Auvi-Q (Page 4 of 5)

Instructions for Use

Read these Instructions for Use carefully before you need to use your AUVI-Q. Before you use AUVI-Q, make sure your healthcare provider shows you the right way to use it. If you have any questions, ask your healthcare provider.

If you are administering AUVI-Q to a young child or infant, hold the leg firmly in place and limit movement prior to and while administering an injection.

Automated Voice Instructions

AUVI-Q contains an electronic voice instruction system to help guide you through each step of your injection. If the voice instructions do not work for any reason, use AUVI-Q as instructed in these Instructions for Use. It will still work during an allergic reaction emergency.

How to use your AUVI-Q

Figure A.

1. Pull AUVI-Q up from the outer case. See Figure B.
Do not go to step 2 until you are ready to use AUVI-Q. If you are not ready to use AUVI-Q, put it back in the outer case.

Figure B.

2. Pull Red safety guard down and off of AUVI-Q. See Figure C. To reduce the chance of an accidental injection, do not touch the black base of the auto-injector, which is where the needle comes out. If an accidental injection happens, get medical help right away.

Note: The red safety guard is made to fit tight. Pull firmly to remove.

Figure C.

3. Place black end of AUVI-Q against the middle of the outer thigh (through clothing, if needed), then push firmly until you hear a click and hiss sound, and hold in place for 2 seconds. See Figure D.

Only inject into the middle of the outer thigh. Do not inject into any other part of the body.

If you are administering AUVI-Q to a young child or infant, hold the leg firmly in place while administering an injection See Figure E.

Figure D.

(For AUVI-Q 0.3 mg and AUVI-Q 0.15 mg)

Figure E.

(For AUVI-Q 0.1 mg)

Note: AUVI-Q makes a distinct sound (click and hiss) when you push it against your outer thigh. This is normal and indicates AUVI-Q is working correctly. Do not pull AUVI-Q away from your leg when you hear the click and hiss sound.

The needle automatically retracts after the injection is complete, so the needle will not be visible after the injection. AUVI-Q includes a 2-second countdown after it is activated, then the voice instruction will indicate the injection is complete, and to seek emergency medical attention, AUVI-Q will beep, and the lights will blink red.

4. Get emergency medical help right away.

Replace the outer case and talk to your healthcare provider about the right way to throw away your AUVI-Q.

Ask your healthcare provider for an AUVI-Q prescription refill. After the use of AUVI-Q:

• The black base will lock into place.
• The voice instruction system will say “seek emergency medical attention”, say “this AUVI-Q has been used…”, and the lights will blink red.
• The red safety guard cannot be replaced.
• The viewing window will no longer be clear.
• It is normal for some medicine to remain in your AUVI-Q after you have received your dose of medicine.
• Talk to your healthcare provider about the right way to throw away your AUVI-Q.
• AUVI-Q is a single-use auto-injector and cannot be reused.

Until you throw away your used AUVI-Q, the electronic voice instruction system will remind you that it has been used when the outer case is removed.

If you will be administering AUVI-Q to a young child or infant, ask your healthcare provider to show you how to properly hold the leg in place while administering a dose.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Rev Nov 2017

Manufactured for:
Kaleo, Inc.
Richmond, VA 23219 USA
This product may be covered by one or more U.S. patents or pending patent applications. See www.kaleopharma.com/pat for details.

^* For California Only: This product uses batteries containing Perchlorate Material – special handling may apply. See www.dtsc.ca.gov/hazardouswaste/perchlorate

TRAINER FOR AUVI-Q® Trainer Instructions for Use

Important:
The TRAINER for AUVI-Q Does Not contain a needle or medicine.

In case of an allergic emergency, use the real AUVI-Q and not the gray Trainer. Always carry your real Auvi-Q with you in case of an allergic emergency.

Important Information about the TRAINER for AUVI-Q:

Inside your TRAINER for AUVI-Q are:

• batteries
• a speaker that will make a beeping sound and that produces electronic voice instructions
• red and green blinking lights

The TRAINER for AUVI-Q batteries are made to last long enough for you to practice 1 time each day for 2 years. If your TRAINER for AUVI-Q does not work properly call your healthcare provider for a new Trainer.

What is the TRAINER for AUVI-Q? The TRAINER for AUVI-Q does not contain a needle or medicine and can be reused to practice your injection. Practice with the TRAINER for AUVI-Q before an allergic emergency happens to make sure you are able to safely use the real AUVI-Q in an emergency.
Your TRAINER for AUVI-Q Figure A
TRAINER for AUVI-Q (click image for full-size original) Top view	AUVI-Q AUVI-Q 0.3 mg is orange AUVI-Q 0.15 mg is blue AUVI-Q 0.1 mg is white and lavender
TRAINER for AUVI-Q: is inside a gray outer case does not have a needle or medicine inside can be reused (the red safety guard can be placed back on the base of the Trainer after use) has no expiration date has embossed “TRAINER” on top of the device	AUVI-Q: is inside an orange (0.3 mg) or blue (0.15 mg) or white and lavender (0.1 mg) outer case contains a needle and epinephrine medicine cannot be reused (the red safety guard cannot be placed back on the base of AUVI-Q after use) has a medicine expiration date listed on the device
In case of an allergic emergency, use the real AUVI-Q and not the gray Trainer.
Who should practice using the TRAINER for AUVI-Q? Anyone who may need to help you with AUVI-Q in case of an allergic emergency: You Caregivers Family Friends Co-workers Teachers Child Care or Day Care Workers Have them practice using the Trainer and review the Patient Information Leaflet included in the packaging with each prescription of AUVI-Q. For more information and video instructions on the use of AUVI -Q, go to www.AUVI-Q.com or call 1-844-828-8472.
Practicing with the TRAINER for AUVI-Q Practice with the TRAINER for AUVI-Q before an allergic emergency happens to make sure you are able to safely use the real AUVI-Q in an emergency. You should practice daily for the first week after you receive your TRAINER for AUVI-Q to help you feel comfortable using AUVI-Q quickly and safely. Even when you are comfortable using the Trainer, continue to practice using it often.
How to Use the Trainer
How the TRAINER for AUVI-Q works Although the Trainer does not have a needle and contains no medicine, it works the same way as the real AUVI-Q. As with the real AUVI-Q, the TRAINER for AUVI-Q contains an electronic voice instruction system to help guide you through each step of your injection. If the voice instructions do not work for the TRAINER for AUVI-Q for any reason, you can still use the TRAINER for AUVI-Q as instructed in this leaflet to practice. The TRAINER for AUVI-Q has the same blinking red and green lights as the real AUVI-Q. As with the real AUVI-Q, if practicing with a young child or infant, hold the leg firmly in place while using the TRAINER for AUVI-Q. Ask your healthcare provider to show you how to properly hold the leg to practice so that you will be prepared before an allergic emergency happens.

Follow These Steps
1.Pull the TRAINER for AUVI-Q from the outer case. See Figure B 2. Pull Red safety guard down and off of the Trainer. See Figure C.
Figure B	Figure C
Note: The red safety guard is made to fit tight similar to the safety guard on the real AUVI-Q. Pull firmly to remove.
3. Place black end against the middle of the outer thigh (through clothing, if needed), then push firmly until you hear a click and hiss sound, and hold in place for 2 seconds. See Figure D. As with the real AUVI-Q, if practicing with a young child or infant, hold the leg firmly in place while using the TRAINER for AUVI-Q. (See Figure E).
Figure D (click image for full-size original)	Figure E
Note: In an actual emergency, after the injection you would need to seek medical help right away. Only practice using the middle of your outer thigh. The outer thigh is where you would inject with the real Auvi-Q. Note: The TRAINER for AUVI-Q makes a distinct sound (click and hiss) when you push it firmly against your outer thigh. This is the same sound that is made with the real AUVI-Q. This is normal, and indicates AUVI-Q is working correctly. Do not pull AUVI-Q away from your leg when you hear the click and hiss sound.
4. After practicing, reset the TRAINER for AUVI-Q: a. Replace the Red safety guard. Do not hold the black base while inserting the Red safety guard. The Black base will drop down into its original location during Red safety guard insertion. See Figure F. b. Slide the TRAINER for AUVI-Q all the way back into the gray outer case to reset the electronic voice system. See Figure G.
Figure F	Figure G
Note: Leave the TRAINER for AUVI-Q in its outer case for at least 5 seconds between each time you practice to allow the electronic voice system to reset.

Storage:

• Store the TRAINER for AUVI-Q at room temperature; the TRAINER for AUVI-Q should not be used at temperatures less than 50°F (10°C) or greater than 104°F (40°C).
• Store the TRAINER for AUVI-Q in its outer case.
• Keep the TRAINER for AUVI-Q away from dirt, chemicals, and water.

Disposal:
The TRAINER for AUVI-Q contains electronics and lithium coin cell batteries, and should be disposed of in the correct manner. Follow your State and local environmental regulations for disposal.

For California Only: This product uses batteries containing Perchlorate Material — special handling may apply. See www.dtsc.ca.gov/hazardouswaste/perchlorate

Manufactured for:
Kaleo, Inc. Richmond, VA 23219 USA

This product may be covered by one or more U.S. patents or pending patent applications. See www.kaleopharma.com/pat for details.

Rev Nov 2017