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Makena Dosage

Generic name: HYDROXYPROGESTERONE CAPROATE 250mg in 1mL
Dosage form: injection

Medically reviewed on February 26, 2018.

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)


Instructions for Use: Read this carefully before each use.
FOR SUBCUTANEOUS USE ONLY


Makena®
hydroxyprogesterone caproate injection
275 mg/1.1 mL (250 mg/mL) Auto-injector


For subcutaneous injection.
Single Use.
Administer one injection weekly.
Administration by Healthcare Professionals only.

IFU Description of Parts
Preparation IFU Warning Supplies You Will Need
1 Makena Auto-Injector
1 alcohol swab
1 cotton ball or gauze
Storage Conditions
  • DO NOT refrigerate or freeze.
  • Protect from light.
  • Store at 20°- 25°C (68° - 77°F).
  • Keep away from children.
1 Inspect Makena Auto-Injector
Inspect the Makena Auto-Injector for any visible damage. DO NOT use if it appears damaged or broken, or if cap is missing or not secure.
Check the expiration date. DO NOT use if expired.
Inspect the medication liquid through the Viewing Window; it should be clear to light yellow and free of particles. (See Figure 1).
DO NOT use if the liquid is cloudy or if particles are present. You may notice an air bubble, this is normal.
IFU Figure 1
2 Select & Prepare Subcutaneous Injection Site
Only use the back of either upper arm for injection site.
Rotate the injection site to the alternate arm from the previous week. (See Figure 2).
Wash your hands with soap and water.
Wipe the injection site with an alcohol swab.
Allow the site to dry on its own. DO NOT fan or blow on the injection site. DO NOT touch the site again before injecting.

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.
IFU Figure 2
Administering Subcutaneous Injection

3 Remove Cap
Twist the cap counter clockwise (this will break the red safety seal), and pull cap straight off. (See Figure 3).

After the cap is removed, a few drops of liquid may appear - this is normal.
Auto-Injector should be used or discarded once cap is removed.
DO NOT recap for later use. DO NOT use if device is dropped.
IFU Figure 3
4 Position Makena Auto-Injector
Support the upper arm with the opposite hand. (See Figure 4).
On the relaxed outstretched arm to be injected, gently place the Makena Auto-Injector at a 90° angle to the injection site (back of upper arm, See Figure 4).
Check that you can see the viewing window clearly.
IFU Figure 4
5 Begin Injection
It will take approximately 15 seconds for the full dose to be delivered.
  • Push down while supporting the upper arm with the opposite hand.
    A click will occur when the injection begins. (See Figure 5).
  • Hold the Auto-Injector against the arm.
IFU Figure 5
6 Complete Injection
While holding against the arm, watch the viewing window until it turns orange
Verify viewing window has turned completely orange before removing from injection site.
It is normal if there is slight bleeding after injection. If this occurs, hold a cotton ball or gauze on the area with light pressure for a few seconds. DO NOT rub the area.

If the Viewing Window is not blocked:

  • DO NOT use another Makena Auto-Injector or attempt another injection.
  • Call 1-877-411-2510 for assistance.

Record the location of the injection site in the patient's record to ensure rotation of the injection site each week.

IFU Figure 6
7 Disposal After Injection
After completing injection, dispose of Makena Auto-Injector and cap in a sharps disposal container immediately after use.
IFU Sharps Disposal

Distributed by: AMAG Pharmaceuticals, Inc.
Waltham, MA 02451


900232-001 rev05


Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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