Available in the form of an injection, Makena is a medication used to prevent preterm birth. It is approved for use in women who have delivered prematurely in the past. It is started between weeks 16 and 21 of pregnancy, and is given once a week until week 37. The most common side effect of this drug is pain at the injection site.
What Is Makena?
Makena™ (hydroxyprogesterone caproate) is a prescription injection used to prevent preterm birth in women who have delivered a baby too early in the past. It is the first and only medication approved by the United States Food and Drug Administration (FDA) for this use.
The manufacturer of this medication is committed to helping women afford it. The company will work with you, your insurance, available state assistance programs (such as Medicaid), and any other options to help you afford Makena.
They will help you obtain prior authorization with your insurance company, if necessary. They can also provide financial assistance for eligible women. This process is started automatically when your healthcare provider prescribes Makena and registers you with the Makena Care Connection™, which is required to receive the medication.
What About Compounded Hydroxyprogesterone?
Hydroxyprogesterone injections have been available through compounding pharmacies for quite some time, long before Makena was approved. These compounded injections cost much less than Makena and have long been used to prevent preterm birth.
Usually, once a manufacturer performs all the necessary studies and receives FDA approval, compounding pharmacies are no longer allowed to make such products. However, the FDA recognizes that this is a unique situation and has stated that it will allow compounding pharmacies to continue to make hydroxyprogesterone injections, at least for the time being.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Makena [package insert]. St. Louis, MO: Ther-Rx Corporation;2011 February.
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed April 19, 2011.
Food and Drug Administration, Center for Drug Evaluation and Research. FDA Statement on Makena (3/30/2011). FDA Web site. Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm249025.htm. Accessed April 18, 2011.
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