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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 Care Connection®

Personalized patient support. Healthcare professional resources. More than Makena.

Makena Care Connection offers support that helps make filling prescriptions easier, addresses your patients’ financial concerns, and encourages adherence to therapy

When you choose Makena for your patients, they get more than the medicine, they get one centralized resource that’s designed specifically to assist your patients throughout their Makena experience. Your patients won’t just get Makena to help reduce the risk of recurrent preterm birth, but also the support when they need it.

Same Makena. Same Support

Together we can work toward one goal—helping your patients achieve a full-term pregnancy. To ensure this goal is met, a dedicated Makena Care Connection Care Manager will be available, based on your practice and your patients’ needs, to provide tailored support from the moment you prescribe Makena to the delivery of your patient’s baby.

Select a topic below to learn more

Have Questions? Connect with us

We speak your patient’s language

Makena Care Connection offers translation services for moms in more than 240 languages.

Rx support

Each woman is unique, and so are her insurance benefits. Because timely access is so important to your practice, we’ll aid in processing prescriptions, verifying insurance coverage, and obtaining prior authorizations (when applicable) to help your patients get their Makena prescriptions on time. 

Makena Prescription Form

Downloadable form used to prescribe Makena. Information may be typed or written and submitted via fax to Makena Care Connection.

Makena Authorization for Release of Personal Health Information Form (HIPAA form)

The HIPAA release form allows Makena Care Connection to communicate with the healthcare provider, insurer, and specialty pharmacy on the patient’s behalf.

Note: this form does not need to be completed if the patient has already signed Step 2 (Patient Authorization) of the Makena Prescription Form.

Lyn talks about her experience with preterm birth

“Having the personalized support from the Makena Care Connection helped me feel like I had someone there to support me throughout my experience.”
—Sarah, mom of a 34-week preemie

Watch video (6:25)

Financial assistance

AMAG Pharmaceuticals is committed to ensuring affordable access to Makena. We proactively screen and offer eligible patients* financial assistance with no upper-level income caps.

Commercially insured moms whose health plans cover Makena Helps lower out-of-pocket costs associated with copays, coinsurance, and deductibles*
Uninsured and commercially underinsured moms Offers a free course of therapy*

*Each patient’s eligibility is evaluated on an individual basis. To be eligible, patients must meet the FDA-approved indication (pregnant with a single baby with a history of singleton spontaneous preterm birth <37 weeks).1 In compliance with federal regulations, patients insured by a government-funded program (Medicaid, TRICARE, etc) are not eligible. There are no upper-level income caps.

Lyn talks about her experience with preterm birth

“I was so happy that I was approved for financial assistance. I feel very thankful that my family and I had this opportunity with the Makena Care Connection.”

—Nalleli, mom of a 36-week preemie
Watch video (7:28)

Home injections by healthcare professionals

We can help coordinate Makena injections through a home healthcare organization. Once approved by insurance, moms who are prescribed Makena can choose to receive their injections by a healthcare professional in the comfort of their homes or another location that’s convenient for them. 

Benefits may include:

  • Supporting adherence with weekly injections (every 7 days)
  • Addressing logistical barriers for patients
  • Simplifying scheduling challenges for your office

Education & adherence

We understand that moms receiving Makena injections may need some encouragement and support in order to stick to their weekly injection schedule, and we want to help. This free service offers educational and adherence support to encourage women to make Makena part of their pregnancy and take an active role in their health.

A level of personalized support you and your patients can expect: 

  • Injection reminders that support weekly treatment
  • Educational materials to address topics during pregnancy
  • Encouragement so patients can take an active role in their health
Lyn talks about her experience with preterm birth

“Knowing my Care Manager was just a phone call away gave me peace of mind. I appreciated feeling like I had someone supporting me every step of the way.”

—Shanise, mom of a 22-week preemie
Watch video (6:27)

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.