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LILETTA
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LILETTA
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Welcome to
LILETTA AccessConnectSM
A comprehensive resource for your office providing 24/7 support for LILETTA
procurement, billing, and benefits investigation
A comprehensive resource for your office providing 24/7 support for LILETTA
procurement, billing, and benefits investigation
Register now to take advantage of:
Register Now
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Order OnlineOrder LILETTA directly from AbbVie and manage your inventory.
Benefits InvestigationGain access to patient records for on-demand results.
Patient Savings ProgramLearn about savings for eligible patients.
Register now to take advantage of:
Order OnlineOrder LILETTA directly from AbbVie and manage your inventory.
Benefits InvestigationGain access to patient records for on-demand results.
Patient Savings ProgramLearn about savings for eligible patients.
For help, please call 1-855-LILETTA (1.855.545.3882)
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INDICATIONS

LILETTA® is a sterile, levonorgestrel-releasing intrauterine system indicated
for prevention of pregnancy for up to 8 years; replace after 8 years if
continued use is desired. LILETTA is indicated for the treatment of heavy
menstrual bleeding (HMB) for up to 5 years in women who choose intrauterine
contraception as their method of contraception; replace after 5 years if
continued HMB treatment is needed.

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 leiomyomas, that distorts the uterine cavity and would be incompatible
with correct intrauterine system (IUS) placement; known or suspected breast
cancer or other hormone-sensitive cancer, now or in the past; known or suspected
uterine or cervical malignancy; acute liver disease or liver tumor; untreated
acute cervicitis or vaginitis, including lower genital tract infections (eg,
bacterial vaginosis), until infection is controlled; postpartum endometritis or
infected abortion in the past 3 months; unexplained uterine bleeding; a current
IUS; acute pelvic inflammatory disease (PID); 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 women 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,
expulsed or perforated the uterus), remove it.

Pregnancy-related risks with LILETTA

If pregnancy should occur with LILETTA in place, remove the IUS 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. 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 have 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. IUSs have been associated with an increased risk of PID,
most likely due to organisms being introduced into the uterus during insertion.
In the LILETTA contraception study, 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. In the HMB study, one woman was
diagnosed with PID about 5 months after LILETTA insertion. Counsel women who use
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, including
ectopic 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 increased if inserted in women who
have fixed retroverted uteri, are postpartum, or are lactating. Delay LILETTA
insertion a minimum of 4 weeks or until uterine involution is complete following
a delivery or a second-trimester abortion.

Partial or complete expulsion of LILETTA may occur, resulting in the loss of
contraceptive protection. Expulsion risk is increased when inserted immediately
after delivery; it appears to be increased with insertions after
second-trimester abortion, based on limited data. Risk of expulsion is increased
for patients with a history of HMB or greater than normal BMI at the time of
insertion. Remove a partially expelled LILETTA. If expulsion has occurred, a new
LILETTA may be inserted when there is reasonable certainty the patient is not
pregnant.

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

In the LILETTA contraception study, the most common adverse reactions (≥5%
users) were vulvovaginal mycotic infections (20.2%), vaginal bacterial
infections (19.2%), acne (15.5%), nausea or vomiting (10.5%), headache (10.1%),
breast tenderness or pain (10.1%), abdominal discomfort or pain (10.0%),
dyspareunia (9.6%), anxiety (9.6%), depression (9.1%), pelvic discomfort or pain
(8.7%), dysmenorrhea (7.3%), mood changes (6.5%), back pain (6.5%), increased
weight (6.1%), and vaginal discharge (5.8%). In the LILETTA HMB study, the
adverse reaction profile was consistent with the adverse reaction profile in the
contraception study.

Teach patients to recognize and immediately report signs or symptoms of the
aforementioned conditions. Consider evaluating patients 4 to 6 weeks after
LILETTA insertion and during routine care, or more often if clinically
indicated. Check threads during each evaluation.

Please see full Prescribing Information.

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 leiomyomas, that distorts the uterine cavity and would be incompatible
with correct intrauterine system (IUS) placement; known or suspected breast
cancer or other hormone-sensitive cancer, now or in the past; known or suspected
uterine or cervical malignancy; acute liver disease or liver tumor; untreated
acute cervicitis or vaginitis, including lower genital tract infections (eg,
bacterial vaginosis), until infection is controlled; postpartum endometritis or
infected abortion in the past 3 months; unexplained uterine bleeding; a current
IUS; acute pelvic inflammatory disease (PID); 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 women 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,
expulsed or perforated the uterus), remove it.

Pregnancy-related risks with LILETTA

If pregnancy should occur with LILETTA in place, remove the IUS 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. 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 have 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. IUSs have been associated with an increased risk of PID,
most likely due to organisms being introduced into the uterus during insertion.
In the LILETTA contraception study, 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. In the HMB study, one woman was
diagnosed with PID about 5 months after LILETTA insertion. Counsel women who use
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, including
ectopic 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 increased if inserted in women who
have fixed retroverted uteri, are postpartum, or are lactating. Delay LILETTA
insertion a minimum of 4 weeks or until uterine involution is complete following
a delivery or a second-trimester abortion.

Partial or complete expulsion of LILETTA may occur, resulting in the loss of
contraceptive protection. Expulsion risk is increased when inserted immediately
after delivery; it appears to be increased with insertions after
second-trimester abortion, based on limited data. Risk of expulsion is increased
for patients with a history of HMB or greater than normal BMI at the time of
insertion. Remove a partially expelled LILETTA. If expulsion has occurred, a new
LILETTA may be inserted when there is reasonable certainty the patient is not
pregnant.

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

In the LILETTA contraception study, the most common adverse reactions (≥5%
users) were vulvovaginal mycotic infections (20.2%), vaginal bacterial
infections (19.2%), acne (15.5%), nausea or vomiting (10.5%), headache (10.1%),
breast tenderness or pain (10.1%), abdominal discomfort or pain (10.0%),
dyspareunia (9.6%), anxiety (9.6%), depression (9.1%), pelvic discomfort or pain
(8.7%), dysmenorrhea (7.3%), mood changes (6.5%), back pain (6.5%), increased
weight (6.1%), and vaginal discharge (5.8%). In the LILETTA HMB study, the
adverse reaction profile was consistent with the adverse reaction profile in the
contraception study.

Teach patients to recognize and immediately report signs or symptoms of the
aforementioned conditions. Consider evaluating patients 4 to 6 weeks after
LILETTA insertion and during routine care, or more often if clinically
indicated. Check threads during each evaluation.

INDICATIONS

LILETTA® is a sterile, levonorgestrel-releasing intrauterine system indicated
for prevention of pregnancy for up to 8 years; replace after 8 years if
continued use is desired. LILETTA is indicated for the treatment of heavy
menstrual bleeding (HMB) for up to 5 years in women who choose intrauterine
contraception as their method of contraception; replace after 5 years if
continued HMB treatment is needed.

Please see full Prescribing Information.



For additional information about LILETTA, call the AbbVie Medical Information
department toll-free at 1.800.678.1605



© 2023 AbbVie and Medicines360®. All rights reserved.

Medicines360® and its design are registered trademarks of Medicines360.

LILETTA® and its design are registered trademarks of Odyssea Pharma SPRL, an
AbbVie company.

LILETTA AccessConnectSM and its design are service marks of Odyssea Pharma SPRL,
an AbbVie company.

LILETTA PATIENT SAVINGS PROGRAM® and its design are registered service marks of
Odyssea Pharma SPRL, an AbbVie company.

US-LLT-230204 10/23

 

This site is intended for U.S. healthcare professionals only.

For additional information about LILETTA, call the AbbVie Medical Information
department toll-free at 1.800.678.1605



© 2023 AbbVie and Medicines360®. All rights reserved.

Medicines360® and its design are registered trademarks of Medicines360.

LILETTA® and its design are registered trademarks of Odyssea Pharma SPRL, an
AbbVie company.

LILETTA AccessConnectSM and its design are service marks of Odyssea Pharma SPRL,
an AbbVie company.

LILETTA PATIENT SAVINGS PROGRAM® and its design are registered service marks of
Odyssea Pharma SPRL, an AbbVie company.

US-LLT-230204 10/23

 

This site is intended for U.S. healthcare professionals only.

   
   
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