Clinical Guideline

Injectable HPC is recommended by the SMFM to reduce the risk of preterm birth for clinically indicated patients2

smfm clinical guideline chart

Per the 2017 SMFM statement on choice of progestogen, vaginal progesterone should not be considered a substitute for HPC in these at‑risk women.3

Adapted from the SMFM Clinical Guideline published in the May 2012 American Journal of Obstetrics & Gynecology.2
Emphasis added to highlight patient identification and initiation, and duration of therapy.

HPC=hydroxyprogesterone caproate; SMFM=Society for Maternal-Fetal Medicine; PTB=preterm birth; SPTB=spontaneous preterm birth; TVU=transvaginal ultrasound; CL=cervical length.

In a clinical study, comparable bioavailability was seen between Makena Auto-Injector dosed subcutaneously (1.1 mL; back of upper arm) and Makena dosed IM (1 mL; gluteus maximus).1*

View the study

*In a single-dose, open-label, randomized, parallel design bioavailability study in 120 healthy post-menopausal women.

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On April 6, 2023, the U.S. Food and Drug Administration (FDA) issued a final decision ordering the withdrawal of the approval of Makena®. FDA has stated that it recognizes that a limited supply of these drugs has already been distributed, including to physicians’ offices and pharmacies. FDA acknowledges that some health care providers might continue to prescribe or administer that limited remaining supply to their patients. However, we recommend health care practitioners consider FDA’s conclusions.

If you have questions about Makena, please call our Medical Information Call Center at +1-877-411-2510, Monday-Friday from 9:00 AM-7:00 PM EST.

Please see Full Prescribing Information for Makena.

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PP-MKN-US-00713 08/23