WHEREVER HER JOURNEY TAKES HER,
SHE CHOOSES LILETTA®.

Provide her with a long-acting reversible contraceptive.1

*LILETTA is an intrauterine system, or IUS, otherwise known as an IUD, intrauterine device

 

THE LILETTA® ACCESS IUS* TRIAL

THE LARGEST HORMONAL IUD* STUDY CONDUCTED EXCLUSIVELY IN U.S.

Designed to evaluate generally healthy women aged 16-45 across a wide range of BMIs (15.8 kg/m2 to 61.6 kg/m2 )1

 

6 Years EVALUATED OVER THE COURSE OF 6 YEARS1,5

Open-label, multicenter trial conducted at 29 U.S. study centers over 72 months (N=1751)

PRIMARY OUTCOME1

  • Efficacy of LILETTA for pregnancy prevention in nulliparous and parous females of childbearing potential (16-35 years old)

SECONDARY OUTCOMES2

  • Safety and bleeding patterns
  • Return of menses after discontinuation
BMI=body mass index.
*LILETTA is an intrauterine system, or IUS, otherwise known as an IUD, intrauterine device.
ACCESS IUS=A Comprehensive Contraceptive Efficacy and Safety Study of an IUS.5
 

A STUDY THAT INCLUDED A DIVERSE GROUP OF WOMEN

The ACCESS IUS trial studied LILETTA in 1751 generally healthy patients.1

Parity1
58%
nulliparous women
42%
parous women
BODY MASS INDEX (BMI)1
15.8-61.6 kg/m2
Overall range
26.9 kg/m2
Mean BMI
The LILETTA trial included women across a wide BMI range.
AGE1
16-45 Years

Efficacy was evaluated among women aged 16-35 years.
RACE AND ETHNICITY1

Caucasian

Black/
African American
Asian
Other
14.7 %
of women indicated Hispanic ethnicity.
 

EFFICACY

EFFICACY SHE WANTS, WITHOUT DAILY MAINTENANCE, DEMONSTRATED FOR UP TO 6 YEARS1

Pregnancy rate calculated as the Pearl Index was the primary efficacy endpoint in women aged 16-35.

>99% efficacy at preventing pregnancy for up to 6 years
99.85%
efficacy at 1 year
99.13%
cumulative efficacy
over 6 years
 

Patients should be counseled to check that LILETTA is in the proper position by feeling the threads once a month. Healthcare providers should re-examine and evaluate patients 4 to 6 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.

 

A LONG-ACTING, REVERSIBLE CONTRACEPTIVE METHOD FOR UP TO 6 YEARS1

PREGNANCY RATES AFTER
DISCONTINUATION OF LILETTA1
79%
within 6 months
85%
within 12 months

Data based on an analysis of 191 women who desired pregnancy after study discontinuation.

Conception rates after removal of LILETTA were assessed and appeared consistent with conception rates in the general population of women having regular, unprotected sexual intercourse for 12 months.

 

BLEEDING PROFILE

RATES OF SPOTTING AND BLEEDING1

During the first 3 to 6 months of LILETTA use, the number of bleeding and spotting days may be increased and bleeding patterns may be irregular. Thereafter, the number of bleeding and spotting days usually decreases but bleeding may remain irregular.1

RATES OF AMENORRHEA THROUGH THE END OF THE SIXTH YEAR1,5

If a significant change in bleeding develops during prolonged use, conduct diagnostic tests to assess possible endometrial pathology. Consider the possibility of pregnancy if menstruation does not occur within 6 weeks of the onset of a previous menstruation.

Most Common Adverse Reactions Seen During the Clinical Trial

ADVERSE REACTIONS OCCURRING IN ≥5% OF LILETTA USERS1
System organ class/
preferred term
% LILETTA
subjects
(N=1751)
Vulvovaginal mycotic infections 19.2%
Vaginal bacterial infections 18.6%
Acne 15.3%
Nausea or vomiting 10.3%
Abdominal discomfort or pain 9.9%
Headache 9.5%
Breast tenderness or pain 9.5%
Dyspareunia 9.3%
System organ class/
preferred term
% LILETTA
subjects
(N=1751)
Anxiety 8.8%
Pelvic discomfort or pain 8.4%
Depression 8.3%
Dysmenorrhea 6.4%
Mood changes 6.3%
Weight increased 5.9%
Back pain 5.9%
Vaginal discharge 5.5%
<1% OF WOMEN TREATED WITH LILETTA EXPERIENCED ECTOPIC PREGNANCIES, PELVIC INFLAMMATORY DISEASE, OR ENDOMETRITIS1,5
System organ class/
preferred term
% LILETTA subjects
(N=1751)
Ectopic pregnancy 0.4%
Pelvic inflammatory disease 0.5%
Endometritis 0.3%
 

RESOURCES

LILETTA® PRODUCT PRESENTATION

 

ORDER DIRECTLY THROUGH THE LILETTA® VOLUME DISCOUNT PROGRAM

Volume Discount Program Information*
Number of Units Volume Discount Illustrative Aquisition Cost
5-19 8.0% $777.49
20-49 15.0% $718.33
50-99 28.0% $608.47
100-199 32.0% $574.67
200+ 36.0% $540.86

For purchases of 300 or more units, please contact LILETTA AccessConnectSM at 1-855-LILETTA (1.855.545.3882) for more information.
Please see the Supplemental Terms and Conditions of Sale for the LILETTA® Volume Discount Program here. These Supplemental Terms and Conditions of Sale constitute a supplement for purposes of the LILETTA VDP to the Seller’s Direct Terms and Conditions of Sale, available here, and updated from time to time at the sole discretion of Seller.
* Information subject to change. Seller reserves the right to amend all prices, discounts, and volume requirements without notice.
Number of units in a single purchase order, as fulfilled and invoiced by Seller.
Illustrative acquisition cost based on a WAC of $845.10 (effective January 1, 2021 and subject to change). Actual acquisition cost for a LILETTA VDP order may vary depending on the WAC in effect at the time the customer’s order is received by Seller. WAC is a list price that may not reflect the actual price paid by an individual purchaser after discounts.
Payment terms: 90 days. Please note that customers purchasing product pursuant to the 340B Drug Pricing Program, a group purchasing organization agreement, or a direct agreement with Seller’s are not eligible to participate in the LILETTA Volume Discount Program.

ORDER THROUGH A SPECIALTY PHARMACY
Specialty Pharmacy Providers
Specialty Pharmacy Contact Information
Accredo® 1.866.759.1557
CVS Caremark® 1.855.438.2574
 

LILETTA ACCESSCONNECTSM24/7 REAL-TIME SUPPORT

Online ordering services
Order LILETTA directly from AbbVie and manage your inventory
On-demand benefits investigations
Gain access to patient records for on-demand results

Visit LILETTAAccessConnect.com for more information.

 

HELP

ONE NUMBER FOR ALL QUESTIONS
1-855-LILETTA
(1.855.545.3882)
micon-oval

PURCHASING:

For information regarding pricing and ordering LILETTA

micon-oval

BENEFITS INVESTIGATIONS:

For help with patient benefits investigations and billing and coding

micon-oval

LILETTA PATIENT SAVINGS PROGRAM®:

For information on eligibility criteria, enrollment process, and terms and conditions

micon-oval

ADVERSE EVENTS/MEDICAL INFORMATION:

To report any Adverse Events or to request additional medical information on LILETTA. You may also call our direct Medical Information line at: 1.800.678.1605

micon-oval

PRODUCT QUALITY:

To report any product quality complaints

micon-oval

REQUEST A FIELD SALES REPRESENTATIVE:

To request a visit from a field sales representative

 

Watch the LILETTA® Single-Handed Insertion Video

 

LILETTA® is a sterile, levonorgestrel-releasing intrauterine system indicated for prevention of pregnancy for up to 6 years. The system should be replaced after 6 years if continued use is desired.

IMPORTANT SAFETY INFORMATION
Who is not appropriate for LILETTA

Use of LILETTA is contraindicated in women with the following: pregnancy; for use as post-coital contraception; congenital or acquired uterine anomaly, including fibroids, if they distort the uterine cavity and would be incompatible with correct IUS placement; known or suspected breast cancer or other hormone-sensitive cancer, now or in the past; known or suspected uterine or cervical neoplasia; acute liver disease or liver tumor; untreated acute cervicitis or vaginitis, including lower genital tract infections (eg, bacterial vaginosis) until infection is controlled; infected abortion in the past 3 months; unexplained uterine bleeding; a current IUS; acute pelvic inflammatory disease (PID) or endometritis or history of PID (except with later intrauterine pregnancy); conditions increasing susceptibility to pelvic infection; or hypersensitivity to any component of LILETTA.

Clinical considerations for use and removal of LILETTA

Use LILETTA with caution after careful assessment in patients with coagulopathy or taking anticoagulants; migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia; exceptionally severe or frequent headache; marked increase of blood pressure; or severe arterial disease such as stroke or myocardial infarction. Consider removing LILETTA if the following arise during use: uterine or cervical malignancy or jaundice. Because irregular bleeding/spotting is common during the first months of LILETTA use, exclude endometrial pathology (polyps or cancer) prior to the insertion of LILETTA in women with persistent or uncharacteristic bleeding. If the threads are not visible or are significantly shortened, they may have broken or retracted into the cervical canal or uterus. If LILETTA is displaced (eg, expelled or perforated the uterus), remove it.

Pregnancy-related risks with LILETTA

If pregnancy should occur with LILETTA in place, remove the intrauterine system because leaving it in place may increase the risk of spontaneous abortion and preterm labor. Removal or manipulation may result in pregnancy loss. Evaluate women for ectopic pregnancy because the likelihood of a pregnancy being ectopic is increased with LILETTA. Tell women about the signs of ectopic pregnancy and associated risks, including loss of fertility. Women with a history of ectopic pregnancy, tubal surgery, or pelvic infection carry a higher risk of ectopic pregnancy.

Educate her about PID or endometritis

Insertion of LILETTA is contraindicated in the presence of known or suspected PID or endometritis or a history of PID unless there has been a subsequent intrauterine pregnancy. IUSs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. One woman diagnosed with PID and two women diagnosed with endometritis developed the infection within a week of insertion. One endometritis case was diagnosed at 39 days after insertion. The remaining 11 cases of PID and endometritis were diagnosed more than 6 months after insertion, including one at 30 days after IUS removal. Counsel women who receive LILETTA to notify a healthcare provider if they develop lower abdominal or pelvic pain, fever, chills, unusual or malodorous discharge, unexplained bleeding, genital lesions or sores, or dyspareunia. PID and endometritis are often associated with sexually transmitted infections (STIs); LILETTA does not protect against STIs, including HIV. PID or endometritis may be asymptomatic but still result in tubal damage and its sequelae. Inform women about the possibility of PID or endometritis and that these infections can cause tubal damage leading to ectopic pregnancy or infertility, or infrequently can necessitate hysterectomy, or cause death.

Expect changes in bleeding patterns with LILETTA

Spotting and irregular or heavy bleeding may occur during the first 3 to 6 months. Periods may become shorter and/or lighter thereafter. Cycles may remain irregular, become infrequent, or even cease. Consider pregnancy if menstruation does not occur within 6 weeks of the onset of previous menstruation. If a significant change in bleeding develops during prolonged use, conduct diagnostic tests to assess possible endometrial pathology.

Be aware of other serious complications and most common adverse reactions

Some serious complications with IUSs like LILETTA are sepsis, perforation, and expulsion. Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of LNG-releasing IUSs. Aseptic technique during insertion of LILETTA is essential to minimize serious infections such as GAS.

Perforation (total or partial, including penetration/embedment of LILETTA in the uterine wall or cervix) may occur, most often during insertion, although the perforation may not be detected until sometime later. Perforation may also occur at any time during use. Perforation may reduce contraceptive efficacy. If perforation is suspected, locate and remove LILETTA as soon as possible. Surgery may be required. Delayed detection or removal of LILETTA in case of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses, and erosion of adjacent viscera. The risk of perforation is higher if inserted in lactating women and may be higher if inserted in women who are postpartum or when the uterus is fixed retroverted.

Partial or complete expulsion of LILETTA may occur, resulting in the loss of contraceptive protection.

Delay LILETTA insertion a minimum of 4 weeks or until uterine involution is complete following a delivery or a second trimester abortion. Remove a partially expelled LILETTA. If expulsion has occurred, a new LILETTA may be inserted within 7 days after the onset of a menstrual period after pregnancy has been ruled out.

Ovarian cysts may occur and are generally asymptomatic, but may be accompanied by pelvic or abdominal pain or dyspareunia. Evaluate persistent ovarian cysts.

In the LILETTA clinical trial, the most common adverse reactions (≥5% users) were vulvovaginal mycotic infections (19.2%), vaginal bacterial infections (18.6%), acne (15.3%), nausea or vomiting (10.3%), abdominal discomfort or pain (9.9%), headache (9.5%), breast tenderness or pain (9.5%), dyspareunia (9.3%), anxiety (8.8%), pelvic discomfort or pain (8.4%), depression (8.3%), dysmenorrhea (6.4%), mood changes (6.3%), increased weight (5.9%), back pain (5.9%), and vaginal discharge (5.5%).

Teach patients to recognize and immediately report signs or symptoms of the aforementioned conditions. Evaluate patients 4 to 6 weeks after insertion of LILETTA and then yearly or more often if clinically indicated.

Please see full Prescribing Information.


References: 1. LILETTA (levonorgestrel-releasing intrauterine system) 52 mg [prescribing information]. Irvine, CA: Allergan USA, Inc., and San Francisco, CA: Medicines360; 2020. 2. Mirena (levonorgestrel-releasing intrauterine system) 52 mg [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc., 2020. 3. Kyleena (levonorgestrel-releasing intrauterine system) 19.5 mg [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc., 2018. 4. Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg [prescribing information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc., 2018. 5. Data on file. Medicines360: San Francisco, CA.

IMPORTANT SAFETY INFORMATION
Who is not appropriate for LILETTA

Use of LILETTA is contraindicated in women with the following: pregnancy; for use as post-coital contraception; congenital or acquired uterine anomaly, including fibroids, if they distort the uterine cavity and would be incompatible with correct IUS placement; known or suspected breast cancer or other hormone-sensitive cancer, now or in the past; known or suspected uterine or cervical neoplasia; acute liver disease or liver tumor; untreated acute cervicitis or vaginitis, including lower genital tract infections (eg, bacterial vaginosis) until infection is controlled; infected abortion in the past 3 months; unexplained uterine bleeding; a current IUS; acute pelvic inflammatory disease (PID) or endometritis or history of PID (except with later intrauterine pregnancy); conditions increasing susceptibility to pelvic infection; or hypersensitivity to any component of LILETTA.

Clinical considerations for use and removal of LILETTA

Use LILETTA with caution after careful assessment in patients with coagulopathy or taking anticoagulants; migraine, focal migraine with asymmetrical visual loss or other symptoms indicating transient cerebral ischemia; exceptionally severe or frequent headache; marked increase of blood pressure; or severe arterial disease such as stroke or myocardial infarction. Consider removing LILETTA if the following arise during use: uterine or cervical malignancy or jaundice. Because irregular bleeding/spotting is common during the first months of LILETTA use, exclude endometrial pathology (polyps or cancer) prior to the insertion of LILETTA in women with persistent or uncharacteristic bleeding. If the threads are not visible or are significantly shortened, they may have broken or retracted into the cervical canal or uterus. If LILETTA is displaced (eg, expelled or perforated the uterus), remove it.

Pregnancy-related risks with LILETTA

If pregnancy should occur with LILETTA in place, remove the intrauterine system because leaving it in place may increase the risk of spontaneous abortion and preterm labor. Removal or manipulation may result in pregnancy loss. Evaluate women for ectopic pregnancy because the likelihood of a pregnancy being ectopic is increased with LILETTA. Tell women about the signs of ectopic pregnancy and associated risks, including loss of fertility. Women with a history of ectopic pregnancy, tubal surgery, or pelvic infection carry a higher risk of ectopic pregnancy.

Educate her about PID or endometritis

Insertion of LILETTA is contraindicated in the presence of known or suspected PID or endometritis or a history of PID unless there has been a subsequent intrauterine pregnancy. IUSs have been associated with an increased risk of PID, most likely due to organisms being introduced into the uterus during insertion. One woman diagnosed with PID and two women diagnosed with endometritis developed the infection within a week of insertion. One endometritis case was diagnosed at 39 days after insertion. The remaining 11 cases of PID and endometritis were diagnosed more than 6 months after insertion, including one at 30 days after IUS removal. Counsel women who receive LILETTA to notify a healthcare provider if they develop lower abdominal or pelvic pain, fever, chills, unusual or malodorous discharge, unexplained bleeding, genital lesions or sores, or dyspareunia. PID and endometritis are often associated with sexually transmitted infections (STIs); LILETTA does not protect against STIs, including HIV. PID or endometritis may be asymptomatic but still result in tubal damage and its sequelae. Inform women about the possibility of PID or endometritis and that these infections can cause tubal damage leading to ectopic pregnancy or infertility, or infrequently can necessitate hysterectomy, or cause death.

Expect changes in bleeding patterns with LILETTA

Spotting and irregular or heavy bleeding may occur during the first 3 to 6 months. Periods may become shorter and/or lighter thereafter. Cycles may remain irregular, become infrequent, or even cease. Consider pregnancy if menstruation does not occur within 6 weeks of the onset of previous menstruation. If a significant change in bleeding develops during prolonged use, conduct diagnostic tests to assess possible endometrial pathology.

Be aware of other serious complications and most common adverse reactions

Some serious complications with IUSs like LILETTA are sepsis, perforation, and expulsion. Severe infection or sepsis, including Group A streptococcal sepsis (GAS), have been reported following insertion of other LNG-releasing IUSs. Aseptic technique during insertion of LILETTA is essential to minimize serious infections such as GAS.

Perforation (total or partial, including penetration/embedment of LILETTA in the uterine wall or cervix) may occur, most often during insertion, although the perforation may not be detected until sometime later. Perforation may also occur at any time during use. Perforation may reduce contraceptive efficacy. If perforation is suspected, locate and remove LILETTA as soon as possible. Surgery may be required. Delayed detection or removal of LILETTA in case of perforation may result in migration outside the uterine cavity, adhesions, peritonitis, intestinal perforations, intestinal obstruction, abscesses, and erosion of adjacent viscera. The risk of perforation is higher if inserted in lactating women and may be higher if inserted in women who are postpartum or when the uterus is fixed retroverted.

Partial or complete expulsion of LILETTA may occur, resulting in the loss of contraceptive protection.

Delay LILETTA insertion a minimum of 4 weeks or until uterine involution is complete following a delivery or a second trimester abortion. Remove a partially expelled LILETTA. If expulsion has occurred, a new LILETTA may be inserted within 7 days after the onset of a menstrual period after pregnancy has been ruled out.

Ovarian cysts may occur and are generally asymptomatic, but may be accompanied by pelvic or abdominal pain or dyspareunia. Evaluate persistent ovarian cysts.

In the LILETTA clinical trial, the most common adverse reactions (≥5% users) were vulvovaginal mycotic infections (19.2%), vaginal bacterial infections (18.6%), acne (15.3%), nausea or vomiting (10.3%), abdominal discomfort or pain (9.9%), headache (9.5%), breast tenderness or pain (9.5%), dyspareunia (9.3%), anxiety (8.8%), pelvic discomfort or pain (8.4%), depression (8.3%), dysmenorrhea (6.4%), mood changes (6.3%), increased weight (5.9%), back pain (5.9%), and vaginal discharge (5.5%).

Teach patients to recognize and immediately report signs or symptoms of the aforementioned conditions. Evaluate patients 4 to 6 weeks after insertion of LILETTA and then yearly or more often if clinically indicated.

Please see full Prescribing Information.