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Makena Generic Name & Formulations
Legal Class
Rx
General Description
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.
Pharmacological Class
Progestin.
How Supplied
Single-dose vial (1mL)—1; Multidose vial (5mL)—1 (contains preservative benzyl alcohol); Auto-injector—1
Manufacturer
Makena Indications
Indications
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.
Makena Dosage and Administration
Adult
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.
Children
<16yrs: not established.
Makena Contraindications
Contraindications
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.
Makena Boxed Warnings
Not Applicable
Makena Warnings/Precautions
Warnings/Precautions
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.
Makena Pharmacokinetics
See Literature
Makena Interactions
Makena Adverse Reactions
Adverse Reactions
Inj site reactions (pain, swelling, pruritus, nodule), urticaria, nausea, diarrhea; allergic reactions, pregnancy-related fetal and maternal complications.
Makena Clinical Trials
See Literature
Makena Note
Not Applicable
Makena Patient Counseling
See Literature
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