Makena® is a prescription hormone medicine (progestin) used to lower the risk
of preterm birth in women who are pregnant with one baby and who have delivered
one baby too early (preterm) in the past. Makena was shown to work based on a lower
number of women who delivered babies at less than 37 weeks of pregnancy. There are
no studies showing 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.
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 www.fda.gov/medwatch
or call 1-800-FDA-1088.