Page 2 - Makena Auto-Injector Patient Storybook

Makena Makena is is is is a a a a a a a a a a a a progestin indicated to to to to reduce the the risk of of of preterm preterm birth birth in in in in in in women with a a a a a a a a a a a a singleton singleton pregnancy who have a a a a a a a a a a a a a a a a history of of of of of singleton singleton spontaneous preterm preterm birth birth The The effectiveness of of of of of Makena Makena is is is is based on on on on on on on on improvement in in in in in in in the the proportion of of of of women who delivered <37 weeks of of of of gestation There are no controlled trials demonstrating a a a a a a a a a a a a a a a a direct clinical benefit such as improvement in in neonatal mortality and morbidity Limitation of of use: While there are many risk factors for for preterm preterm birth birth safety and efficacy of of Makena has been demonstrated only in in in in women women with with a a a a a a a a a a a a a a a prior spontaneous singleton preterm preterm preterm birth birth birth It is is is not intended for for for use use in in in in women women with with multiple gestations or or or or other risk factors for preterm preterm birth birth Important Safety Information for for Makena (hydroxyprogesterone caproate injection)
Makena should not be used in in in in women with any of of the the the the following conditions: blood blood clots or or or or or other other blood blood clotting problems problems breast cancer cancer or or or or or other other hormone-sensitive cancers or or or or or history of of of these conditions conditions unusual vaginal bleeding not related to to to your current pregnancy pregnancy yellowing of of the the the skin due to to to liver liver liver problems problems problems during pregnancy pregnancy liver liver liver problems including liver tumors or or uncontrolled high blood pressure Before you you you receive Makena Makena tell your healthcare provider if you you you have an an allergy to to hydroxyprogesterone caproate castor oil or or or or or any of the the other ingredients in in in Makena Makena diabetes diabetes or or or or or prediabetes epilepsy migraine headaches asthma heart problems problems kidney problems problems depression or or or or high blood pressure In a a a a a a a a a a a a a clinical study certain complications or or or events associated with pregnancy pregnancy pregnancy occurred more often in in in in women who received Makena These included miscarriage (pregnancy loss before 20 20 weeks of of of pregnancy) pregnancy) stillbirth (fetal death occurring during or or or or after the 20th week week of of pregnancy) pregnancy) hospital admission for for preterm labor preeclampsia (high (high blood blood pressure pressure and and too much protein in in in in in your urine) gestational gestational hypertension (high (high blood blood pressure pressure caused by pregnancy) gestational gestational diabetes and and oligohydramnios (low amniotic fluid levels) Makena Makena may cause serious side side effects effects including blood clots allergic reactions reactions depression and and yellowing of of of your your skin and and and the whites of of of your your eyes The most common side side effects effects of of of Makena Makena include injection site reactions reactions (pain swelling itching itching bruising or a a a a a a a a a a a hard bump) hives itching itching nausea and and diarrhea Please see full Prescribing Information for for Makena in in the the pocket at at the the back