Instructions for Use
AIMOVIG™ (AIM-oh-vig) (erenumab-aooe)
Injection, For Subcutaneous Use
Single-Dose Prefilled SureClick® Autoinjector
Guide to parts
Before use
After use
Important: Needle is inside
Important
Before you use AIMOVIG SureClick autoinjector, read this important information:
Storing your AIMOVIG SureClick autoinjector
- Keep the autoinjector out of the reach of children.
- Keep the autoinjector in the original carton to protect from light.
- The autoinjector should be kept in the refrigerator at 36°F to 46°F (2°C to 8°C).
- After removing AIMOVIG from the refrigerator, it can be stored at room temperature between 68°F to 77°F (20°C to 25°C) for up to 7 days.
- Throw away AIMOVIG that has been left at room temperature for more than 7 days.
- Do not freeze.
Using your AIMOVIG SureClick autoinjector
- The needle shield within the white cap of the AIMOVIG autoinjector contains dry natural rubber, which is made from latex. Tell your healthcare provider if you are allergic to latex.
- It is important that you do not try to give the injection unless you or your caregiver has received training from your healthcare provider.
- Do not use the autoinjector after the expiration date on the label.
- Do not shake the autoinjector.
- Do not remove the white cap from the autoinjector until you are ready to inject.
- Do not freeze or use the autoinjector if it has been frozen.
- Do not use the autoinjector if it has been dropped on a hard surface. Part of the autoinjector may be broken even if you cannot see the break. Use a new autoinjector, and call 1-800-77-AMGEN (1-800-772-6436).
Step 1: Prepare
Read this before you inject.
Check your prescription.
AIMOVIG comes as a single-dose (1 time) prefilled autoinjector. Your healthcare provider will prescribe the dose that is best for you.
- If your healthcare provider prescribes the 70 mg dose for you, take 1 injection, using a prefilled autoinjector.
- If your healthcare provider prescribes the 140 mg dose for you, take 2 separate injections one after another, using a different prefilled autoinjector for each injection.
Before you inject, always check the label of your single-dose prefilled autoinjector to make sure you have the correct medicine and the correct dose of AIMOVIG.
Remove autoinjector from the carton. You may need to use more than 1 autoinjector based on your prescribed dose.
Carefully lift the autoinjector straight up out of the carton.
Leave the autoinjector at room temperature for at least 30 minutes before injecting.
- Do not put the autoinjector back in the refrigerator after it has reached room temperature.
- Do not try to warm the autoinjector by using a heat source such as hot water or microwave.
- Do not leave the autoinjector in direct sunlight.
- Do not shake the autoinjector.
- Do not remove the white cap from the autoinjector yet.
Inspect the autoinjector.
Make sure the medicine in the window is clear and colorless to slightly yellow.
- Do not use the autoinjector if the medicine is cloudy or discolored or contains flakes or particles.
- Do not use the autoinjector if any part appears cracked or broken.
- Do not use the autoinjector if the autoinjector has been dropped.
- Do not use the autoinjector if the white cap is missing or not securely attached.
- Do not use the autoinjector if the expiration date printed on the label has passed.
In all cases, use a new autoinjector, and call 1-800-77-AMGEN (1-800-772-6436).
Gather all materials needed for your injection.
Wash your hands thoroughly with soap and water.
On a clean, well-lit work surface, place the:
- New autoinjector
- Alcohol wipes
- Cotton balls or gauze pads
- Adhesive bandages
- Sharps disposal container
Prepare and clean your injection site.
You can use:
- Your thigh
- Stomach area (abdomen), except for a 2 inch area right around your navel
- Outer area of upper arm (only if someone else is giving you the injection)
Clean your injection site with an alcohol wipe. Let your skin dry.
- Do not touch this area again before injecting.
- If you want to use the same body site for the two separate injections needed for the 140 mg dose, make sure the second injection is not at the same spot you used for the first injection.
- Do not inject into areas where the skin is tender, bruised, red, or hard.
- Avoid injecting directly into raised, thick, red, or scaly skin patch or lesion, or areas with scars or stretch marks.
Step 2: Get ready
Pull the white cap straight off, only when you are ready to inject. Do not leave the white cap off for more than 5 minutes. This can dry out the medicine.
It is normal to see a drop of liquid at the end of the needle or green safety guard.
- Do not twist or bend the white cap.
- Do not put the white cap back onto the autoinjector.
- Do not remove the white cap from the autoinjector until you are ready to inject.
Stretch or pinch your injection site to create a firm surface.
Stretch method
Stretch skin firmly by moving your thumb and fingers in opposite directions, creating an area about 2 inches wide.
ORPinch method
Pinch skin firmly between your thumb and fingers, creating an area about 2 inches wide.
Important: Keep skin stretched or pinched while injecting.
Step 3: Inject
Hold the stretch or pinch. With the white cap off, place the autoinjector on your skin at 90 degrees.
Important: Do not touch the purple start button yet.
Firmly push the autoinjector down onto skin until the autoinjector stops moving.
Important: You must push all the way down but do not touch the purple start button until you are ready to inject.
When you are ready to inject, press the purple start button. You will hear a click.
Keep pushing down on your skin. Your injection could take about 15 seconds. When the injection is complete, you may hear or feel a click and the window will turn yellow.
Note: After you remove the autoinjector from your skin, the needle will be automatically covered.
Important: When you remove the autoinjector, if the window has not turned yellow, or if it looks like the medicine is still injecting, this means you have not received a full dose. Call your healthcare provider immediately.
Step 4: Finish
Discard the used autoinjector and the white cap.
Put the used AIMOVIG autoinjector and white cap in a FDA-cleared sharps disposal container right away after use. Do not throw away (dispose of) the SureClick autoinjector in your household trash.
If you do not have a FDA-cleared sharps disposal container, you may use a household container that is:
- Made of a heavy-duty plastic
- Can be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out
- Upright and stable during use
- Leak-resistant
- Properly labeled to warn of hazardous waste inside the container
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes. For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: http://www.fda.gov/safesharpsdisposal
- Do not reuse the autoinjector.
- Do not recycle the autoinjector or sharps disposal container or throw them into household trash.
Important: Always keep the sharps disposal container out of the reach of children.
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 an adhesive bandage if needed.
Check your prescription. If your dose is 140 mg, repeat Steps 1 through 4.
The second injection will complete your dose.
Commonly asked questions
What will happen if I press the purple start button before I am ready to do the injection on my skin?
Even when you press the purple start button, the injection will only happen when the green safety guard is also pushed into the autoinjector.
Can I move the autoinjector around on my skin while I am choosing an injection site?
It is okay to move the autoinjector around on the injection site as long as you do not press the purple start button. However, if you press the purple start button and the green safety guard is pushed into the autoinjector, the injection will begin.
Can I release the purple start button after I start my injection?
You can release the purple start button, but continue to hold the autoinjector firmly against your skin during the injection.
Will the purple start button pop up after I release my thumb?
The purple start button may not pop up after you release your thumb if you held your thumb down during the injection. This is okay.
What do I do if I did not hear a click after pushing the device down on my skin for 15 seconds?
If you did not hear a click, you can confirm a complete injection by checking that the window has turned yellow.
Whom do I contact if I need help with the autoinjector or my injection?
If you need more information or help, visit www.aimovig.com or call 1-800-77-AMGEN (1-800-772-6436).
For more information, go to www.aimovig.com or call 1-800-77-AMGEN (1-800-772-6436).
AIMOVIG™ (erenumab-aooe)
Manufactured by:
Amgen Inc.
One Amgen Center Drive
Thousand Oaks, CA 91320-1799 USA
U.S. License No. 1080
Marketed by:
Amgen Inc. (Thousand Oaks, CA 91320), and
Novartis Pharmaceuticals Corporation (East Hanover, NJ 07936)
© 2018 Amgen Inc. All rights reserved.
Symbol table
This product contains dry natural rubber
Do not reuse
CAUTION,
consult accompanying documents
Lot number
This Instructions for Use has been approved by the U.S. Food and Drug Association.
Approved: 05/2018
TS00517 v1