For US Healthcare Providers Only

For US Healthcare Providers Only

Contact Us

AMAG is a pharmaceutical company focused on bringing innovative products to patients with unmet medical needs, many of which are related to complex yet under-treated health conditions. For more information about other AMAG Pharmaceuticals products, please contact Medical Affairs at 1-877-411-2510, Monday−Friday, 9am‑5pm (ET).

You may report an adverse event related to AMAG Pharmaceuticals’ products by calling 1-877-411-2510 or emailing medinfoUS@covispharma.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.

If you are enrolled to receive support through Makena Care Connection®, please contact us at 1-800-847-3418, or write to us at info@makenacareconnection.com.

http://www.amagpharma.com/

1100 Winter Street
Suite 3000
Waltham, MA 02451
www.amagpharma.com

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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:

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You are now leaving makenahcp.com. AMAG Pharmaceuticals is not responsible for the information contained in any of the linked third-party sites. Please review the site's Privacy Policy and Terms of Use, as AMAG's policies do not apply to third-party sites.

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On April 6, 2023, the U.S. Food and Drug Administration (FDA) issued a final decision ordering the withdrawal of the approval of Makena®. FDA has stated that it recognizes that a limited supply of these drugs has already been distributed, including to physicians’ offices and pharmacies. FDA acknowledges that some health care providers might continue to prescribe or administer that limited remaining supply to their patients. However, we recommend health care practitioners consider FDA’s conclusions.

If you have questions about the status of your prescription, or would like to talk with a Care Manager, please call 1-800-847-3418, Monday–Friday from 8:00 AM–5:00PM EST.