Miscellaneous Ob/Gyn conditions:

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.

Adult Dosage:

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 Dosage:

<16yrs: not established.

MAKENA 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 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 Classification:


Adverse Reactions:

Inj site reactions (pain, swelling, pruritus, nodule), urticaria, nausea, diarrhea; allergic reactions, pregnancy-related fetal and maternal complications.

How Supplied:

Single-dose vial (1mL)—1; Multidose vial (5mL)—1 (contains preservative benzyl alcohol); Auto-injector—1