Active Ingredient(s):
Levonorgestrel 13.5mg; intrauterine system.

Company
Bayer Healthcare Pharmaceuticals Inc.

Indication(s):

Prevention of pregnancy for up to 3 years.

Pharmacology:

The mechanism by which continuously released levonorgestrel (LNG) enhances contraceptive effectiveness of Skyla has not been conclusively demonstrated. Studies of Skyla and similar LNG 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.
 
After insertion into the uterine cavity with Skyla, 13.5mg of LNG was released in vivo at a rate of approximately 14mcg/day after 24 days. This rate decreases progressively to 5mcg/day after 3 years. The average release rate of LNG is approximately 6mcg/day over a period of 3 years.

Clinical Trials:

The efficacy of Skyla was demonstrated in a multicenter, randomized open label study conducted in 11 countries involving healthy women aged 18–35, 1,432 of whom received Skyla.
 
The primary endpoint was the pregnancy rate calculated as the Pearl Index (PI) in women aged 18–35 years to assess contraceptive reliability. The PI was calculated based on 28-day equivalent exposure cycles; eva luable cycles excluded those in which back-up contraception was used unless a pregnancy occurred in that cycle. Skyla-treated women provided 15,763 eva luable 28-day cycle equivalents in the first year and 39,368 eva luable cycles over the 3 year treatment period. The PI estimate for the first year of use based on the 5 pregnancies that occurred after the onset of treatment and within 7 days after Skyla removal or expulsion was 0.41 with a 95% upper confidence limit of 0.96. The cumulative 3-year pregnancy rate, based on 10 pregnancies, estimated by the Kaplan- Meier method was 0.9 per 100 women or 0.9% with a 95% upper confidence limit of 1.7%. About 77% of women wishing to become pregnant conceived within 12 months after removal of Skyla.

Legal Classification:

Rx

Adults:

See full labeling. Insert into uterine cavity as directed. Reexamine and eva luate 4–6 weeks after insertion; then yearly or more if needed. Remove or replace after 3 years.

Children:

Pre-menarche: not recommended.

Contraindication(s):

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. Pregnancy.

Warnings/Precautions:

eva luate for ectopic pregnancy. Risk of spontaneous abortion, miscarriage, sepsis, premature labor or delivery, congenital anomalies: remove if pregnant. Consider risks of PID before using. Bleeding pattern alterations: ­exclude endometrial pathology prior to insertion in women with persistent bleeding. Risk of perforation, expulsion and ovarian cysts. Consider removal if coagulopathy, migraine, transient cerebral ischemia, severe headache, marked increase in BP, severe ­arterial disease, uterine/cervical malignancy, or jaundice occurs. May be scanned with MRI under specific conditions. Nursing mothers.

Interaction(s)

Caution with anticoagulants; consider removal. May be antagonized by barbiturates, bosen­tan, carbamazepine, efavirenz, felbamate, griseofulvin, nevirapine, oxcarbazepine, phenytoin, rifabutin, rifampin, St. John’s wort, topiramate. May be affected by HIV PIs or NNRTIs. May be potentiated by CYP3A4 inhibitors (eg, ketoconazole, itraconazole).

Adverse Reaction(s)

Bleeding pattern alterations, vulvovaginitis, abdominal/pelvic pain, acne/seborrhea, ovarian cyst, headache; ectopic pregnancy, intrauterine pregnancy, sepsis, PID, perforation, expulsion.

How Supplied:

System—1

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