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Single-Use On-Body Infusor and Prefilled Cartridge
Cartridge bottom
Medicine
Front view
Cartridge door
(Do not close
without cartridge)
Back view
Battery
Strip
Left pull tab
Important: Needle is inside.
Instructions for Use:
Pushtronex
Repatha
®
(evolocumab)
Guide to parts
Prefilled Cartridge
White plunger
On-Body Infusor
Skin
Status
adhesive
light
Needle cover
®
System for
(ri-PAth-a)
Cartridge top (Do not rotate)
Cartridge label
Start button
(Do not press until ready to inject)
Adhesive paper
Needle inside
(under cover)
Right pull tab
Medicine window
Pull tabs
Page 1
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Summary of Contents for Repatha Pushtronex
- Page 1 Instructions for Use: Pushtronex ® System for Repatha ® (ri-PAth-a) (evolocumab) Single-Use On-Body Infusor and Prefilled Cartridge Guide to parts Prefilled Cartridge White plunger Cartridge top (Do not rotate) Cartridge bottom Medicine Cartridge label On-Body Infusor Front view Skin Status...
- Page 2 Important Before you use the on-body infusor and prefilled cartridge for use with Repatha (evolocumab), read this important information: ● It is important that you do not try to give yourself the injection unless you have received training from your healthcare provider.
- Page 3 The on-body infusor and prefilled cartridge are not made with natural rubber latex. A healthcare provider who knows how to use the on-body infusor should be able to answer your questions. For more information, call 1-844-REPATHA (1-844-737-2842) or visit www.REPATHA.com.
- Page 4 Gather all materials needed for your injection and then wash your hands well with soap and water. On a clean, well-lit work surface, place the: ● Clear tray containing the on-body infusor and prefilled cartridge ● Alcohol wipes ● Cotton ball or gauze pad ●...
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Page 5: Step 2: Get Ready
● Do not use if any part of the cartridge looks cracked or broken. ● Do not use if pieces of the cartridge are missing or not securely attached. In any above cases, use a new on-body infusor and prefilled cartridge and call 1-844-REPATHA (1-844-737-2842) or visit www.REPATHA.com. Page 5... - Page 6 Clean the cartridge bottom. Grab Here With 1 hand, hold the cartridge barrel and clean the cartridge bottom with an alcohol wipe. ● Do not remove or rotate the cartridge top or bottom. ● Do not touch the bottom of the cartridge after cleaning with alcohol wipe. Load the cleaned cartridge into the on-body infusor and firmly press on the top until it is secured in place.
- Page 7 Swing the door to the left. Then, squeeze firmly until it snaps shut. Apply enough pressure when closing the door and make sure there is a “snap” before going to the next step. Squeeze Tight “snap” Make sure the cartridge fits securely in the on-body infusor before you close the door. ●...
- Page 8 You must remove both green pull tabs to turn the loaded on-body infusor on. You will hear beeping and see a flashing blue status light. ● Do not pull the skin adhesive backing off the on-body infusor. ● Do not touch the skin adhesive. ●...
- Page 9 Make sure you see a green, flashing status light. You may hear beeps that mean your injection has started. Important: If medication leaks from the on-body infusor, call 1-844-REPATHA (1-844-737-2842) or visit www.REPATHA.com. The injection takes about nine minutes to finish. The status light turns solid green, and the device beeps, when done.
- Page 10 Check to see that the used plunger fills the medicine window all the way, and the green solid light turns off, letting you know all medicine has been injected. If the plunger did not fill the window, call 1-844-REPATHA (1-844-737-2842) or visit www.REPATHA.com. ● The used on-body infusor will beep when removed from your skin.
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Page 11: Troubleshooting
What do I do if the loaded on-body infusor status light continuously flashes red and I hear beeps? Stop using the loaded on-body infusor. If the on-body infusor is attached to your body, carefully remove it. Call 1-844-REPATHA (1-844-737-2842) or visit www.REPATHA.com. Page 11... -
Page 12: Commonly Asked Questions
What if I cannot open the cartridge door to insert the cartridge? To open the on-body infusor door, press on the left side of the door to release the door latch. If you are still unable to open the door, call 1-844-REPATHA (1-844-737-2842) or visit www.REPATHA.com. -
Page 13: Symbol Table
Manufactured by: Amgen Inc. One Amgen Center Drive Thousand Oaks, CA 91320-1799 © 2015-2017, 2019 Amgen Inc. All rights reserved. <part number> Revised: 04/2019 v5 U.S. License Number 1080 Additional environmental conditions Relative humidity range is 15% to 85%. Altitude range is -984 feet to 11483 feet (-300 meters to 3500 meters). During injection, keep the on-body infusor a minimum of 4 inches (10 cm) away from other electronics such as cellular phones.
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