partners with
DRSP to regulate your menstrual cycle in order to help
prevent unwanted breakthrough bleeding.

NEXTSTELLIS is the first and only
FDA-approved birth control pill
to contain E4.

E4 has selective actions in tissues. It supports the health of your uterus, vagina, and bones and has a low impact on liver and breast tissue.

The E4 in NEXTSTELLIS is produced from a plant source. This form is identical to the human estrogen E4 that is found naturally in the body during pregnancy.

Е4 is what makes
NEXTSTELLIS unique

Other birth control pills contain modified, synthetic versions of the same type of estrogen. E4 is a completely different type of estrogen.

NEXTSTELLIS is the first and only
FDA-approved birth control pill to
contain E4.

E4 has selective actions in tissues. It
supports the health of your uterus, vagina,
and bones and has a low impact on liver
and breast tissue.

The E4 in NEXTSTELLIS is produced from
a plant source. This form is identical to
the human estrogen E4 that is found
naturally in the body during pregnancy.

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

Choose NEXTSTELLIS
with confidence

How well does NEXTSTELLIS work with a plant-sourced estrogen?
The numbers speak for themselves.

98 ^%

effective at preventing pregnancy

When taken every day as directed, NEXTSTELLIS is 98% effective at
preventing pregnancy* and provides a predictable cycle.

When taken every day as directed,
NEXTSTELLIS is 98% effective at preventing
pregnancy* and provides a predictable cycle.

*NEXTSTELLIS may be less effective if your body mass index (BMI) is 30 kg/m ² or higher. It is not known whether NEXTSTELLIS is safe and effective in those with a BMI of 35 kg/m ² or higher, as they were not included in the clinical studies.

Proven to work,
predictable cycle

Less than 2% experienced breakthrough bleeding. This was most
common in the first month and became even less common over
time
85% experienced predictable monthly bleeding, just like a
natural period
On average, breakthrough bleeding or spotting lasted less than
1 day ^†
It’s normal to have some bleeding and spotting ^† between
periods when starting the pill

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

Side effects of NEXTSTELLIS

During clinical studies, low rates of certain side
effects were reported. Those same side effects
are often associated with birth control pills.

To give some examples:

3.7% reported cases of acne
5.4% had breast-related symptoms like pain and tenderness
2.0% experienced a lowered sex drive
1.1 lbs was the average change in weight

In addition, NEXTSTELLIS had a low impact on:

Cholesterol
Triglycerides
Glucose

Side effects that occurred in ≥2% of NEXTSTELLIS users during the 1-year-long clinical studies with 3,632 women

Side effects that occurred in ≥2% of NEXTSTELLIS users during the 1-year-long clinical studies with 3,632 women
Change in mood 9.1%
Irregular bleeding 10.8%
Breast-related symptoms 5.4%
Headache 6.3%
Cramps during your period 3.7%
Weight increase 3.0%
Acne 3.7%
Lowered sex drive 2.0%

2.8% of women withdrew from treatment with NEXTSTELLIS due to bleeding irregularities.

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.

These are not all the possible side effects. Talk to your doctor if you are experiencing any symptoms while taking NEXTSTELLIS.

The trials did not include women with complications from diabetes, women with diabetes diagnosed ≥20 years ago, or women taking lipid-lowering medications.

How to take
NEXTSTELLIS

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.

Top

indication

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.

Important Safety Information

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.

The NEXTSTELLIS Difference

E4

Proven to Work

Side Effects

The NEXTSTELLIS Difference

The next generation of birth control pills has arrived

The NEXTSTELLIS Difference

The next generation of birth control pills has arrived

Your response might be, “What does that mean?” Which is why we broke down how NEXTSTELLIS works.

Е4 is what makes NEXTSTELLIS unique

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

Choose NEXTSTELLIS with confidence

Proven to work, predictable cycle

Side effects of NEXTSTELLIS

What is NEXTSTELLIS?

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

Who should not take NEXTSTELLIS?

What else should I know about taking NEXTSTELLIS?

What are the most serious risks of taking NEXTSTELLIS?

What are the possible side effects of NEXTSTELLIS?

indication

Important Safety Information

WARNING TO FEMALES WHO SMOKE

The next generation of
birth control pills has arrived

The next generation of
birth control pills has arrived

Your response might be, “What
does that mean?”
Which is why we broke down
how NEXTSTELLIS works.

Е4 is what makes
NEXTSTELLIS unique

Choose NEXTSTELLIS
with confidence

Proven to work,
predictable cycle