Company Announces Collaboration With NurseWise(R) to Help Enhance Adherence to Makena(R) (hydroxyprogesterone caproate injection) Therapy
WALTHAM, Mass., May 20, 2015 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (Nasdaq:AMAG) a specialty pharmaceutical company, today announced its Lumara Health division is partnering with NurseWise(R), a national nurse triage and health education provider, to launch My Adherence Program(TM). This new program is designed to facilitate improved patient compliance with Makena(R) (hydroxyprogesterone caproate injection) therapy.
Makena is the only FDA-approved treatment indicated to reduce the risk of preterm birth in women who are pregnant with one baby and who have delivered one preterm baby spontaneously in the past. Makena is a weekly injection administered by a healthcare provider, starting as early as week 16 of the pregnancy, and given weekly until week 37 or the baby is born, whichever occurs first.
Each expecting mother who has been prescribed Makena and enrolls (at no additional cost) in My Adherence Program will be paired with a dedicated maternal health nursing specialist who will contact the patient weekly to:
-- Educate patients on the importance of achieving a full-term pregnancy;
-- Provide educational materials that address important topics during
pregnancy, such as coping with stress, good nutrition, relaxation
techniques, and when applicable, recommendations for stopping smoking and
drug use during pregnancy;
-- Encourage adherence to the weekly Makena injection schedule;
-- Identify barriers to adherence and provide potential solutions to
overcome those barriers; and
-- Empower patients to take an active role in their health.
"For patients who are at risk for preterm birth, every week of pregnancy counts. AMAG's new compliance program can address and remove barriers that may inhibit patients' adherence to therapy," said Robert Kaper, M.D., senior vice president, medical and scientific affairs, at AMAG Pharmaceuticals. "Supporting improved patient compliance is important for giving at-risk expecting mothers the best chance of reducing the risk of another preterm birth."
Some of the key features of My Adherence Program include:
-- Weekly telephonic patient outreach by a dedicated maternal health nursing
-- Notification to the patient's healthcare provider through a
HIPAA-compliant and secure platform, as needed;
-- Data collection regarding compliance, including patient-reported reasons
for missing injections or discontinuing therapy; and
-- 24/7 availability of maternal health nursing specialists to answer
certain patient questions
"My Adherence Program is a high-touch, customized program that identifies and addresses unique barriers to Makena adherence that some women face," said Kim Tuck, President and Chief Executive Officer of NurseWise. "We use motivational interviewing and recognized evidence-based practices to identify potential for non-compliance. Our NurseWise team can help support patient follow-through with weekly Makena treatment and may help improve expecting mothers' chances of carrying their babies to full term. We are excited to partner with AMAG Pharmaceuticals to support this important program to help women stay on track with their treatment and help more women achieve a full-term pregnancy."
Tuck continued, "As a leading provider of nursing, health education and patient engagement services nationwide, NurseWise has a deep understanding of some of the unique challenges to medication adherence faced by patients - and has more than 20 years of experience delivering positive, measurable and sustainable solutions to help overcome some of these obstacles."
Women who are prescribed Makena and meet the FDA-approved indication are eligible to participate in the program. Along with patients' healthcare providers, the Makena Care Connection, a dedicated customer support program provided by Lumara Health, a division of AMAG, will introduce patients to the My Adherence Program when facilitating the prescription process and screening patients for financial assistance.
For more information about Makena, visit www.makena.com. For more information, please contact the Makena Care Connection at 1-800-847-3418.
About Makena(R) (hydroxyprogesterone caproate injection)
Makena(R) is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.
Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.
Makena should not be used in women with any of the following conditions: blood clots or other blood clotting problems, breast cancer or other hormone-sensitive cancers, or history of these conditions; unusual vaginal bleeding not related to the current pregnancy, yellowing of the skin due to liver problems during pregnancy, liver problems, including liver tumors, or uncontrolled high blood pressure.
Before patients receive Makena, they should tell their healthcare provider if they have an allergy to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena; diabetes or prediabetes, epilepsy, migraine headaches, asthma, heart problems, kidney problems, depression, or high blood pressure.
In one clinical study, certain complications or events associated with pregnancy occurred more often in women who received Makena. These included miscarriage (pregnancy loss before 20 weeks of pregnancy), stillbirth (fetal death occurring during or after the 20th week of pregnancy), hospital admission for preterm labor, preeclampsia (high blood pressure and too much protein in the urine), gestational hypertension (high blood pressure caused by pregnancy), gestational diabetes, and oligohydramnios (low amniotic fluid levels).
Makena may cause serious side effects including blood clots, allergic reactions, depression, and yellowing of the skin and the whites of the eyes. The most common side effects of Makena include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.
For additional U.S. product information, including full prescribing information, please visit www.makena.com.
AMAG Pharmaceuticals, Inc. is a specialty pharmaceutical company with a focus on maternal health, anemia and cancer supportive care. The primary goal of AMAG and its maternal health division, Lumara Health(TM), is to bring to market therapies that provide clear benefits and improve patients' lives. In addition to continuing to pursue opportunities to make new advancements in patients' health and to enhance treatment accessibility, AMAG intends to continue to expand and diversify its portfolio through the in-license or purchase of additional pharmaceutical products or companies. For additional company information, please visit www.amagpharma.com.
NurseWise is a wholly owned subsidiary of Centene Corporation in the business of providing multilingual telehealth (nurse triage and health education) services. We partner with health plans, hospitals, providers, colleges and universities, and other specialty organizations to ensure all callers have access to high quality, appropriate care. NurseWise holds full Health Call Center Accreditation from URAC, an accrediting organization that establishes quality standards for the health care industry, and Health Information Product (HIP) 2 certification from the National Committee for Quality Assurance (NCQA), which both demonstrate our emphasis on continuous improvement and commitment to quality at all levels of the organization. Our services are designed to encourage callers to become active participants in their health care, engaging in activities that promote appropriate utilization of care resources as well as better health outcomes for individuals and their families. We have provided uninterrupted service every day since 1995. NurseWise experienced Customer Care Professionals and Registered Nurses at our Clinical Care Centers(TM) across the country provide Care.Right.Now. through delivery of health information, education, and advice in a culturally and linguistically sensitive manner. NurseWise has locations in Tempe, Ariz.; El Paso, Texas; Tyler, Texas; Fort Lauderdale, Fla.; Atlanta, Ga.; and St. Louis, Mo. For more
information, please visit our website at www.nursewise.com or contact us at [email protected]
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, statements regarding plans and expectations for the My Adherence Program, including its key features and that it will improve patient adherence to therapy; beliefs regarding NurseWise and expectations regarding collaboration and partnering efforts; and AMAG's goals and plans to expand and diversify its portfolio, involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements.
Such risks and uncertainties include, among others, AMAG's ability to successfully commercialize Makena, AMAG's success in implementing Makena's lifecycle management program and perceptions related to pricing and access, and such other risks and uncertainties identified in AMAG's filings with the U.S. Securities and Exchange Commission (SEC), including in its Annual Report on Form 10-K for the year ended December 31, 2014 and subsequent filings with the SEC. AMAG cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made.
AMAG disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.
AMAG Pharmaceuticals(R) and My Adherence Program(TM) are trademarks of
AMAG Pharmaceuticals, Inc.
Lumara Health(TM) and Makena(R) are trademarks of Lumara Health IP Ltd.
CONTACT: AMAG Pharmaceuticals, Inc. Contact:
Vice President, External Affairs