The content on this website is only for individuals that have been prescribed NEXTSTELLIS in Australia.

The following content is for Australian patients who have been prescribed this product. To access the content, please insert only the numbers that appear after the letters AUST R as printed on the product's pack

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Frequently
asked questions

What is NEXTSTELLIS?

NEXTSTELLIS is a new oral contraceptive pill that contains two hormones: an estrogen and a progestin to maintain your body's natural balance.

  • NEXTSTELLIS is used for the prevention of pregnancy.
  • NEXTSTELLIS does not protect against HIV infections (AIDS) and other sexually transmitted diseases.

How does NEXTSTELLIS work?

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

estetrol+progestin

Typically, levels of these hormones rise and fall during the menstrual cycle. NEXTSTELLIS keeps the levels of these hormones constant, which blocks the hormonal changes that signal the body to release an egg (ovulate). Without ovulation, it is not possible to get pregnant.

What makes NEXTSTELLIS different from other contraceptive pills?

NEXTSTELLIS is the only contraceptive pill made with a type of estrogen called estetrol (E4).

  • Estetrol (E4) is found naturally in the body during pregnancy.
  • The majority of contraceptive pills contain ethinylestradiol, a synthetic form of estrogen.4
  • The E4 in NEXTSTELLIS originates from a plant source, to match the body’s naturally occurring E4.

What should I know before taking NEXTSTELLIS?

Before taking NEXTSTELLIS, tell your healthcare professional about all of your medical conditions, including if you are scheduled for surgery.

  • Like other combined oral contraceptive pills, 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. NEXTSTELLIS may increase your risk of blood clots after surgery. Talk to your healthcare professional about taking NEXTSTELLIS before and after your surgery, or if you are going to be unable to walk for an extended period of time.
  • Other serious risks may 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,
    • gall bladder problems,
    • irregular or unusual vaginal bleeding, spotting, or absence of menstrual periods,
    • depression.
  • If over the age of 35 and you smoke, like other combined oral contraceptive pills, it is not recommended to use NEXTSTELLIS. Smoking increases your risk of serious cardiovascular side effects (heart and blood vessel problems) from contraceptive pills, including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
  • 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 professional whether NEXTSTELLIS is appropriate for you.

How to take NEXTSTELLIS?

  1. Take your first pink pill from the purple section on the first day of your period.
  2.  If you start NEXTSTELLIS on any day other than the first day of your period, use a back-up non-hormonal contraception method (such as condoms) until you have taken 1 active (pink) pill every day for 7 days.
  3. Continue taking the pills in order (following the arrows on the blister pack) every day, including the white pills at the end of your pack.

How to switch from another contraceptive to NEXTSTELLIS?

Make sure you know which are active (hormonal) pills and which are inactive from your previous contraception.

From another contraceptive pill : start an active pink NEXTSTELLIS pill the day after your last active pill from your previous contraceptive.
From an IUD, implant, patch, or vaginal ring : start NEXTSTELLIS the same day of removal.
From an injection: start NEXTSTELLIS the same day you are due for your next injection.
From emergency contraception: (the morning after pill)  Please talk with your doctor as the instructions for starting NEXTSTELLIS will vary depending on the emergency pill used.
 
  • If your IUD is removed on any day other than the first day of your period, use an alternative contraceptive method (such as condoms) for 7 days.
  • If you have not taken an active pill every day for 7 days, or you are switching from a mini pill you will need to use an alternative contraceptive method (such as condoms) for 7 days.
Tip: Take your pills at the same time every day. Set an alarm on your phone to help you remember.

What if I miss a pill?

 
    If it has been less than 24 hours, take the pill immediately as it will still be effective. If more than 24 hours have passed, please see below.
 

Each blister has 24 pink (active) pills and 4 white (inactive) pills.

Missed 1 of the 24 pink pills in any week?
Take the missed pill as soon as possible and take the next pill at the usual time, even if it means you might take two pills on the same day.
Keep taking one pill a day until the pack is finished.
 
Missed 2 or more pink pills in week 1 or 2?
Take the most recently missed pill straight away, then take the next pill at the usual time, even if it means you might take two pills on the same day. Discard the other missed pink pills. Use a non-hormonal contraceptive (such as condoms) for 7 days.
 
Missed 2 or more pink pills in week 3?
Take the most recently missed pill straight away, then take the next pill at the usual time, even if it means you might take two pills on the same day. Discard the other missed pink pill(s). Finish the remaining pink active pills until you reach the white inactive pills, then start a new pack the next day. Discard the white pills. Use a non-hormonal contraceptive (such as condoms) for 7 days.
 
Missed 1 or more white pills?
Skip the missed pill days and keep taking one pill a day until the pack is finished. No extra contraception is needed.
 
Unsure about the number or the colour of pills missed?
Non-hormonal contraception (such as condoms) should be used as back-up until pink active pills have been taken for 7 days in a row.
 
It’s important to understand that if you miss pink pills and you have sex, you could get pregnant. The more pills you miss, the more likely you are to get pregnant, especially if you miss taking the first few or the last few pink pills in your pack. If unsure, call your healthcare professional right away.

What will happen to my period?

  • Most women using NEXTSTELLIS had predictable monthly bleeding.

  • In clinical trials, a small number of women had light mid-cycle bleeding or spotting. This is normal and usually resolves within the first few months.3

On average, mid-cycle bleeding or spotting lasted less than 1 day2,3

Remember if you miss pills you may have some spotting or light bleeding even if you take the missed pills. 

What about side effects?

  • Most women experience very little side effects when taking NEXTSTELLIS. If you do experience any side effects, these will likely be minor and temporary, however, some side effects may require medical attention. Speak to your healthcare professional if you have any questions or notice anything unusual.
  • Blood clots or deep vein thrombosis (DVT) are known to occur rarely with contraceptive pill use. Very occasionally blood clots may cause serious permanent disability or even be fatal. However, the risk of clotting on the pill is much lower than when you are pregnant. If you are concerned speak to your healthcare professional.

Does NEXTSTELLIS cause fluid retention like some other contraceptive pills?

NEXTSTELLIS has drospirenone, a progestin that reduces fluid retention, so you may see improvement in symptoms related to fluid retention like bloating or swelling if you’ve been on another pill that doesn’t have drospirenone.

Can I take NEXTSTELLIS with other medicines?

Tell your healthcare professional about all of the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.

Is a break from taking NEXTSTELLIS needed sometimes?

There is no need to stop taking NEXTSTELLIS unless you want to become pregnant. Please speak to your healthcare professional first before stopping NEXTSTELLIS for any reason.

Will NEXTSTELLIS affect my fertility?

If you are taking NEXTSTELLIS correctly the chances of you becoming pregnant are very small. As soon as you stop taking the pill, contraceptive protection stops, allowing you to become pregnant.

IMPORTANT SAFETY INFORMATION FOR NEXTSTELLIS® (estetrol/drospirenone tablets) 

▼  This medicine is new and is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may experience to your doctor, or directly at www.tga.gov.au/reporting-problems

References

1. Gemzell-Danielsson K, et al. Estetrol-Drospirenone combination oral contraceptive: a clinical study of contraceptive efficacy, bleeding pattern and safety in Europe and Russia. BJOG. 2022; 129: 63-71. 2. NEXTSTELLIS Product Information. 3. NEXTSTELLIS Consumer Medicine Information. 4. Stanczyk FZ, et al. Ethinyl estradiol and 17β-estradiol in combined oral contraceptives: pharmacokinetics, pharmacodynamics and risk assessment. Contraception. 2013;87(6):706-727.

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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