Makena injection reduces risk of preterm labor

Makena helps give baby more time to develop1

  • Benefits of FDA-Approved Therapy Read more 
  • Society for Maternal-Fetal Medicine (SMFM) Clinical Guideline Read more 
  • Financial Assistance Read more 

Learn how the Makena Care Connection® facilitates the prescription process. Click here

Makena helps reduce the risk of recurrent preterm birth

Makena efficacy vs. placebo study

Makena efficacy vs. placebo study

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

The SMFM Clinical Guideline recommends IM HPC weekly injections to reduce the risk of preterm birth for clinically indicated patients2

  • Adapted from the SMFM Clinical Guideline published in May 2012 in the American Journal of Obstetrics & Gynecology2
  • Emphasis added to highlight patient identification and initiation and duration of therapy

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

SMFM Clinical Guidelines algorithm

SMFM Clinical Guidelines algorithm

Makena meets the FDA's stringent quality standards

FDA-approved products, like Makena, provide a greater assurance of safety, effectiveness, and quality than compounded products3,4

  • Makena–a sterile injectable–must meet FDA quality standards (identity, potency, purity, and sterility) before it can be released for patient use3
  • FDA-approved Makena is available in both a single-dose, preservative-free vial and a multi-dose vial (5 weekly injections)

FDA-quality standard differences between Makena and compounded 17P

FDA-quality standard differences between Makena and compounded 17P


GMPs = Good Manufacturing Practices.

 

Watch a video on the differences between brand or generic medications and compounded drugs.

Are compounded products and generic medications the same?

Jennifer Gudeman, PharmD, Executive Director of Medical Affairs, 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 20146,7:

  • “If there is an FDA-approved drug that is medically appropriate for a patient, the FDA-approved product should be prescribed and used.”
  • Compounded drugs should be reserved for patients who have a medical necessity that cannot be met by the FDA-approved product

Understand why the FDA recommends FDA-approved drugs when medically appropriate

Watch the Jennifer Gudeman benefits of FDA approval video

Understand why the FDA recommends FDA-approved drugs when medically appropriate

Jennifer Gudeman, PharmD, Executive Director of Medical Affairs, 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

Watch the Jennifer Gudeman FDA statement on hydroxyprogesterone caproate video

The benefits of FDA approval

Jennifer Gudeman, PharmD, Executive Director of Medical Affairs, 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.

Makena patient and her baby
Watch Heather's video

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.

A known safety and tolerability profile

More information on the safety of Makena for mothers

Adverse reactions occurring in ≥2% of Makena-treated subjects and at a higher rate than control subjects1

Makena adverse events table

Makena adverse events table

  • The most common adverse events were local injection site reactions1
  • Incidence of adverse events observed with Makena was similar to placebo, with the exception of injection site swelling1
  • Certain pregnancy-related fetal and maternal complications or events were numerically increased in Makena-treated subjects as compared to placebo subjects, including miscarriage (2.4% vs. 0%) and stillbirth (2% vs. 1.3%), admission for preterm labor (16% vs. 13.8%), preeclampsia or gestational hypertension (8.8% vs. 4.6%), gestational diabetes (5.6% vs. 4.6%), and oligohydramnios (3.6% vs. 1.3%)1

 

Makena potential side effects video

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.

More information on the safety of Makena for baby

Makena is classified Pregnancy Category B

  • Studies in pregnant women have shown that Makena does not increase the risk of abnormalities when administered during the second and third trimesters of pregnancy1
  • There are no adequate and well-controlled studies of Makena use in women during the first trimester of pregnancy
More information on the long-term safety of Makena for young children
  • A follow-up study of Makena in pregnant women assessed children at a mean of 4 years (ages 2–5 years) using the Ages & Stages Questionnaire, which evaluates child development by various physical, mental, and social measures8
  • The proportion of children whose scores met the screening threshold for developmental delay in each developmental domain was similar for each treatment group8

Dosing and administration for Makena

Indication

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.

Important safety information for Makena (hydroxyprogesterone caproate injection)
  • Do not use Makena in women with any of the following conditions:
    • Current or history of thrombosis or thromboembolic disorders
    • Known or suspected breast cancer, other hormone-sensitive cancer or history of these conditions
    • Undiagnosed abnormal vaginal bleeding unrelated to pregnancy
    • Cholestatic jaundice of pregnancy
    • Liver tumors, benign or malignant, or active liver disease
    • Uncontrolled hypertension
  • Makena should be discontinued if thrombosis or thromboembolism occurs
  • Allergic reactions, including urticaria, pruritus and angioedema have been reported with use of Makena or with other products containing castor oil
  • Women receiving Makena should be monitored if they:
    • Are prediabetic or diabetic
    • Have conditions that may be affected by fluid retention, such as preeclampsia, epilepsy, cardiac or renal dysfunction
    • Have a history of clinical depression; Makena should be discontinued if depression recurs
    • Develop jaundice; consider whether benefit of use warrants continuation
    • Develop hypertension
  • Certain pregnancy-related fetal and maternal complications or events were numerically increased in Makena-treated subjects as compared to placebo subjects, including miscarriage (2.4% vs. 0%) and stillbirth (2% vs. 1.3%), admission for preterm labor (16% vs. 13.8%), preeclampsia or gestational hypertension (8.8% vs. 4.6%), gestational diabetes (5.6% vs. 4.6%), and oligohydramnios (3.6% vs. 1.3%)
  • The most common adverse reactions reported in ≥2% of subjects and at a higher rate in the Makena group than in the control group were injection site reactions (pain [35% vs. 33%], swelling [17% vs. 8%], pruritus [6% vs. 3%], and nodule [5% vs. 2%]), urticaria (12% vs. 11%), pruritus (8% vs. 6%), nausea (6% vs. 5%), and diarrhea (2% vs. 1%)

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. US Food and Drug Administration. Updated FDA statement on compounded versions of hydroxyprogesterone caproate (the active ingredient in Makena). http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm308546.htm. August 3, 2012. Accessed May 5, 2016. 4. US Food and Drug Administration. FDA's drug review process. http://www.fda.gov/Drugs/ResourcesForYou/Consumers/ucm289601.htm. August 24, 2015. Accessed May 5, 2016. 5. Sellers S, Utian WH. Pharmacy compounding primer for physicians: prescriber beware. Drugs. 2012;72:2043-2050. 6. US Food and Drug Administration. Questions and answers on updated FDA statement on compounded versions of hydroxyprogesterone caproate (the active ingredient in Makena). http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm310215.htm. June 29, 2012. Accessed May 5, 2016. 7. US Food and Drug Administration. Hydroxyprogesterone caproate (17P). http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/PharmacyCompounding/ucm402614.htm. December 9, 2014. Accessed May 5, 2016. 8. Northen AT, Norman GS, Anderson K, et al. Follow-up of children exposed in utero to 17 α-hydroxyprogesterone caproate compared with placebo. Obstet Gynecol. 2007;110:865-872.

Important safety information and Indication
INDICATION
IMPORTANT SAFETY INFORMATION
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