Label Changes for:
Makena (hydroxyprogesterone caproate injection) 250ml/mg
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)
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