DUBLIN, Oct. 6, 2015 /PRNewswire/ -- Allergan plc
(NYSE: AGN) and Medicines 360 today announced that
LILETTA® will be featured in 3 abstracts
presenting new data at the FIGO World Congress of Gynecology and
Obstetrics, which takes place from October
4-9, 2015 in Vancouver,
Canada.
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Data will be presented from studies evaluating the following:
Amenorrhea rates in women using LILETTA, a 52 mg levonorgestrel
intrauterine system, for up to 4 years; Plasma levonorgestrel
levels over 36 months in non-obese and obese women using LILETTA;
Evaluation of pelvic infection in women using LILETTA, for up to 2
years.
The scheduled times and titles of the presentations are as
follows:
Presentation Date: Tuesday, October
6th, Presentation Time: 1:45 – 3:15pm
- Amenorrhea rates in women using LILETTA®, a new 52mg
levonorgestrel intrauterine system, for up to 4 years
Presentation Date: Tuesday, October
6th, Presentation Time: 1:45 – 3:15pm
- Evaluation of pelvic infection in women using LILETTA®, a
new 52mg levonorgestrel-releasing intrauterine system, for up to 2
years
Presentation Date: Tuesday, October
6th, Presentation Time: 3:30 – 5:00pm
- Plasma levonorgestrel levels over 36 months in non-obese and
obese women using LILETTA®, a 52mg levonorgestrel-releasing
intrauterine system
IMPORTANT SAFETY INFORMATION LILETTA®
(levonorgestrel-releasing intrauterine system) 52 mg
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; known or suspected
breast cancer or other progestin-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; postpartum endometritis or infected
abortion in the past 3 months; unexplained uterine bleeding;
current IUS; acute pelvic inflammatory disease (PID) 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
headache; marked increase of blood pressure; or severe arterial
disease such as stroke or myocardial infarction. Consider removing
the intrauterine system if these or 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
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. About
1/3 of women 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 is 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 and that PID 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 in order 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 reduce contraceptive
efficacy. If perforation occurs, locate and remove LILETTA. 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 6 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 clinical trial of LILETTA the most common adverse
reactions (≥5% users) were vaginal infections (13.6%), vulvovaginal
infections (13.3%), acne (12.3%), headache or migraine (9.8%),
nausea or vomiting (7.9%), dyspareunia (7.0%), abdominal pain or
discomfort (6.8%), breast tenderness or pain (6.7%), pelvic
discomfort or pain (6.1%), depression or depressed mood (5.4%), and
mood changes (5.2%).
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 go to
www.liletta.com
About Allergan
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a unique, global
pharmaceutical company and a leader in a new industry model—Growth
Pharma. Allergan is focused on developing, manufacturing, and
commercializing innovative branded pharmaceuticals, high-quality
generic and over-the-counter medicines, and biologic products for
patients around the world.
Allergan markets a portfolio of best-in-class products that
provide valuable treatments for the central nervous system, eye
care, medical aesthetics, gastroenterology, women's health,
urology, cardiovascular and anti-infective therapeutic categories,
and operates the world's third-largest global generics business,
providing patients around the globe with increased access to
affordable, high-quality medicines. Allergan is an industry leader
in research and development, with one of the broadest development
pipelines in the pharmaceutical industry and a leading position in
the submission of generic product applications globally.
With commercial operations in approximately 100 countries,
Allergan is committed to working with physicians, health care
providers, and patients to deliver innovative and meaningful
treatments that help people around the world live longer, healthier
lives.
For more information, visit Allergan's website at
www.allergan.com.
About Medicines360
Medicines360, located in San
Francisco, California, is an innovative nonprofit global
women's health pharmaceutical company with a mission to expand
access to quality medicines for all women regardless of their
socioeconomic status, insurance status or geographic location.
Medicines360 was founded in 2009 and gained FDA approval of its
first product, LILETTA a progestin intrauterine device (IUD) in
February 2015. Medicines360 is committed to working with
healthcare providers, advocacy groups and patients to deliver
innovative and meaningful treatments that help women around the
world have greater choice and access to the medicines they
need.
For more information, visit www.medicines360.org.
Medicines360 Media Contact: Caren
Begun (856-424-2023;Caren@greenroompr.com)
Allergan Forward-Looking Statement
Statements contained in this press release that refer to future
events or other non-historical facts are forward-looking statements
that reflect Allergan's current perspective of existing trends and
information as of the date of this release. Except as expressly
required by law, Allergan disclaims any intent or obligation to
update these forward-looking statements. Actual results may differ
materially from Allergan's current expectations depending upon a
number of factors affecting Allergan's business. These factors
include, among others, the risks associated with acquisition
transactions; the difficulty of predicting the timing or outcome of
FDA approvals or actions, if any; the impact of competitive
products and pricing; market acceptance of and continued demand for
Allergan's products; difficulties or delays in manufacturing; and
other risks and uncertainties detailed in Allergan's periodic
public filings with the Securities and Exchange Commission,
including but not limited to Allergan's Quarterly Report on Form
10-Q for the quarter ended March 31,
2015 (such periodic public filings having been filed under
the "Actavis plc" name) and from time to time in Allergan's other
investor communications . Except as expressly required by law,
Allergan disclaims any intent or obligation to update these
forward-looking statements.
CONTACTS:
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Investors:
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Lisa
DeFrancesco
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(862)
261-7152
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Media:
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Mark
Marmur
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(862)
261-7558
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SOURCE Allergan