Makena is the only
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
Some of the key features of My Adherence Program include:
- Weekly telephonic patient outreach by a dedicated maternal health nursing specialist;
- 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
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
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® (hydroxyprogesterone caproate injection)
Makena® 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.
NurseWise is a wholly owned subsidiary of
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
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.
Lumara Health™ and Makena® are trademarks of
AMAG Pharmaceuticals, Inc.Contact: Katie PayneVice President, External Affairs 617-498-3303