Indications for: KYLEENA

Prevention of pregnancy for up to 5yrs.

Adult Dosage:

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 Dosage:

Pre-menarche: not recommended.

KYLEENA 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 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 Classification:

Progestin IUD.

KYLEENA Interactions:

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

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.

Generic Drug Availability:


How Supplied: