Safety Information

Indication and clinical use:

  • Kyleena® (levonorgestrel [LNG]-releasing intrauterine system (IUS) [19.5 mg]) is indicated for conception control for up to 5 years.
  • Kyleena® is not indicated for use in postmenopausal women.
  • Safety and efficacy have been studied in women aged 18 and over.
  • Kyleena® is not indicated for use before menarche.

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:

  • Sexually Transmitted Infections (STIs): Hormonal contraceptives DO NOT PROTECT against Sexually Transmitted Infections (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 intrauterine contraceptives including Kyleena®. If partial perforation (uterine embedment) or complete perforation occurs, Kyleena® must be located and removed and 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 breast-feeding at the time of insertion and insertion up to 36 weeks after giving birth are 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 a minimum of 6 weeks after delivery or until uterine involution is complete.

Other relevant warnings and precautions:

  • Efficacy is expected to be the same for post-menarcheal adolescents under the age of 18 as for users 18 years and older
  • 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 current or history of cardiovascular disease
  • Hypertension; if a significant elevation of blood pressure in previously normotensive or hypertensive subjects occurs at any time during Kyleena® 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
  • 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®; partial expulsion may lead to a decrease or loss of contraceptive protection
  • Ovarian cysts/enlarged ovarian follicles
  • Increased risk of pelvic inflammatory disease (PID) during 20 days following insertion of intrauterine devices
  • Sepsis
  • 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 to 12 weeks following insertion and at least once a year thereafter, or more frequently if clinically indicated

For more information:

Please consult the product monograph at: omr.bayer.ca/omr/online/kyleena-pm-en.pdf for important information relating to adverse reactions, interactions and dosing information which have not been discussed in this piece.