KYLEENA

Kyleena Generic Name & Formulations

Legal Class

General Description

Levonorgestrel 19.5mg; intrauterine system.

Pharmacological Class

Progestin IUD.

How Supplied

System—1

Manufacturer

Bayer Corporation

Generic Availability

Mechanism of Action

Studies of Kyleena and similar intrauterine system prototypes have suggested several mechanisms that prevent pregnancy: thickening of cervical mucus preventing passage of sperm into the uterus, inhibition of sperm capacitation or survival, and alteration of the endometrium.

Kyleena Indications

Indications

Prevention of pregnancy for up to 5yrs.

Kyleena Dosage and Administration

Adult

See full labeling. Insert into uterine cavity as directed. Reexamine and evaluate 4–6wks after insertion; then yearly or more if needed. Remove or replace after 5yrs.

Children

Pre-menarche: not recommended.

Administration

Kyleena is supplied within an inserter in a sterile package that must not be opened until required for insertion. Follow the insertion instructions exactly as described in order to ensure proper placement and avoid premature release of Kyleena from the inserter. Once released, Kyleena cannot be re-loaded.

Nursing Considerations

Counsel the patient on how to check that the threads still protrude from the cervix and caution them not to pull on the threads and displace Kyleena. Inform the patient that there is no contraceptive protection if Kyleena is displaced or expelled.

Kyleena Contraindications

Contraindications

Pregnancy. Post-coital contraception. Congenital or acquired uterine anomaly including fibroids. Acute or history of pelvic inflammatory disease (PID) unless there has been a subsequent intrauterine pregnancy. Postpartum endometritis or infected abortion in past 3 months. Uterine or cervical neoplasia. Breast or other progestin-sensitive cancer. Uterine bleeding of unknown etiology. Untreated acute cervicitis or vaginitis. Active liver disease or tumor. Conditions associated with increased susceptibility to pelvic infections. Retained IUD.

Kyleena Boxed Warnings

Not Applicable

Kyleena Warnings/Precautions

Warnings/Precautions

Evaluate for ectopic pregnancy. Risk of spontaneous abortion, miscarriage, sepsis, premature labor or delivery, congenital anomalies: remove if pregnant. Consider risks of PID before using. Remove if endometritis or PID recurs or if acute pelvic infection is severe or unresponsive to treatment. Bleeding pattern alterations: exclude endometrial pathology prior to insertion in women with persistent or uncharacteristic bleeding. Risk of perforation, expulsion and ovarian cysts. Increased risk of perforation in women recently given birth, who are breastfeeding, ≤6 weeks postpartum, if inserted in women with fixed retroverted or not completely involuted uteri. Consider removal if coagulopathy, migraine, transient cerebral ischemia, severe headache, marked increase in BP, severe arterial disease, uterine/cervical malignancy, jaundice, or symptomatic actinomycosis occurs. May be scanned with MRI under specific conditions. Nursing mothers.

Kyleena Pharmacokinetics

Absorption

Mean serum concentrations of levonorgestrel: 199 ± 171 pg/mL at year 1; 120 ± 57 pg/mL at year 2; 122 ± 65 pg/mL at year 3; 79 ± 12 pg/mL at year 4; 65 ± 15 pg/mL at year 5.

Distribution

Apparent volume of distribution: ~1.8 L/kg.

Metabolism

Hepatic.

Elimination

Renal (45%), fecal (32%).

Kyleena Interactions

Interactions

Caution with anticoagulants; consider removal. May be antagonized by CYP3A4 inducers. May be potentiated by CYP3A4 inhibitors.

Kyleena Adverse Reactions

Adverse Reactions

Vulvovaginitis, ovarian cyst, abdominal/pelvic pain, headache/migraine, acne/seborrhea, dysmenorrhea/uterine spasm, breast pain/breast discomfort, increased bleeding; ectopic pregnancy, intrauterine pregnancy, sepsis, PID, perforation, expulsion.

Kyleena Clinical Trials

See Literature

Kyleena Note