New Formulation of Makena Approved
February 14, 2018 – The U.S. FDA has approved AMAG Pharmaceuticals’ Makena® (hydroxyprogesterone caproate) subcutaneous (SC) auto-injector as a drug-device combination. It is indicated to reduce the risk of preterm births for women who are pregnant with a single child, and have delivered a single child preterm in the past.
Originally approved in 2011, Makena was previously available as an intramuscular (IM) injection only. The approval of the new SC auto-injector allows the drug to be delivered via a shorter, thinner, hidden needle. Both the IM and SC versions of Makena must be administered by a healthcare provider. Recommended dosing for the SC form is 275mg once per week, beginning as early as 16 weeks into gestation, and lasting until delivery or week 37 of gestation, whichever comes first.
Makena is the first and only FDA-approved drug therapy for prevention of spontaneous preterm births. However, generics for the IM form are expected to enter the U.S. market in the summer of 2018. Antares plans to launch the new SC formulation in mid-March. Its pricing is anticipated to be similar to that of the IM formulation.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.