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LILETTA®: RESOURCES FOR YOU

RESOURCES

 

PURCHASING OPTIONS

ORDER DIRECTLY FROM ALLERGAN THROUGH THE LILETTA® VOLUME DISCOUNT PROGRAM
Volume Discount Program Information*
Number of Units Volume Discount Illustrative Aquisition Cost
5-19 8.0% $689.45
20-49 15.0% $636.99
50-99 28.0% $539.57
100-199 32.0% $509.59
200+ 36.0% $479.62

For purchases of 300 or more units, please contact LILETTA AccessConnectSM at 1-855-LILETTA (1.855.545.3882) for more information.
For the LILETTA® Volume Discount Program Supplemental Terms and Conditions of Sale, please click here.
*Information subject to change. Allergan 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 Allergan.
Illustrative acquisition cost based on a WAC of $749.40 (effective January 1, 2019 and subject to change). Actual acquisition cost may vary depending on WAC in effect at the time the customer's order is received by Allergan. 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 Allergan 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
 

24/7 REAL-TIME SUPPORT WITH LILETTA ACCESSCONNECTSM

Benefit Investigations

On-demand medical benefits investigations

Gain access to patient records for on-demand results

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Online ordering services

Easily manage your LILETTA inventory

Easily accessible through a variety of channels

Visit LILETTAAccessConnect.com for more information.

 

RESOURCES FOR YOUR ELIGIBLE PATIENTS

ELIGIBLE PATIENTS MAY BE ABLE TO SAVE ON THE LILETTA PRODUCT WITH THE LILETTA PATIENT SAVINGS PROGRAM®

  • Your commercially insured patients may be eligible to participate in the LILETTA Patient Savings Program®

  • Patients can learn more at LILETTAcard.com

Please note that the LILETTA Patient Savings Program® only applies to the cost of the product. It does not cover the cost of insertion or medical examination.

SAVINGS ON LILETTA
Eligible patients
pay

$100,
then save up to
a maximum of

$700,
for the LILETTA product.*

*Depending on insurance coverage, eligible patients pay $100, then save up to a maximum of $700, for the LILETTA® product. Offer applies to product only, and does not apply to costs associated with medical examination or product administration. Check with your pharmacist or healthcare provider for your copay discount. Patient out-of-pocket expense may vary. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs. Program expires 10/31/19. Please see full LILETTA Patient Savings Program® Terms, Conditions, and Eligibility Criteria here.  

 

MEDICINES360 PARTNERSHIP

Allergan has a groundbreaking partnership with Medicines360, a non-profit women’s health pharmaceutical company.

Allergan is proud to partner with Medicines360 to expand access to LILETTA for IUD-appropriate women

Medicines360 uses part of the proceeds from the sales of LILETTA to support its mission of developing effective and safe healthcare options for women, including expanded access to contraception

 

FOR HELP WITH LILETTA®

ONE NUMBER FOR ALL QUESTIONS
1-855-LILETTA
(1.855.545.3882)
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Purchasing:

For information regarding pricing and ordering LILETTA

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Benefits Investigations:

For help with patient benefits investigations and billing and coding

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LILETTA Patient Savings Program®:

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

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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

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Product Quality:

To report any product quality complaints

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Request a Field Sales Representative:

To request a visit from a field sales representative

 

LILETTA® is a sterile, levonorgestrel-releasing intrauterine system indicated for prevention of pregnancy for up to 5 years. The system should be replaced after 5 years if continued use is desired.

Important Safety Information
Who is not appropriate for LILETTA

Use of LILETTA is contraindicated in women with: known or suspected pregnancy and cannot be used for 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 tumors; 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; 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 developed the infection within a week of LILETTA insertion, while the remainder were diagnosed more than six months after insertion. Counsel women who receive LILETTA to notify a healthcare provider if they have complaints of lower abdominal or pelvic pain, odorous discharge, unexplained bleeding, fever, or genital lesions or sores. 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, take appropriate diagnostic measures to rule out 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 pain or dyspareunia. Evaluate persistent ovarian cysts.

In the LILETTA clinical trial, the most common adverse reactions (≥5% users) were vaginal bacterial infections (18.6%), vulvovaginal mycotic infections (18.6%), acne (14.9%), nausea or vomiting (9.8%), dyspareunia (9.1%), headache (8.9%), breast tenderness or pain (8.3%), pelvic discomfort or pain (8.3%), anxiety (8.1%), abdominal discomfort or pain (7.8%), depression (6.9%), dysmenorrhea (6.1%), mood changes (5.8%), increased weight (5.7%), back pain (5.5%), and vaginal discharge (5.4%).

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 and Medicines360; 2018. 2. Data on file. Medicines360: San Francisco, CA. 3. Mirena (levonorgestrel-releasing intrauterine system) 52 mg [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; 2017. 4. Skyla (levonorgestrel-releasing intrauterine system) 13.5 mg [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; 2018. 5. Kyleena (levonorgestrel-releasing intrauterine system) 19.5 mg [Prescribing Information]. Whippany, NJ: Bayer HealthCare Pharmaceuticals Inc; 2018.

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IMPORTANT SAFETY INFORMATION
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Who is not appropriate for LILETTA

Use of LILETTA is contraindicated in women with: known or suspected pregnancy and cannot be used for 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 tumors; 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; 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 developed the infection within a week of LILETTA insertion, while the remainder were diagnosed more than six months after insertion. Counsel women who receive LILETTA to notify a healthcare provider if they have complaints of lower abdominal or pelvic pain, odorous discharge, unexplained bleeding, fever, or genital lesions or sores. 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, take appropriate diagnostic measures to rule out 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 pain or dyspareunia. Evaluate persistent ovarian cysts.

In the LILETTA clinical trial, the most common adverse reactions (≥5% users) were vaginal bacterial infections (18.6%), vulvovaginal mycotic infections (18.6%), acne (14.9%), nausea or vomiting (9.8%), dyspareunia (9.1%), headache (8.9%), breast tenderness or pain (8.3%), pelvic discomfort or pain (8.3%), anxiety (8.1%), abdominal discomfort or pain (7.8%), depression (6.9%), dysmenorrhea (6.1%), mood changes (5.8%), increased weight (5.7%), back pain (5.5%), and vaginal discharge (5.4%).

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.