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
[email protected]
1-877-411-2510 (M-F, 8am-5pm ET)
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
Society for Maternal-Fetal Medicine (SMFM) Clinical Guideline
Outlines the role of progestogens to reduce the risk of preterm birth
2017 SMFM Statement Choice of Progestogen
Reaffirms the choice of injectable HPC for certain at-risk women
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
Blackwell et al, 2019 (PROLONG)
FDA-required confirmatory trial
Medical society statements released following PROLONG
Resources for Your Patients
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.
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.
Makena Auto-Injector Patient eStorybook
Help your patients envision what their journey with Makena Auto-Injector might look like with this illustrated, bilingual (English and Spanish text) downloadable eStorybook. Developed at a 4th grade level for ease of reading, it follows the journey of a mom at risk for recurrent preterm birth as she navigates discussions about treatment options with her doctor, makes the decision to receive Makena injections, and utilizes programs offered at no cost from Makena Care Connection based on her eligibility* and that meet her needs.
*Restrictions apply. Please contact Makena Care Connection for program eligibility details.
Prescribing Resources
Telemedicine Resources
If you are incorporating telemedicine into your practice, you can prescribe Makena Auto-Injector electronically by completing the prescription form available at www.eprescribeMakenaAI.com. Your patients are also able to complete their authorizations (Step 2) by visiting www.GetMakenaSupport.com.
We’ve also created a downloadable Telemedicine Toolkit to support you and your patients that includes prescribing resources and patient education materials.
Download Toolkit
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
- CuraScript, Inc.
1-877-599-7748 - McKesson Plasma and Biologics
1-877-625-2566
- 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 |
|
| 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.
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.
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
Hear about financial assistance offered to Nalleli
Makena Care Connection helped Shanise with adherence
Lyn's story of preterm birth risk
See why Makena was important to Kate
Sarah received personalized support for Makena treatment
Understand the risk factors for preterm birth
An Ob/Gyn discusses Makena
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
