KYLEENA®
A 5-YEAR 
LOW DOSE IUS

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

Click here for additional safety information and for a link to the Product Monograph discussing:

  • 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 component of the container components of KYLEENA®; 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 regarding sexually transmitted infections (STIs), cigarette smoking and 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 breast-feeding women; 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; 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 cast; impaired liver function; jaundice/history of pregnancy-related cholestasis; history of severe headache/migraine with focal neurological symptoms; 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 KYLEENA®; 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.
hCG=human chorionic gonadotropin; PID=pelvic inflammatory disease; VTE=venous thromboembolism.

KYLEENA®
A 5-YEAR 
LOW DOSE IUS

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

Click here for additional safety information and for a link to the Product Monograph discussing:

  • 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 component of the container components of KYLEENA®; 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 regarding sexually transmitted infections (STIs), cigarette smoking and 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 breast-feeding women; 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; 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 cast; impaired liver function; jaundice/history of pregnancy-related cholestasis; history of severe headache/migraine with focal neurological symptoms; 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 KYLEENA®; 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.
hCG=human chorionic gonadotropin; PID=pelvic inflammatory disease; VTE=venous thromboembolism.

SMILING WOMAN