Skip to main content
Log in

17 α-Hydroxyprogesterone Caproate (Makena®)

A Guide to Its Use in the Prevention of Preterm Birth

  • Adis Drug Clinical Q&A
  • Published:
Clinical Drug Investigation Aims and scope Submit manuscript

Abstract

Intramuscular 17 α-hydroxyprogesterone caproate (Makena®), a synthetic progestin, is indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of a singleton spontaneous preterm birth. Makena® reduces the risk of preterm birth in this patient population, and is associated with improvements in certain fetal/neonatal outcomes. The use of this US FDA-approved formulation of 17 α-hydroxyprogesterone caproate reduces the inherent risks associated with the use of pharmacy-compounded formulations of the drug.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1

Similar content being viewed by others

References

  1. Deeks ED. 17 α-hydroxyprogesterone caproate (Makena): in the prevention of preterm birth. Pediatr Drugs. 2011;13(5):337–45.

    Article  Google Scholar 

  2. Meis PJ, Klebanoff M, Thom E, et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med. 2003;348(24):2379–85.

    Article  PubMed  CAS  Google Scholar 

  3. Cohen AW, Copel JA, Macones GA, et al. Unjustified increase in cost of care resulting from U.S. Food and Drug Administration approval of Makena (17alpha-hydroxyprogesterone caproate). Obstet Gynecol. 2011;117(6):1408–12.

    Article  PubMed  Google Scholar 

  4. Makena® (hydroxyprogesterone caproate injection) for intramuscular use: US prescribing information. St. Louis: Ther-Rx Corporation; 2011.

  5. Spong CY, Meis PJ, Thom EA, et al. Progesterone for prevention of recurrent preterm birth: impact of gestational age at previous delivery. Am J Obstet Gynecol. 2005;19(3 Pt 2):1127–31.

    Article  Google Scholar 

  6. Meis PJ, Klebanoff M, Dombrowski MP, et al. Does progesterone treatment influence risk factors for recurrent preterm delivery? Obstet Gynecol. 2005;106(3):557–61.

    Article  PubMed  CAS  Google Scholar 

  7. Rebarber A, Istwan NB, Russo-Stieglitz K, et al. Increased incidence of gestational diabetes in women receiving prophylactic 17alpha-hydroxyprogesterone caproate for prevention of recurrent preterm delivery. Diabetes Care. 2007;30(9):2277–80.

    Article  PubMed  CAS  Google Scholar 

  8. Northen AT, Norman GS, Anderson K, et al. Follow-up of children exposed in utero to 17 alpha-hydroxyprogesterone caproate compared with placebo. Obstet Gynecol. 2007;110(4):865–72.

    Article  PubMed  Google Scholar 

  9. Sellers S, Utian WH. Pharmacy compounding primer for physicians: prescriber beware. Drugs. 2012;72(16):2043–50.

    Article  PubMed  Google Scholar 

  10. US Department of Health and Human Services. US Food and Drug Administration. The special risks of pharmacy compounding. 2012. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm107836.htm. Accessed 8 Jan 2013.

  11. US Department of Health and Human Services. US Food and Drug Administration. Questions and answers on updated FDA statement on compounded versions of hydroxyprogesterone caproate (the active ingredient in Makena). 2012. http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm310215.htm. Accessed 8 Jan 2013.

  12. Chollet JL, Jozwiakowski MJ. Quality investigation of hydroxyprogesterone caproate active pharmaceutical ingredient and injection. Drug Dev Ind Pharm. 2012;38(5):540–9.

    Article  PubMed  CAS  Google Scholar 

  13. Society for Maternal-Fatal Medicine Publications Committee. Progesterone and preterm birth prevention: translating clinical trials data into clinical practice. Am J Obstet Gynecol. 2012;206(5):376–86.

    Article  Google Scholar 

  14. ClinicalTrials.gov. http://www.clinicaltrials.gov/ct2/results?term=makena. Accesssed 8 Jan 2013.

Download references

Disclosure

This article was updated from Pediatric Drugs 2011;13(5):337–45 [1]. The preparation of this review was not supported by any external funding. During the peer review process, the manufacturer of the agent under review was offered an opportunity to comment on the article. Changes resulting from comments received were made by the authors on the basis of scientific and editorial merit.

Author information

Authors and Affiliations

Authors

Corresponding author

Correspondence to Katherine A. Lyseng-Williamson.

Additional information

The manuscript was reviewed by: D.J. Dudley, Department of Obstetrics and Gynecology, University of Texas Health Sciences Center at San Antonio, San Antonio, TX, USA

Rights and permissions

Reprints and permissions

About this article

Cite this article

Hines, M., Lyseng-Williamson, K.A. & Deeks, E.D. 17 α-Hydroxyprogesterone Caproate (Makena®). Clin Drug Investig 33, 223–227 (2013). https://doi.org/10.1007/s40261-013-0060-6

Download citation

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s40261-013-0060-6

Keywords

Navigation