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KYLEENA is a brand name for Levonorgestrel, supplied as a insert (extended-release). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: KYLEENA (levonorgestrel-releasing intrauterine system [19.5 mg]) is indicated for conception control for up to 5 years. 1.1 Pediatrics Pediatrics (< 18 years of age): No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use. 1.2 Geriatrics Geriatrics: KYLEENA…
Verbatim from this product's HC label. Tap a section to expand.
5 mg]) is effective for up to 5 years. KYLEENA must be removed by the end of the fifth year and can be replaced at the time of removal with a new KYLEENA if continued contraceptive protection is desired. The in vivo release curve is characterized by an initial steep decline that slows down progressively resulting in little change after 1 year until the end of the intended 5-year period of use.
Estimated in vivo delivery rates for different time points are provided in Table 1. 4 Administration Medical Examination/Consultation Before insertion, the woman must be informed of the efficacy, risks, and side effects of KYLEENA. A thorough history and physical examination should also be performed prior to insertion, including a blood pressure determination.
Breasts, liver, extremities, and pelvic organs should be examined. Cervical smear (Papanicolaou smear) should be performed as needed, according to healthcare professional’s evaluation. Pregnancy and sexually transmitted infections should be excluded and any genital infections must be successfully treated.
For timing of insertion to exclude pregnancy, see 4 DOSAGE AND ADMINISTRATION - Insertion, Removal and Replacement. The position of the uterus and the size of the uterine cavity should be determined. Fundal position of KYLEENA is particularly important in order to ensure uniform exposure of the endometrium to the progestogen, prevent expulsion and maximize efficacy.
Because irregular bleeding is common during the first months of therapy with all IUSs, including KYLEENA, it is recommended to exclude endometrial pathology before insertion (see 7 WARNINGS AND PRECAUTIONS - Genitourinary: Bleeding Irregularities; and 8 ADVERSE REACTIONS).
The instructions for insertion should be followed carefully. The patient should be re-examined 4 to 12 weeks after insertion and once a year thereafter, or more frequently if clinically indicated. KYLEENA is not for use as a postcoital contraceptive.
Insertion, Removal and Replacement It is recommended that KYLEENA only be inserted by healthcare professionals who are experienced in IUS insertions and/ or have undergone training on the KYLEENA insertion procedure. KYLEENA can be distinguished from other IUSs by the silver ring which is visible upon ultrasound as well as the blue colour of the removal threads.
). The instructions for insertion should be followed carefully. The patient should be re-examined 4 to 12 weeks after insertion and once a year thereafter, or more frequently if clinically indicated. KYLEENA is not for use as a postcoital contraceptive.
Insertion, Removal and Replacement It is recommended that KYLEENA only be inserted by healthcare professionals who are experienced in IUS insertions and/ or have undergone training on the KYLEENA insertion procedure. KYLEENA can be distinguished from other IUSs by the silver ring which is visible upon ultrasound as well as the blue colour of the removal threads.
The T-body of KYLEENA contains barium sulphate, which makes it visible in X-ray examination. In women of fertile age, KYLEENA should be inserted within 7 days of the onset of menstruation. In this case no back up contraception is needed.
KYLEENA can be inserted any time during the cycle if the healthcare professional can be reasonably certain (as defined by the World Health Organization) that the woman is not pregnant. If insertion is more than 7 days since menstrual bleeding started, a barrier method of contraception should be used or the patient should abstain from vaginal intercourse for the next 7 days to prevent pregnancy.
Consider the possibility of ovulation and conception before using this product. KYLEENA may be replaced by a new system at any time during the cycle. The system can also be inserted immediately after first trimester abortion. Insertions following second trimester abortion should be postponed for a minimum of 6 weeks or until the uterus is fully involuted.
If involution is delayed, wait until involution is complete before insertion. Postpartum insertions should be postponed until the uterus is fully involuted, and not earlier than 6 weeks after delivery. If involution is substantially delayed, consider waiting until 12 weeks postpartum.
Cardiovascular section). Uterine Perforation may occur with the use of intrauterine contraceptives including KYLEENA (see 7 WARNINGS AND PRECAUTIONS - Uterine Perforation section). 5 mg]) is effective for up to 5 years. KYLEENA must be removed by the end of the fifth year and can be replaced at the time of removal with a new KYLEENA if continued contraceptive protection is desired.
The in vivo release curve is characterized by an initial steep decline that slows down progressively resulting in little change after 1 year until the end of the intended 5-year period of use. Estimated in vivo delivery rates for different time points are provided in Table 1.
4 Administration Medical Examination/Consultation Before insertion, the woman must be informed of the efficacy, risks, and side effects of KYLEENA. A thorough history and physical examination should also be performed prior to insertion, including a blood pressure determination.
Breasts, liver, extremities, and pelvic organs should be examined. Cervical smear (Papanicolaou smear) should be performed as needed, according to healthcare professional’s evaluation. Pregnancy and sexually transmitted infections should be excluded and any genital infections must be successfully treated.
For timing of insertion to exclude pregnancy, see 4 DOSAGE AND ADMINISTRATION - Insertion, Removal and Replacement. The position of the uterus and the size of the uterine cavity should be determined. Fundal position of KYLEENA is particularly important in order to ensure uniform exposure of the endometrium to the progestogen, prevent expulsion and maximize efficacy.
Because irregular bleeding is common during the first months of therapy with all IUSs, including KYLEENA, it is recommended to exclude endometrial pathology before insertion (see 7 WARNINGS AND PRECAUTIONS - Genitourinary: Bleeding Irregularities; and
5 mg]) is contraindicated in patients with the following conditions: known or suspected pregnancy current or recurrent pelvic inflammatory disease or conditions associated with increased risk for pelvic infections postpartum endometritis or septic abortion during the previous three months abnormal uterine bleeding of unknown etiology congenital or acquired uterine anomaly, including fibroids, that distort the uterine cavity uterine or cervical malignancy known or suspected progestogen-dependent neoplasia, including breast cancer cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled cervical dysplasia active liver disease or dysfunction actual benign or malignant liver tumours hypersensitivity to levonorgestrel or any of the other ingredients in the formulation or components of KYLEENA.
5 mg]) Page 5 of 51
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The T-body of KYLEENA contains barium sulphate, which makes it visible in X-ray examination. In women of fertile age, KYLEENA should be inserted within 7 days of the onset of menstruation. In this case no back up contraception is needed.
KYLEENA can be inserted any time during the cycle if the healthcare professional can be reasonably certain (as defined by the World Health Organization) that the woman is not pregnant. If insertion is more than 7 days since menstrual bleeding started, a barrier method of contraception should be used or the patient should abstain from vaginal intercourse for the next 7 days to prevent pregnancy.
Consider the possibility of ovulation and conception before using this product. KYLEENA may be replaced by a new system at any time during the cycle. The system can also be inserted immediately after first trimester abortion. Insertions following second trimester abortion should be postponed for a minimum of 6 weeks or until the uterus is fully involuted.
If involution is delayed, wait until involution is complete before insertion. Postpartum insertions should be postponed until the uterus is fully involuted, and not earlier than 6 weeks after delivery. If involution is substantially delayed, consider waiting until 12 weeks postpartum.
In case of a difficult insertion and/or exceptional pain or bleeding during or after insertion, the possibility of perforation should be considered and appropriate steps should be taken, such as physical examination and ultrasound.
If bleeding irregularities develop during prolonged treatment, appropriate diagnostic measures should be taken as irregular bleeding may be a symptom of endometrial polyps, hyperplasia or cancer. The removal threads may be felt by the partner during intercourse.
5 mg]) Page 7 of 51 KYLEENA can be removed by gently pulling on the removal threads with forceps. If the threads are not visible and the system is in the uterine cavity, it may be removed using forceps. This may require dilatation of the cervical canal or other surgical intervention, such as hysteroscopy.
After removal of KYLEENA, verify that the system is intact. The system should be removed after 5 years of use. If the patient wishes to continue using KYLEENA, a new system can be inserted at the time of removal of the old one. If pregnancy is not desired, removal should be carried out within 7 days of the onset of menstruation in women of fertile age provided that there appears to be a menstrual cycle.
If the system is removed at some other time 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 new system should be immediately inserted or an alternative contraceptive method should have been initiated.
Insertion and removal may be associated with some pain […]
In case of a difficult insertion and/or exceptional pain or bleeding during or after insertion, the possibility of perforation should be considered and appropriate steps should be taken, such as physical examination and ultrasound.
If bleeding irregularities develop during prolonged treatment, appropriate diagnostic measures should be taken as irregular bleeding may be a symptom of endometrial polyps, hyperplasia or cancer. The removal threads may be felt by the partner during intercourse.
5 mg]) Page 7 of 51 KYLEENA can be removed by gently pulling on the removal threads with forceps. If the threads are not visible and the system is in the uterine cavity, it may be removed using forceps. This may require dilatation of the cervical canal or other surgical intervention, such as hysteroscopy.
After removal of KYLEENA, verify that the system is intact. The system should be removed after 5 years of use. If the patient wishes to continue using KYLEENA, a new system can be inserted at the time of removal of the old one. If pregnancy is not desired, removal should be carried out within 7 days of the onset of menstruation in women of fertile age provided that there appears to be a menstrual cycle.
If the system is removed at some other time 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 new system should be immediately inserted or an alternative contraceptive method should have been initiated.
Insertion and removal may be associated with some pain and bleeding. The procedure may cause a fainting spell or precipitate a seizure in an epileptic patient. It is recommended to wait 24 to 48 hours before having sexual intercourse in the event of general discomfort after insertion of KYLEENA.
Expulsion Partial or complete expulsion of KYLEENA may occur resulting in the loss of efficacy. Symptoms of the partial or complete expulsion of KYLEENA may include bleeding or pain; however, a system may be expelled from the uterine cavity without the patient noticing it.
Since KYLEENA decreases menstrual flow, an increase in menstrual flow may indicate an expulsion. 5% (59 of 1690 subjects over 5 years), and in the same range as that reported for other IUDs and IUSs. Overall, more than half of the expulsions occurred during the first 12 months after insertion.
5%). 74 per 100 IUS/IUD insertions. e. 95 per 100 insertions among women without documented delivery in the past 52 weeks. The expulsion rate among women at other postpartum intervals were generally similar to that of women without delivery in the past 52 weeks.
10 expulsions per 100 insertions). - Women with greater than normal BMI at the time of insertion: this risk increases gradually with increasing BMI. 39 per 100 insertions in women […]