Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medication.

How should I receive Makena?

Makena comes in ready-to-use vials. There are 5 doses of medicine in each vial. Your healthcare professional should give you only one dose (1 mL) of Makena as prescribed each week.

Makena should be used within 5 weeks after the first use.

It is very important that you do not miss a dose of Makena and that you continue to receive the medicine once a week. If you miss a dose, talk to your healthcare provider for specific directions on how to get back on schedule.

What are the possible side effects of Makena?

Makena may cause serious side effects, including:

The most common side effects of Makena include:

Call your healthcare provider if you have the following at your injection site:

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Makena. For more information, ask your healthcare provider or pharmacist.

In a clinical study, certain complications or events associated with pregnancy occurred more often in women who received Makena compared to women who did not receive Makena, including:

Call your healthcare provider for medical advice about side effects or pregnancy complications. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Makena?

General information about the safe and effective use of Makena.

Medicines are sometimes prescribed for purposes other than those mentioned in the Patient Information Leaflets. Do not take Makena for conditions for which it was not prescribed. Do not give Makena to other people, even if they have the same condition you have. It may harm them.

This leaflet summarizes the most important information about Makena. If you would like more information, talk with your healthcare provider. You can ask for information about Makena that is written for healthcare professionals.

For more information, go to www.makena.com or call Ther-Rx Corporation Customer Service at the toll free number 1-877-567-7676.

To refill a prescription or to check on prescription status, call the Makena Care Connection at the toll free number 1-800-847-3418.

What are the ingredients in Makena?

Active ingredient: hydroxyprogesterone caproate

Inactive ingredients: castor oil, benzyl benzoate, and benzyl alcohol (a preservative)

Manufactured by:Baxter Pharmaceutical Solutions LLCBloomington, IN 47403

Marketed by:Ther-Rx CorporationSt. Louis, MO 63044

P10059-13-1214-3032/2011
PRINCIPAL DISPLAY PANEL

NDC 64011-243-01

Makena hydroxyprogesterone caproate injection

1250 mg/5 mL(250 mg/mL)

FOR INTRAMUSCULAR USE

5 mL multidose vialRx ONLY
Manufacturer
Ther-Rx Corporation

Active Ingredients
Source
U.S. National Library of Medicine
DailyMed
Last Updated: 2nd of March 2011