HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use MAKENA safely and effectively.
See full prescribing information for MAKENA.
MAKENATM (hydroxyprogesterone caproate injection) for intramuscular use.
Initial U.S. Approval: 1956
INDICATIONS AND USAGE
Makena is a progestin indicated to reduce the risk of preterm birth in women with a singleton pregnancy who have a history of singleton spontaneous preterm birth.
Limitation of use: Makena is not intended for use in women with multiple gestations or other risk factors for preterm birth. (1)
DOSAGE AND ADMINISTRATION
Administer intramuscularly at a dose of 250 mg (1 mL) once weekly
Begin treatment between 16 weeks, 0 days and 20 weeks, 6 days of gestation
Continue administration once weekly until week 37 (through 36 weeks, 6 days) of gestation or delivery, whichever occurs first (2.1)
DOSAGE FORMS AND STRENGTHS
5 mL multidose vial (250 mg/mL) contains 1250 mg hydroxyprogesterone caproate. (3)
CONTRAINDICATIONS
Current or history of thrombosis or thromboembolic disorders (4)
Known or suspected breast cancer, other hormone-sensitive cancer, or history of these conditions (4)
Undiagnosed abnormal vaginal bleeding unrelated to pregnancy (4)
Cholestatic jaundice of pregnancy (4)
Liver tumors, benign or malignant, or active liver disease (4)
Uncontrolled hypertension (4)
WARNINGS AND PRECAUTIONS
Thromboembolic disorders: Discontinue if thrombosis or thromboembolism occurs (5.1)
Allergic reactions: Consider discontinuing if allergic reactions occur (5.2)
Decreased glucose tolerance: Monitor prediabetic and diabetic women receiving Makena (5.3)
Fluid retention: Monitor women with conditions that may be affected by fluid retention, such as preeclampsia, epilepsy, cardiac or renal dysfunction (5.4)
Depression: Monitor women with a history of clinical depression; discontinue Makena if depression recurs (5.5)
ADVERSE REACTIONS
Most common adverse reactions reported in ≥2% of subjects and at a higher rate in the Makena group than in the control group are injection site reactions (pain [35%], swelling [17%], pruritus [6%], nodule [5%]), urticaria (12%), pruritus (8%), nausea (6%), and diarrhea (2%). (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Ther-Rx Corporation at 1-877-567-7676 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Metabolism of drugs metabolized by CYP1A2, CYP2A6 and CYP2B6 may be increased if used with Makena. (7.1)
USE IN SPECIFIC POPULATIONS
Pregnancy: Controlled studies show no increase in congenital anomalies, including genital abnormalities in male or female infants, from exposure during pregnancy to hydroxyprogesterone caproate. (8.1)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling.
Revised: 02/2011
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Back to Highlights and TabsFULL PRESCRIBING INFORMATION: CONTENTS*
*Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dosing
2.2 Preparation and Administration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Thromboembolic Disorders
5.2Allergic Reactions
5.3 Decrease in Glucose Tolerance