Resources for healthcare providers

The resources section is designed to provide you with helpful information, forms, and quick links to Makena® (hydroxyprogesterone caproate injection) videos that you will find throughout the website, all in one convenient place. You will also find useful links to clinical research and other websites that pertain to preterm labor and preterm birth.

For medical questions about Makena or to report an adverse event or product complaint:

Call Medical Affairs, Monday–Friday, 8 AM – 5 PM (ET)

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to your personalized toolkit

Informational
Resources
Makena Care
Connection®
Purchasing/Stocking/
Billing

Informational resources

Meis et al clinical trial
Meis PJ, et al, 2003

Clinical trial that served as the basis for FDA approval of Makena.

View Study
FDA statement July 2014
FDA statements on Hydroxyprogesterone Caproate (17P).

July 2014

View Statement
SMFM clinical guideline
Society for Maternal-Fetal Medicine (SMFM) clinical guideline

Outlines the role of Makena in reducing the risk of preterm birth in the indicated patient population.

View Study
FDA statement July 2012
FDA statements on Hydroxyprogesterone Caproate (17P).

July 2012

View Statement
Dr. Gilbert webcast
Clinical presentation by Dr. William Gilbert

Provides information on reducing the risk of recurrent preterm birth in certain at-risk women.

Watch Presentation
Centers for Medicare statement
Centers for Medicare & Medicaid Services (CMS) statement issued June 15, 2012.
View PDF
Potential Risks of Pharmacy compounding
Gudeman J, Jozwiakowski M, Chollet J, Randell M. Potential risks of pharmacy compounding. Drugs R D. 2013;13:1-8.

View Study
NCMHEP initiative
National Child & Maternal Health Education Program’s Initiative to Reduce Elective Deliveries Before 39 Weeks of Pregnancy
View PDF
Sarah Sellers primer
Sellers S, Utian WH. Pharmacy compounding primer for physicians. Drugs. 2012;72:2043-2050.
View Study
ACOG District II Preventing Preterm Birth education video
ACOG District II Preventing Preterm Birth Education Video Series

Provides an overview of preterm birth and treatment strategies to help reduce the risk of occurrence.

Watch Video

Makena Care Connection®

Makena Prescription Form
Makena Prescription Form

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

Get started at iAssist.com Download
Makena Care Connection Brochure with Patient Tear Sheets

A downloadable brochure describing the personalized support offered by Makena Care Connection, includes: Rx support, financial assistance, home injections, and education & adherence.

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Makena Care Connection Overview

A downloadable brochure providing an overview of the personalized support offered by Makena Care Connection.

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Makena Authorization for Release of Personal Health Information Form
Makena Authorization for Release of Personal Health Information Form


The HIPAA release authorization 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 of the Makena Prescription Form.

If the patient is not present at the time the prescription is completed, she can complete this form separately and the office or the patient can fax it to Makena Care Connection. Patient authorization can also be secured via eMakena. Visit iAssist to learn more.

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Purchasing/Stocking/Billing

Makena Patient Information and Coding Worksheet
Patient Information and Coding Worksheet

Download a worksheet designed to help track verified codes and file with the patient’s chart for quick and easy reference.

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Makena Returns Policy
Makena Returns Policy

Provides details on the AMAG Pharmaceuticals return policy for Makena when purchased through a specialty distributor.

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Makena Billing Guide
Makena Billing Guide

Contains billing and coding information to be used when completing the CMS 1500 claim form in addition to FAQs about insurance coverage.

Download
Makena Returns Request Form
Makena Returns Request Form

Form must be filled out and faxed to AMAG Pharmaceuticals in order to initiate the return process.

Download
Makena Prior Authorization Support Tool
Makena Prior Authorization Support Tool

View examples of statements that you may consider using when contacting insurance plans should you encounter a denial of coverage for Makena, or for prior authorization before a plan will cover Makena. Please use your professional judgment in regard to your specific patient when contacting plans.

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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.

Important Safety Information and Indication
INDICATION
IMPORTANT SAFETY INFORMATION
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