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KYLEENA
Contraception
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Drug Name:

KYLEENA Rx

Generic Name and Formulations:
Levonorgestrel 19.5mg; intrauterine system.

Company:
Bayer Healthcare Pharmaceuticals Inc.

Therapeutic Use:

Indications for KYLEENA:

Prevention of pregnancy for up to 5yrs.

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.

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.

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 lactating women or if inserted in women with fixed retroverted or not completely involuted uteri or during postpartum period; delay insertion a minimum of 6wks, until involution is complete after delivery or a second trimester abortion. 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.

Interactions:

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

Pharmacological Class:

Progestin IUD.

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.

Metabolism:

Hepatic.

Elimination:

Renal, fecal.

Generic Availability:

NO

How Supplied:

System—1

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