Makena (hydroxyprogesterone caproate injection) 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 (hydroxyprogesterone caproate injection) 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 (hydroxyprogesterone caproate injection) 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.

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

Preparation and Administration

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Makena (hydroxyprogesterone caproate injection) is a clear, yellow solution. Do not use if solid particles appear or if the solution is cloudy.

Instructions for administration:

1. Clean the vial top with an alcohol swab before use.
2. Draw up 1 mL of drug into a 3 mL syringe with an 18 gauge needle.
3. Change the needle to a 21 gauge 1½ inch needle.
4. 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.
5. Applying pressure to the injection site may minimize bruising and swelling.

Discard any unused product 5 weeks after first use.

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.

Storage And Handling

Makena (hydroxyprogesterone caproate injection) (NDC 64011-243-01) is supplied as 5 mL of a sterile solution in a multidose glass vial.

Each 5 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (28.6% v/v) and benzyl benzoate USP (46% v/v) with the preservative benzyl alcohol NF (2% v/v).

Single unit carton: Contains one 5 mL multidose vial of Makena (250 mg/mL) containing 1250 mg of hydroxyprogesterone caproate.

Store at controlled room temperature [15°-30° C (59°-86° F)]. Use within 5 weeks after first use.

Caution: Protect vial from light. Store vial in its box. Store upright.

Manufactured by: Baxter Pharmaceutical Solutions LLC, Bloomington, IN 47403. Marketed by: Ther-Rx Corporation, St. Louis, MO 63044

Last reviewed on RxList: 3/29/2011
This monograph has been modified to include the generic and brand name in many instances.