5.4 Fluid Retention
5.5 Depression
5.6 Jaundice
5.7 Hypertension
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Clinical Trial to eva luate Reduction of Risk of Preterm Birth
14.2 Infant Follow-Up Safety Study
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
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FULL PRESCRIBING INFORMATION
1 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. The effectiveness of Makena is based on improvement in the proportion of women who delivered <37 weeks of gestation. There are no controlled trials demonstrating a direct clinical benefit, such as improvement in neonatal mortality and morbidity.
Limitation of use: While there are many risk factors for preterm birth, safety and efficacy of Makena has been demonstrated only in women with a prior spontaneous singleton preterm birth. It is not intended for use in women with multiple gestations or other risk factors for preterm birth.
2 DOSAGE AND ADMINISTRATION
2.1 Dosing
Administer intramuscularly at a dose of 250 mg (1 mL) once weekly (every 7 days) by a healthcare provider
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
2.2 Preparation and Administration
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Makena is a clear, yellow solution. Do not use if solid particles appear or if the solution is cloudy.
Instructions for administration:
Clean the vial top with an alcohol swab before use.
Draw up 1 mL of drug into a 3 mL syringe with an 18 gauge needle.
Change the needle to a 21 gauge 1 1/2 inch needle.
After preparing the skin, inject in the upper outer quadrant of the gluteus maximus. The solution is viscous and oily. Slow injection (over one minute or longer) is recommended.
Applying pressure to the injection site may minimize bruising and swelling.
Discard any unused product 5 weeks after first use.
3 DOSAGE FORMS AND STRENGTHS
Makena (250 mg/mL) is a sterile solution of hydroxyprogesterone caproate in castor oil for injection. Each 5 mL multidose vial contains 1250 mg hydroxyprogesterone caproate.
4 CONTRAINDICATIONS
Do not use Makena in women with any of the following conditions:
Current or history of thrombosis or thromboembolic disorders
Known or suspected breast cancer, other hormone-sensitive cancer, or history of these conditions
Undiagnosed abnormal vaginal bleeding unrelated to pregnancy
Cholestatic jaundice of pregnancy
Liver tumors, benign or malignant, or active liver disease
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