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

AUST R
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E4: A new low impact estrogen

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

  • Estetrol (E4) is selective about where in the body it works - targeting those tissues needed for effective contraception with less impact on areas where you don't need it, like your liver.
  • E4 is made naturally during pregnancy and in NEXTSTELLIS has been produced from a plant source. 

Combined with drospirenone

NEXTSTELLIS combines 2 hormones — estetrol (es-tet-rol) (E4) monohydrate (mon-oh-hi-drate), and a progestin called drospirenone (dro-SPEAR-eknown).

The main role of drospirenone is to prevent pregnancies while E4 works with drospirenone to prevent unwanted changes in your menstrual cycle like mid-cycle bleeding.

When taken every day as prescribed, NEXTSTELLIS is up to 99.6% effective at preventing pregnancy when taken every day as prescribed.1

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progestin
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What to expect with your period2,3

In clinical trials, less than 2% of women experienced breakthrough bleeding. This was most common in the first month and became even less frequent over time.

  • When studied, 90% 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, mid-cycle bleeding or spotting lasted less than 1 day*2

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

Side effects of NEXTSTELLIS

In studies with women taking NEXTSTELLIS, low side effect rates were reported

The estrogen (ethinylestradiol) used in many other contraceptive pills affects cells throughout the body—even the parts you might not expect. Estetrol is unique because it has selective effects on the body.

Here’s what that looks like:2,3

  • After 12 months on NEXTSTELLIS, the average change in weight was less than 0.7kg
  • Low rates of acne (3%) and lowered sex drive (1.5%)
  • 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 trials 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

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

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 even if it means you might take 2 pills on the same day. Continue taking 1 pill per day-about 24 hours apart-until you finish the month.
Click here for more information on missed pills.

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.

NEXTSTELLIS is a registered trademark used under license.All other brands are trademarks of their respective owners.© 2022 Mayne Pharma International Pty Ltd Main North Rd Salisbury South, SA. 5106
All rights reserved.NEX0015 Aug 2022
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