Label Changes for:

Makena (hydroxyprogesterone caproate injection) 250ml/mg

September 2013

Changes have been made to the PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)

 

September 2013

6 ADVERSE REACTIONS

6.2 Postmarketing Experience
  • added.....outcomes related to pregnancy, puerperium, and perinatal conditions and reproductive and breast disorders.

7 DRUG INTERACTIONS

  • results of an in vitro study in human hepatocytes to determine the potential of hydroxyprogesterone caproate to induce or alter the metabolic activities of CYP1A2, 2A6 and 2B6
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