"The U.S. Food and Drug Administration on Wednesday approved a request by Danco Laboratories to expand authorized use of its abortion pill Mifeprex (mifepristone), formerly known as RU-486, to 70 days of gestation from 49 days.
Skyla™ is indicated to prevent pregnancy for up to 3 years.
The system should be replaced after 3 years if continued use is desired.
DOSAGE AND ADMINISTRATION
Skyla contains 13.5 mg of levonorgestrel (LNG) released in vivo at a rate of approximately 14 mcg/day after 24 days. This rate decreases progressively to 5 mcg/day after 3 years. The average in vivo release rate of LNG is approximately 6 mcg/day over a period of 3 years.
Skyla must be removed by the end of the third year and can be replaced at the time of removal with a new Skyla if continued contraceptive protection is desired.
Skyla is supplied within an inserter in a sterile package (see Figure 1) that must not be opened until required for insertion [see DESCRIPTION]. Do not use if the seal of the sterile package is broken or appears compromised. Use strict aseptic techniques throughout the insertion procedure [see WARNINGS AND PRECAUTIONS].
Skyla and Inserter
- A complete medical and social history should be obtained to determine conditions that might influence the selection of a levonorgestrel-releasing intrauterine system (LNG IUS) for contraception. If indicated, perform a physical examination, and appropriate tests for any forms of genital or other sexually transmitted infections. [See CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
- 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.
- Skyla should be inserted by a trained healthcare provider. Healthcare providers should become thoroughly familiar with the insertion instructions before attempting insertion of Skyla.
- Insertion may be associated with some pain and/or bleeding or vasovagal reactions (for example, syncope, bradycardia) or seizure in an epileptic patient, especially in patients with a predisposition to these conditions. Consider administering analgesics prior to insertion.
Timing of Insertion
- Insert Skyla into the uterine cavity during the first seven days of the menstrual cycle or immediately after a first trimester abortion. Back up contraception is not needed when Skyla is inserted as directed.
- Postpone postpartum insertion and insertions following second trimester abortions a minimum of six weeks or until the uterus is fully involuted. If involution is delayed, wait until involution is complete before insertion [see WARNINGS AND PRECAUTIONS].
Tools for Insertion
- Sterile gloves
- Skyla with inserter in sealed package
- Instruments and anesthesia for paracervical block, if anticipated
- Consider having an unopened backup Skyla available
- Sterile, sharp curved scissors
Preparation for insertion
- Exclude pregnancy and confirm that there are no other contraindications to the use of Skyla.
- Ensure that the patient understands the contents of the Patient Information Booklet and obtain the signed patient informed consent located on the last page of the Patient Information Booklet.
- With the patient comfortably in lithotomy position, do a bimanual exam to establish the size, shape and position of the uterus.
- Gently insert a speculum to visualize the cervix.
- Thoroughly cleanse the cervix and vagina with a suitable antiseptic solution.
- Prepare to sound the uterine cavity. Grasp the upper lip of the cervix with a tenaculum forceps and gently apply traction to stabilize and align the cervical canal with the uterine cavity. Perform a paracervical block if needed. If the uterus is retroverted, it may be more appropriate to grasp the lower lip of the cervix. The tenaculum should remain in position and gentle traction on the cervix should be maintained throughout the insertion procedure.
- Gently insert a uterine sound to check the patency of the cervix, measure the depth of the uterine cavity in centimeters, confirm cavity direction, and detect the presence of any uterine anomaly. If you encounter difficulty or cervical stenosis, use dilatation, and not force, to overcome resistance. If cervical dilatation is required, consider using a paracervical block.
Proceed with insertion only after completing the above steps and ascertaining that the patient is appropriate for Skyla. Ensure use of aseptic technique throughout the entire procedure.
Step 1–Opening of the package
- Open the package (Figure 1). The contents of the package are sterile.
Figure 1: Opening the Skyla
Using sterile gloves, lift the handle of the sterile inserter and remove from the sterile package.
Step 2–Load Skyla into the insertion tube
- Push the slider forward as far as possible in the direction of the arrow thereby moving the insertion tube over the Skyla T-body to load Skyla into the insertion tube (Figure 2). The tips of the arms will meet to form a rounded end that extends slightly beyond the insertion tube.
Figure 2: Move slider all
the way to the forward position to load Skyla
- Maintain forward pressure with your thumb or forefinger on the slider. DO NOT move the slider downward at this time as this may prematurely release the threads of Skyla. Once the slider is moved below the mark, Skyla cannot be re-loaded.
Step 3–Setting the Flange
- Holding the slider in this forward position, set the upper edge of the flange to correspond to the uterine depth (in centimeters) measured during sounding (Figure 3).
Figure 3: Setting the flange
Step 4–Skyla is now ready to be inserted
- Continue holding the slider in this forward position. Advance the inserter through the cervix until the flange is approximately 1.5–2 cm from the cervix and then pause (Figure 4).
Figure 4: Advancing insertion tube until flange is 1.5
to 2 cm from the cervix
Do not force the inserter. If necessary, dilate the cervical canal.
Step 5–Open the arms
- While holding the inserter steady, move the slider down to the mark to release the arms of Skyla (Figure 5). Wait 10 seconds for the horizontal arms to open completely.
Figure 5: Move the slider back to the mark to release
and open the arms
Step 6–Advance to fundal position
Advance the inserter gently towards the fundus of the uterus until the flange touches the cervix. If you encounter fundal resistance do not continue to advance. Skyla is now in the fundal position (Figure 6). Fundal positioning of Skyla is important to prevent expulsion.
Figure 6: Move Skyla into the fundal position
Step 7–Release Skyla and withdraw the inserter
- Holding the entire inserter firmly in place, release Skyla by moving the slider all the way down (Figure 7).
Figure 7: Move the slider
all the way down to release Skyla from the insertion tube
- Continue to hold the slider all the way down while you slowly and gently withdraw the inserter from the uterus.
- Using a sharp, curved scissor, cut the threads perpendicular, leaving about 3 cm visible outside of the cervix [cutting threads at an angle may leave sharp ends (Figure 8)]. Do not apply tension or pull on the threads when cutting to prevent displacing Skyla. .
Figure 8: Cutting the threads
Skyla insertion is now complete. Prescribe analgesics, if indicated. Keep a copy of the Consent Form with lot number for your records.
Important information to consider during or after insertion
- If you suspect that Skyla is not in the correct position, check placement (for example, using transvaginal ultrasound). Remove Skyla if it is not positioned completely within the uterus. A removed Skyla must not be re-inserted.
- If there is clinical concern, exceptional pain or bleeding during or after insertion, appropriate steps should be taken immediately to exclude perforation, such as physical examination and ultrasound.
- Patients should be reexamined and evaluated 4 to 6 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.
Removal of Skyla
Timing of Removal
- Skyla should not remain in the uterus after 3 years.
- If pregnancy is not desired, the removal should be carried out during menstruation, provided the woman is still experiencing regular menses. If removal will occur at other times during the cycle, consider starting a new contraceptive method a week prior to removal. If removal occurs at other times during the cycle and the woman has had intercourse in the week prior to removal, she is at risk of pregnancy.
Tools for Removal
- Sterile forceps
- Remove Skyla by applying gentle traction on the threads with forceps (Figure 9).
Figure 9: Removal of Skyla
- If the threads are not visible, determine location of Skyla by ultrasound [see WARNINGS AND PRECAUTIONS].
- If Skyla is found to be in the uterine cavity on ultrasound exam, it may be removed using a narrow forceps, such as an alligator forceps. This may require dilation of the cervical canal. After removal of Skyla, the system should be examined to ensure that it is intact.
- Removal may be associated with some pain and/or bleeding or vasovagal reactions (for example, syncope, or a seizure in an epileptic patient).
Continuation of Contraception after Removal
- If pregnancy is not desired and if a woman wishes to continue using Skyla, a new system can be inserted immediately after removal any time during the cycle.
- If a patient with regular cycles wants to start a different birth control method, time removal and initiation of new method to ensure continuous contraception. Either remove Skyla during the first 7 days of the menstrual cycle and start the new method or start the new method at least 7 days prior to removing Skyla if removal is to occur at other times during the cycle.
- If a patient with irregular cycles or amenorrhea wants to start a different birth control method, start the new method at least 7 days before removal.
Dosage Forms And Strengths
Skyla is a LNG-releasing IUS consisting of a T-shaped polyethylene frame with a steroid reservoir containing a total of 13.5 mg LNG.
Storage And Handling
Skyla (levonorgestrel-releasing intrauterine system), containing a total of 13.5 mg LNG, is available in a carton of one sterile unit. NDC# 50419-422-01
Skyla is supplied sterile. Skyla is sterilized with ethylene oxide. Do not resterilize. For single use only. Do not use if the inner package is damaged or open. Insert before the end of the month shown on the label.
Store at 25°C (77°F); with excursions permitted between 15–30°C (59–86°F) [see USP Controlled Room Temperature].
Manufactured for: Bayer HealthCare Pharmaceuticals Inc. Wayne, NJ 07470 Manufactured in Finland. Approved: September 2013This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 10/10/2013
Additional Skyla Information
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