Apretude Patient Counseling Information

At each visit, one injection is required; APRETUDE 3 mL (600 mg).
APRETUDE is a suspension that does not need further dilution or reconstitution.
APRETUDE is for intramuscular use only. It must be administered to the gluteal sites.
Note: The ventrogluteal site is recommended.
Storage information: Do not freeze.
For each injection, you need: 1 vial of APRETUDE.
To prepare the injection: 1 Luer-Lock syringe (5 mL); 1 Luer-Lock aspiration needle or aspiration device (to draw up the suspension).
To administer the injection: 1 additional Luer-Lock needle (use safety needle if available) of 23 gauge, 1.5 inches.
Consider the patient's build and use medical judgment to select an appropriate injection needle length.
You will also need: Non-sterile gloves; 2 alcohol swabs; 1 gauze pad; A suitable sharps container.
Preparation: 1. Inspect vial: Check that the expiry date has not passed. Do not use if the expiry date has passed.
Inspect the vial immediately. If you can see foreign matter, do not use the product.
Note: The APRETUDE vial has a brown tint to the glass.
2. Shake vigorously: Hold the vial firmly and vigorously shake for a full 10 seconds.
Invert the vial and check the resuspension. It should look uniform. If the suspension is not uniform, shake the vial again.
It is also normal to see small air bubbles.
Remove the cap from the vial.
Wipe the rubber stopper with an alcohol swab. Do not allow anything to touch the rubber stopper after wiping it.
3. Prepare syringe and needle: Continue to prepare the injection in line with local guidelines.
It is recommended that you inject 1 mL of air into the vial to allow the required volume to be drawn up.
4. Slowly draw up dose: Invert the syringe and vial, and slowly withdraw as much of the liquid as possible into the syringe. There might be more liquid than dose amount.
Note: Check that the suspension looks uniform and white to light pink.
5. Attach injection needle: Peel open the needle packaging partway to expose the needle base.
Keeping the syringe upright, firmly twist the syringe onto the injection needle.
Attach injection needle.
Remove the needle packaging from the needle.
6. Prepare injection site: Injections must be administered to the gluteal sites. Select from the following areas for the injection: Ventrogluteal (recommended) or Dorsogluteal (upper outer quadrant).
Note: For gluteal intramuscular use only. Do not inject intravenously.
7. Remove extra liquid: Pull off the injection needle cap.
Hold the syringe with the needle pointing up. Press the plunger to the 3 mL dose to remove extra liquid and any air bubbles.
Note: Clean the injection site with an alcohol swab. Allow the skin to air dry before continuing.
8. Stretch skin: Use the z-track injection technique to minimise medicine leakage from the injection site.•
Firmly drag the skin covering the injection site, displacing it by about an inch (2.5 cm). Keep it held in this position for the injection.
9. Inject dose: Insert the needle to its full depth, or deep enough to reach the muscle.•
Still holding the skin stretched, slowly press the plunger all the way down.
Ensure the syringe is empty.
Withdraw the needle and release the stretched skin immediately.
10. Assess the injection site: Apply pressure to the injection site using a gauze pad.
A small bandage may be used if a bleed occurs.
Dispose of used needles, syringe, and vial according to local health and safety laws.
Do not massage the area.
Questions and Answers: If the pack has been stored in the refrigerator, is it safe to warm the vial up to room temperature more quickly: You should wait at least 15 minutes before you are ready to give the injection to allow the medication to come to room temperature.
It is best to let the vial come to room temperature naturally. However, you can use the warmth of your hands to speed up the warm-up time, but make sure the vial does not get above 30°C (86°F).
Do not use any other heating methods.
How long can the medicine be left in the syringe: It is best to inject the (room temperature) medicine as soon as possible after drawing it up. However, the medicine can remain in the syringe for up to 2 hours before injecting.
If the medicine remains in the syringe for more than 2 hours, the filled syringe and needle must be discarded.
Why do I need to inject air into the vial: Injecting 1 mL of air into the vial makes it easier to draw up the dose into the syringe.
Without the air, some liquid may flow back into the vial unintentionally, leaving less medicine than intended in the syringe.
Why is the ventrogluteal administration approach recommended: The ventrogluteal approach, into the gluteus medius muscle, is recommended because it is located away from major nerves and blood vessels. A dorso-gluteal approach into the gluteus maximus muscle is acceptable, if preferred by the health care professional. The injection should not be administered in any other site.