Active ingredients: Levonorgestrel
Jaydess 13.5 mg intrauterine delivery system
Indications Why is Jaydess used? What is it for?
Jaydess is indicated for the prevention of pregnancy (contraception) for up to three years.
Jaydess is a T-shaped intrauterine delivery system (IUS) that, when inserted into the uterus, slowly releases a small amount of the hormone levonorgestrel.
Jaydess reduces the monthly growth of the inner lining of the uterus and makes the cervical mucus denser. In this way it prevents the contact between the sperm and the oocyte and therefore the fertilization of the oocyte by the spermatozoa.
Contraindications When Jaydess should not be used
General consideration
Before you can start using Jaydess, your healthcare professional will ask you a few questions about your medical history.
This leaflet describes several situations in which Jaydess must be removed or in which the reliability of Jaydess may be reduced. In such circumstances, she must forgo sexual intercourse or use a condom or other barrier method of birth control.
Jaydess, like other hormonal contraceptives, does not protect against HIV infection (AIDS) or other sexually transmitted diseases.
Jaydess is not indicated as an emergency contraceptive (postcoital contraceptive).
DO NOT use Jaydess
- if you are pregnant (see section "Pregnancy, breast-feeding and fertility")
- if you have pelvic inflammatory disease (PID; infection of the female reproductive organs) or have suffered from it several times in the past
- if you suffer from disorders associated with increased susceptibility to pelvic infections
- if you have a "lower genital tract infection (an" infection of the vagina or cervix [neck of the womb])
- if you have had a "womb infection" after childbirth, after a pregnancy loss or after an abortion within the last 3 months.
- if you currently have cervical cell abnormalities
- if you have known or suspected malignancy of the cervix or uterus
- if you have tumors that are sensitive to progestogen hormones to grow (for example, breast cancer)
- if you have vaginal bleeding of unknown origin
- if you have abnormalities of the cervix or uterus, including fibroids, which deform the uterine cavity
- if you have active liver disease or liver cancer
- if you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).
Precautions for use What you need to know before taking Jaydess
Talk to your healthcare provider before using Jaydess if:
- have diabetes. It is generally not necessary to change the antidiabetic therapy while using Jaydess but the healthcare professional may need to monitor the treatment.
- suffer from epilepsy. A seizure may occur during insertion or removal of the device.
- have had an ectopic or extrauterine pregnancy (a pregnancy outside the womb) in the past.
Also, talk to your healthcare provider if any of the following apply to you, before you start using Jaydess or if it first occurs while using Jaydess:
- migraine with visual disturbances or other symptoms which may be signs of transient cerebral ischaemia (temporary blockage of the blood supply to the brain)
- exceptionally severe headache
- jaundice (yellowing of the skin, whites of the eyes and / or nails)
- marked increase in blood pressure
- severe artery disease such as stroke or heart attack.
The following signs and symptoms may be indicative of an ectopic pregnancy and therefore you should contact your healthcare provider immediately:
- Menstruation has stopped and persistent bleeding or pain subsequently appears
- You have severe or persistent pain in your lower abdomen
- She has the normal signs of pregnancy but also bleeding and dizziness
- The pregnancy test is positive
Contact your healthcare professional immediately if you have any of the following conditions:
- severe pain (similar to menstrual cramps) or heavy bleeding after placement or if you have pain / bleeding that persists for more than a few weeks. For example this can be a sign of infection, perforation or it could mean that Jaydess is not in the correct position.
- she no longer feels the threads in her vagina. This can be a sign of expulsion or perforation. You can check gently by inserting a finger into the vagina and feel the threads at the end of the vagina near the opening of the uterus (cervix). Don't pull the strings as you may accidentally pull Jaydess out. Avoid sexual intercourse or use barrier methods of contraception (such as condoms) as long as your healthcare professional has checked that the IUD is still in place.
- you or your partner feel Jaydess' lower extremity. Avoid sexual intercourse until your health care professional has checked that the intrauterine system is still in place.
- her partner feels the removal threads during intercourse
- thinks she may be pregnant
- have persistent abdominal pain, fever or unusual vaginal discharge which may be a sign of infection. Infections must be treated immediately.
- you experience pain or discomfort during sexual intercourse, which may be for example a sign of infection, ovarian cyst or which may mean that Jaydess is not in the correct position.
- menstruation characteristics change suddenly (for example, if menstruation is low or absent and persistent bleeding or pain or very heavy bleeding subsequently appears), which may indicate that Jaydess is not in the correct position or that she has been expelled.
The use of sanitary pads is recommended. If you are using tampons, you should change them taking special care not to pull out Jaydess's threads.
Children and adolescents
The use of Jaydess is not indicated before the onset of the first menstruation (menarche).
Interactions Which drugs or foods may change the effect of Jaydess
Tell your healthcare professional if you are taking, have recently taken or might take any other medicines
Warnings It is important to know that:
Pregnancy, breastfeeding and fertility
Pregnancy
Jaydess should not be used during pregnancy.
While using Jaydess, some women may stop menstruating altogether. Absence of menstruation is not necessarily a sign of pregnancy. If you are not menstruating and have other symptoms of pregnancy, get a medical examination and a pregnancy test.
If you haven't had a period in six weeks and are worried, consider taking a pregnancy test. If the test is negative, it does not need to be repeated unless there are other signs of pregnancy.
If you become pregnant while using Jaydess, contact your healthcare professional immediately to have the device removed. If Jaydess is removed during pregnancy there is a risk of miscarriage. If Jaydess remains in place during pregnancy, risk of miscarriage, infection or increased preterm labor. Discuss the risks of continuing pregnancy with your healthcare professional. If you wish to become pregnant you should contact your healthcare provider for the removal of Jaydess.
Extrauterine pregnancy (pregnancy outside the uterus)
It is uncommon for a woman to become pregnant while using Jaydess. However, if she becomes pregnant while using Jaydess, the risk of pregnancy developing outside the womb (ectopic or ectopic pregnancy) is increased. Women who have already had an ectopic pregnancy, fallopian tube surgery or "pelvic infection are most at risk. Ectopic pregnancy is a serious condition that requires immediate medical attention (see section," Warnings and precautions "for signs and symptoms) and may affect future fertility.
Feeding time
You can use Jaydess if you are breastfeeding. Levonorgestrel (the active substance in Jaydess) has been found in small amounts in breast milk. However, no adverse effects have been observed on the growth or development of the nursing baby or on the quantity or quality of breast milk. .
Fertility
Fertility returns to normal after Jaydess has been removed.
Driving and using machines
Jaydess does not affect the ability to drive or use machines.
Dose, Method and Time of Administration How to use Jaydess: Posology
Jaydess Insertion Jaydess can be inserted:
- within seven days of the start of menstruation (monthly cycle)
- immediately after a first trimester abortion, provided you do not have a "genital infection."
- after delivery, only when the uterus has regained its normal size and not before 6 weeks after delivery (see section "Possible side effects - Perforation").
The visit carried out by the health worker prior to insertion may include:
- a cervical smear (Pap smear)
- breast exam
- other tests, for example to diagnose any infections, including sexually transmitted diseases, if necessary. The health care practitioner will also perform a gynecological visit to determine the position and size of the uterus.
After the gynecological examination:
- An instrument called a speculum is inserted into the vagina and the cervix can be cleaned with an antiseptic solution. Jaydess is inserted into the uterus by means of a thin, flexible plastic tube (insertion tube). Local anesthesia of the cervix can be performed before insertion.
- Some women feel dizzy or faint during or after inserting Jaydess or after its removal.
- Pain and bleeding may occur during or shortly after insertion
Follow-up visit:
Jaydess should be monitored 4-6 weeks after insertion and at least annually thereafter. The doctor can determine the frequency and type of checks necessary in your particular case.
Removal of Jaydess
Jaydess must be removed no later than the end of the third year of use.
Jaydess can be removed at any time by your healthcare professional; after its removal, it is possible to become pregnant. Some women feel dizzy or faint during or after the removal of Jaydess. You may feel pain and bleeding while removing Jaydess. does not want to become pregnant, Jaydess should not be removed after the seventh day of your menstrual cycle, unless you are using other birth control methods (eg condoms) for at least seven days before IUS is removed.
If you are not menstruating you should use a barrier contraceptive for seven days prior to removal.
A new Jaydess device can be inserted immediately after removing the previous one; in this case it is not necessary to adopt additional protection methods.
Side Effects What are the side effects of Jaydess
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following list lists the possible side effects by their frequency:
Very common side effects: may affect more than 1 in 10 people
- headache
- abdominal / pelvic pain
- acne / oily skin
- menstrual changes such as increased and decreased menstruation, spotting, infrequent menstruation and absent menstruation (see also section below on irregular and infrequent bleeding)
- ovarian cyst (see also the following section on ovarian cysts)
- inflammation of the external genital organs and vagina (vulvovaginitis)
Common side effects: may affect up to 1 in 10 people
- depressed mood / depression
- migraine
- nausea
- upper genital tract infection
- painful menstruation
- breast pain / discomfort
- ejection of the device (complete and partial) - (see the following paragraph on "ejection)
- hair loss
- genital discharge
Uncommon side effects: may affect up to 1 in 100 people
- increased body hair
Rare side effects: may affect up to 1 in 1,000 people
- perforation 1 of the uterus (see also paragraph below on perforation)
1 The risk of perforation is higher (up to 1 in every 100 patients) in women who are breastfeeding at the time of insertion of the intrauterine device and when the intrauterine device is inserted up to 36 weeks after delivery.
Description of some possible side effects
- Allergic reactions including rash, urticaria and angioedema (characterized by sudden swelling, for example, of the eyes, mouth, throat) have been reported with similar products.
Irregular or infrequent bleeding
Jaydess is likely to change the menstrual cycle. Menstruation may present as spotting (slight bleeding), bleeding of shorter or longer duration or less or greater intensity, or even complete absence of menstruation.
Bleeding and spotting may occur between menstruation, especially in the first 3-6 months. Sometimes, at the beginning, menstruation is more abundant than usual.
Overall, the amount and duration in days of menstruation are likely to decrease gradually each month. In some women, menstruation may stop altogether.
The lining of the uterus cannot thicken monthly due to hormonal action and therefore there is no material to be expelled with menstruation. This does not necessarily mean that you are menopausal or pregnant. Your hormone levels remain. generally normal.
After the system is removed, menstruation should soon return to normal.
Pelvic infection
The Jaydess Inserter and Jaydess Device are sterile. However, the risk of pelvic infection (infections of the lining of the uterus or fallopian tubes) is increased upon insertion and in the first 3 weeks thereafter.
Pelvic infections in SUI users are often due to sexually transmitted diseases. The risk of infection is higher if you or your partner have multiple sexual partners or if you have had pelvic inflammatory disease (PID) in the past.
Pelvic infections need to be treated promptly.
Pelvic infections such as PID can have serious consequences, impair fertility and increase the risk of a future ectopic pregnancy (pregnancy outside the uterus). In extremely rare cases, serious infections or sepsis can occur soon after insertion. severe can be fatal).
Jaydess should be removed for recurrent PIDs or if the infection is severe or unresponsive to treatment.
Expulsion
Muscle contractions of the uterus during menstruation can sometimes move or eject the IUS device.
It is a rare, but possible, occurrence that Jaydess is expelled during her period without her noticing.
It is also possible for Jaydess to be partially expelled from the uterus and then moved but not fully expelled (you and your partner may notice this during intercourse). If Jaydess is fully or partially expelled, she is no longer protected from pregnancy. .
Drilling
During the insertion of Jaydess, penetration or perforation of the wall of the uterus may occur, but it is possible that the perforation will be found only after some time. If Jaydess is found outside the uterine cavity, it is not effective in preventing pregnancy. Surgery may be required to remove Jaydess.
The risk of perforation increases during breastfeeding and in women in which it is inserted up to 36 weeks after delivery, and may be increased:
- in women who have the uterus facing back (fixed retroverted uterus)
Ovarian cyst
Since the contraceptive action of Jaydess is mainly due to local effects in the uterus, ovulation (the release of an egg) normally continues while using Jaydess. Sometimes an ovarian cyst can develop. In most cases, the woman experiences no symptoms.
An ovarian cyst may require medical attention, more rarely surgery, but it generally disappears on its own
Reporting of side effects
If you get any possible side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system at https: //www.aifa. .gov.it / content / adverse-reaction-reports
By reporting side effects you can help provide more information on the safety of this medicine.
Expiry and Retention
This medicine does not require any special storage conditions.
Keep this medicine out of the sight and reach of children.
Do not open the blister. Only the doctor or nurse are authorized to do this.
Do not use this medicine after the expiry date which is stated on the carton and blister after EXP. The expiry date refers to the last day of that month.
What Jaydess contains
The active ingredient is levonorgestrel. The intrauterine delivery system contains 13.5 mg of levonorgestrel.
The other ingredients are:
- polydimethylsiloxane elastomer
- anhydrous colloidal silica
- polyethylene
- barium sulfate
- black iron oxide (E172)
- silver
What Jaydess looks like and contents of the pack
Jaydess is a T-shaped intrauterine delivery system (IUS). The vertical arm of the T-body contains a reservoir containing the drug levonorgestrel. Two wires intended for the removal of the device are attached to the eyelet at the lower end of the vertical arm. In addition, the vertical support contains a silver ring located near the horizontal arms, visible on ultrasound.
Packaging:
- 1x1 intrauterine delivery system.
- 5x1 intrauterine delivery system.
Not all pack sizes may be marketed.
The following information is intended for healthcare professionals only
INSTRUCTIONS FOR INSERTION
Jaydess 13.5 mg intrauterine delivery system
Insertion by a healthcare professional under aseptic conditions.
Jaydess is supplied with an inserter in a sterile package which must not be opened until ready for insertion. Do not resterilize. Jaydess is for single use only. Do not use if the blister is damaged or opened. Do not insert after the expiration date stated on the carton. and on the blister after EXP.
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations
Preparation for insertion
- Visit the patient to determine the size and position of the uterus and to detect any signs of acute genital infection or other contraindications to Jaydess insertion. If there is any doubt about a pregnancy, a pregnancy test should be performed.
- Insert a speculum, visualize the cervix and carefully cleanse the cervix and vagina with a suitable antiseptic solution.
- Use an assistant if necessary.
- Grasp the anterior lip of the cervix with tenaculum forceps or other forceps to stabilize the uterus. If the uterus is retroverted it may be appropriate to grasp the posterior lip of the cervix. A slight traction on the forceps may be applied to straighten the cervical canal. countertraction on the cervix.
- Advance a uterine probe through the cervical canal to the fundus to measure depth, confirm the direction of the uterine cavity and rule out the presence of intrauterine abnormalities (e.g. septum, submucosal fibroids) or a previously inserted intrauterine contraceptive and not removed. If you have difficulty, consider dilating the canal. If dilation of the cervical canal is necessary, consider the possibility of using analgesics and / or a paracervical block
Insertion
1) First, open the sterile package completely. Operate under aseptic conditions using sterile gloves.
2) Push the slider forward in the direction of the arrow to the furthest position to load Jaydess into the insertion tube
IMPORTANT! Do not pull the slider down as this will cause Jaydess to be released prematurely. Once released, Jaydess cannot be reloaded.
3) Keeping the cursor in the furthest position, set the upper edge of the flange in correspondence with the uterine depth measured with the probe.
4) While holding the slider in the furthest position, advance the inserter into the cervix until the flange is approximately 1.5 to 2.0 cm from the cervix.
IMPORTANT! Do not force the inserter. If necessary, dilate the cervical canal.
5) While holding the inserter, pull the slider up to the mark to open the horizontal arms of Jaydess. Wait 5-10 seconds for the horizontal arms to fully deploy.
6) Gently advance the inserter towards the fundus until the flange touches the cervix. Jaydess is now located at the fundus.
7) Keeping the inserter in place, release Jaydess by pulling the slider all the way down. Keeping the slider down, gently remove the inserter by pulling it. Cut the threads leaving about 2-3 cm protruding from the cervix.
IMPORTANT! If you suspect that the system is not in the correct position, check its location (e.g. by ultrasound). Remove the system if it is not properly seated in the uterine cavity. Once the face is removed, the system does not need to be re-entered.
Removal / replacement
For removal / replacement see Jaydess Summary of Product Characteristics.
To remove Jaydess, pull the wires with pliers.
A new Jaydess system can be inserted immediately after removal.
After Jaydess has been removed, the system should be examined to ensure it is healthy.
Source Package Leaflet: AIFA (Italian Medicines Agency). Content published in January 2016. The information present may not be up-to-date.
To have access to the most up-to-date version, it is advisable to access the AIFA (Italian Medicines Agency) website. Disclaimer and useful information.
01.0 NAME OF THE MEDICINAL PRODUCT
JAYDESS 13.5 MG INTRAUTERINE RELEASE SYSTEM
▼ Medicinal product subject to additional monitoring. This will allow the rapid identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for information on how to report adverse reactions.
02.0 QUALITATIVE AND QUANTITATIVE COMPOSITION
The intrauterine delivery system contains 13.5 mg of levonorgestrel.
For the full list of excipients, see section 6.1.
For details on the release rates, see paragraph 5.2.
03.0 PHARMACEUTICAL FORM
Intrauterine delivery system (intrauterine delivery system, IUS).
The product consists of a whitish or pale yellow drug core covered by a semi-opaque membrane, mounted on the vertical support of a T-shaped body. Furthermore, the vertical support contains a silver ring located near the horizontal arms. The T-body has an eyelet at one end of the vertical support and two horizontal arms at the other end. Removal wires are attached to the eyelet. The vertical support of the IUS is contained in the insertion tube, at the apex of the inserter. The IUS and inserter are essentially free of visible impurities.
Dimensions of Jaydess: 28 x 30 x 1.55mm
04.0 CLINICAL INFORMATION
04.1 Therapeutic indications
Contraception up to 3 years.
04.2 Posology and method of administration
Dosage
Jaydess is inserted into the uterine cavity and is effective for up to three years.
Insertion and removal / replacement
Jaydess should only be inserted by physicians / healthcare professionals experienced in the insertion of IUS devices and / or who have been trained in the Jaydess insertion procedure.
Jaydess must be inserted into the uterine cavity within seven days of starting menstruation. Jaydess can be replaced with a new system at any time during your cycle. Jaydess can also be inserted immediately after a first trimester abortion.
After delivery, insertion must be postponed until the uterus is completely involution and in any case it must not take place until six weeks after delivery. If involution is significantly delayed, consider waiting up to 12 weeks after delivery.
In the event of difficulty in insertion and / or unusual pain or bleeding during or after insertion, appropriate measures should be taken immediately to exclude perforation, such as a medical examination and ultrasound. The gynecological examination may not be sufficient to exclude partial perforation.
Jaydess stands out from other IUSs thanks to the silver ring, visible on ultrasound. Jaydess's T-body contains barium sulfate which makes it visible on X-ray.
To remove Jaydess, lightly pull the wires with pliers. If the wires cannot be found and the system is visible in the uterine cavity on ultrasound, it can be removed with fine forceps, in which case the cervical canal may need to be dilated or surgery.
The system must be removed by the end of the third year at the latest. If the woman wishes to continue using the same method, a new system can be inserted immediately after removing the previous device.
If the woman does not wish to become pregnant, the device must be removed within 7 days of the start of menstruation, as long as the cycle is still regular.If the system is removed at another time in the cycle and the woman has had sexual intercourse within a week, there is a risk of pregnancy, unless a new system is inserted immediately after the previous one is removed.
After removal, the Jaydess system should be examined for integrity.
Elderly patients
Jaydess has not been studied in women over the age of 65. 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. Jaydess is contraindicated in women with acute liver disease or liver cancer (see section 4.3).
Patients with renal impairment
Jaydess has not been studied in women with renal impairment.
Pediatric population
The use of the product is not indicated before the menarche. For data on safety and efficacy in adolescents, see section 5.1.
Method of administration
Insertion by a healthcare professional under aseptic conditions.
Jaydess is supplied with an inserter in a sterile package which must not be opened until ready for insertion. Do not resterilize. Jaydess is for single use only. Do not use if the blister is damaged or opened. Do not insert the device after the stated expiration date. on the carton and blister after EXP.
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.
Preparation for insertion
• Visit the patient to determine the size and position of the uterus and to detect any signs of acute genital infection or other contraindications to Jaydess insertion. If there is any doubt about a current pregnancy, a pregnancy test should be performed.
• Insert a speculum, visualize the cervix and carefully cleanse the cervix and vagina with a suitable antiseptic solution.
• Use an assistant if necessary.
• Grasp the anterior lip of the cervix with tenaculum forceps or other forceps to stabilize the uterus. If the uterus is retroverted it may be appropriate to grasp the posterior lip of the cervix. Gentle traction on the forceps may be applied to straighten the cervical canal. countertraction on the cervix.
• Advance a uterine probe through the cervical canal to the fundus to measure depth, confirm the direction of the uterine cavity and rule out the presence of intrauterine abnormalities (eg septum, submucosal fibroids) or a previously inserted intrauterine contraceptive and not removed. If you have difficulty, consider dilating the canal. If dilation of the cervical canal is necessary, consider using analgesics and / or a paracervical block.
Insertion
1. First, fully open the sterile package. Operate under aseptic conditions using sterile gloves.
2. Push the slider forward in the direction of the arrow to the furthest position to load Jaydess into the insertion tube.
IMPORTANT! Do not pull the slider down as this will cause Jaydess to be released prematurely. Once released, Jaydess cannot be reloaded
3. Keeping the cursor in the furthest position, set the upper edge of the flange to correspond to the uterine depth measured with the probe.
4. While holding the slider in the furthest position, advance the inserter into the cervix until the flange is approximately 1.5-2.0cm from the cervix.
IMPORTANT! Do not force the inserter. If necessary, dilate the cervical canal
5. While holding the inserter, pull the slider up to the mark to open the horizontal arms of Jaydess. Wait 5-10 seconds for the horizontal arms to fully deploy.
6. Gently advance the inserter toward the fundus until the flange touches the cervix. Jaydess is now located at the fundus
7. While holding the inserter in place, release Jaydess by pulling the slider all the way down. Keeping the slider down, gently remove the inserter by pulling it. Cut the threads leaving about 2-3 cm protruding from the cervix.
IMPORTANT! If you suspect that the system is not in the correct position, check its location (e.g. by ultrasound). Remove the system if it is not properly seated in the uterine cavity. Once removed, the system does not need to be re-armed
Removal / replacement
For removal / replacement, see paragraph 4.2 Insertion and removal / replacement.
To remove Jaydess, pull the wires with pliers.
A new Jaydess system can be inserted immediately after removal.
After Jaydess has been removed, the system should be examined to ensure it is healthy.
04.3 Contraindications
• Pregnancy (see section 4.6);
• Acute or recurrent pelvic inflammatory disease or conditions associated with an increased risk of pelvic infection;
• Acute cervicitis or vaginitis;
• Postpartum endometritis or infected abortion within the previous three months;
• Cervical intraepithelial neoplasia until resolution;
• Uterine or cervical malignant neoplasm;
• Progestin-sensitive tumors, eg. breast cancer;
• Abnormal vaginal bleeding of unknown etiology;
• Congenital or acquired uterine abnormality, including fibroids, which can interfere with the insertion and / or permanence of the intrauterine system (ie if they deform the uterine cavity);
• Acute liver disease or liver cancer;
• Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
04.4 Special warnings and appropriate precautions for use
If any of the following conditions exist or occur for the first time, Jaydess should be used with caution after consultation with a specialist, or removal of the system should be considered:
• migraine, focal migraine with asymmetric loss of vision or other symptoms suggestive of transient cerebral ischaemia
• headache of exceptional intensity
• jaundice
• marked increase in blood pressure
• severe arterial disease such as stroke or myocardial infarction
Low doses of levonorgestrel may impair glucose tolerance and blood glucose should be monitored in diabetic Jaydess users. However, it is generally not necessary to change the treatment regimen in diabetic women using levonorgestrel-based IUS.
Medical examination / consultation
Prior to insertion, the woman should 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 medical examination including pelvis and breast and a smear should be performed. cervical. An ongoing pregnancy and the presence of sexually transmitted diseases must be excluded. Genital infections must be treated successfully before insertion. The position of the uterus and the size of the uterine cavity must be determined. To achieve maximum efficacy and reduce the risk of expulsion, it is important that Jaydess is positioned at the fundus. The instructions for insertion must be strictly followed.
Particularly important is the training for the correct insertion technique.
Insertion and removal may be associated with some degree of pain and bleeding. The procedure may trigger a vasovagal reaction (eg, syncope or seizure in patients with epilepsy).
The woman must be re-examined 4-6 weeks after insertion to check the wires and verify the correct position of the system. Thereafter, annual check-ups are recommended, or more frequent if clinically indicated.
Jaydess is not intended for use as a post-coital contraceptive.
The use of Jaydess to treat heavy menstrual flows or to protect against endometrial hyperplasia during estrogen replacement therapy has not been proven. Therefore Jaydess should not be used in these conditions.
Ectopic pregnancy
In clinical studies, the overall incidence of ectopic pregnancy with Jaydess was approximately 0.11 per 100 woman-years. Approximately half of the pregnancies that occur while using Jaydess may be ectopic.
Women considering the use of Jaydess should be advised of the signs, symptoms and risk of ectopic pregnancy. For women who become pregnant while using Jaydess the possibility of an ectopic pregnancy should be considered and evaluated. .
Women with a history of ectopic pregnancy, tubal surgery, or pelvic infection are at increased risk for ectopic pregnancy. The possibility of an ectopic pregnancy should be considered in case of pain in the lower abdomen, especially if associated with absent menstruation or if "bleeding" occurs in an amenorrhoeic woman.
Since an ectopic pregnancy may have an effect on future fertility, the benefits and risks of using Jaydess should be carefully considered, especially for nulliparous women.
Use in nulliparous women: As clinical experience is limited, Jaydess is not the first choice treatment for contraception in nulliparous women.
Effects on the menstrual cycle
Effects on the menstrual cycle are expected in most users of Jaydess. These effects are due to the direct action of levonorgestrel on the endometrium and may not be related to ovarian activity.
Irregular bleeding and spotting are common in the first few months of use. Subsequently, marked suppression of the endometrium results in a reduction in the duration and volume of menstrual blood loss. Poor flow often evolves into oligomenorrhea or amenorrhea.
In clinical studies, infrequent bleeding and / or amenorrhea developed gradually in approximately 22.3% and 11.6% of users, respectively. If menstruation does not occur within six weeks after the onset of the previous menstruation, the possibility of pregnancy should be considered. There is no need to repeat the pregnancy test in women with persistent amenorrhea, unless other signs of pregnancy are present.
If, over time, blood loss becomes more abundant and / or irregular, appropriate diagnostic measures should be taken, because irregular blood loss may be a symptom of endometrial polyps, hyperplasia or carcinoma and heavy bleeding may be indicative of an unconscious expulsion of the IUS.
Pelvic infection
Although Jaydess and the inserter are sterile, following bacterial contamination during insertion, they can become a vehicle for the transport of bacteria into the upper genital tract. Pelvic infection has been reported with the use of any IUS or IUD. In clinical trials, pelvic inflammatory disease (pelvic inflammatory disease, PID) was observed more frequently at the start of the use of Jaydess, similarly to what has been published for copper IUDs, with which the highest frequency of PID is found in the first 3 weeks after insertion, to decrease thereafter.
Before using Jaydess, all risk factors associated with pelvic infection (eg multiple sexual partners, sexually transmitted infections, PID history) should be evaluated in patients. Pelvic infections such as PID can have serious consequences, impair fertility and increase the risk of ectopic pregnancy.
As with other gynecological or surgical procedures and although it is extremely rare, severe infection or sepsis (including group A streptococcal sepsis) can occur following the insertion of the IUD.
In women with recurrent endometritis or pelvic inflammatory disease, or with severe acute infection or unresponsive to treatment, Jaydess should be removed.
Bacteriological examination is indicated and monitoring is recommended even if symptoms suggestive of infection are moderate.
Expulsion
In clinical trials with Jaydess, the incidence of expulsion was low and within the same range as seen with other IUDs and IUS. Symptoms of partial or complete expulsion of Jaydess may include bleeding or pain. However, a "partial or complete expulsion can occur without the woman noticing, resulting in a reduction or loss of contraceptive protection. Since Jaydess reduces menstrual bleeding over time, an increase in such losses may be indicative of a" expulsion.
In case of partial expulsion, Jaydess must be removed. On this occasion, a new system can be inserted, provided that a pregnancy has been ruled out.
The woman should be instructed on how to check Jaydess wires and urged to contact the health care professional if she cannot feel the wires.
Drilling
Perforation or penetration of the body or cervix by an intrauterine contraceptive may occur, especially during insertion, although it may not be detected until sometime later, reducing the effectiveness of Jaydess. In case of difficulty in insertion and / or exceptional pain or bleeding during or after insertion, appropriate measures should be taken immediately to exclude perforation, such as physical examination and ultrasound. The system must be removed; surgery may be required.
In a large prospective comparative non-interventional cohort study conducted in intrauterine device users (N = 61,448 women), the incidence of perforation was 1.3 (95% CI: 1.1-1.6) per 1000 insertions. in the entire study cohort; 1.4 (95% CI: 1.1-1.8) for every 1000 insertions in the cohort of another levonorgestrel-based intrauterine device and 1.1 (95% CI: 0.7-1.6) for every 1000 insertions in the cohort with copper intrauterine devices.
The study showed that both breastfeeding at insertion and insertion up to 36 weeks postpartum were associated with an increased risk of perforation (see table 1). These risk factors were independent of device type. intrauterine inserted.
Table 1: Incidence of perforation per 1000 insertions for the entire cohort study, stratified by lactation and insertion time after delivery (women who have given birth)
The risk of perforation may be increased in women with a fixed retroverted uterus.
Post-insertion review should follow the instructions given under "Medical Exam / Consultation" which can be adapted as clinically indicated in women with risk factors for perforation.
Loss of threads
If the threads are not visible at the cervix during follow-up visits, an unconscious expulsion and an ongoing pregnancy must be excluded. The threads may have retreated into the uterus or cervical canal and may reappear in the next menstrual cycle. If pregnancy has been ruled out, the threads are usually found by gently exploring the cervical canal with a suitable instrument. If not, it must be the possibility of expulsion or perforation is considered. Ultrasound can be used to verify the position of the system. If an ultrasound is not available or if the ultrasound does not provide results, Jaydess can be located by x-ray.
Ovarian cysts / enlargement of ovarian follicles
Since the contraceptive effect of Jaydess is mainly due to its local effects on the uterus, there is generally no change in ovulatory function, including regular follicle development, oocyte release and follicular atresia in women of childbearing age. Sometimes, follicular atresia is delayed and folliculogenesis can continue. These enlarged follicles are not clinically distinguishable from ovarian cysts and have been reported as adverse events in clinical trials in 13.2% of Jaydess users, including ovarian cysts, haemorrhagic ovarian cysts and rupture of ovarian cysts. Most cysts are asymptomatic, but some may be accompanied by pelvic pain or dyspareunia.
In most cases, dilated follicles resolve spontaneously within two to three months of observation. If a dilated follicle does not regress spontaneously, ultrasound monitoring and other diagnostic or therapeutic measures may be indicated. Surgery is rarely required. .
04.5 Interactions with other medicinal products and other forms of interaction
Interactions with drugs that induce microsomal liver enzymes, particularly cytochrome P450 enzymes, may occur, resulting in increased metabolism of levonorgestrel and increased clearance of sex hormones (e.g. phenytoin, barbiturates, primidone, carbamazepine, rifampicin, rifabutin , nevirapine, efavirenz, bosentan and possibly oxcarbazepine, topiramate, felbamate, griseofulvin and products containing the herbal remedy St. John's wort).
On the other hand, substances that inhibit the enzymes responsible for drug metabolism (eg.itraconazole, ketoconazole) may increase the serum concentrations of levonorgestrel.
The effect of these medicinal products on the efficacy of Jaydess is not known but is not believed to be of particular relevance due to the local mechanism of action.
Magnetic Resonance (MRI) Image Acquisition
Non-clinical analyzes have shown that patients can be safely examined after Jaydess insertion with the following settings: static magnetic field equal to or less than 3 tesla, maximum spatial gradient magnetic field equal to or less than 720 gauss / cm. Under these conditions, with a 15-minute scan, the maximum temperature rise at Jaydess was 1.8 ° C. Small artifacts can occur if the area of interest exactly matches or is relatively close to Jaydess's position. .
04.6 Pregnancy and lactation
Fertility
The use of an intrauterine system that releases levonorgestrel does not compromise future fertility. After removal of the intrauterine system, the woman regains normal fertility (see section 5.1).
Pregnancy
The insertion of Jaydess is contraindicated in pregnant women (see section 4.3).
If a woman becomes pregnant while using Jaydess, ectopic pregnancy should be excluded and prompt removal of the system is recommended, as any intrauterine contraceptive left in place may increase the risk of miscarriage and preterm delivery. Removal of Jaydess or the use of uterine probes can also induce miscarriage. If the woman wishes to continue the pregnancy and the system cannot be removed, she should be informed of the risks and possible consequences of premature birth of the baby. be closely monitored The woman should be educated about the need to report all symptoms suggestive of complications, such as crampy abdominal pain with fever.
Due to intrauterine administration and local exposure to levonorgestrel the possible virilizing effects in female fetuses should be considered. Clinical experience on pregnancy outcomes during the use of Jaydess is limited due to the high contraceptive efficacy. Women should be advised that there is currently no evidence of birth defects due to the use of a levonorgestrel-releasing intrauterine system in cases where the pregnancy has continued with the levonorgestrel-releasing IUS remaining in place.
Feeding time
In general, there appears to be no harmful effect on the growth or development of the infant if a progestogen-only method is used six weeks after delivery. A levonorgestrel-releasing intrauterine system does not compromise the quantity or quality of breast milk. Small amounts of progestogen (approximately 0.1% of the levonorgestrel dose) pass into breast milk.
04.7 Effects on ability to drive and use machines
Jaydess does not affect the ability to drive or use machines.
04.8 Undesirable effects
Summary of the safety profile
Most women experience changes in their menstrual cycle after inserting Jaydess. Over time, the frequency of amenorrhea and infrequent bleeding increases and the frequency of prolonged and frequent menstruation decreases. In clinical studies, menstrual cycles have been observed with women. following features:
Table 2: Menstrual cycle characteristics observed with Jaydess in clinical studies
* Women with prolonged bleeding may also fall into one of the other categories (excluding amenorrhea)
Summary table of adverse reactions
The frequency of adverse drug reactions (Adverse Drug Reactions, ADR) reported with Jaydess is summarized in the table below. Within each frequency class, undesirable effects are listed in order of decreasing severity. The frequencies are defined as follows:
very common (≥ 1/10),
common (≥ 1/100,
uncommon (≥ 1 / 1,000,
rare (≥ 1 / 10,000,
very rare (
* In clinical trials ovarian cysts had to be reported as AEs in case of abnormal, non-functional and / or> 3 cm diameter cysts on ultrasound.
** This frequency is based on clinical studies that exclude lactating women. In a large prospective comparative non-interventional cohort study conducted in users of another levonorgestrel-based intrauterine device and copper intrauterine devices, the frequency of perforation in women who were breastfeeding or had insertion up to 36 weeks postpartum was "uncommon" (see section 4.4 "Perforation")
Description of selected adverse reactions
Cases of hypersensitivity including rash, urticaria and angioedema have been observed with the use of another levonorgestrel-based IUS.
In women who become pregnant while using Jaydess, the relative probability of an ectopic pregnancy is increased (see section 4.4 under Ectopic pregnancy).
The wires used to remove the device can be felt by the partner during sexual intercourse.
The following ADRs have been reported in association with the Jaydess insertion or removal procedure:
pain due to the procedure, bleeding during the procedure, insertion-related vasovagal reaction with dizziness or syncope. The procedure may trigger a seizure in patients with epilepsy.
For other IUDs, cases of sepsis (including group A streptococcal sepsis) have been reported following insertion (see section 4.4 Pelvic infection).
Pediatric population
The safety profile of Jaydess from a study of 304 adolescents is consistent with that observed in the adult population
Reporting of suspected adverse reactions
The reporting of suspected adverse reactions occurring after authorization of the medicinal product is
important, as it allows continuous monitoring of the benefit / risk ratio of the medicine.
Healthcare professionals are asked to report any suspected adverse reactions via the system
national reporting at the address https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
04.9 Overdose
Not relevant.
05.0 PHARMACOLOGICAL PROPERTIES
05.1 Pharmacodynamic properties
Pharmacotherapeutic group: Plastic IUD with progestogen, ATC code: G02BA03
Pharmacodynamic effects
Jaydess is mainly endowed with local progestin effects in the uterine cavity.
The high endometrial concentration of levonorgestrel causes a decrease in endometrial estrogen and progesterone receptors. The endometrium becomes relatively insensitive to circulating estradiol and a marked antiproliferative effect is observed. During use, morphological changes of the endometrium and a mild foreign body reaction. The denser cervical mucus prevents the transit of spermatozoa into the cervical canal. The local environment in the uterus and fallopian tubes inhibits the mobility and function of spermatozoa and therefore fertilization. In clinical studies conducted with Jaydess, ovulation was observed in the majority of the subpopulation of the people studied. Signs of ovulation were found in 34 out of 35 women in the first year, in 26 out of 27 women in the second year, and in all 27 women in the third year.
Clinical efficacy and safety
The contraceptive efficacy of Jaydess was investigated in a clinical study with 1,432 women aged 18 to 35 years, comprising 38.8% of nulliparous of whom 83.6% were nulligravid during use of Jaydess. . The 1-year Pearl Index was 0.41 (95% confidence interval of 0.13 - 0.96) and the 3-year Pearl Index was 0.33 (95% confidence interval 95% equal to 0.16 - 0.60). The failure rate was approximately 0.4% at 1 year and the cumulative failure rate was approximately 0.9% at 3 years. failure also includes pregnancies due to undiagnosed expulsions and perforations. Use of an intrauterine system that releases levonorgestrel does not compromise future fertility. Based on data obtained with a higher-dose levonorgestrel-based IUS, approximately 80% of women planning pregnancy conceived within 12 months after removal of the system.
The safety profile of Jaydess from a study of 304 adolescents is consistent with that observed in the adult population. The expected efficacy is the same for adolescents under 18 years of age as it is for users aged 18 and over.
With Jaydess, changes in the menstrual cycle are due to the direct action of levonorgestrel on the endometrium and may not mirror the ovarian cycle. There are no obvious differences in follicular development, ovulation or estradiol and progesterone production in women with different menstrual characteristics. In the process of inhibiting the proliferation of the endometrium, an initial increase in spotting may occur in the first months of use. Subsequently, the marked suppression of the endometrium results in a reduction in the duration and volume of menstrual blood loss during use of Jaydess. poor flow often progresses to oligomenorrhea or amenorrhea Ovarian function remains normal and estradiol levels remain constant, even in users of amenorrhoeic Jaydess.
05.2 "Pharmacokinetic properties
Levonorgestrel is locally released into the uterine cavity. The release curve in vivo it is characterized by a large initial reduction which gradually fades, giving rise to a minimum variation after 1 year until the end of the expected use period of 3 years. Estimated percentages of release in vivo at different times are shown in Table 3.
Table 3: Estimated release rates in vivo based on data ex vivo on the residual content
Absorption
Following insertion, levonorgestrel is immediately released from the IUS into the uterine cavity, as demonstrated by the determination of serum concentrations. Maximum serum concentrations of levonorgestrel are achieved in the first two weeks following Jaydess insertion. Seven days after insertion, an average levonorgestrel concentration of 162 pg / ml was determined. Subsequently, the serum concentrations of levonorgestrel decrease over time, reaching mean concentrations of 59 pg / ml after 3 years. of a levonorgestrel-releasing intrauterine system, the high local exposure to the drug in the uterine cavity results in a marked concentration gradient between the endometrium and myometrium (endometrial gradient: myometrium> 100) and low concentrations of levonorgestrel in the serum (endometrium gradient : serum> 1,000).
Distribution
Levonorgestrel binds non-specifically to serum albumin and specific binding to sex hormone transport proteins (SHBG). Less than 2% of circulating levonorgestrel is present in free form. Levonorgestrel binds SHBG with high affinity. As a result, changes in serum SHBG concentration result in an increase (at higher SHBG concentrations) or decrease (at lower SHBG concentrations) in total serum levonorgestrel concentration. Within one month after Jaydess insertion, the SHBG concentration decreases. about 30%. Concentrations of SHBG are subsequently observed a plateau, with a tendency to increase to baseline levels over time. The mean apparent volume of distribution of levonorgestrel is approximately 106 liters.
Biotransformation
Levonorgestrel is extensively metabolised. The major plasma metabolites are the conjugated and unconjugated forms of 3a, 5b-tetrahydrolevonorgestrel. Based on the studies in vitro And in vivo, CYP3A4 is the main enzyme involved in the metabolism of levonorgestrel.
Elimination
Total clearance of levonorgestrel from plasma is approximately 1.0 ml / min / kg. Only traces of levonorgestrel are excreted in unchanged form. The metabolites are excreted in the faeces and urine with an excretion ratio of approximately 1. The half-life of excretion is approximately 1 day.
Linearity / non-linearity
The pharmacokinetics of levonorgestrel depends on the concentration of SHBG, which in turn is influenced by estrogens and androgens. In the first month of use of Jaydess, an average reduction in SHBG of approximately 30% is observed, with consequent reduction in serum levonorgestrel, a sign of non-linear pharmacokinetics of levonorgestrel with respect to time. Due to the mainly local action of Jaydess, no repercussions on the efficacy of Jaydess are expected.
Pediatric population
In a one-year phase 3 study in post-menarche adolescents (mean age 16.2 range 12-18 years) the pharmacokinetic analysis of 283 subjects demonstrated slightly higher (10%) estimated LNG concentrations in adolescents versus adults This result correlates with the generally lower body weight of adolescents.The estimated ranges for adolescents are, however, within those estimated for adults, demonstrating a high level of similarity.
05.3 Preclinical safety data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, pharmacokinetics and toxicity, including genotoxicity and carcinogenic potential of levonorgestrel. Studies conducted in monkeys with intrauterine release of levonorgestrel for 9-12 months confirmed local pharmacological activity, with good tolerability and the absence of signs of systemic toxicity. In the rabbit, no embryonic toxicity was found after intrauterine administration of levonorgestrel. The safety assessments of the elastomeric components of the hormone reservoir, the polyethylene material of the product, the silver profile and the combination of elastomer and levonorgestrel, based on the evaluation of genotoxicity in standard tests in vitro And in vivo and biocompatibility tests in mice, rats, guinea pigs, rabbits and in tests in vitrodid not show the presence of biological incompatibility.
06.0 PHARMACEUTICAL INFORMATION
06.1 Excipients
Polydimethylsiloxane elastomer
Anhydrous colloidal silica
Polyethylene
Barium sulfate
Black iron oxide (E172)
Silver
06.2 Incompatibility
Not relevant.
06.3 Period of validity
3 years.
06.4 Special precautions for storage
This medicine does not require any special storage conditions.
06.5 Nature of the immediate packaging and contents of the package
The product is supplied individually in a thermoformed blister (PETG) with tear-open (PE).
Packaging: 1x1 and 5x1.
Not all pack sizes may be marketed.
06.6 Instructions for use and handling
The product is supplied in a sterile package which must not be opened until the moment of insertion. Each system must be handled under aseptic conditions. If the seal of the sterile package is broken, the system contained within must be disposed of in compliance with local regulations on hazardous medical waste. Similarly, the removed Jaydess system and the inserter must be disposed of. The outer packaging and inner blister can be disposed of as household waste.
Insertion by a healthcare professional under aseptic conditions (see section 4.2).
07.0 MARKETING AUTHORIZATION HOLDER
Bayer S.p.A - Viale Certosa 130 - 20156 Milan
08.0 MARKETING AUTHORIZATION NUMBER
042522019 - "13.5 MG INTRAUTERINE RELEASE SYSTEM", 1 PTEG / PE BLISTER
042522021 - "13.5 MG INTRAUTERINE RELEASE SYSTEM", 5 x 1 PTEG / PE BLISTER
09.0 DATE OF FIRST AUTHORIZATION OR RENEWAL OF THE AUTHORIZATION
Date of first authorization: 13.12.2013
10.0 DATE OF REVISION OF THE TEXT
07/2015
