Frequently
asked questions

  • What is NEXTSTELLIS?

    NEXTSTELLIS is a birth control pill that uses 2 hormones to prevent pregnancy. It combines a type of progestin called drospirenone and a unique estrogen called E4 (estetrol). E4 is the first and only plant-sourced estrogen that is identical to the naturally occurring human E4 that circulates between mother and baby during pregnancy.

    When taken as directed, NEXTSTELLIS is 98% effective at preventing pregnancy. 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.

  • What makes NEXTSTELLIS different from other birth control pills?

    NEXTSTELLIS is the only birth control pill made with a type of estrogen called estetrol, also known as E4.

    Ninety-nine percent of birth control pills that contain estrogen use a modified form of estrogen called ethinyl estradiol. E4 is unique because it can be found naturally in the body, circulating between mother and baby during pregnancy. The E4 in NEXTSTELLIS is produced from a plant source.

  • What are the most common side effects of NEXTSTELLIS?

    When studied, women taking NEXTSTELLIS reported low rates of side effects often associated with birth control pills, including acne (3.7%), breast symptoms like pain and tenderness (5.4%), and lowered sex drive (2%).

    Other common side effects experienced were changes in mood (9.1%), irregular bleeding (10.8%), headache (6.3%), and cramps during your period (3.7%).

    You can learn more about potential risks and side effects within the website.

  • Will NEXTSTELLIS affect my period?

    In clinical trials, most women taking NEXTSTELLIS had predictable monthly bleeding. Less than 2% experienced breakthrough bleeding. This was most common in the first month and became less common over time.

    It’s normal for your body to take a few months to adjust. Meaning it’s normal to have some spotting between periods when starting the pill. Spotting is any light bleeding that doesn’t require the use of sanitary protection (even pantyliners).

  • What should I do if I miss my period while taking NEXTSTELLIS?

    Some people may miss their period while taking hormonal birth control, even when they are not pregnant. However, if you miss a period and have not taken NEXTSTELLIS according to the directions, or miss 2 periods in a row, or feel like you may be pregnant, contact your healthcare provider. If you have a positive pregnancy test, you should stop taking NEXTSTELLIS.
  • How do I take NEXTSTELLIS?

    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 non-hormonal 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. You can explore tips on how to stick to your schedule here. Talk to your healthcare provider for any additional questions concerning your pill schedule.
  • What happens if I miss taking a pill?

    You can explore tips on how to stick to your schedule here.


    If you miss 1 pink active pill in Week 1, 2, or 3:

    • Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day
    • Then continue taking 1 pill every day until you finish the pack
    • You do not need to use a backup non-hormonal birth control method if you have sex

    If you miss 2 or more pink pills during Week 1 or 2:

    • Take 1 missed pill as soon as you can, and take the pill for the current day (taking 2 pills on the same day)
    • Throw out the other missed pills and continue taking 1 pill per day until you finish the month
    • Use backup non-hormonal contraception until you have taken the pink pills at the appropriate time for 7 days in a row

    If you miss 2 pink pills during Week 3

    • Take it as soon as you remember. Take the next pill at your regular time. This means you may take 2 pills in 1 day
    • Throw out the other missed pills and continue taking 1 pill per day
    • When you finish taking the remainder of the pink pills, throw the white pills out and start your next pack of NEXTSTELLIS
    • Use backup non-hormonal contraception until you have taken the pink pills at the appropriate time for 7 days in a row

    Talk to your healthcare provider for any additional questions concerning your pill schedule.

  • What if I want to become pregnant?

    You may stop taking the pill whenever you wish. Consider first talking to your healthcare provider for a prepregnancy checkup before you stop taking the pill.
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.