"In a drug safety communication issued today, the US Food and Drug Administration (FDA) says it is aware of recent reports "questioning" the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy, but that it l"...
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.
DOSAGE AND ADMINISTRATION
- 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 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 1½ 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.
If the 5 mL multidose vial is used, 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 1 mL single dose vial contains 250 mg hydroxyprogesterone caproate. Each 5 mL multidose vial contains 1250 mg hydroxyprogesterone caproate.
Storage And Handling
Makena (NDC 64011-247-02) is supplied as 1 mL of a sterile solution in a single dose glass vial.
Each 1 mL vial contains hydroxyprogesterone caproate USP, 250 mg/mL (25% w/v), in castor oil USP (30.6% v/v) and benzyl benzoate USP (46% v/v).
Single unit carton: Contains one 1 mL single dose vial of Makena containing 250 mg of hydroxyprogesterone caproate.
Makena (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 multidose vials within 5 weeks after first use.
Caution: Protect vial from light. Store vial in its box. Store upright.
Marketed by: Lumara Health, Inc., A division of AMAG Pharmaceuticals, Inc., Waltham, MA 02451. Revised: Dec 2015This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 5/25/2016
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