Frequently asked questions about purchasing and stocking Makena® (hydroxyprogesterone caproate injection)

How is Makena ordered?

Makena can be ordered through either of the specialty distributors listed below. Please call for specific ordering instructions.

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.

What are the payment terms?

When Makena is ordered—from CuraScript, Inc. or TheraCom—the payment terms allow 90 days to pay for the product.

What is the return policy?

Under certain circumstances, Makena may be returned for credit when purchased through CuraScript, Inc., TheraCom, or via drop shipment. The policy has certain limitations and applies to opened, partially used vials with expired doses that are not billable. Please call the Makena Care Connection^® to obtain the Return Request Form and next steps.*

*	Product that is returned without a completed and approved Return Request Form will be destroyed without credit.

Click here for the Makena Return Policy.

The storage guidelines state that doses need to be used within 5 weeks after
the first use. Unused, expired product can be returned for credit.

Is 340B/PHS pricing available?

Yes. 340B-eligible hospitals and other eligible facilities can obtain Makena through CuraScript, Inc. or TheraCom with 90-day payment terms.

Is Makena available at the list price per vial or is it priced higher due to distributor markups?

Makena is purchased at the product acquisition price (ie, list price/WAC, or 340B pricing for eligible hospitals) with 90-day payment terms. There are no distributor markups when Makena is purchased through CuraScript, Inc. or TheraCom.

Are drop shipments available?

Yes. Drop shipments from wholesalers are available. Drop shipment capabilities must be established between the wholesaler and the specialty distributor (CuraScript, Inc. or TheraCom). Payment terms are governed by the Customer/Wholesaler agreement, independent of the Makena specialty distributors.

What codes are needed to submit claims for Makena?

Refer to the billing and coding procedures. When verifying a patient’s insurance benefits, confirm the codes required by the payer, as the required codes may vary.

Confirm patient benefits and the correct payer-specific codes for each
patient to help prevent errors and ensure timely reimbursement.

If Makena is purchased and stocked, do patients still have access to the Makena Patient Assistance Program?

Yes. If a patient cannot afford her co-pay, she should contact the Makena Care Connection (1-800-847-3418) directly to assess her eligibility. The patient should let the Care Coordinator at the Makena Care Connection know that she is receiving Makena and is in need of co-pay assistance.

How is Makena insurance coverage determined for a specific patient?

If Makena is ordered and stocked in the office, contact the individual’s payer/insurer and conduct the benefits investigation. If the prescription is processed via specialty pharmacy, the patient’s benefits will be investigated by the Makena Care Connection or the specialty pharmacy. The prescription will be processed accordingly.

What happens if a patient does not have insurance?

If the patient is uninsured, a Referral/Prescription Form should be submitted to the Makena Care Connection with the “Patient does not have insurance” box checked in Step 1. She will immediately be assessed for participation in the Makena Patient Assistance Program.

For additional questions, please contact the Makena Care Connection
at 1-800-847-3418.

Adobe^® Reader^® is required to view PDF files.
If you do not have it installed, download it free.

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%)
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.