Nucala Caution For Usage

Incompatibilities: In the absence of compatability studies, this medicinal product must not be mixed with other medicinal products.
Special precautions for disposal and other handling: Before administration, the solution should be inspected visually. The liquid should be clear to opalescent, colourless to pale yellow to pale brown. If the solution is cloudy, discoloured or contains particles, the solution should not be used.
After removing the pre-filled pen or pre-filled syringe from the refrigerator, allow the pen or syringe to reach room temperature for at least 30 minutes before injecting NUCALA.
Comprehensive instructions for subcutaneous administration of NUCALA in a pre-filled pen or pre-filled syringe are provided at the end of the package leaflet.
Disposal: Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Instructions for Use: Solution for injection in pre-filled pen/syringe (auto-injector/safety syringe): NUCALA pre-filled pen/syringe (auto-injector/safety syringe) (mepolizumab): Administer once every 4 weeks.
Follow these instructions on how to use the pre-filled pen/syringe. Failure to follow these instructions may affect proper function of the pre-filled pen/syringe. The patient should also receive training on how to use the pre-filled pen/syringe. NUCALA pre-filled pen/syringe is for use under the skin only (subcutaneous).
How to store NUCALA: Keep refrigerated before use.
Do not freeze.
Keep the pre-filled pen/syringe in the carton to protect from light.
Keep out of the sight and reach of children.
If necessary, the pre-filled pen/syringe may be kept at room temperature, up to 30°C, for no more than 7 days, when stored in the original carton. Safely, throw the pre-filled pen/syringe away if it has been kept out of the refrigerator for more than 7 days.
Do not store it above 30°C.
Before using NUCALA: The pre-filled pen/syringe should be used only once and then discarded.
Do not share NUCALA pre-filled pen/syringe with another person.
Do not shake the pen/syringe.
Do not use the pen/syringe if dropped onto a hard surface.
Do not use the pen/syringe if it appears damaged.
Do not remove the needle cap until just before the injection.
Know the pre-filled pen/syringe.
Prepare: 1. Get ready what the patient needs: Find a comfortable, well-lit and clean surface. Make sure the patient has within reach: NUCALA pre-filled pen/syringe, Alcohol wipe (not included), Gauze pad or cotton wool ball (not included).
2. Take out the pre-filled pen/syringe: Take the carton out of the refrigerator. Check the security seals are not broken.
Remove the tray from the carton.
Peel back the film cover from the tray.
Holding the middle of the pen/syringe, carefully take it out of the tray.
Place the pen/syringe on a clean, flat surface, at room temperature, away from direct sunlight and out of the reach of children.
Do not use the pen/syringe if the security seal on the carton is broken.
Do not remove the needle cap at this stage.
3. Inspect and wait 30 minutes before use: Check the expiry date on the label of the pen/syringe.
Look in the inspection window to check that the liquid is clear (free from cloudiness or particles) and colourless to pale yellow to pale brown.
It is normal to see one or more air bubbles.
Wait 30 minutes (and no more than 8 hours) before use.
Do not use if the expiry date has passed.
Do not warm the pen/syringe in a microwave, hot water, or direct sunlight.
Do not inject if the solution looks cloudy or discoloured, or has particles.
Do not use the pen/syringe if left out of the carton for more than 8 hours.
Do not remove the needle cap during this step.
4. Choose the injection site: Can inject NUCALA into the thighs or abdomen.
If someone else gives the injection, they can also use the upper arm.
If the patient needs more than one injection to complete the dose, then leave at least 5 cm between each injection site.
Do not inject where the skin is bruised, tender, red or hard.
Do not inject within 5 cm of the navel (belly button).
5. Clean the injection site: Wash hands with soap and water.
Clean the injection site by wiping the skin with an alcohol wipe and allowing the skin to air dry.
Do not touch the injection site again until finished with the injection.
Inject: 6. Remove the clear needle cap.
Remove the clear needle cap from the pen/syringe by firmly pulling it straight off; extending the hand away from the needle end. The patient may need to pull the needle cap quite firmly to remove it (for pre-filled syringe).
Do not worry if a drop of liquid is seen at the end of the needle. This is normal.
Inject straight after removing the needle cap, and always within 5 minutes.
Pre-filled pen: Do not touch the yellow needle guard with the fingers. This could activate the pen too soon and may cause a needle injury.
After removal, do not put the needle cap back onto the pen, as it may accidentally start the injection.
Pre-filled syringe: Do not let the needle touch any surface.
Do not touch the needle.
Do not touch the plunger at this stage, as the patient can accidentally push liquid out and will not receive the full dose.
Do not expel any air bubbles from the syringe.
Do not put the needle cap back onto the syringe. This could cause a needle injury.
7. Start the injection: Pre-filled pen: The patient should hold the pen with its inspection window facing towards the patient, so the patient can see it, and with the yellow needle guard facing down.
Place the pen straight onto the injection site with the yellow needle guard flat against the surface of the skin
To start the injection, push the pen down all the way and keep it held down against the skin. The yellow needle guard will slide up into the pen.
The patient should hear the 1st "click" to tell that the injection has started.
The yellow indicator will move down through the inspection window as the patient receives the dose.
Do not lift the pen from the skin at this stage, as that may mean the patient doesn't get the full dose of medicine. The injection may take up to 15 seconds to complete.
Do not use the pen if the yellow needle guard doesn't slide up as described. Dispose of it (see Step 9), and start again with a new pen.
Pre-filled syringe: Use the free hand to pinch the skin around the injection site. Keep the skin pinched throughout the injection.
Insert the entire needle into the pinched skin at a 45° angle.
Move thumb to the plunger and place fingers on the white finger grip.
Slowly push down on the plunger to inject the full dose.
8. Pre-filled pen: Hold the pen in place to complete the injection: Continue to hold the pen down until the patient hears the 2nd "click", and the stopper and yellow indicator have stopped moving and fill the inspection window.
Continue to hold the pen in place while counting to 5. Then lift the pen away from the skin.
If the patient does not hear the 2nd "click": Check that the inspection window is filled with the yellow indicator; if the patient is not sure, hold the pen down for another 15 seconds to make sure the injection is complete.
Do not lift the pen until the patient is sure to have completed the injection.
The patient may notice a small drop of blood at the injection site. This is normal. Press a cotton wool ball or gauze on the area for a few moments if necessary.
Do not rub the injection site.
Pre-filled syringe: Complete the injection: Make sure the plunger is pushed all the way down, until the stopper reaches the bottom of the syringe and all of the solution is injected.
Slowly lift the thumb up. This will allow the plunger to come up and the needle to retract (rise up) into the body of the syringe.
Once complete, release the pinched skin.
The patient may notice a small drop of blood at the injection site. This is normal. Press a cotton wool ball or gauze on the area for a few moments if necessary.
Do not put the needle cap back onto the syringe.
Do not rub the injection site.
Dispose: 9. Dispose of the used pen.
Dispose of the used pen/syringe and needle cap according to local requirements. Ask the doctor or pharmacist for advice if necessary.
Keep the used pens/syringes and needle caps out of the sight and reach of children.