Makenna Reise

Makenna Reise

Makenna Reise-Tiny Makenna Takes It-17-06-20

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Prescribing Information
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Makena should not be used in women with any of the following conditions: blood clots or other blood clotting problems, breast cancer or other hormone-sensitive cancers, or history of these conditions; unusual vaginal bleeding not related to your current pregnancy, yellowing of the skin due to liver problems during pregnancy, liver problems, including liver tumors, or uncontrolled high blood pressure.
Before you receive Makena, tell your healthcare provider if you have an allergy to hydroxyprogesterone caproate, castor oil, or any of the other ingredients in Makena; diabetes or prediabetes, epilepsy, migraine headaches, asthma, heart problems, kidney problems, depression, or high blood pressure.
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.
In a clinical study, certain complications or events associated with pregnancy occurred more often in women who received Makena. These included miscarriage (pregnancy loss before 20 weeks of pregnancy), stillbirth (fetal death occurring during or after the 20th week of pregnancy), hospital admission for preterm labor, preeclampsia (high blood pressure and too much protein in your urine), gestational hypertension (high blood pressure caused by pregnancy), gestational diabetes, and oligohydramnios (low amniotic fluid levels).
Makena may cause serious side effects including blood clots, allergic reactions, depression, and yellowing of your skin and the whites of your eyes. The most common side effects of Makena include injection site reactions (pain, swelling, itching, bruising, or a hard bump), hives, itching, nausea, and diarrhea.
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 .
References: 1. March of Dimes. Long-term health effects of premature birth. https://www.marchofdimes.org/baby/long-term-health-effects-of-premature-birth.aspx. October 2013. Accessed January 22, 2019. 2. American College of Obstetricians and Gynecologists. Committee opinion no. 579: definition of term pregnancy. Obstet Gynecol. 2013;122:1139-1140. 3. American College of Obstetricians and Gynecologists. Preterm (premature) labor and birth. https://www.acog.org/-/media/For-Patients/faq087.pdf. November 2016. Accessed January 22, 2019. 4. March of Dimes. Why at least 39 weeks is best for your baby. https://www.marchofdimes.org/pregnancy/why-at-least-39-weeks-is-best-for-your-baby.aspxa. October 2018. Accessed January 22, 2019. 5. March of Dimes. Preterm labor and preterm birth. https://www.marchofdimes.org/pregnancy/preterm-labor-and-premature-birth.aspx. October 2014. Accessed January 22, 2019. 6. March of Dimes. Fighting premature birth: the prematurity campaign. https://www.marchofdimes.org/research/prematurity-research.aspx. Accessed January 22, 2019. 7. March of Dimes. 2018 premature birth report card – United States. https://www.marchofdimes.org/materials/PrematureBirthReportCard-United%20States-2018.pdf. November 2018. Accessed January 22, 2019. 8. Makena ® (hydroxyprogesterone caproate injection) prescribing information, AMAG Pharmaceuticals, 2018. 9. 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.
Marketed by AMAG Pharmaceuticals, Inc. Waltham, MA 02451
©2019 AMAG Pharmaceuticals, Inc. All rights reserved. AMAG Pharmaceuticals, Makena, Makena Care Connection, and the logo designs presented in this material are trademarks or registered trademarks of AMAG Pharmaceuticals, Inc. or its subsidiaries. PP-MKN-US-00558 05/19
©2021 Covis Pharma GmbH
Makena is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history
Makena should not be used in women with any of the following:
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You are now leaving makena.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.
There may be some confusion about the current status of Makena. Makena remains available to patients and prescribers. If you have questions or concerns about receiving your therapy as prescribed, consult your healthcare provider.
If you have questions about the status of your prescription or would like to talk with a Care Manager about participation in our patient support program, please call 1-800-847-3418, Monday–Friday from 8:00 AM–8:00 PM ET.
©2020 AMAG Pharmaceuticals, Inc. All rights reserved. PP-MKN-US-00648 10/20

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