Skyla - Dosage Levonorgestrel

SKYLA (levonorgestrel intrauterine device) comes in different strengths and amounts, which is referred to as the dosing of Skyla. The appearance of Skyla can differ based on the dosing. Your doctor may change the dosage and prescription of Skyla to get you the best results possible.

Dosage & Administration

  • Release rate of levonorgestrel (LNG) is 14 mcg/day after 24 days and declines to 5 mcg/day after 3 years; Skyla must be removed or replaced after 3 years. (2.1)
  • To be inserted by a trained healthcare provider using strict aseptic technique. Follow insertion instructions exactly as described. (2.2)
  • Patient should be re-examined and evaluated 4 to 6 weeks after insertion; then, yearly or more often if clinically indicated. (2.3)

dosing over time

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 ( 11.2)]. 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)].

image 01.jpg

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).] Because irregular bleeding/spotting is common during the first months of Skyla use, exclude endometrial pathology (polyps or cancer) prior to the insertion of Skyla in women with persistent or uncharacteristic bleeding [see Warnings and Precautions (5.8)].
  • 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

  • Insert Skyla any time there is reasonable certainty that 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

  • Insert Skyla 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

  • Insert Skyla at any time; a non-hormonal back-up birth control (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.
  • Insert Skyla at any time during the menstrual cycle.

Inserting Skyla after first trimester abortion or miscarriage

  • Insert Skyla immediately after a first-trimester abortion or miscarriage, unless it is a septic abortion [see Contraindications (4)].

Inserting Skyla after childbirth or second-trimester abortion or miscarriage

  • Immediate insertion after childbirth or second-trimester abortion or miscarriage
  • Insert Skyla after removal of the placenta. Back-up contraception is not needed. [See Contraindications (4), Warnings and Precautions (5.5, 5.6), Adverse Reactions (6.2)].

Interval insertion following complete involution of the uterus

  • Wait a minimum of 6 weeks or until the uterus is fully involuted before inserting Skyla [see Warnings and Precautions (5.5, 5.6), Adverse Reactions (6.2)].
  • Insert Skyla any time there is reasonable certainty 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 woman should abstain from vaginal intercourse for 7 days to prevent pregnancy [see Contraindications (4), Warnings and Precautions (5.2)].
tools for insertion

Note: The inserter provided with Skyla (see Figure 1) and the Insertion Procedure described in this section are not applicable for immediate insertion after childbirth or second-trimester abortion or miscarriage. For immediate insertion, remove Skyla from the inserter by first loading (see Figure 2) and then releasing (see Figure 7) Skyla from the inserter, and insert according to accepted practice.

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 back-up Skyla available
  • Sterile, sharp curved scissors
preparation for insertion
  • Exclude pregnancy and confirm that there are no other contraindications to the use of Skyla.
  • 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.
image 07.jpg

  • 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.
image 08.jpg

  • 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).
image 09.jpg

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).
image 10.jpg

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.
image 11.jpg

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.

image 12.jpg

step 7–release skyla & withdraw the inserter
  • Holding the entire inserter firmly in place, release Skyla by moving the slider all the way down (Figure 7).
image 13.jpg

  • 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.

.

image 14.jpg

  •  Skyla insertion is now complete. Prescribe analgesics, if indicated. Record the Skyla lot number in the patient 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, remove Skyla during the first 7 days of the menstrual cycle, provided the woman is still 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 (2.5).]
tools for removal
preparation
  • Gloves
  • Speculum
procedure
  • Sterile forceps
removal procedure
  • Remove Skyla by applying gentle traction on the threads with forceps (Figure 9).
image 15.jpg

  • 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.

Dosage Form & Strengths

Skyla is a LNG-releasing IUS (a type of intrauterine device, or IUD) consisting of a T-shaped polyethylene frame with a steroid reservoir containing a total of 13.5 mg LNG.

  • One sterile intrauterine system consisting of a T-shaped polyethylene frame with a steroid reservoir containing 13.5 mg levonorgestrel packaged within a sterile inserter (3)

Storage & 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].

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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