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Results from a pivotal study conducted by the NIH. This double-blind, placebo-controlled trial evaluated 463 women with a history of spontaneous preterm delivery (singleton). Weekly injections of Makena 250 mg or weekly injections of an inert oil placebo were initiated between 16–20 weeks of gestation and continued until the 37th week of gestation or delivery.1
SMFM = Society for Maternal-Fetal Medicine, HPC = hydroxyprogesterone caproate, SPTB = spontaneous preterm birth, TVU = transvaginal ultrasound, CL = cervical length.
FDA-approved products, like Makena, provide a greater assurance of safety, effectiveness, and quality than compounded products4-8
*Applies to compounding facilities not registered as an outsourcing facility with the FDA.
GMPs = Good Manufacturing Practices.
As noted in the 2016 FDA draft guidance on compounded drugs,† using compounded drugs in patients who can take an FDA-approved drug “unnecessarily exposes patients to drug products that have not been shown to be safe and effective”10
†Compounded drugs that are essentially copies of approved drugs under section 503B of the Federal Food, Drug, and Cosmetic Act.
Watch a video on the differences between brand medications and compounded drugs.
Are compounded products and generic medications the same?
Jennifer Gudeman, PharmD, Vice President of Medical Affairs, Maternal Health, describes the differences between FDA-approved drugs (brand and generic) made in accordance with Good Manufacturing Practices (GMPs) and compounded drugs made in a pharmacy.
View the FDA's July 2014 statement on hydroxyprogesterone caproate (17P). Click here
According to a public statement issued by the FDA in June 2012 and reinforced in July 201411,12:
In a recent 2017 FDA Progress Report, the FDA reported8:
Understand why the FDA recommends FDA-approved drugs when medically appropriate
Understand why the FDA recommends FDA-approved drugs when medically appropriate
Jennifer Gudeman, PharmD, Vice President of Medical Affairs, Maternal Health, describes the FDA's statement that FDA-approved medications should be used when medically appropriate rather than compounded formulations, unless there is a specific medical need for the patient.
Help patients understand the benefits of FDA approval
The benefits of FDA approval
Jennifer Gudeman, PharmD, Vice President of Medical Affairs, Maternal Health, discusses the differences between FDA-approved medications and treatments that are compounded at pharmacies, and why the FDA recommends using FDA-approved products when medically appropriate.
Hear why Heather chose an FDA-approved product in her fight against recurrent preterm birth
After giving birth to her daughter, Astrid, 5 weeks early, Heather’s doctor told her she was at risk for another preterm birth. Heather and her healthcare provider talked about Makena® (hydroxyprogesterone caproate injection) as a treatment option to help give her second baby a better chance to have more time to develop.
Adverse reactions occurring in ≥2% of Makena-treated subjects and at a higher rate than control subjects1
Review most common and most serious side effects potentially associated with use of Makena
What are the potential side effects of Makena® (hydroxyprogesterone caproate injection)?
It's understandable that your patients may have a lot of questions about taking a medication while pregnant. Learn more about what your patients can expect when receiving Makena injections so you can weigh the benefits and risks associated with therapy.
Makena is classified Pregnancy Category B
Begin once-weekly injections between weeks 160 and 206 and continue until 37 weeks (last injection as late as week 366) or delivery, whichever occurs first1
Makena is administered by a healthcare provider via intramuscular injection in the upper-outer quadrant of the gluteus maximus1
Makena can be administered:
Establishing best practices: Proper injection technique for Makena
This easy-to-follow instructional video reviews the proper technique for administering Makena. By creating a sense of calm and comfort, and following the steps outlined when administering therapy, you can help make weekly injections a more positive experience.
Home injections by healthcare professionals
We can help coordinate Makena injections through a home healthcare organization. Once approved by insurance, moms prescribed Makena can choose to receive their injections by a healthcare professional in the comfort of their home or another location that‘s convenient for them.
Makena (hydroxyprogesterone caproate injection) is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.
Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.
Please see full Prescribing Information for Makena.
References: 1. Makena® (hydroxyprogesterone caproate injection) prescribing information, AMAG Pharmaceuticals, 2016. 2. Berghella V; for the Society for Maternal-Fetal Medicine Publications Committee. Progesterone and preterm birth prevention: translating clinical trials data into clinical practice. Am J Obstet Gynecol. 2012;206:376-386. 3. SMFM Publications Committee. SMFM Statement: The choice of progestogen for the prevention of preterm birth in women with singleton pregnancy and prior preterm birth. Am J Obstet Gynecol. 2017. doi:10.1016/j.ajog.2017.01.022. 4. US Food and Drug Administration. Updated FDA statement on compounded versions of hydroxyprogesterone caproate (the active ingredient in Makena). https://wayback.archive-it.org/7993/20170112232040/http:/www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm308546.htm. August 3, 2012. Accessed March 30, 2017. 5. US Food and Drug Administration. Letters to stakeholders: dear colleague. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/UCM380597.pdf. January 8, 2014. Accessed December 19, 2016. 6. US Food and Drug Administration. FDA‘s drug review process. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm289601.htm. August 24, 2015. Accessed December 19, 2016. 7. Sellers S, Utian WH. Pharmacy compounding primer for physicians: prescriber beware. Drugs. 2012;72:2043-2050. 8. US Food and Drug Administration. FDA‘s human drug compounding progress report: three years after enactment of the Drug Quality and Security Act. http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm535968.htm. January 2017. Accessed January 30, 2017. 9. US Food and Drug Administration. Orange book: approved drug products with therapeutic equivalence evaluations. http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm. December 2016. Accessed February 8, 2017. 10. US Food and Drug Administration. Compounded drug products that are essentially copies of approved drug products under section 503B of the Federal Food, Drug, and Cosmetic Act. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM510153.pdf. Accessed January 30, 2017. 11. US Food and Drug Administration. Questions and answers on updated FDA statement on compounded versions of hydroxyprogesterone caproate (the active ingredient in Makena). https://wayback.archive‑it.org/7993/20161024031131/http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310215.htm. June 29, 2012. Accessed April 25, 2017. 12. US Food and Drug Administration. Hydroxyprogesterone caproate (17P). http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm402614.htm. December 9, 2014, Accessed May 5, 2016. 13. Northen AT, Norman GS, Anderson K. Follow-up of children exposed in utero to 17 α-hydroxyprogesterone caproate compared with placebo. Obstet Gynecol. 2007;110:865-872.