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. E4 is the first and only plant-sourced estrogen that works identically to the E4 that can be found naturally in the body.

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

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, which occurs naturally in the human body.

99% of birth control pills that contain estrogen use a modified form of estrogen called ethinyl estradiol. Estetrol is unique because it is found naturally in the body. The estetrol in NEXTSTELLIS is produced from a plant source.

What are the most common side effects of NEXTSTELLIS?

Every woman reacts differently to NEXTSTELLIS.

2.8% of women withdrew from treatment with NEXTSTELLIS due to bleeding irregularities.1

NEXTSTELLIS demonstrated low rates of the side effects often associated with COCs, including acne (3.7%), breast symptoms (e.g., pain, tenderness) (5.4%), and libido changes (3%).

Other common side effects experienced were mood disturbances, bleeding irregularities, headache, dysmenorrhea.

It’s important to understand NEXTSTELLIS potential risks and side effects.

Will NEXTSTELLIS affect my period?

In clinical trials, most women taking NEXTSTELLIS had predictable monthly bleeding. Some had spotting and even less had unscheduled bleeding. Unscheduled bleeding was most common in the first month and became less common after month 4.

It’s normal to have some bleeding or spotting* between periods when starting the pill.

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 doctor. 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 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

What happens if I miss taking a pill?

If you miss 1 pink active pill in Weeks 1, 2, or 3, follow these steps:

  • 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 nonhormonal birth control method if you have sex

Talk to your doctor if you have 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 doctor for a prepregnancy checkup before you stop taking the pill.

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.

mayne pharma logo
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