Resources

Resources for healthcare providers

The resource section is designed to provide you with helpful information, such as forms, clinical resources, videos for you and to share with your patients, all in one convenient place.

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

Contact Medical Affairs

Select a topic below to learn more

Clinical Resources

Meis PJ, et al, 2003

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

View study

Society for Maternal-Fetal Medicine (SMFM) Clinical Guideline

Outlines the role of progestogens to reduce the risk of preterm birth

View study

2017 SMFM Statement Choice of Progestogen

Reaffirms the choice of injectable HPC for certain at-risk women

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Bioavailability of Makena Subcutaneous Auto-Injector and Makena Intramuscular Injection Study

Clinical study that showed comparable bioavailability between Makena Auto-Injector dosed subcutaneously (1.1 mL; back of upper arm) and Makena dosed IM (1 mL; gluteus maximus) in a single-dose, open-label, randomized, parallel design bioavailability study in 120 healthy post-menopausal women1

View study

Resources for Your Patients

Healthcare Provider Discussion Guide

Healthcare Provider Discussion Guide

A printable discussion guide that can assist patients in their discussion with a healthcare provider about Makena and reducing the risk of preterm birth.

Healthcare Provider Discussion Guide

Makena Patient Education Brochure

Makena Patient Education Brochure

A downloadable brochure that provides educational information on preterm birth, risk factors, and how Makena can help reduce the risk of preterm birth.

Prescribing Resources

Makena Prescription Form

Downloadable form used to prescribe Makena. Information may be typed or written and submitted via fax to Makena Care Connection®. If you prefer your patients receive branded Makena and support from Makena Care Connection, it is recommended that you complete the Dispense As Written/Do Not Substitute line per your state regulations, located in Step 6 of the Makena Prescription Form.
Download

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.

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. Patients can complete the form electronically by visiting www.getmakenasupport.com.

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

Download in EnglishDownload in Spanish

 

Purchasing and Stocking

Makena may be purchased from specialty distributors or direct from a wholesaler and stocked for use as needed

  • Purchase directly from one of the following specialty distributors: Please call the specialty distributor for specific ordering instructions
  • Order via drop shipment from your preferred wholesaler: Please contact them directly for more information
  • Volume discount: Offices purchasing Makena may receive a volume discount from their specialty distributor
  • Makena returns policy: Under certain circumstances, Makena can be returned for credit. Please see our returns policy to see if your order qualifies.
    Download

Billing and coding

Below is billing and coding information that is required for Makena when completing the CMS 1500 claim form. Please note, code and claim information requirements may vary by insurer and benefit plan. Patient coverage and codes should be verified before purchasing and billing.

Code Type Description Code
Code Type: NDC1,*
NDC1,*

Makena® (hydroxyprogesterone caproate injection)

1.1 mL=275 mg per dose

Subcutaneous auto-injector
64011-301-03 OR 64011-0301-03
Code Type: Administration procedures: CPT5,†
Administration procedures:
CPT5,†
Injection code
(therapeutic, prophylactic, or diagnostic
injection)
96372
-OR- -OR-
Office/outpatient visit codes (new patient;
length of visit (established patient; length of visit)
99201, 99202, 99203, 99204, 99205, 99211, 99212, 99213, 99214
Code Type: ICD-10-CM6,‡
ICD-10-CM6,‡ Supervision of pregnancy with history of preterm labor, second trimester O09.212
Supervision of pregnancy with history of preterm labor, third trimester O09.213
Supervision of pregnancy with history of preterm labor, unspecified trimester O09.219

Note: The ICD-10 codes start with an uppercase “O,” which is followed by a
zero.

Code Type: Drug: HCPCS7,8,§
Drug: HCPCS7,8,§ Makena J code J1726 (1 billable unit=10 mg)
Some payers require the use of J3490.
Please check with the payer.

*National Drug Code (payer requirements regarding 10-digit and 11-digit NDC may vary); Current Procedural Terminology;

International Classification of Diseases– 10th Revision –Clinical Modification; §Healthcare Common Procedure Coding System.

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.

Download

Makena Billing Guide

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

Download

Videos

The Makena video gallery has resources for healthcare providers and for use with their patients, and covers a variety of topics, including risks associated with preterm birth, treatment of Makena for patients who are at-risk for recurrent preterm birth, guidance for HCPs on how to administer Makena, patient experiences, and more in-depth information about personalized support provided by Makena Care Connection.

Makena Auto-Injector is HCP administered. 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

(8:57)

Hear about financial assistance offered to Nalleli

(7:28)

Makena Care Connection helped Shanise with adherence

(6:27)

Lyn's story of preterm birth risk

(7:41)

See why Makena was important to Kate

(8:11)

Sarah received personalized support for Makena treatment

(6:25)

Understand the risk factors for preterm birth

(6:56)

An Ob/Gyn discusses Makena

(5:53)

Makena Auto-Injector is HCP administered. 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

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IMPORTANT SAFETY INFORMATION

Indication

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

Important Safety Information for Makena
(hydroxyprogesterone caproate injection)

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