ildren of control subjects. The primary endpoint was the score on the Ages & Stages Questionnaire (ASQ), which eva luates communication, gross motor, fine motor, problem solving, and personal/social parameters. The proportion of children whose scores met the screening threshold for developmental delay in each developmental domain was similar for each treatment group.
Meis PJ, Klebanoff M, Thom E, et al. Prevention of recurrent preterm delivery by 17 alpha-hydroxyprogesterone caproate. N Engl J Med. 2003;348(24):2379-85.
Northen A, Norman G, Anderson K, et al. Follow-up of children exposed in utero to 17 alpha-hydroxyprogesterone caproate. Obstet & Gynecol. 2007;110:865-872.
Makena (NDC 64011-243-01) is supplied as 5 mL of a sterile solution in a multidose glass vial.
Each 5 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (28.6% v/v) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v).
Single unit carton: Contains one 5 mL multidose vial of Makena (250 mg/mL) containing 1250 mg of hydroxyprogesterone caproate.
Store at controlled room temperature [15°-30°C (59°-86°F)]. Use within 5 weeks after first use.
Caution: Protect vial from light. Store vial in its box. Store upright.
See FDA-approved patient labeling (Patient Information).
Counsel patients that Makena injections may cause pain, soreness, swelling, itching or bruising. Inform the patient to contact her physician if she notices increased discomfort over time, oozing of blood or fluid, or inflammatory reactions at the injection site [see Adverse Reactions (6.1)].
Patient Information
Makena (mah-KEE-na)(hydroxyprogesterone caproate injection) 250 mg/mL
Read this Patient Information Leaflet before you receive Makena. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
What is Makena?
Makena is a prescription hormone medicine (progestin) used in women who are pregnant and who have delivered a baby too early (preterm) in the past. Makena is used in these women to help lower the risk of having a preterm baby again.
Makena is for women who:
How well does Makena work?
Makena was studied in women who were at risk for having a preterm baby because they had previously given birth to a preterm baby. In the main study, about 37 of 100 women who received Makena gave birth preterm (before 37 weeks of pregnancy), compared to about 55 of 100 women who did not receive Makena. Another study of Makena is going on to see whether Makena reduces the number of babies who have serious problems shortly after birth or who die.
It is not known whether Makena is safe and effective in women who have other risk factors for preterm birth.
It is not known whether Makena is safe and effective in women less than 16 years old.
Makena is not intended for use to stop active preterm labor.
Who should not receive Makena?
Makena should not be used if you:
What should I tell my healthcare provider before receiving Makena?
Before you receive Makena, tell your healthcare provider if you have:
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Makena may affect the way other medicines work, and other medicines may affect how Makena work
