Prolia Administration | Osteoporosis | Amgen

ADMINISTRATION OF PROLIA®

Prolia injection techniques and dosage administration.
The recommended dose of Prolia® is 60 mg administered as a single subcutaneous injection once every 6 months into the thigh, abdomen or upper arm.1
No dose adjustment is required for elderly patients (aged ≥65 years) or patients with renal impairment. The safety and efficacy of denosumab have not been studied in those with hepatic impairment.1

Administration of Prolia® should be performed by a person properly trained in injection techniques.1

Instructions for use2

Guide to parts
HOW IS PROLIA ADMINISTERED
IMPORTANT
Before you use a Prolia® pre-filled syringe with automatic needle guard, read this important information:
  • Administration should be performed by an individual who has been adequately trained in injection techniques.
  • Prolia® is given as an injection into the tissue just under the skin (subcutaneous injection).
  • The needle cap on the pre-filled syringe contains a derivative of latex, which may cause allergic reaction.
✗ Do not remove the grey needle cap from the pre-filled syringe until you are ready to inject.
✗ Do not use the pre-filled syringe if it has been dropped on a hard surface. Use a new pre-filled syringe.
✗ Do not attempt to activate the pre-filled syringe prior to injection.
✗ Do not attempt to remove the clear pre-filled syringe safety guard from the pre-filled syringe.
Step 1: Prepare
  1. Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, cotton ball or gauze pad, a plaster and a sharps disposal container (not included).
    For a more comfortable injection, leave the pre-filled syringe at room temperature for about 30 minutes before injecting. Wash your hands thoroughly with soap and water.
    On a clean, well-lit work surface, place the new pre-filled syringe and the other supplies.
    ✗ Do not try to warm the syringe by using a heat source such as hot water or microwave.
    ✗ Do not leave the pre-filled syringe exposed to direct sunlight.
    ✗ Do not shake the pre-filled syringe.
    • Keep the pre-filled syringe out of the sight and reach of children.
  2. Open the tray, peeling away the cover. Grab the pre-filled syringe safety guard to remove the pre-filled syringe from the tray.
    HOW IS PROLIA ADMINISTERED
    For safety reasons:
    ✗ Do not grasp the plunger.
    ✗ Do not grasp the grey needle cap.
  3. Inspect the medicine and pre-filled syringe.
    HOW IS PROLIA ADMINISTERED
    ✗ Do not use the pre-filled syringe if:
    • The medicine is cloudy or there are particles in it. It must be a clear, colourless to slightly yellow solution.
    • Any part appears cracked or broken.
    • The grey needle cap is missing or not securely attached.
    • The expiry date printed on the label has passed the last day of the month shown.
Step 2: Get ready
  1. Wash your hands thoroughly. Prepare and clean your injection site.
    HOW IS PROLIA ADMINISTERED
    You can use:
    • Upper part of your thigh.
    • Belly, except for a 5 cm (2-inch) area right around your belly button.
    • Outer area of upper arm (only if someone else is giving you the injection).
    Clean the injection site with an alcohol wipe. Let your skin dry.
    ✗ Do not touch the injection site before injecting.
    ! Do not inject into areas where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.
  2. Carefully pull the grey needle cap straight out and away from your body.
    HOW IS PROLIA ADMINISTERED
  3. Pinch your injection site to create a firm surface.
    HOW IS PROLIA ADMINISTERED
    ! It is important to keep the skin pinched when injecting.
Step 3: Inject
  1. Hold the pinch. INSERT the needle into skin.
    HOW IS PROLIA ADMINISTERED
    ✗ Do not touch the cleaned area of the skin.
  2. PUSH the plunger with slow and constant pressure until you feel or hear a “snap”. Push all the way down through the snap.
    HOW IS PROLIA ADMINISTERED
    ! It is important to push down through the “snap” to deliver the full dose.
  3. RELEASE your thumb. Then LIFT the syringe off skin.
    HOW IS PROLIA ADMINISTERED
    After releasing the plunger, the pre-filled syringe safety guard will safely cover the injection needle.
    ✗ Do not put the grey needle cap back on used pre-filled syringes.
Step 4: Finish
  1. Discard the used pre-filled syringe and other supplies in a sharps disposal container.
    HOW IS PROLIA ADMINISTERED
    Medicines should be disposed of in accordance with local requirements. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
    Keep the syringe and sharps disposal container out of sight and reach of children.
    ✗ Do not reuse the pre-filled syringe.
    ✗ Do not recycle pre-filled syringes or throw them into household waste.
  2. Examine the injection site.
    If there is blood, press a cotton ball or gauze pad on your injection site. Do not rub the injection site. Apply a plaster if needed.

Pack contents2

  • A 1-ml solution in a single use pre-filled syringe made from type I glass with stainless steel 27-gauge needle; with or without needle guard.
  • The needle cover of the pre-filled syringe contains dry natural rubber, which is a derivative of latex.
  • Pack size of one pre-filled syringe, presented in blistered (pre-filled syringe with or without a needle guard) or unblistered packaging (pre-filled syringe without a needle guard only).

Storage information2

  • Store in a refrigerator (2–8°C).
  • Do not freeze.
  • Once removed from a refrigerator, Prolia® (denosumab) may be stored at room temperature (up to 25°C) for up to 30 days in the original container. It must be used within this 30-day period.
  • Keep the container in the outer carton to protect from light.
  • Do not shake.

References:
  1. Prolia® (denosumab) Summary of Product Characteristics. Amgen. Last revised February 2020.
  2. European Public Assessment Report (EPAR) for Prolia®. Amgen.

SMPC

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