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Prolia® Posology & method of administration

Prolia® (denosumab) is an injection for osteoporosis administered subcutaneously 

Please read the following information carefully before administering the Prolia® (denosumab) injection.

Pack contents, storage information and disposal information

Nature and contents of container

  • One 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, presented in blistered (pre-filled syringe with or without a needle guard) or unblistered packaging (pre-filled syringe only).

Special precautions for storage

  • Store in a refrigerator. (2°C – 8°C).
  • Do not freeze.
  • Prolia® (denosumab) may be stored at room temperature (up to 25°C) for up to 30 days in the original container. Once removed from the refrigerator, Prolia® (denosumab) must be used within this 30 day period. 
  • Keep the pre-filled syringe in the original carton in order to protect from light.
  • Do not shake excessively.
  • Keep this medicine out of the sight and reach of children.
  • Do not use the medicine after the expiry date which is stated on the label and carton after EXP. The expiry date refers to the last day of that month.

Special precautions for disposal

Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.


Prolia® (denosumab) dosing

The recommended dose of Prolia® is 60 mg administered subcutaneously as a single injection once every 6 months. No dose adjustment is required for elderly patients or patients with renal impairment. 

Patients with severe renal impairment (creatinine clearance < 30 ml/min) are at greater risk of developing hypocalcaemia. Adequate intake of calcium, vitamin D and regular monitoring of calcium is especially important in these patients.

instructions for use

Guide to parts




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 cover of the pre-filled syringe contains dry natural rubber (a derivative of latex), which may cause allergic reactions


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 

A  Remove the pre-filled syringe tray from the package and gather the supplies needed for your injection: alcohol wipes, a 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 pre-filled syringes out of the sight and reach of children.



B  Open the tray, peeling away the cover. Grab the pre-filled syringe safety guard to remove the pre-filled syringe from the tray. 

For safety reasons: 

✗   Do not grasp the plunger. 
✗   Do not grasp the grey needle cap.



C       Inspect the medicine and pre-filled syringe.



      ✗   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

A        Wash your hands thoroughly. Prepare and clean your injection site.


 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.



B
        Carefully pull the grey needle cap straight out and away from your body.



C       Pinch your injection site to create a firm surface. 

!     It is important to keep the skin pinched when injecting.



Step 3: Inject
A       Hold the pinch. INSERT the needle into skin.





    Do not touch the cleaned area of the skin.



B        PUSH the plunger with slow and constant pressure until you feel or hear a “snap”. Push all the way down through the snap. 


! It is important to push down through the “snap” to deliver the full dose. 



C    RELEASE your thumb. Then LIFT the syringe off skin.

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


A Discard the used pre-filled syringe and other supplies in a sharps disposal container.


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.



B 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.