Dosing

•

Makena auto-injector: Administer subcutaneously using auto-injector at a dose of 275 mg (1.1 mL) once weekly (every 7 days) in the back of either upper arm by a healthcare provider

•

Makena (single- and multi-dose vials): Administer intramuscularly at a dose of 250 mg (1 mL) once weekly (every 7 days) in the upper outer quadrant of the gluteus maximus 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. The solution must be clear at the time of use; replace vial if visible particles or crystals are present.

Specific instructions for administration by dosage form:

Makena single-dose or multi-dose vials (intramuscular use only)

Makena single-dose or multi-dose vials are only for intramuscular injection with a syringe into the upper outer quadrant of the gluteus maximus, rotating the injection site to the alternate side from the previous week, using the following preparation and administration procedure:

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.

If the 5 mL multi-dose vial is used, discard any unused product 5 weeks after first use.

Makena auto-injector (subcutaneous use only)

Makena auto-injector is a single-use, pre-filled, disposable device containing a 27 gauge, 0.5 inch needle that delivers one dose subcutaneously in the back of the upper arm.

Because Makena auto-injector is preservative-free, once the cap is removed the device should be used immediately or discarded.

Rotate the injection site to the alternate arm from the previous week. Do not use in areas where the skin is tender, bruised, red, scaly, raised, thick, or hard. Avoid areas with scars, tattoos, or stretch marks.

The solution is viscous and oily. The auto-injector takes approximately 15 seconds to deliver the dose; when the viewing window is fully blocked (completely orange), the full dose has been administered.

The “Instructions for Use” contains detailed steps for administering the subcutaneous injection using the auto-injector [see Dosage and Administration (2.3)]. Read the “Instructions for Use” carefully before administering Makena auto-injector.

Instructions for Use (Makena Auto-injector)