The single-dose formulation is an expansion of the Makena product line. Packaged in trays of four (a month’s supply), the single-dose formulation provides an alternative package size to the current multi-dose vial, which contains five weekly injections. AMAG currently expects to commercialize the new single-dose, preservative-free formulation of Makena in the second quarter of 2016.
“We are pleased to receive
The new single-dose formulation:
- Provides the convenience of a single-use vial for once-weekly dosing, without the need for storage of a multi-dose vial;
- Allows pharmacists to dispense a month’s supply of single-dose Makena vials or to dispense individual single-dose vials for women who are nearing the end of their course of therapy; and
- Offers an
FDA-approved, preservative-free version of Makena for patients and healthcare providers who prefer this option.
“We are pleased
For more information about Makena, visit www.makena.com.
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.
Important Safety Information for Makena (hydroxyprogesterone caproate injection)
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.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA) and other federal securities laws. Any statements contained herein which do not describe historical facts, including, among others, statement regarding our expectations to begin to commercialize the new single-dose formulation of Makena in the second quarter of 2016; the expected benefits of the single-dose vial of Makena to healthcare providers and patients; expectations for the next generation development program for Makena; AMAG’s ability to provide clear benefits and improve people’s lives; and plans to expand and diversify AMAG’s portfolio are forward-looking statements which 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, those risks 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.
AMAG Pharmaceuticals® is a registered trademark of
Linda LennoxVice President, Investor Relations 617-498-2846 Media Contact: Katie PayneVice President, External Affairs 617-498-3303