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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:

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: Click here for billing resources. Please call the specialty distributor for specific ordering instructions

CuraScript, Inc. 
1-877-599-7748

McKesson Plasma and Biologics 
1-877-625-2566

TheraCom 
1-888-214-8313

CuraScript, Inc. 
1-877-599-7748

McKesson Plasma and Biologics 
1-877-625-2566

TheraCom 
1-888-214-8313

  • Order via drop shipment from your preferred wholesaler: Please contact them directly for more information

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

Makena Care Connection® offers personalized support that helps verify insurance and obtain prior authorizations (when applicable), addresses your patients’ financial concerns, and encourages adherence to therapy. Learn More >

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
NDC1,*

Makena® (hydroxyprogesterone caproate injection)

1.1 mL=275 mg per dose

Subcutaneous auto-injector
64011-301-03 OR 64011-0301-03

-OR-

-OR-

Makena® (hydroxyprogesterone caproate injection)

1 mL=250 mg per dose

Single-dose, preservative-free vial
64011-247-02 OR 64011-0247-02

Multi-dose vial (5 weekly injections)
64011-243-01 OR 64011-0243-01

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

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.

Drug: HCPCS7,8,§ Makena J code J1726 (1 billable unit=10 mg)
Previously J1725 or Q9986
Description Code
Code Type: NDC1,*

Makena® (hydroxyprogesterone caproate injection)

1.1 mL=275 mg per dose

-OR-

Makena® (hydroxyprogesterone caproate injection)

1 mL=250 mg per dose

Subcutaneous auto-injector
64011-301-03 OR 64011-0301-03

-OR-

Single-dose, preservative-free vial
64011-247-02 OR 64011-0247-02

Multi-dose vial (5 weekly injections)
64011-243-01 OR 64011-0243-01

Code Type: Administration procedures: CPT5,†

Injection code
(therapeutic, prophylactic, or diagnostic injection)

-OR-

Office/outpatient visit codes (new patient; length of visit) (established patient; length of visit)

96372

-OR-

99201, 99202, 99203, 99204, 99205, 99211, 99212, 99213, 99214

Code Type: ICD-10-CM6,‡
Supervision of pregnancy with history of preterm labor, second trimester

O09.212

O09.213

O09.219

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

Code Type: Drug: HCPCS7,8,§
Makena J code J1726 (1 billable unit=10 mg)
Previously J1725 or Q9986

*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

Helps you keep track of your patients’ insurance information and codes needed for reimbursement for Makena.

Makena Billing Guide

Use for assistance when completing the CMS 1500 claim form.

Volume discounts and returns

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.

Purchasing and stocking FAQs

Makena can be ordered from specialty distributors. Makena is also available via drop shipment through your preferred wholesaler. If you prefer to receive your order via drop shipment, please contact your wholesaler directly for more information.

Obtain the correct claim requirements in writing from the patient’s insurer before submitting a claim for each weekly dose of Makena.

Under certain circumstances, Makena can be returned for credit. Please see our returns policy to see if your order qualifies.

Makena Returns Policy

Yes. 340B-eligible hospitals and other eligible facilities can obtain Makena through a specialty distributor. Please contact us at 1-800-847-3418 (M-F, 8am-8pm ET) or by email at info@makenacareconnection.com for further details.

Yes. Drop shipments from wholesalers are available. Drop shipment capabilities must be established between the wholesaler and the specialty distributor. Payment terms are governed by the customer/wholesaler agreement, independent of the Makena specialty distributors.

Refer to the billing and coding proceduresConfirm patient benefits and the correct payer-specific codes for each patient to help prevent errors and ensure timely reimbursement.

Yes. If a patient cannot afford her out-of-pocket expense, she should contact Makena Care Connection directly to assess her eligibility. The patient should let Makena Care Connection know she is receiving Makena and is in need of assistance (applies to copays, coinsurance, and deductibles).

We are committed to helping ensure cost is not a barrier to acceptance of therapy. If the patient is uninsured, a Makena Prescription Form should be submitted to Makena Care Connection with the “Patient does not have insurance” box checked in Step 1. Makena Care Connection will determine if she is eligible for a free course of therapy.

If Makena is ordered and stocked in the office, contact the individual’s payer/insurer and inquire about the patient’s benefits. This coding worksheet will assist in verifying the correct billing codes. Reach out to Makena Care Connection with any non-medical questions and to get help determining patient benefits.

Have Questions? Connect with us

Call Makena Care Connection1-800-847-3418 (M-F, 8am-8pm ET)

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.