SAN FRANCISCO and DUBLIN, Feb. 15, 2017 /PRNewswire/ -- Medicines360, a nonprofit women's health pharmaceutical company with a mission of expanding access to quality medicines, and Allergan plc (NYSE: AGN), a leading global pharmaceutical company, today announced a partnership with 340B-eligible health centers and other safety net providers in Puerto Rico and Florida, both areas where there is local transmission of the Zika virus, to make available their hormonal contraceptive, LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg. LILETTA is an IUS, intrauterine system (otherwise known as an intrauterine device or IUD), that is approved for the prevention of pregnancy for up to three years. Research has shown that pregnant women infected with the Zika virus are at risk of giving birth to infants born with microcephaly -- a birth defect caused by the exposure to the Zika virus where a baby's head is smaller than expected when compared to babies of the same sex and age. LILETTA, is available at a lower cost to public health clinics enrolled in the 340B Drug Pricing Program.
The health center partnership is part of the renewed Zika response that Congress recently enacted into law, on a bi-partisan basis. Specifically, Congress has appropriated an additional $40 million for health centers in Puerto Rico and the territories, and the Health Resources and Services Administration (HRSA) announced the availability of the funding on October 28, 2016.
"There is a clear and immediate need for effective contraceptive options in Puerto Rico and communities throughout the world to give women reproductive choices. Where the risk of contracting the Zika virus is high, the ability for a woman to plan if and when to become pregnant is particularly important," said Gavin Corcoran, Chief Medical Officer at Allergan. "Women in Puerto Rico urgently need contraceptives to help prevent unplanned pregnancies and to plan the timing of their pregnancies to occur as safely as possible."
The partnership is designed to help reduce unintended pregnancies in Puerto Rico and the territories where risk of the Zika virus is high. An estimated 138,000 young Puerto Rican women have reported the desire to not get pregnant and are not using an effective form of birth control1. Additionally, the Centers for Disease Control and Prevention (CDC) recently reported that 2,451 pregnant women have been identified as Zika-infected in Puerto Rico and the territories.
On April 13, 2016, scientists from the CDC announced that the Zika virus causes microcephaly and other severe fetal brain defects. Women who do not want to get pregnant should talk with their doctor or healthcare provider about ways to prevent unintended pregnancy, including how to use birth control.
Allergan and Medicines360 intend to continue to partner with HRSA and health centers in other areas in the United States at high risk for Zika transmission this spring and summer.
"Medicines360's mission is to expand access to quality medicines for all women regardless of their socioeconomic status, insurance coverage, or geographic location," said Jessica Grossman, MD, CEO of Medicines360. "We wanted to do our part to respond to this emergency. LILETTA offers an option for public health clinics to continue to access a hormonal IUD as the crisis spreads to other areas in the mainland United States. The lower price we offer will continue to serve these communities after the crisis."
LILETTA is a hormone-releasing system placed in a woman's uterus to prevent pregnancy for up to three years and is more than 99 percent effective. LILETTA is reversible and can be removed at any time by a healthcare provider. LILETTA and oral contraceptives do not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs), including Zika virus.
Medicines360 and Allergan were granted FDA approval in February 2015 for LILETTA. By continuing to expand access to LILETTA in the U.S. and all over the world, Medicines360 and Allergan together remain committed to impacting the lives of women around the globe, removing patient cost and access barriers and increasing awareness to transform women's health and enable every woman to make appropriate medical choices.
Important Safety Information
(scroll to see additional Important Safety Information and full Prescribing Information link)
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.
For full prescribing information, visit www.LILETTA.com
Medicines360, located in San Francisco, California, is a 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 coverage, or geographic location. 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 access to the medicines they need. For more information, visit www.medicines360.org.
ABOUT ALLERGAN WOMEN'S HEALTHCARE
Allergan is a leader in women's health care that is dedicated to developing and commercializing best-in-class pharmaceuticals to improve the health and wellness of women. Allergan takes a holistic and a best-in-class approach to women's healthcare as it prioritizes educational partnerships with OB/GYNs. The mission of Allergan Women's HealthCare extends beyond its pharmaceutical products to ensure that all women can make informed decisions about their health and have access to high-quality medications. Allergan is committed to investing in programs that support the education and well-being of all women.
Allergan plc (NYSE: AGN), headquartered in Dublin, Ireland, is a bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma. Allergan is focused on developing, manufacturing and commercializing branded pharmaceuticals, devices and biologic products for patients around the world.
Allergan markets a portfolio of leading brands and best-in-class products for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology and anti-infective therapeutic categories.
Allergan is an industry leader in Open Science, the Company's R&D model, which defines our approach to identifying and developing game-changing ideas and innovation for better patient care. This approach has led to Allergan building one of the broadest development pipelines in the pharmaceutical industry with 70+ mid-to-late stage pipeline programs in development.
Our Company's success is powered by our more than 15,000 global colleagues' commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
With commercial operations in approximately 100 countries, Allergan is committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live healthier lives every day. For more information, visit Allergan's website at www.Allergan.com.
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 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 Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 (certain of such periodic public filings having been filed under the "Actavis plc" name). Except as expressly required by law, Allergan disclaims any intent or obligation to update these forward-looking statements.
1 Tepper NK, Goldberg HI, Bernal MI, et al. Estimating Contraceptive Needs and Increasing Access to Contraception in Response to the Zika Virus Disease Outbreak — Puerto Rico, 2016. MMWR Morb Mortal Wkly Rep 2016;65:311–314. DOI: http://dx.doi.org/10.15585/mmwr.mm6512e1.
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