DUBLIN, Sept. 16, 2015 /PRNewswire/ -- Allergan plc, (NYSE: AGN) a leading global pharmaceutical company, and U.S. Women's Health Alliance (USWHA), an organization focused on promoting high-quality, affordable healthcare for women, announced an agreement to make LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg available to patients across USWHA's 26 Alliance health care groups nationwide. The agreement paves the way for 1,500 Alliance physicians to offer LILETTA as a contraceptive option to the millions of reproductive-age women that they care for across the country.
"As a leader in women's healthcare, the U.S. Women's Health Alliance believes in offering safe, effective treatment options to our patients, and the IUD is among the most efficacious forms of contraception on the market," said Jack Feltz, MD, President of USWHA and President/CEO of Lifeline Medical Associates, LLC in New Jersey. "The range of women studied in the LILETTA Phase 3 clinical trial is representative of the diverse population of women treated by our physicians throughout the United States."
LILETTA received marketing approval from the U.S. Food and Drug Administration (FDA) in February 2015, supported by the largest hormonal IUD trial (ACCESS IUS) conducted in the U.S. designed to reflect the U.S. population. This multi-center, open-label clinical trial included 1,751 women who received LILETTA. LILETTA was studied in women aged 16-45, with a body mass index (BMI) range of 15.8kg/m2 - 61.6kg/m2 (26.9 kg/m2 mean BMI) across women of various races and ethnicities. Most women were Caucasian (78.4 percent) or Black/African American (13.3 percent); 14.7 percent of women were of Hispanic ethnicity. Nearly 58 percent of trial participants were nulliparous (had not previously given birth), the largest percentage of nulliparous IUD patients ever studied. LILETTA was found to be 99.45 percent effective in preventing pregnancy in women regardless of age, parity (previous births), or BMI for up to 3 years. The trial is ongoing to evaluate the use of LILETTA for up to four, five, and seven years.
"When barriers such as cost, education and access are removed, more women choose IUDs," said Herm Cukier, Vice President, Women's Healthcare at Allergan. "By partnering with the U.S. Women's Health Alliance, we have increased our ability to effectively reach IUD-appropriate women across the country and offer LILETTA as a potential contraceptive option."
Since the product became available for customers in April 2015, clinics in all 50 states have ordered LILETTA, with thousands of women treated during the past several months. LILETTA is currently available in a number of U.S. Women's Health Alliance practices. For more information on a practice near you, visit http://www.uswomenshealthalliance.com/.
LILETTA® (levonorgestrel-releasing intrauterine system) 52 mg 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; 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 (link to the PI)
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 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, healthcare 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 the U.S. Women's Health Alliance
The U.S. Women's Health Alliance is a partnership of 26 women's health care groups with more than 1,500 physicians caring for over 8 million women across the country. The Alliance is designed to promote high-quality, affordable healthcare through collaboration with doctors, insurance companies, hospitals, government and private industry. Alliance members work together to improve women's health care by creating an affordable health care system and to protect and preserve the private practice of medicine through member group collaboration, pooled resources; development of new models of healthcare delivery including evidence based quality metrics, and shared savings initiatives. The Alliance collaborates on medical technology, operational and practice management benchmarks and group purchasing programs.
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.
SOURCE Allergan plc