KYLEENA^®

Indication and clinical use:

KYLEENA^® (levonorgestrel [LNG]-releasing intrauterine system (IUS) [19.5 mg]) is indicated for conception control for up to 5 years.

No data are available to Health Canada; therefore, Health Canada has not authorized an indication for pediatric use or geriatric use.
Not indicated for use in postmenopausal women.

Contraindications:

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 the container
A previously inserted intrauterine contraceptive (IUC) that has not been removed
Recent trophoblastic disease while hCG levels are elevated
Bacterial endocarditis

Most serious warnings and precautions:

Sexually transmitted infections (STIs): Hormonal contraceptives DO NOT PROTECT against STIs, including HIV/AIDS. For protection against STIs, it is advisable to use latex or polyurethane condoms in combination with KYLEENA^®.

Cigarette smoking: Increases the risk of serious adverse effects on the heart and blood vessels. Women should be counseled not to smoke.

Uterine perforation: May occur with the use of IUCs, including KYLEENA^®. If partial perforation (uterine embedment) or complete perforation occurs, KYLEENA^® must be located and removed; surgery may be required. Pregnancy may result from partial or complete perforation. Delayed detection of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal perforation and obstruction, abscesses and erosion of adjacent viscera. Both breastfeeding at the time of insertion and insertion ≤36 weeks after giving birth were associated with an increased risk of perforation. The risk of perforation may be increased in women with abnormal uterine anatomy or fixed retroverted uterus. To reduce the possibility of perforation, it is important to follow the recommended insertion technique. Inform patients before the procedure about the risk of uterine perforation. KYLEENA^® insertion should be delayed ≥6 weeks after delivery or until uterine involution is complete.

Other relevant warnings and precautions:

Before insertion, the woman must be informed of the efficacy, risks, and side effects of KYLEENA^®; a thorough history and physical examination should be performed prior to insertion and 4–12 weeks following insertion and at least once a year thereafter, or more frequently if clinically indicated
Hormonal contraceptives are not recommended as the contraceptive method of first choice in breast-feeding women
Not for use as a postcoital contraceptive
Breast cancer; breast self-examination should be discussed with women receiving hormonal contraceptives
Caution in patients with current or history of cardiovascular disease
If a significant elevation of blood pressure in previously normotensive or hypertensive subjects occurs at any time during use, KYLEENA^® removal should be considered
Caution in women with congenital or valvular heart disease at risk of infective endocarditis
Diabetic patients, and those with a family history of diabetes, should be observed closely for changes in carbohydrate metabolism
Gastrointestinal disorders
Menstrual bleeding pattern changes are common in the first few months of use; bleeding irregularities after prolonged use should be appropriately investigated
Arterial and venous thromboembolism
VTE may be temporarily increased with prolonged immobilization, major surgery, or trauma; patients with varicose veins and leg cast should be closely monitored
Impaired liver function
Jaundice; history of pregnancy-related cholestasis
Caution in women with a history of severe headache or migraine with focal neurological symptoms
Eye problems or discomfort, including those relating to contact lens use
Patients with a history of emotional disturbances especially the depressive type, may be more prone to have a recurrence of depression while using KYLEENA^®. In cases of a serious recurrence, consideration should be given to removing KYLEENA^®, since the depression may be drug-related.
Ectopic pregnancy; in the event of pregnancy, the relative likelihood of ectopic pregnancy is increased. Women should be informed of the risk of ectopic pregnancy, and subsequent risk of impaired or loss of fertility
Complete or partial expulsion of KYLEENA^® may occur resulting in the loss of efficacy
Ovarian cysts/enlarged ovarian follicles
Increased risk of PID for 20 days following insertion of intrauterine devices related to the insertion procedure
The use of KYLEENA^® does not alter the course of future fertility; upon removal, women return to their normal fertility
Sepsis
Skin and subcutaneous tissue disorders

For more information:

Please consult the Product Monograph at: https://www.bayer.com/sites/default/files/2020-11/kyleena-pm-en.pdf for important information relating to adverse reactions, interactions and dosing information which have not been discussed in this piece. The Product Monograph is also available by calling 1-800-265-7382.

MIRENA^®

MIRENA^® (levonorgestrel-releasing intrauterine system) is indicated for:

conception control for maximum up to 5 years
treatment of idiopathic menorrhagia following appropriate diagnostic investigation in women accepting the contraceptive effect of MIRENA^®

Consult the Product Monograph at https://www.bayer.com/sites/default/files/mirena-pm-en.pdf for information about:

Contraindications in patients with known/suspected pregnancy; current/recurrent PID; lower genital tract infection; postpartum endometritis; undiagnosed abnormal uterine bleeding; uterine anomalies, including fibroids if they distort the uterine cavity; uterine or cervical malignancy; known/suspected progestin-dependent neoplasia, including breast cancer; cervicitis; cervical dysplasia; active liver disease/dysfunction; actual benign or malignant liver tumours; septic abortion within the previous 3 months; bacterial endocarditis; established immunodeficiency; acute malignancies affecting blood or leukemias; recent trophoblastic disease while hCG levels are elevated
Most serious warnings and precautions regarding sexually transmitted infections, cigarette smoking, uterine perforation
Other relevant warnings and precautions regarding Health Canada not authorizing an indication for pediatric or geriatric use (due to no data being available to Health Canada) or for use in post-menopausal women; hormonal contraceptive use in breastfeeding women; use in only women of child-bearing age; postcoital contraception; breast cancer/breast self-examination; current/history of cardiovascular disease; significant elevation of blood pressure in previously normotensive or hypertensive subjects; congenital/valvular heart disease; migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia, severe headache, marked increase in blood pressure, or active or previous severe arterial disease such as stroke or myocardial infarction; patients with diabetes/those with a family history of diabetes; gastrointestinal disorders; bleeding irregularities after prolonged use; arterial and venous thromboembolism; increased risk of VTE with prolonged immobilization, major surgery, or trauma and in those with varicose veins and leg casts; impaired liver function; jaundice/history of pregnancy-related cholestasis; eye problems/discomfort, including those relating to contact lens use; history of emotional disturbances, especially the depressive type; ectopic pregnancy; complete or partial expulsion of MIRENA^®; ovarian cysts/enlarged ovarian follicles; increased risk of PID for 20 days following insertion; no alterations to the course of future fertility; sepsis; skin and subcutaneous tissue disorders; discussion of efficacy, risks and side effects before insertion; perform thorough history and physical examination prior to insertion, 4–12 weeks after insertion, and ≥1/year thereafter
Conditions of clinical use, adverse reactions, drug interactions and dosing

The Product Monograph is also available by calling 1-800-265-7382.

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5-year IUS. Low dose

KYLEENA®