SKYLA

Skyla Generic Name & Formulations

Legal Class

General Description

Levonorgestrel 13.5mg; intrauterine system.

Pharmacological Class

Progestin IUD.

How Supplied

System—1

Manufacturer

Bayer Corporation

Generic Availability

Mechanism of Action

Studies of Skyla 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.

Skyla Indications

Indications

Prevention of pregnancy for up to 3yrs.

Skyla 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 3yrs.

Children

Pre-menarche: not indicated.

Administration

Skyla 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 Skyla from the inserter. Once released, Skyla 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 Skyla. Inform the patient that there is no contraceptive protection if Skyla is displaced or expelled.

Skyla Contraindications

Contraindications

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.

Skyla Boxed Warnings

Not Applicable

Skyla 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. Bleeding pattern alterations: exclude endometrial pathology prior to insertion in women with persistent 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.

Skyla Pharmacokinetics

Absorption

Mean serum concentrations of levonorgestrel: 77 ± 21 pg/mL at year 1; 62 ± 38 pg/mL at year 2; 72 ± 29 pg/mL at year 3.

Distribution

Apparent volume of distribution: ~1.8 L/kg.

Metabolism

Hepatic.

Elimination

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

Skyla Interactions

Interactions

Caution with anticoagulants; consider removal.

Skyla Adverse Reactions

Adverse Reactions

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

Skyla Clinical Trials

See Literature

Skyla Note