Special precautions for disposal and other handling: Before administration, the solution should be inspected visually. The solution should not be injected if it is cloudy, distinctly yellow or contains flakes or particles.
Pre-filled pen: To avoid discomfort at the site of injection, the pre-filled pen(s) should be left to stand at room temperature (up to 25°C) for at least 30 minutes before injecting. It should also be protected from direct sunlight. The entire contents of the pre-filled pen(s) must be injected. The pen(s) must not be warmed by using a heat source such as hot water or microwave and must not be shaken.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
Instructions for use of Aimovig pre-filled pen: Step 1: Prepare: Note: The prescribed dose of Aimovig is either 70 mg or 140 mg. This means that for the 70 mg dose the patient must inject the contents of one 70 mg single-use pen. For a dose of 140 mg the patient must inject the contents of two 70 mg single-use pens, one after the other, to get the full dose of this medicine.
(A) Carefully lift Aimovig pre-filled pen out of the carton. The patient may need to use either one or two pens based on the prescribed dose. Do not shake.
To avoid discomfort at the site of injection, leave the pen(s) at room temperature for at least 30 minutes before injecting.
Note: Do not try to warm the pen(s) by using a heat source such as hot water or microwave.
(B) Inspect each pen. Make sure the solution the patient sees in the window is clear and colourless to light yellow.
Note: Do not use the pen if any part of it appears cracked or broken.
Do not use the pen if it has been dropped.
Do not use the pen if the white cap is missing or is not securely attached.
In all cases described previously, use a new pen, and if the patient is unsure contact the doctor or pharmacist.
(C) Gather all materials needed for the injections.
Wash the hands thoroughly with soap and water.
On a clean, well-lit work surface, place the: New pen, Alcohol wipes, Cotton balls or gauze pads, Adhesive plasters, Sharps disposal container.
(D) Prepare and clean the injection site(s).
The patient can use any of the following injection sites: Thigh, Stomach area (abdomen) (except for a 5 cm area around the navel), Outer area of upper arm (only if someone else is giving the injection).
Clean the injection site with an alcohol wipe and let the skin dry.
Choose a different site each time the patient gives himself/herself an injection. If the patient needs to use the same injection site, just make sure it is not the same spot on that site used last time.
Note: After the patient has cleaned the area, do not touch it again before injecting.
Do not choose an area where the skin is tender, bruised, red, or hard. Avoid injecting into areas with scars or stretch marks.
Step 2: Get ready: (E) Pull the white cap straight off, only when ready to inject. The injection must be administered within 5 minutes. It is normal to see a drop of liquid at the end of the needle or green safety guard.
Note: Do not leave the white cap off for more than 5 minutes. This can dry out the medicine.
Do not twist or bend the white cap.
Do not put the white cap back onto the pen once it has been removed.
(F) Stretch or pinch the injection site to create a firm surface.
Stretch method: Stretch skin firmly by moving the thumb and fingers in opposite directions, creating an area about five cm wide.
Pinch method: Pinch skin firmly between the thumb and fingers, creating an area about five cm wide.
Note: Keep skin stretched or pinched while injecting.
Step 3: Inject: (G) Keep holding the stretch or pinch. With the white cap off, place the pen on the skin at an angle of 90 degrees.
Note: Do not touch the purple start button yet.
(H) Firmly push the pen down onto the skin until it stops moving.
Note: The patient must push all the way down but must not touch the purple start button until ready to inject.
(I) Press the purple start button. The patient will hear a click.
(J) Remove the thumb from the button, but keep pushing down on the skin. The injection could take about 15 seconds.
Note: When the injection is completed, the window will turn yellow and the patient may hear a second click.
Note: After the patient removes the pen from the skin, the needle will automatically be covered by the green safety guard.
When the patient removes the pen, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means the patient has not received a full dose. Contact the doctor immediately.
Step 4: Finish: (K) Discard the used pen and the white cap.
Put the used pen in a sharps disposal container immediately after use. Talk to the doctor or pharmacist about proper disposal. There may be local regulations for disposal.
Note: Do not reuse the pen.
Do not recycle the pen or sharps disposal container, or throw them into household waste.
(L) Examine the injection site.
If there is any blood on the skin, press a cotton ball or gauze pad onto the injection site. Do not rub the injection site. Apply an adhesive plaster if needed.
In case the dose is 140 mg, repeat all steps with the second pen to inject the full dose.
Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.