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Important Safety Information for Makena (hydroxyprogesterone caproate injection)

  • Do not use Makena in women with any of the following

Indication

Makena is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of

INDICATION

Makena 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

IMPORTANT SAFETY INFORMATION

  • Do not use Makena in women with any of the following conditions:

Makena Subcutaneous Auto‑Injector

Same Makena. Same support. Innovative delivery device.

The Makena you know—ready to go

Designed for ease of use, the FDA‑approved Makena subcutaneous auto‑injector is1:

  • Pre‑filled auto-injector that is ready to use out of the box 
  • Administered in ~15 seconds
  • Shorter, thinner, nonvisible needle 
  • Administered in the back of the upper arm—no need for patients to disrobe
  • Protective needle guard to help minimize accidental needle‑sticks 
  • Appointment flexibility—no need for private exam rooms
Makena1
Active ingredient Hydroxyprogesterone caproate
Concentration 250 mg/mL
Dose 275 mg (1.1 mL) 250 mg (1 mL)
Delivery Single-use, pre-filled, disposable auto-injector Traditional needle and syringe
Administration Subcutaneous (SQ) via healthcare provider Intramuscular (IM) via healthcare provider
Injection location
Subcutaneous auto-injector icon
Back of upper arm
Intramuscular injection option for Makena
Upper-outer quadrant of the gluteus maximus
Injection duration ~15 seconds One minute or longer
Needle size Fine 27-gauge, 0.5" SQ needle 21-gauge, 1.5" IM needle
Makena1
Subcutaneous
Intramuscular
Active ingredient Hydroxyprogesterone caproate
Concentration 250 mg/mL
Dose 275 mg (1.1 mL)
Delivery Single-use, pre-filled, disposable auto-injector
Administration Subcutaneous (SQ) via healthcare provider
Injection location Back of upper arm
Injection duration ~15 seconds
Needle size Fine 27-gauge, 0.5" SQ needle

Establishing best practices

Lyn talks about her experience with preterm birth

Proper injection technique for Makena subcutaneous auto‑injector. This easy‑to‑follow instructional video reviews the proper technique for administering Makena for subcutaneous use. Please see Instructions for Use before administering Makena using the subcutaneous auto‑injector.

Watch video (8:57)

Personalized Patient Support. Healthcare Professional Resources. More Than Makena. Learn More >

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

Indication

Makena 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.

Indication

Makena 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%)
  • In a study where the Makena intramuscular injection was compared with placebo, the most common adverse reactions reported with Makena intramuscular injection (reported incidence in ≥2% of subjects and higher than in the control group) were: injection site reactions (pain [35%], swelling [17%], pruritus [6%], nodule [5%]), urticaria (12%), pruritus (8%), nausea (6%), and diarrhea (2%)
  • In studies where the Makena subcutaneous injection using auto-injector was compared with Makena intramuscular injection, the most common adverse reaction reported with Makena Auto-Injector use (and higher than with Makena intramuscular injection) was injection site pain (10% in one study and 34% in another)

You may report an adverse event related to AMAG Pharmaceuticals' products by calling 1-877-411-2510 or emailing amag@druginfo.com. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly at fda.gov/medwatch or call 1-800-FDA-1088.

References: 1. Makena® (hydroxyprogesterone caproate injection) prescribing information, AMAG Pharmaceuticals, 2018. 2. 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(5):376-386. 3. Society for Maternal-Fetal Medicine Publications Committee. The choice of progestogen for the prevention of preterm birth in women with singleton pregnancy and prior preterm birth. Am J Obstet Gynecol. 2017;216(3):B11-B13. 4. 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(4):865-872. 5. American Medical Association. Current Procedural Terminology 2017: Professional Edition. Chicago, IL: American Medical Association; 2016. 6. American Medical Association. ICD-10-CM: The Complete Official Codebook. 2017 ed. Chicago, IL: American Medical Association; 2016. 7. Practice Management Information Corporation. HCPCS: Health Care Procedure Coding System. Los Angeles, CA: Practice Management Information Corporation; 2016. 8. Centers for Medicare and Medicaid Services. US Department of Health and Human Services. Quarterly healthcare common procedure coding system (HCPCS) drug/biological code changes—2017 update. Baltimore, MD: Centers for Medicare and Medicaid Services; 2017. Transmittal 3776.