Category Archives: ellaOne®

ellaOne® can be used by women of reproductive age.

Adolescent pregnancy is a recognized public health concern. EC constitutes an important tool in the arsenal of contraceptive option that reduces the risk of intended pregnancies.

ellaOne is suitable for any woman of childbearing age, including adolescents.

For national policies in dispensing emergency contraception to adolescents please scroll to your country.

 

 

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References
  1. ellaOne® European Union pack leaflet

As with any drug, ellaOne® has some contraindications. ellaOne® should not be taken by women who:

• Are hypersensitive to the active substance or to any of the excipients1

Always refer to the ellaOne® product information if you are in any doubt.

Situations where ellaOne® is not recommended

• Severe asthma treated by oral glucocorticoids1

• Severe hepatic impairment1

• For women taking CYP3A4 inducers1

• Concomitant use of EC containing levonorgestrel1

• ellaOne® contains lactose. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

• Breastfeeding is not recommended for one week after ellaOne® intake1

 

References
1.ellaOne® European Union Summary of Product Characteristics.

One of the criteria for a medecine to become available OTC is for it to be well tolerated.1

With ellaOne® :

• The vast majority of adverse events recorded during clinical trials in 2637 women were mild or moderate and resolved spontaneously3

• The most commonly reported adverse reactions were headache, nausea, abdominal pain and dysmenorrhea2

• The safety profile is comparable to levonorgestrel3

 

EllaOnePharmacyBook_AnnotatedDiagrams_12021416

ellaOne® effect on the menstrual cycle

Most women had their next menstrual period at the expected time (74.6 % within ± 7 days of expected time)

  • Early period – 6.8% had their period more than 7 days earlier than expected2
  • Late period – 18.5% had a delay of more than 7 days2

A minority of women (8.7%) reported intermenstrual bleeding lasting an average of 2,4 days. The majority was reported as spotting (88.2%)2

Only 0.4% reported heavy intermenstrual bleeding2

For full details of adverse events refer to the ellaOne® European Summary of Product Characteristics.

Adverse events should be reported. Healthcare professionals are asked to report any suspect adverse events via their national reporting system. Adverse events should also be reported to HRA Pharma at pharmacovigilance@hra-pharma.com.

ellaOne® significantly reduces the risk of unintended pregnancy vs levonorgestrel.1

A meta-analysis of the two, large, head-to-head trials comparing ellaOne® with levonorgestrel showed that the risk of pregnancy was significantly reduced with ulipristal acetate compared to levonorgestrel :1

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For a woman who comes to you for help, what does this mean ?

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Her risk of getting pregnant is :

Intake within

  • 24h
  • 72h

of unprotected intercourse

  • With
    no intervention
  • With
    levonorgestrel
  • With
    ellaOne®
  • arrow
    5.5 %
    5.5 %
  • arrow
    2.3 %
    2.2 %
  • arrow
    0.9 %
    1.4 %

P- value: 0.035

P- value: 0.046

Two comparative non-inferiority studies showed ellaOne® is at least as effective in preventing pregnancy as levonorgestrel.1,2

 

References
1.Glasier AF et al. The Lancet 2010; 375: 555-562.
2.Creinin M et al. Obstet Gynecol 2006; 108(5): 1089–1097.
3.HRA Pharma Report. Women and emergency contraception in 2012. A European Survey.

Ovulation is a result of a surge in luteinising hormone (LH). ellaOne® delays ovulation by inhibiting or delaying the LH surge.1  

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If the woman is due to ovulate tomorrow or the next day after unprotected sex, when the risk of pregnancy is highest, only ellaOne® can delay ovulation

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This is when LH has started to surge but has not yet peaked. At this time, levonorgestrel will not prevent the follicle from rupturing whereas ellaOne® is highly effective1

Intake after LH surge, but before peak1

EllaOnePharmacyBook_AnnotatedDiagrams_2411142


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If she is due to ovulate 3 or more days after unprotected intercourse, both ellaOne® and levonorgestrel can delay ovulation. 1 However, ellaOne® remains more effective in preventing follicle rupture and therefore unintended pregnancy.1

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Intake before LH surge1

EllaOnePharmacyBook_AnnotatedDiagrams_2411144


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If the woman has already ovulated, or is due to ovulate, in the immediate 24 hours following unprotected intercourse, no emergency contraceptive pill will help1

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This is because the LH has already peaked, meaning the ovulation process is at a point where it cannot be stopped, or has already happened.

This explains why:

• Speed of emergency contraceptive pill intake is critical
• Emergency contraception is not 100% effective

Intake after LH peak 1

EllaOnePharmacyBook_AnnotatedDiagrams_2411143

ellaOne® can delay ovulation even when it is about to happen (when risk of fertilisation is highest)1

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pack ellaOne

 

 

References

1.Brache V et al. Contraception 2013; 88(5): 611-618.

2.Glasier AF et al. The Lancet 2010; 375: 555-562.

 

 

To understand better why ellaOne® is an advanced emergency contraceptive pill, remember that: 

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And ellaOne® is now available directly from you, without a prescription5.

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References
1.Wilcox AJ et al. BMJ 2000; 321: 1259-62.
2.Wilcox AJ et al. N Engl J Med 1995; 333: 1517-21.
3.Brache V et al. Contraception 2013; 88(5): 611-618.
4.Glasier AF et al. The Lancet® 2010; 375: 555-562.
5.ellaOne has been granted OTC status in the European Union. Accessed at : http://ec.europa.eu/health/documents/community-register/html/h522.htm

ellaOne® – specifically developed for emergency contraception1

  • ellaOne® is an emergency contraception pill which contains 30 mg ulipristal acetate2, and which was specifically developed for EC1
  • Ulipristal acetate is an orally-active selective progesterone receptor modulator (SPRM)2
  • Having undergone a rigorous, centralised European Union (EU) authorisation process, it first became available as a prescription medicine in the EU in 20091
  • Since then it has been made available in over 70 countries as a prescription medicine1 and now for pharmacy supply, without prescription across the EU
  • ellaOne® works by inhibiting or delaying ovulation2

What is ellaOne®?

  • ellaOne® is an emergency contraceptive pill intended to prevent pregnancy after unprotected sexual intercourse or contraceptive failure2
  • ellaOne® should be taken as soon as possible, but no later than 120 hours (5 days) after UPSI or contraceptive failure2
  • ellaOne® is for women of reproductive age who want to avoid unintended pregnancy2

How to use ellaOne® ?

  • The treatment consists of one tablet to be taken orally as soon as possible after UPSI or contraceptive failure2
  • ellaOne® does not offer protection from pregnancy for subsequent acts of unprotected sex. Women should be advised to use a reliable barrier method until their next menstrual period2

Although the use of ellaOne® does not contraindicate the continued use of regular hormonal contraception, ellaOne® may reduce its contraceptive action2. Therefore, if a woman wishes to start or continue using hormonal contraception, she can do so after using ellaOne®, however, she should be advised to use a reliable barrier method until the next menstrual period2.

  • The tablet can be taken with or without food2
  • If vomiting occurs within 3 hours of ellaOne® intake, another tablet should be taken2
  • ellaOne® can be taken at any time during the menstrual cycle2

What ellaOne® is not

  • ellaOne® is not a regular contraceptive, it is for occasional use only2

In any case, women should be advised to adopt a regular method of contraception.

  • ellaOne® does not cause abortion, it does not interrupt an existing pregnancy2
  • ellaOne® does not protect from sexually transmitted infections5

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