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Skyla IUD Dosage

Generic name: LEVONORGESTREL 13.5mg
Dosage form: intrauterine device

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

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 approximately 6 mcg/day after 1 year and to 5 mcg/day after 3 years. The average in vivo release rate of LNG is approximately 8 mcg/day over the first year of use and 6 mcg/day over a period of 3 years. [See Clinical Pharmacology (12.3).]

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 can be physically distinguished from other intrauterine systems (IUSs) by the combination of the visibility of the silver ring on ultrasound and the brown color of the removal threads.

Skyla is supplied in a sterile package within an inserter that enables single-handed loading (see Figure 1). Do not open the package until required for insertion [see Description (11)]. 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 (5.3)].

Inserter

Insertion Instructions

Obtain a complete medical and social history 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 (4) and Warnings and Precautions (5.10).]
Follow the insertion instructions exactly as described 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 with seizure, especially in patients with a predisposition to these conditions. Consider administering analgesics prior to insertion.

Timing of Insertion

Table 1: When to Insert Skyla

Starting Skyla in women not currently using hormonal or intrauterine contraception

Skyla can be inserted any time the provider can be reasonably certain the woman is not pregnant. Consider the possibility of ovulation and conception prior to initiation of this product [see Contraindications (4)].
If Skyla is inserted during the first seven days of the menstrual cycle or immediately after a first trimester abortion, back up contraception is not needed.
If Skyla is not inserted during the first seven days of the menstrual cycle, a barrier method of contraception should be used or the patient should abstain from vaginal intercourse for seven days to prevent pregnancy.

Switching to Skyla from an oral, transdermal or vaginal hormonal contraceptive

Skyla may be inserted at any time, including during the hormone-free interval of the previous method.
If inserted during active use of the previous method, continue that method for 7 days after Skyla insertion or until the end of the current treatment cycle.
If the woman was using continuous hormonal contraception, discontinue that method seven days after Skyla insertion.

Switching to Skyla from an injectable progestin contraceptive

Skyla may be inserted at any time; a back-up method of contraception (such as condoms or spermicide) should also be used for 7 days if Skyla is inserted more than 3 months (13 weeks) after the last injection.

Switching to Skyla from a contraceptive implant or another IUS

Insert Skyla on the same day the implant or IUS is removed.
Skyla may be inserted at any time during the menstrual cycle.

Inserting Skyla after abortion or miscarriage

First-trimester

Skyla may be inserted immediately after a first-trimester abortion or miscarriage.

Second-trimester

Do not insert Skyla until a minimum of 6 weeks after second trimester abortion or miscarriage, or until the uterus is fully involuted. If involution is delayed, wait until involution is complete before insertion [see Warnings and Precautions (5.6, 5.7)].
If the woman has not yet had a period, consider the possibility of ovulation and conception occurring prior to insertion of Skyla. [See Contraindications (4), Warnings and Precautions (5.2), and FDA-Approved Patient Labeling.] Skyla can be inserted any time the provider can be reasonably certain the woman is not pregnant.
If Skyla is not inserted during the first 7 days of the menstrual cycle, a back-up method of contraception should be used or the patient should abstain from vaginal intercourse for 7 days to prevent pregnancy.

Inserting Skyla after Childbirth

Do not insert Skyla until a minimum of 6 weeks after delivery, or until the uterus is fully involuted. If involution is delayed, wait until involution is complete before insertion [see Warnings and Precautions (5.6, 5.7)].
If the woman has not yet had a period, consider the possibility of ovulation and conception occurring prior to insertion of Skyla. [See Contraindications (4), Warnings and Precautions (5.2), and FDA-Approved Patient Labeling.] Skyla can be inserted any time the provider can be reasonably certain the woman is not pregnant.
If Skyla is not inserted during the first 7 days of the menstrual cycle, a back-up method of contraception should be used or the patient should abstain from vaginal intercourse for 7 days to prevent pregnancy.
There is an increased risk of perforation in lactating women. [See Warnings and Precautions (5.7).]

Tools for Insertion

Preparation
Gloves
Speculum
Sterile uterine sound
Sterile tenaculum
Antiseptic solution, applicator
Procedure
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.
Check expiration date of Skyla prior to initiating insertion.
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.

Insertion Procedure

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.
Opening the Package

Figure 1. Opening the Skyla Package

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.
Loading Skyla

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).
Setting Flange

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).
Advancing Tube

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.
Releasing Arms

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.

Fundal Position

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).
Moving Slider to Release

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.

.

Cutting Threads

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. Do not reinsert a removed Skyla.
If there is clinical concern, exceptional pain or bleeding during or after insertion, take appropriate steps (such as physical examination and ultrasound) immediately to exclude perforation.

Patient Follow-up

Reexamine and evaluate patients 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 the first 7 days of the menstrual cycle, provided the woman is experiencing regular menses. If removal will occur at other times during the cycle or the woman does not experience regular menses, she is at risk of pregnancy: start a new contraceptive method a week prior to removal for these women. [See Dosage and Administration (2.4).]

Tools for Removal

Preparation
Gloves
Speculum
Procedure
Sterile forceps

Removal Procedure

Remove Skyla by applying gentle traction on the threads with forceps (Figure 9).
Remove Skyla

Figure 9. Removal of Skyla

If the threads are not visible, determine location of Skyla by ultrasound [see Warnings and Precautions (5.10)].
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, examine the system to ensure that it is intact.
Removal may be associated with some pain and/or bleeding or vasovagal reactions (for example, syncope, bradycardia) or seizure, especially in patients with a predisposition to these conditions.

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 contraceptive method, time removal and initiation of the new method to ensure continuous contraception. Either remove Skyla during the first 7 days of the menstrual cycle and start the new method immediately thereafter 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 contraceptive method, start the new method at least 7 days before removal.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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