HYDROXYprogesterone

Class: Progestins
Chemical Name: 17-[(1-Oxohexyl)oxy]-pregn-4-ene-3,20-dione
Molecular Formula: C₂₇H₄₀O₄
CAS Number: 630-56-8
Brands: Makena

Medically reviewed by Drugs.com on Jan 17, 2022. Written by ASHP.

Introduction

Synthetic progestin.

Uses for HYDROXYprogesterone

Preterm Birth Risk Reduction

Reduction of risk of preterm birth in women with a singleton pregnancy having a history of singleton spontaneous preterm birth (designated an orphan drug by FDA for this use).

Efficacy determined based on improvement in proportion of women who delivered at <37 weeks of gestation; direct clinical benefit (e.g., improvement in neonatal morbidity and mortality) not established.

Safety and efficacy demonstrated only in women with a prior spontaneous singleton birth; not intended for use in women with multiple gestations or other risk factors for preterm birth.

ACOG recommends offering progesterone supplementation for prevention of recurrent preterm birth to women with a singleton pregnancy and a prior spontaneous preterm birth at <37 weeks of gestation due to spontaneous preterm labor or premature rupture of membranes.

HYDROXYprogesterone Dosage and Administration

General

Prior to commercial availability, another formulation containing the active ingredient was available to patients from pharmacists who compounded the injection.
FDA currently not intending to take action against such pharmacies compounding an injection on a valid prescription for an individual patient and in accordance with appropriate standards for compounding sterile products.

Administration

IM Administration

Administer by slow IM injection ( ≥1 minute) by a clinician. Patients should not self-administer the drug.

Withdraw appropriate dose from the vial using a 3-mL syringe with an 18-gauge needle; prior to administration, replace the 18-gauge needle with a 21-gauge, 1.5-inch needle.

After preparing the skin, administer by slow IM injection into the upper outer quadrant of the gluteus maximus. Apply pressure to the injection site to minimize bruising and swelling.

Hydroxyprogesterone caproate injection is a clear, yellow, viscous, oily solution; discard if solution is cloudy or solid particles appear. Discard any unused portions 5 weeks after first use.

Dosage

Adults

Preterm Birth Risk Reduction

IM

250 mg once weekly (every 7 days); begin therapy between 16 weeks, 0 days and 20 weeks, 6 days of gestation; continue until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first.

Special Populations

No specific dosage recommendations at this time.