Generic name: LEVONORGESTREL 52mg
Dosage form: intrauterine device
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
2.1 Dosing Over Time
LILETTA contains 52 mg of levonorgestrel (LNG). Initially, LNG is released at a rate of 19.5 mcg/day. This rate decreases progressively to approximately 17.0 mcg/day at 1 year, 14.8 mcg/day at 2 years, 12.9 mcg/day at 3 years and 11.3 mcg/day at 4 years after insertion. The average in vivo release rate of LNG is approximately 15.4 mcg/day over a period of 4 years.
LILETTA can be removed at any time but must be removed by the end of the fourth year. LILETTA can be replaced at the time of removal with a new LILETTA if continued contraceptive protection is desired.
2.2 Timing of Insertion
Refer to Table 1 for instruction on when to start use of LILETTA.
|Starting LILETTA in women not currently using hormonal or intrauterine contraception
|Switching to Liletta from an oral, transdermal or vaginal hormonal contraceptive||
|Switching to LILETTA from an injectable progestin contraceptive||
|Switching to LILETTA from a contraceptive implant or another IUS||
|Inserting Liletta after abortion or miscarriage|
|Inserting Liletta after Childbirth
2.3 Insertion Instructions
LILETTA (Figure 1) is provided in a sterile pouch [see Description (11)] and is inserted into the uterine cavity with the provided inserter (Figure 2) by carefully following the insertion instructions. 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)].
Figure 1 LILETTA Intrauterine Contraceptive System (IUS)
Figure 2: LILETTA IUS with Inserter
LILETTA should only be inserted by a trained healthcare provider. Healthcare providers should become thoroughly familiar with the product, product educational materials, product insertion instructions, prescribing information, and patient labeling before attempting insertion of LILETTA.
- Obtain a complete medical and social history to determine conditions that might influence the selection of LILETTA for contraception. If indicated, perform a physical examination and appropriate tests for genital or sexually transmitted infections. [See Contraindications (4) and Warnings and Precautions (5.4, 5.10).]
- Check the expiration date on the box before opening it. Do not insert LILETTA after the expiration date.
- Visually inspect the packaging (sealed pouch) containing LILETTA to verify that the packaging has not been damaged (e.g., torn, punctured, etc.). If the packaging has any visual damage that could compromise sterility, do not use the unit for insertion [see Warnings and Precautions (5.3)].
- Ensure that the patient understands the contents of the Patient Information Booklet and obtain consent. A sample consent form that includes the lot number is on the last page of the Patient Information Booklet.
- Complete the pelvic examination, speculum placement, tenaculum placement, and sounding of the uterus before opening the LILETTA pouch.
- Do not open the pouch to insert LILETTA if:
○ the cervix is unable to be properly visualized
○ the uterus cannot be adequately instrumented (during sounding)
○ the uterus sounds to less than 5.5 cm
Planning for Insertion
- Ensure all needed items for LILETTA insertion are readily available:
○ Sterile uterine sound
○ Sterile tenaculum
○ Antiseptic solution
○ LILETTA with inserter in sealed pouch
○ Sterile, blunt-tipped scissors
○ Additional items that may be useful could include:
• Local anesthesia, needle, and syringe
• Os finder and/or cervical dilators
• Ultrasound with abdominal probe
- Exclude pregnancy and confirm that there are no other contraindications to the insertion and use of LILETTA.
- Follow the insertion instructions exactly as described in order to ensure proper insertion.
- If you encounter cervical stenosis at any time during uterine sounding or LILETTA insertion, use cervical dilators, not force, to overcome resistance. If necessary, dilation, sounding, and insertion may be performed with ultrasound guidance.
- Insertion may be associated with some pain and/or bleeding or vasovagal reactions (e.g., diaphoresis, syncope, bradycardia, or seizure), especially in patients with a predisposition to these conditions. Consider administering analgesics prior to insertion.
Use aseptic technique during the entire insertion procedure. Loading and inserting LILETTA can be done with or without sterile gloves. If not using sterile gloves, complete all steps for loading the IUS (Steps 1-7) inside the pouch. Maintain sterility during LILETTA insertion; do not touch LILETTA or parts of any sterile instrument that will pierce tissue (e.g., a tenaculum on the cervix) or go into the uterine cavity. If, at any step, there is a need to touch a sterile surface, sterile gloves should be used.
Preparation for Insertion
- With the patient comfortably in lithotomy position, do a bimanual exam to establish the size, shape, and position of the uterus and to evaluate any signs of uterine infection.
- Gently insert a speculum to visualize the cervix.
- Thoroughly cleanse the cervix and vagina with antiseptic solution.
- Administer cervical anesthetic, if needed.
- Apply a tenaculum to the cervix and use gentle traction to align the cervical canal with the uterine cavity. If the uterus is retroverted, it may be more appropriate to grasp the lower lip of the cervix. Keep the tenaculum in position and maintain gentle traction on the cervix throughout the insertion procedure.
- Carefully sound the uterus to measure its depth.
- The uterus should sound to a depth of at least 5.5 cm. Insertion of LILETTA into a uterine cavity that sounds to less than 5.5 cm may increase the incidence of expulsion, bleeding, pain, perforation, and possibly pregnancy. LILETTA should not be inserted if the uterus sounds to less than 5.5 cm.
- After ascertaining that the patient is appropriate for LILETTA, replace contaminated glove(s) and open the pouch containing LILETTA.
Loading the IUS into the Inserter
- Place the LILETTA pouch on a flat surface with the clear side of the pouch facing up (Figure 3).
Figure 3: Place the LILETTA pouch on a flat surface.
- Open the sterile LILETTA pouch from the bottom (end with the rod ring) approximately 1/3 of the way until the lower ends of the IUS threads, the rod, and the insertion tube are exposed (Figure 4).
If using sterile gloves, you can open the pouch completely before putting on the sterile gloves.
Figure 4: Release the threads from the flange and insert the rod.
- Pull back the blue threads to dislodge them from the flange.
- Be careful to not pull the IUS down at the same time (Figure 4).
- Hold the exposed end of the insertion tube containing the IUS (Figure 4) while keeping the end of the insertion tube with the IUS inside the packaging.
- Remove the rod from the pouch.
- Do not touch the end of the rod that will go into the insertion tube.
- Place the rod into the insertion tube (alongside the IUS threads) to about the 5 cm marking (Figure 4).
- While holding the insertion tube and the rod firmly between the fingers and thumb of one hand, pull downward on both blue threads with the other hand to draw the IUS into the insertion tube (Figure 5).
- The arms of the IUS should be kept in a horizontal plane, parallel to the flat side of the flange (refer to Figure 4).
- Do not pull the IUS all of the way through the insertion tube; only pull the threads until the IUS is loaded at the top of the insertion tube. Note: If you accidentally remove the IUS completely out of the insertion tube, do not use or attempt to re-load.
- Hold the insertion tube and the rod firmly with one hand.
- With the other hand, adjust the position of the flange (through the sterile packaging if not using sterile gloves) by moving the tube to correspond to the sound measurement (Figure 6).
- The top end of the flange should be at the measurement corresponding to the sounded depth of the uterus.
- Final IUS positioning: position the IUS in the tube so that the knobs of the lateral arms are opposed to each other and protrude slightly above the tip of the insertion tube to form a hemispherical dome (Figure 7).
- Hold the tube at its proximal end between your fingers and thumb of one hand.
- With the other hand, while pulling on the blue threads, slowly advance the rod forward to adjust the position of the IUS.
- When the IUS tips are in the correct position (slightly protruding), pinch and hold the proximal end of the tube firmly to maintain rod position.
- The proximal end of the insertion tube will be approximately at the top of the first indent on the rod (Figure 7).
Figure 7: Final IUS Positioning
ENSURE A HEMISPHERICAL DOME IS ACHIEVED.
When the IUS is in the correct position, the lower end of the tube will be aligned approximately at the upper edge of the upper indent on the rod.
Check to make sure the IUS is correctly loaded. You should note the following:
- The IUS is completely within the insertion tube with the knobs of the arms forming a hemispherical dome at the top of the tube.
- The top of the rod is touching the bottom of the IUS.
- The blue threads are hanging through the end of the insertion tube.
- The flange is marking the depth of the uterus based on pre-insertion sounding.
Remove the loaded IUS insertion tube from the pouch while holding the lower end of the tube firmly between your fingers and thumb.
If not using sterile gloves, do not touch the flange and any part of the insertion tube above the flange during this step and through the IUS insertion procedure.
IUS Insertion into the Uterus
- Apply gentle traction on the tenaculum to straighten the alignment of the cervical canal and uterine cavity.
- While still firmly pinching the proximal end of the insertion tube to maintain the IUS in the correct position (Hand A), slide the loaded IUS insertion tube through the cervical canal until the upper edge of the flange is approximately 1.5 – 2.0 cm from the cervix (Figure 8).
- DO NOT advance flange to the cervix at this step.
- DO NOT force the inserter. If necessary, dilate the cervical canal.
- Release hold on the tenaculum.
- Hold the insertion tube with the fingers of one hand (Hand A) and the rod with the fingers of the other hand (Hand B).
- Hold the rod still (Hand B), relax the firmness of the pinch on the tube, and pull the insertion tube back with Hand A to the edge of the second indent of the rod (Figure 9).
- This will allow the IUS arms to open in the lower uterine segment.
- Wait 10 – 15 seconds for the arms of the IUS to fully open.
- Apply gentle traction with the tenaculum before advancing the IUS.
- With Hand A still holding the proximal end of the tube, advance both the insertion tube and rod simultaneously up to the uterine fundus (Figure 10). You will feel slight resistance when the IUS is at the fundus.
- The flange should be touching the cervix when the IUS reaches the uterine fundus.
Note: Fundal positioning is important to prevent expulsion.
Figure 10: After 10 – 15 seconds, advance to the fundus while holding both the rod and the tube.
- Hold the rod still (Hand B) while pulling the insertion tube back with Hand A to the ring of the rod (Figure 11).
Figure 11: Hold the rod still and pull back the tube to the ring on the rod.
- While holding the inserter tube with Hand A, withdraw the rod from the insertion tube all of the way out to prevent the rod from catching on the knot at the lower end of the IUS.
Note: Ensure the tube is held firmly in place until the rod is completely pulled outside of the tube as there will be some slight resistance while removing the rod from the tube.
- Completely remove the insertion tube.
- Use blunt-tipped sharp scissors to cut the IUS threads perpendicular to the thread length, leaving about 3 cm outside of the cervix (Figure 12). Note: Do not cut threads at an angle as this may leave sharp ends.
- Do not apply tension or pull on the threads when cutting to prevent displacing the IUS.
Figure 12: Cut the threads about 3 cm from the cervix
Insertion of LILETTA is now complete.
Important information to consider during or after insertion:
- If you suspect the IUS is not in the correct position:
○ Check insertion with an ultrasound or other appropriate radiologic test.
○ If incorrect insertion is suspected, remove LILETTA. Do no reinsert the same LILETTA IUS after removal.
- If insertion is difficult because the uterus cannot be appropriately instrumented, consider the following measures:
○ Use of cervical anesthesia to make sounding and manipulation more tolerable.
○ Use of dilators to dilate the cervix if needed to allow passage of the sound or inserter.
○ Abdominal ultrasound guidance during dilation and/or insertion.
○ 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 uterine perforation [see Warnings and Precautions (5.5)].
2.4 Patient Counseling and Record-Keeping
- Keep a copy of the consent form and LILETTA lot number for your records.
- Counsel the patient on what to expect following LILETTA insertion. Give her the Patient Information Booklet, which includes the website address (www.LILETTA.com). Discuss expected bleeding patterns with LILETTA use. Review the signs and symptoms of LILETTA expulsion. [See Patient Counseling Information (17)].
- Prescribe analgesics, if indicated.
2.5 Patient Follow-Up
Re-examine and evaluate patients 4 to 6 weeks after insertion and once a year thereafter, or more frequently if clinically indicated. The healthcare provider should check strings during each routine and follow-up visit.
2.6 Removal of LILETTA
Timing of Removal
- If pregnancy is desired, LILETTA can be removed at any time.
- If pregnancy is not desired, LILETTA can be removed at any time; however, a contraception method should be started prior to removal of LILETTA [see Dosage and Administration (2.5)]. Counsel your patient that she is at risk of pregnancy if she has intercourse in the week prior to removal without use of a backup contraceptive method.
- LILETTA should be removed after 4 years. LILETTA can be replaced at the time of removal with a new LILETTA if continued contraceptive protection is desired.
Planning for Removal
- Ensure all needed items for LILETTA removal are readily available:
○ Sterile forceps
○ Additional items that may be required could include:
• Local anesthetic, needle, and syringe
• Os finder and/or cervical dilators
• Ultrasound with abdominal probe
• Sterile tenaculum
• Antiseptic solution
• Long, narrow forceps
- Removal may be associated with some pain and/or bleeding or vasovagal reactions (e.g., syncope, bradycardia, or seizure), especially in patients with a predisposition to these conditions.
- After removal of LILETTA, examine the system to ensure that it is intact.
- With the patient comfortably in lithotomy position, place a speculum and visualize the cervix.
- When the threads of LILETTA are visible:
○ Remove the IUS by applying traction on the threads with forceps (Figure 13).
○ The arms of the device will fold upward as it is withdrawn from the uterus.
○ If the IUS cannot be removed with traction on the threads, perform an ultrasound examination to confirm location of the IUS, including assessment for partial or total perforation. If the IUS is in the uterus, use long, narrow forceps to grasp LILETTA. Consider use of a tenaculum, cervical anesthesia, cervical dilators, and/or ultrasound guidance as needed.
○ After removal, examine the system to ensure it is intact.
- If the threads of LILETTA are not visible:
○ Determine location of the IUS by ultrasound examination.
○ If the IUS is in the uterine cavity, use long, narrow forceps (e.g., Alligator forceps) to grasp LILETTA. Consider use of a tenaculum, cervical anesthesia, cervical dilators, and/or ultrasound guidance as needed. If LILETTA cannot be removed using the above techniques, consider hysteroscopic evaluation for removal.
○ If the IUS is not in the uterine cavity, consider an abdominal x-ray or CT scan to evaluate if the IUS is in the abdominal cavity. Consider laparoscopic evaluation for removal, as clinically indicated.
○ After removal, examine the system to ensure it is intact.
Figure 13: Removal of LILETTA
2.7 Continuation of Contraception After Removal
- If a patient wishes to continue using LILETTA or another intrauterine contraceptive, insertion can occur immediately after removal.
- If a patient with regular cycles wants to start a different birth control method, time the removal and initiation of a new method to ensure continuous contraception. Either remove LILETTA 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 LILETTA 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 LILETTA removal.
- If LILETTA is removed but no other contraceptive method has already been started, the new contraceptive method can be started on the day LILETTA is removed. The patient should use a backup barrier method of contraception (e.g., condoms and spermicide) or abstain from vaginal intercourse for 7 days to prevent pregnancy.
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