f˜exible choice designed ˚or ˜ong ˛ormonal ˝rotection

Flexible choice designedfor long hormonal protection

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1. Reference – Eisenberg DL, et al. Three-year e� cacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system. Contraception. 2015; 92(1):10-16. 2. Reference – Levosert® Summary of Product Characteristics. November 2018

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Levosert® – highly e� ective contraception design for women1

The e� cacy and safety of Levosert® were assessed in an ongoing 10-year study (ACCESS IUS3).This is the largest hormonal IUS study ever conducted in US (n=1751) and included a diverse range of women.3

* Excluding cycles where other birth control methods were used (n=1538) 1. Reference – Eisenberg DL, Eisenberg DL, et al. Three-year e� cacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system. Contraception. 2015; 92(1):10-16.2. Reference – Levosert® Summary of Product Characteristics. November 2018.3. Reference – https://clinicaltrials.gov/ct2/history/NCT00995150 - ‘The primary objective of this study is to assess the e� cacy of a levonorgestrel-releasing intrauterine system (LNG20) in nulliparous and parous

females of child-bearing potential who request long-term, reversible contraception for up to 10 years.’ [Accessed on December 2018]]4. Reference – Data on fi le. M360-L102 5-Year Contraception Study CSR, 27 November 2017.

Pearl Index

0.2059,39928-day cycles*

59,39928-day cycles*

Pearl Index at year 52At year 5 of ongoing study4

with proven

contraceptive e� cacy


Range of parity:

151 were 36–45 years old

Older:

438 (25.1%) had a BMI of ≥30 kg/m2438 (25.1%) had a BMI of ≥30 kg/m2

Total:1,751 women

High BMI:

Younger:

1,600 were 16–35 years old1,011 (57.7%) were nulliparous

Pivotal study of Levosert® included:1

Levosert® – highly e� ective contraception in diverse range of women1

for women of di� erent age, parity and BMI

25.1%BMI ≥30 kg/m2 1

57.7%Nulliparous1

91%Aged 16-351

n=1,751

1. Reference – Eisenberg DL, et al. Three-year e� cacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system. Contraception. 2015; 92(1):10-16.


4. Reference – Data on fi le. M360-L102 5-Year Contraception Study CSR, 27 November 2017.

Levosert® – E� ectiveness in reducing HMB4

Mean number of bleeding/spotting days with Levosert® per 84-day cycle for the fi rst 2 years

» The mean number of bleeding/spotting days with Levosert® (n=1691) is summarized in the above chart.

Amenorrhea developement among Levosert® users4

» Amenorrhea develops in approximately 19% of Levosert® users by the end of year 1, in 27% by the end of year 2 and 37% by the end of Year 3 and 4, and 42% by the end of Year 5.

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10%

15%

20%

25%

30%

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40%

45%

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27%

2

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Levosert® – E� ectiveness in menstrual blood loss reduction – positive impact on iron-defi ciency anaemia5

Increase in Ferritin level (µg/L) Increase in Hemoglobin level (g/dl)

Median menstrual blood loss reduction, mean concentration haemoglobin and serum ferritin at 12 months.5

LNG-IUS improves a woman’s QoL by making periods lighter, shorter and less painful.6, 7 As a consequence there is a positive impact on iron-defi ciency anaemia, the most common health related threat of HMB.

5. Reference – Mawet Mawet M, Nollevaux F, Nizet D et al. Impact of a new levonorgestrel intrauterine system, Levosert®, on heavy menstrual bleeding: results of a one-year randomised controlled trial. Eur J Contra-cept Reprod Health Care 2014; 19:169-179.

6. Reference – Yoo HJ, Lee MA, Ko YB, Yang JB, Kang BH, Lee KH. The e� cacy of thelevonorgestrelreleasing intrauterine system in perimenopausal women with menorrhagia or dysmenorrhea, Arch Gynecol Obstet 2012; 285:161–166.

7. Reference – Lahteenmaki P, Haukkamaa M, Puolakka J, et al. Open randomized study of use of levonorgestrel-releasing intrauterine system as alternative to hysterectomy. BMJ 1998; 316:1122– 1126.

with all benefi ts from a single IUS

Mirena® N=138Levosert® N=142

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Weak after IUS insertionWeak after IUS insertion


8. Reference – IMS IDAS April 2017.

Name of the product, name of the active substance, strength, ATC code: Levosert® 20 micrograms/24 hours Intrauterine Delivery System. The active substance is levo-norgestrel. ATC code: G02BA03Indications: Contraception. Treatment of heavy menstrual bleeding. Posology: In women of fertile age, Levosert® is inserted into the uterine cavity within seven days of the onset of menstruation. To reduce the risk of perforation, postpartum insertions should be postponed until the uterus is fully involuted. Do not insert earlier than six weeks after delivery. Levosert® can also be inserted immediately after the fi rst trimester abortion.Levosert® should be removed after 5 years of use; a new system can be inserted at the same time. Levosert® should not be used before menarche.Contraindications: Known or suspected pregnancy; Current or recurrent pelvic infl ammatory disease; Lower genital tract infection; Postpartum endometritis; Infected abortion during the past three months; Cervicitis, cervical dysplasia; Suspected or confi rmed uterine or cervical malignancy; Liver tumour or other acute or severe liver disease; Congenital or acquired abnormality of the uterus including fi broids if they distort the uterine cavity; Undiagnosed abnormal uterine bleeding; Conditions associated with increased susceptibility to infections; Current or suspected hormone dependent tumours such as breast cancer; Acute malignancies a� ecting the blood or leukaemias except when in remission; Recent trophoblastic disease while hCG levels remain elevated; Hypersensitivity to the active substance or to any of the excipients.Undesirable e� ects (abbreviated list – for the full list of side-e� ects see the SmPC) Among the most frequent side e� ects are spotting, oligomenorrhoea, amenorrhoea, benign ovarian cysts. Among the most serious side e� ects are uterine perforation, pelvic infl ammatory disease.Interactions: Substances known to induce drug-metabolizing enzymes may decrease serum concentrations of levonorgestrel (e.g. anticonvulsants and anti-infectives).Special warnings and precautions for use: Prior to insertion pregnancy should be excluded and genital infection should be successfully treated. Use Levosert® with cau-tion in patients with migraine, focal migraine with asymmetrical visual loss, or other symptoms indicating transient cerebral ischemia; unusually severe or unusually frequent headache; jaundice; marked increase of blood pressure; malignancies a� ecting the blood or leukaemias in remission; use of chronic corticosteroid therapy; past history of symptomatic functional ovarian cysts; active or previous severe arterial disease, such as stroke or myocardial infarction; severe or multiple risk factors for arterial disease; thrombotic arterial or any current embolic disease; acute venous thromboembolism. Perforation may occur, most often during insertion. The risk of perforation may be increased in post-partum insertions, in lactating women and in women with a fi xed retro-verted uterusKnown risk factors for pelvic infl ammatory disease are multiple sexual partners, frequent intercourse and young age. Pelvic infection may have serious consequences as it may impair fertility and increase the risk of ectopic pregnancy. Symptoms of the partial or complete expulsion of any IUS may include bleeding or pain. However, a system can be expelled from the uterine cavity without the woman noticing.Irregular bleeding: Increased menstrual fl ow or unexpected bleeding may be indicative of expulsion. The absolute risk of ectopic pregnancy in users of Levosert® is low. However, when a woman becomes pregnant with Levosert® in situ, the relative likelihood of ectopic pregnancy is increased. The possibility of ectopic pregnancy should be considered in the case of lower abdominal pain - especially in connection with missed periods or if an amenorrhoeic woman starts bleeding.Ovarian cysts: Ovulatory cycles with follicular rupture usually occur in women of fertile age. Sometimes atresia of the follicle is delayed and folliculogenesis may continue. These enlarged follicles cannot be distinguished clinically from ovarian cysts. Most of these follicles are asymptomatic, although some may be accompanied by pelvic pain or dyspareunia.Cases of breast cancer have been reported in levonorgestrel IUS users (frequency unknown).

Please refer to the Summary of Product Characteristics (SmPC) before prescribing!

delivered by Gedeon Richter, one of the leaders in contraception in Europe and Russia.8


Levosert - long-acting reversible contraception -provides multiple benefi ts for both women and gynaecologist with its fl exible design that is appropriate

for a diverse range of women with various causes and intentions of di� erent length of usage.1,2

1. Reference – Eisenberg DL, et al. Three-year effi cacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system. Contraception. 2015; 92(1):10-16.2. Reference – Levosert® Summary of Product Characteristics. November 2018


The product is available in the listed countries under different brand names:

Austria, Belgium, Czechia, Germany, Hungary, Latvia, Lithuania, Luxembourg, Norway, Poland, Serbia, Slovakia, Spain, Sweden, Switzerland, United Kingdom

Please, refer to your country specific Product SmPC before prescribing.

Document ID: KEDP/DAD8B3, Date of Closure: 17.05.2021.

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f˜exible choice designed ˚or ˜ong ˛ormonal ˝rotection

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