Generic Name and Formulations:
Hydroxyprogesterone caproate 250mg/mL; per vial; soln for IM inj; or, 275mg/1.1mL; per auto-injector; soln for SC inj; contains castor oil, benzyl benzoate.
Indications for MAKENA:
To reduce risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth. Limitation of use: not intended for use in women with multiple gestations or other risk factors for preterm birth.
Begin treatment between 16 weeks 0 days and 20 weeks 6 days gestation. Continue until Week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever comes first. Rotate inj sites. IM (inject slowly over 1min or longer into upper outer quadrant of gluteus maximus): 250mg (1mL) every 7 days. SC (inject into the back of upper arm): 275mg (1.1mL) every 7 days. Avoid areas with scars, tattoos, stretch marks, other areas where skin is tender, bruised, red, scaly, raised, thick or hard.
<16yrs: not established.
Current or history of thrombosis or thromboembolic disorders. Known, suspected, or history of breast or other hormone-sensitive cancers. Undiagnosed abnormal vaginal bleeding. Cholestatic jaundice of pregnancy. Hepatic tumors. Active hepatic disease. Uncontrolled hypertension.
Conditions aggravated by fluid retention (eg, preeclampsia, epilepsy, migraine, asthma, cardiac or renal dysfunction). Monitor prediabetes, diabetes, and depression. Discontinue if depression, thromboembolic events or allergic reactions occur. Reevaluate if jaundice or hypertension occurs. Hepatic impairment. Not for use in stopping active preterm labor. Pregnancy (limited data on 1st trimester use). Nursing mothers.
Inj site reactions (pain, swelling, pruritus, nodule), urticaria, nausea, diarrhea; allergic reactions, pregnancy-related fetal and maternal complications.
Single-dose vial (1mL)—1; Multidose vial (5mL)—1 (contains preservative benzyl alcohol); Auto-injector—1