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 instructions 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 1a) is provided in a tray, sealed with a peel-off lid and is inserted into the uterine cavity with the provided inserter (Figure 1b) [see Description (11)] 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 1a: LILETTA Intrauterine Contraceptive System (IUS)
Figure 1b: LILETTA IUS with Inserter
The LILETTA IUS is packaged partially preloaded within the inserter. The threads are passed through the insertion tube, and exit through an opening in the handle at the cleft.
The handle of the inserter contains a BLUE slider and a GREEN slider. The sliders are labeled with the numbers 1 and 2, and the handle is labeled with the number 3 to assist with the insertion process (Figure 2). Moving the sliders achieves the positions required to complete the insertion process.
Figure 2: Inserter Sliders
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 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 packaging.
- Do not open the packaging 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 tray, sealed with a peel-off lid
° 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, maintain sterility during LILETTA loading and insertion; do not touch LILETTA, the inside of the sterile tray, 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
The overall insertion process is conducted in 5 steps.
Step 1 – Preparation of Patient 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 packaging containing LILETTA.
Step 2 – Opening the Sterile LILETTA Packaging
• Remove the sealed tray containing LILETTA from the box.
• Inspect the sealed tray and do not use the product if the packaging, inserter or IUS is damaged.
• Lay the tray on a flat surface with the peel-off lid side up.
• Remove peel-off lid.
Step 3 – Loading LILETTA into the Inserter
• To remove the inserter from the tray, grasp the handle below the sliders and twist gently.
° NOTE: Do not attempt to remove the inserter by pulling on the tube.
• Ensure both sliders (numbered 1 and 2) are fully forward (Figure 3):
° The handle single line marking will align with the BLUE (number 1) slider single line marking.
° The handle double line markings will align with the GREEN (number 2) slider double line markings.
• Grip the handle keeping your thumb or finger in the groove of the BLUE slider (over the numeral 1) and apply forward pressure while ensuring both sliders are fully forward.
Figure 3: Sliders Completely Forward for Loading LILETTA
• Load LILETTA into the inserter:
° Ensure the arms of the IUS are horizontal (aligned to the horizontal plane of the handle and flange); adjust the rotation of the IUS as needed using the flat sterile surface of the tray.
° While maintaining forward pressure on the blue slider, pull the threads straight back until you feel a hard stop. Ensure even tension is applied to both threads when pulling.
° Pull the threads upward or downward to lock the threads into the cleft at the bottom end of the handle (Figure 4); you must lock the threads in the cleft to prevent the IUS from moving out of the top of the insertion tube. Once the threads are locked in the cleft, stop holding the threads.
° After the IUS is loaded, continue to sustain forward pressure on the BLUE slider to maintain a hemispherical dome with the tips of the IUS.
° When correctly loaded, the IUS is completely within the insertion tube with the tips of the arms forming a hemispherical dome at the top of the tube (Figure 5).
° If the IUS is not correctly loaded, do not attempt insertion. To re-load LILETTA:
■ Pull the BLUE slider back with your thumb until the groove becomes aligned with the GREEN slider to release the IUS.
■ Manually pull the threads out of the cleft.
■ Return the BLUE slider to the forward position and repeat the loading steps.
Figure 4: Locking the Threads in Cleft
Figure 5: Close-up of Hemispherical Dome at Tip of Tube
• Adjust the flange to the measured uterine depth based on sounding. To adjust, place the flat side of the flange in the tray notch (Figure 6) or against a sterile edge inside of the tray. Slide the insertion tube as necessary to move the flange to the correct measurement. Ensure the flat sides of the flange are in the same horizontal plane as the handle. If, at any step, there is a need to touch the flange or another sterile surface, sterile gloves should be used.
Figure 6: Adjusting the Flange
• If an adjustment to the curvature of the insertion tube is required to accommodate the anatomical orientation of the uterus, you may bend or straighten the insertion tube, but do not touch above the flange unless using sterile gloves. When bending the tube, avoid sharp bends to prevent kinking.
• Once the flange has been properly positioned, avoid contact with flange against objects that can change its position (e.g. tray, speculum, tenaculum, etc.).
Step 4 – Inserting LILETTA into the Uterus
• Apply gentle traction on the tenaculum and continue to apply forward pressure on the BLUE slider while inserting the loaded insertion tube through the cervical os. Advance the tube until the upper edge of the flange is 1.5-2 cm from the external cervical os (Figure 7). Maintain forward pressure on the BLUE slider throughout the insertion process.
° DO NOT advance flange to the cervix at this time.
° DO NOT force the inserter. If necessary, dilate the cervical canal.
Figure 7: Advancing Insertion Tube until Flange is 1.5 to 2 cm from the External Cervix
• Using your thumb or finger, gently slide only the BLUE slider back until you feel resistance. The BLUE and GREEN sliders will merge together to form a common thumb recess. Do not move the BLUE slider any more than is necessary to create the recess. Maintain the GREEN slider so that the double line markings on the slider and the insertion handle remain aligned (Figure 8). This will allow the IUS arms to open in the lower uterine segment. Do not pull the sliders back any further as this could result in premature release of the IUS at the incorrect location.
Figure 8: Releasing and Opening the Arms of the IUS
• Wait 10-15 seconds to allow for the arms of the IUS to fully open.
• Without moving the sliders, advance the inserter until the flange touches the cervix. If fundal resistance is encountered, do not continue to advance. LILETTA is now in the fundal position (Figure 9).
Note: Fundal position is important to prevent expulsions.
Figure 9: Move LILETTA into the Fundal Position
Step 5 – Releasing LILETTA and Procedure Completion
While holding the inserter steady and maintaining its position relative to the cervix, move both sliders (BLUE and GREEN) together while maintaining the common thumb recess down toward the number 3 on the handle (Figure 10) until a click is heard and the GREEN indicator at the bottom of the handle is visible (Figure 11).
Figure 10: Releasing LILETTA from the Inserter Tube
• Look at the cleft to ensure the threads were properly released (Figure 11); if not released or if a click is not heard, grasp the threads and gently pull the threads out of the cleft.
Figure 11: Green Indicator Visible and Threads Released from Cleft
• Withdraw the inserter from the uterus.
• 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 not 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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