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JAYDESS is a brand name for Levonorgestrel. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Contraception for up to 3 years.
Verbatim from this product's MHRA label. Tap a section to expand.
Posology Jaydess is inserted into the uterine cavity and is effective for up to three years. Insertion It is recommended that Jaydess should only be inserted by healthcare professionals who are experienced in IUS insertions and/or have undergone training on the Jaydess insertion procedure.
Before insertion, the patient should have been carefully examined in order to detect any contraindication to IUS insertion. Exclude pregnancy before insertion. Consider the possibility of ovulation and conception before using this product.
4 under Medical examination/consultation).
Table 1:
When to insert Jaydess in women of fertile age Starting Jaydess - Jaydess should be inserted into the uterine cavity within 7 days of the onset of menstruation. In this case Jaydess provides contraceptive protection upon insertion and no back-up contraception is needed.
- If insertion within 7 days of the onset of menstruation is not possible or the woman does not experience regular menses, Jaydess may be inserted at any time during the menstrual cycle provided that the healthcare professional can reliably exclude the possibility of prior conception.
However, in this case immediate contraceptive protection upon insertion is not reliably ensured. Therefore, a barrier method of contraception should be used or the patient should abstain from vaginal intercourse for the next 7 days to prevent pregnancy.
Postpartum insertion In addition to the instructions above (Starting Jaydess):
Postpartum insertions should be postponed until the uterus is fully involuted, however should not be performed earlier than 6 weeks after delivery. If involution is substantially delayed, consider waiting until 12 weeks postpartum. Insertion after first- trimester abortion Jaydess can be inserted immediately after first trimester abortion.
In this case no back-up contraception is needed. Replacing Jaydess Jaydess can be replaced by a new system at any time in the menstrual cycle. In this case no back up contraception is needed. , combined hormonal contraceptives, implant) - Jaydess can be inserted immediately if it is reasonably certain that the woman is not pregnant.
- Need for back-up contraception: If it has been more than 7 days since menstrual bleeding began, the woman should abstain from vaginal intercourse or use additional contraceptive protection for the next 7 days. 4). After insertion, women should be re-examined after 4 to 6 weeks to check the threads and ensure that the device is in the correct position.
Summary of the safety profile The majority of women experience changes in menstrual bleeding pattern after insertion of Jaydess. Over time, the frequency of amenorrhoea and infrequent bleeding increases, and the frequency of prolonged, irregular and frequent bleeding decreases.
The following bleeding patterns were observed in clinical trials:
Table 3: Bleeding patterns reported with Jaydess in clinical trials Jaydess First 90 days Second 90 days End of year 1 End of year 3 Amenorrhea <1% 3% 6% 12% Infrequent bleeding 8% 19% 20% 22% Frequent bleeding 31% 12% 8% 4% Irregular bleeding* 39% 25% 18% 15% Prolonged bleeding* 55% 14% 6% 2% *Subjects with irregular bleeding and prolonged bleeding may also be included in one of the other categories (excluding amenorrhea) Tabulated summary of adverse events The frequencies of Adverse Drug Reactions (ADRs) reported with Jaydess are summarised in the table below.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness. Frequencies are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000).
System Organ Class Very Common Common Uncommon Psychiatric disorders Depressed mood/ Depression Decreased libido Nervous system disorders Headache Migraine Vascular disorders Dizziness Gastrointestinal disorders Abdominal/pelvic pain Nausea Skin and subcutaneous tissue disorders Acne/ Seborrhoea Alopecia Hirsutism Reproductive system and breast disorders Bleeding changes including increased and decreased menstrual bleeding, spotting, infrequent bleeding and amenorrhoea Ovarian cyst* Vulvovaginitis Upper genital tract infection Dysmenorrhea Breast pain/discomfort Device expulsion (complete and partial) Genital discharge Uterine perforation** Investigations Increased weight * In clinical trials ovarian cysts had to be reported as AEs if they were abnormal, non-functional cysts and/or had a diameter > 3 cm on ultrasound examination.
Jaydess should be used with caution after specialist consultation, or removal of the system should be considered if any of the following conditions exist or arise for the first time: - migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia - exceptionally severe headache Figure 8 - jaundice - marked increase in blood pressure - severe arterial disease such as stroke or myocardial infarction Low-dose levonorgestrel may affect glucose tolerance, and the blood glucose concentration should be monitored in diabetic users of Jaydess.
However, there is generally no need to alter the therapeutic regimen in diabetics using LNG IUS. Medical examination/ consultation Before insertion, a woman must be informed of the benefits and risks of Jaydess, including the signs and symptoms of perforation and the risk of ectopic pregnancy, see below.
A physical examination including pelvic examination and examination of the breasts should be conducted. Cervical smear should be performed as needed, according to healthcare professional’s evaluation. Pregnancy and sexually transmitted diseases should be excluded.
Genital infections should be successfully treated prior to insertion. The position of the uterus and the size of the uterine cavity should be determined. Fundal positioning of Jaydess is important in order to maximize the efficacy and reduce the risk of expulsion.
The instructions for the insertion should be followed carefully. Emphasis should be given to training in the correct insertion technique. Insertion and removal may be associated with some pain and bleeding. g. syncope, or a seizure in an epileptic patient).
A woman should be re-examined 4 to 6 weeks after insertion to check the threads and ensure that the system is in the correct position. Vaginal ultrasound examination may be considered to ascertain the correct position of the system.
g. e. 1.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Physical examination alone (including checking of threads) may not be sufficient to exclude partial perforation. Jaydess can be distinguished from other IUSs by the combination of the visibility of the silver ring on ultrasound and the brown colour of the removal threads.
The T-frame of Jaydess contains barium sulphate which makes it visible in X-ray examination. Removal/Replacement Jaydess is removed by gently pulling on the threads with forceps. The use of excessive force/sharp instruments during removal may cause breakage of the system.
After removal of Jaydess, the system should be examined to ensure that it is intact and has been completely removed. If the threads are not visible, determine the location of the system via ultrasound or other method. If the system is in the uterine cavity, it may be removed using narrow forceps.
This may require dilatation of the cervical canal or other surgical intervention. The system should be removed no later than by the end of the third year. Continuation of contraception after removal • If the woman wishes to continue using the same method, a new system can be inserted immediately following removal of the original system.
• If the woman does not wish to continue using the same method but pregnancy is not desired, the removal should be carried out within 7 days of the onset of menstruation, provided the woman is experiencing regular menses. If the system is removed at some other time during the cycle or the woman does not experience regular menses and the woman has had intercourse within a week, she is at risk of pregnancy.
To ensure continuous contraception a barrier contraceptive method should be used (such as condoms) starting at least 7 days before the removal. After removal, the new contraceptive method should be started immediately (follow the instructions for use of the new contraceptive method).
Elderly patients Jaydess has not been studied in women over the age of 65 years. There is no indication for the use of Jaydess in postmenopausal women. Patients with hepatic impairment Jaydess has not been studied in women with hepatic impairment.
3). Patients with renal impairment Jaydess has not been studied in women with renal impairment. Paediatric population Use of this product before menarche is not indicated. 1. Method of administration To be inserted by a healthcare professional using aseptic technique.
Jaydess is supplied within an inserter in a sterile package, which should not be opened until needed for insertion. Do not resterilise. As supplied, Jaydess is for single use only. Do not use if the blister is damaged or open. Do not insert after the expiry date which is stated on the carton and the blister after EXP.
Any unused product or waste material should be disposed of in accordance with local requirements. Jaydess is supplied with a patient reminder […]
4 under Perforation). In clinical trials with Jaydess that excluded breastfeeding women the frequency of perforation was “rare”. Description of selected adverse reactions With the use of LNG-IUS, cases of hypersensitivity including rash, urticaria and angioedema have been reported.
4 under Ectopic Pregnancy). The removal threads may be felt by the partner during intercourse. The following ADRs have been reported in connection with the insertion or removal procedure of Jaydess: Procedural pain, procedural bleeding, insertion-related vasovagal reaction with dizziness or syncope.
The procedure may precipitate a seizure in an epileptic patient. 4 under Pelvic Infection). Paediatric population The safety profile of Jaydess observed in a study of 304 adolescents was consistent with that in the adult population. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store. For long-acting products like Jaydess, please report information of when Jaydess was inserted and removed, as applicable.
In case Jaydess cannot be located in the uterine cavity, expulsion or complete perforation should be considered (see paragraph “perforation” below) and X-ray may be used. Thereafter, re- examination should be performed once a year or more frequently if clinically indicated.
Jaydess is not for use as a post-coital contraceptive. The use of Jaydess for the treatment of heavy menstrual bleeding or protection from endometrial hyperplasia during oestrogen replacement therapy has not been established. Therefore it is not recommended for use in these conditions.
Perforation Perforation or penetration of the uterine corpus or cervix by an intrauterine contraceptive may occur, most often during insertion, although it may not be detected until sometime later, and may decrease the effectiveness of Jaydess.
In case of a difficult insertion and/ or exceptional pain or bleeding during or after insertion, appropriate steps should be taken immediately to exclude perforation, such as physical examination and ultrasound. In some of these cases, the device may be located outside of the uterine cavity.
Such a system must be removed; surgery may be required. 6) per 1000 insertions in the copper IUD cohort. The study showed that both breastfeeding at the time of insertion and insertion up to 36 weeks after giving birth were associated with an increased risk of perforation (see Table 2).
Both risk factors were independent of the type of IUD inserted. 5) per 1000 insertions. Breastfeeding at the time of insertion and insertion up to 36 weeks after giving birth were confirmed as risk factors also in the subgroup that were followed up for 5 years.
The risk of perforations may be increased in women with fixed retroverted uterus. Re-examination after insertion should follow the guidance given under the heading “Medical examination/consultation” including the consideration to use vaginal ultrasound examination to ascertain the correct position of the system 4 to 6 weeks thereafter, which may be adapted as clinically indicated in women with risk factors for perforation.
Lost threads If the removal threads are not visible at the cervix on follow-up examinations, unnoticed expulsion and pregnancy must be excluded. The threads may have been drawn up into the uterus or cervical canal and may reappear during the next menstrual period.
If pregnancy has been excluded, the threads may usually be located by gently probing the cervical canal with a suitable instrument. If they cannot be found, the possibility of expulsion or perforation should be considered. Vaginal ultrasound examination may be used to ascertain the position of the system.
If ultrasound is not available or is not successful, X-ray may be used to locate Jaydess. Breast Cancer A meta-analysis from 54 epidemiological studies reported that there is a slightly […]