- "The Company’s recent reorganization demonstrates its focus on maternal health as a core element of its contribution to the women’s healthcare space. The new leadership of the company speaks to the commitment they have towards positively shaping the future of women’s health, particularly in preterm birth."— Roger B. Newman, M.D.Professor and Maas Chair for Reproductive Sciences,
Department of Obstetrics and Gynecology,
Medical University of South Carolina
Resources to help you better serve your patients
Help your patients understand if they are at risk
This video helps your patients understand leading risk factors for preterm birth and why every week counts, and encourages them to talk to you to discuss treatment options.
Patient AssistanCE Programs
Lumara Health™ supports a customer service program called the Makena Care Connection®, which helps facilitate the prescription process and also administers the financial assistance programs for Makena. To learn more about the Makena Care Connection, visit or call 1-800-847-3418 Monday–Friday, 8 am–5 pm (CT). Click here for a fact sheet.
We also provide financial assistance for our other FDA-approved products, including Clindesse® (clindamycin phosphate), Gynazole-1® (Butoconazole Nitrate Vaginal Cream USP, 2%) and Evamist® (estradiol transdermal spray). For more information and to access savings, visit each product’s individual website. Learn More
Established Makena@Home with Walgreens Infusion Services
Through Makena@Home, Lumara Health has established a relationship with Walgreens Infusion Services to provide access to weekly administration of Makena in the home setting when covered by the patient’s insurance. This relationship provides an important option for patients and their healthcare providers through a trusted partner.
To learn more about our portfolio of FDA-approved women’s healthcare products, visit Our Products.
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)
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.
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. Call your healthcare provider right away if you think you have symptoms of a blood clot (leg swelling, redness in your leg, a spot on your leg that is warm to touch, or leg pain that worsens when you bend your foot) or symptoms of an allergic reaction (hives, itching, or swelling of the face). 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 are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.
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