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Evzio

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Evzio

PATIENT INFORMATION

EVZIO™
(EVV-zee-oh)
(naloxone hydrochloride injection) Auto-Injector

You and your caregivers should read this Patient Information leaflet before an opioid emergency happens. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about EVZIO?

EVZIO is used to temporarily reverse the effects of opioid medicines. The medicine in EVZIO has no effect in people who are not taking opioid medicines. Always carry EVZIO with you in case of an opioid emergency.

  1. Use EVZIO right away if you or your caregiver think signs or symptoms of an opioid emergency are present because an opioid emergency can cause severe injury or death. Signs and symptoms of an opioid emergency may include:
    • unusual sleepiness and you are not able to awaken the person with a loud voice or rubbing firmly on the middle of their chest (sternum)
    • breathing problems including slow or shallow breathing in someone difficult to awaken or they look like they are not breathing
    • the black circle in the center of the colored part of the eye (pupil) is very small, sometimes called “pinpoint pupils” in someone difficult to awaken
  2. Family members, caregivers, or other people who may have to use EVZIO in an opioid emergency should know where EVZIO is stored and how to give EVZIO before an opioid emergency happens.
  3. Get emergency medical help right away after using the first dose of EVZIO.
  4. The signs and symptoms of an opioid emergency can return within several minutes after EVZIO is given. If this happens, give additional injections using a new EVZIO auto-injector every 2 to 3 minutes and continue to closely watch the person until emergency help is received.

What is EVZIO?

  • EVZIO is a prescription medicine used for the treatment of an opioid emergency such as an overdose or a possible opioid overdose with signs of breathing problems and severe sleepiness or not being able to respond.
  • EVZIO is to be given right away by a caregiver and does not take the place of emergency medical care. Get emergency medical help right away after the first dose of EVZIO, even if the person wakes up.

Who should not use EVZIO?

Do not use EVZIO if you are allergic to naloxone hydrochloride or any of the ingredients in EVZIO. See the end of this leaflet for a complete list of ingredients in EVZIO.

What should I tell my healthcare provider before using EVZIO?

Before using EVZIO, tell your healthcare provider about all of your medical conditions, including if you:

  • have heart problems
  • are pregnant or plan to become pregnant. Use of EVZIO may cause withdrawal symptoms in your unborn baby. Your unborn baby should be examined by a healthcare provider right away after you use EVZIO.

Tell your healthcare provider about the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

How should I use EVZIO?

Read the “Instructions for Use” at the end of this Patient Information leaflet for detailed information about the right way to use EVZIO.

  • You should use EVZIO exactly as prescribed by your healthcare provider.
  • Each EVZIO auto-injector contains only 1 dose of medicine.
  • EVZIO should be injected into the muscle or skin of the outer thigh. It can be injected through clothing if needed.
  • Caregivers should pinch the thigh muscle while injecting EVZIO into a child under the age of one.
  • A Trainer for EVZIO with a separate “Trainer Instructions for Use” leaflet is included with EVZIO. For additional training information and video instructions go to www.EVZIO.com or call 1-855-773-8946.
    • Practice with the Trainer for EVZIO before an opioid emergency happens to make sure you are able to safely use the real EVZIO in an emergency.
    • The Trainer for EVZIO does not contain a needle or medicine. It can be reused to practice your injection.
    • The red safety guard can be removed and replaced on the Trainer for EVZIO.

What are the possible side effects of EVZIO?

EVZIO may cause serious side effects, including:

  • Sudden opioid withdrawal symptoms. In someone who has been using opioids regularly, opioid withdrawal symptoms can happen suddenly after receiving EVZIO and may include: body aches, fever, sweating, runny nose, sneezing, goose bumps, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, stomach cramping, increased blood pressure, and increased heart rate. In infants under 4 weeks old who have been receiving opioids regularly, sudden opioid withdrawal may be life-threatening if not treated the right way. Signs and symptoms include: seizures, crying more than usual and increased reflexes.

These are not all of the possible side effects of EVZIO. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store EVZIO?

  • Store EVZIO at room temperature between 59°F to 77°F (15°C to 25°C).
  • Keep EVZIO in its outer case until ready to use.
  • Occasionally check EVZIO through the viewing window of the auto-injector. The solution should be clear. If the EVZIO solution is discolored, cloudy, or contains solid particles, replace it with a new EVZIO.
  • Your EVZIO has an expiration date. Replace it before the expiration date.

Keep EVZIO and all medicines out of the reach of children.

General information about the safe and effective use of EVZIO

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use EVZIO for a condition for which it was not prescribed. You can ask your pharmacist or healthcare provider for information about EVZIO that is written for health professionals.

What are the ingredients in EVZIO?

Active ingredient: naloxone hydrochloride

Inactive ingredients: sodium chloride, hydrochloric acid to adjust pH, and water EVZIO is not made with natural rubber latex.

Instructions for Use

EVZIO
(EVV-zee-oh)
(naloxone hydrochloride injection) Auto-Injector

Read the Instructions for Use that comes with EVZIO before using it. Talk to your healthcare provider if you or your caregivers have any questions about the use of EVZIO.

Automated voice instructions

EVZIO has a speaker that provides voice instructions to help guide you through each step of the injection. See Figure A. If the voice instructions do not work for any reason, EVZIO will still work. If this happens, use EVZIO as instructed below and follow the written instructions on the EVZIO auto-injector label.

Figure A

EVZIO auto-injector - Illustration

How to use EVZIO

Step 1. Pull EVZIO from the outer case. See Figure B.

Figure B

Pull EVZIO from the outer case - Illustration

Do not go to Step 2 (Do not remove the Red safety guard.) until you are ready to use EVZIO. If you are not ready to use EVZIO, put it back in the outer case for later use.

Step 2. Pull off the Red safety guard. 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.

Figure C

Pull off the Red safety guard - Illustration

If an accidental injection happens, get medical help right away.

Note: The Red safety guard is made to fit tightly. Pull firmly to remove.

Do not replace the Red safety guard after it is removed.

Step 3. Place the Black end of EVZIO against the outer thigh, through clothing, if needed. Press firmly and hold in place for 5 seconds. See Figure D.

If you give EVZIO to an infant less than 1 year old, pinch the middle of the outer thigh before you give EVZIO and continue to pinch while you give EVZIO.

Figure D

Press firmly and hold in place for 5 seconds - Illustration

Note: EVZIO makes a distinct sound (click and hiss) when it is pressed against the thigh. This is normal and means that EVZIO is working correctly. Keep EVZIO firmly pressed on the thigh for 5 seconds after you hear the click and hiss sound. The needle will inject and then retract back up into the EVZIO auto-injector and is not visible after use.

Step 4. After using EVZIO, get emergency medical help right away. If symptoms return after an injection with EVZIO, an additional injection using another EVZIO may be needed. Give additional injections using a new EVZIO auto-injector every 2 to 3 minutes and continue to closely watch the person until emergency help is received.

EVZIO cannot be reused. After use, place the auto-injector back into its outer case. Do not replace the Red safety guard.

How to know that EVZIO has been used. See Figure E.

  • The Black base will lock into place.
  • The voice instruction system will state that EVZIO has been used and the LED will blink red.
  • The Red safety guard cannot be replaced.
  • The viewing window will no longer be clear. You will see a red indicator.

Figure E

Picture of used EVZIO - illustration

What to do after EVZIO has been used:

  • Get emergency medical help right away.
  • Put the used EVZIO back into its outer case.
  • Do not throw away the EVZIO in household trash. Do not recycle EVZIO.
  • Used EVZIO should be taken to a healthcare setting for proper disposal in a sharps container.

There may be local or state laws about how to throw away used auto-injectors.*

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

How should I store EVZIO?

  • Store EVZIO at room temperature between 59°F to 77°F (15°C to 25°C).
  • Keep EVZIO in its outer case until ready to use.
  • Occasionally check EVZIO through the viewing window of the auto-injector. The solution should be clear. If the EVZIO solution is discolored, cloudy, or contains solid particles, replace it with a new EVZIO.
  • Your EVZIO has an expiration date. Replace it before the expiration date.

Keep EVZIO and all medicines out of the reach of children.

Trainer for EVZIO™

Trainer Instructions for Use

Important:

The Trainer for EVZIO Does Not contain a needle or medicine. Always carry your real EVZIO with you in case of an opioid emergency.

Tell your family, friends, co-workers or other individuals who may need to use EVZIO during an opioid emergency, where you keep your EVZIO.

Important Information about the Trainer for EVZIO:

Inside your Trainer for EVZIO are:

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

The Trainer for EVZIO batteries are made to last for over 1,000 demonstrations or practices.

If the electronic voice instructions do not work properly, the Trainer for EVZIO can still be used for demonstration or practice. If this happens, use the instructions below and follow the written instructions on the Trainer for EVZIO label.

What is the Trainer for EVZIO?

  • The Trainer for EVZIO does not contain a needle or medicine and can be reused to practice your injection.
  • Practice with the Trainer for EVZIO before an opioid emergency happens to make sure you are able to safely use the real EVZIO in an emergency.
  • A Trainer for EVZIO comes with each EVZIO prescription so that you and your caregiver can practice and demonstrate how to use EVZIO.

Figure A

Trainer for EVZIO - Illustration

Trainer for EVZIO:

  • is inside a white and black outer case
  • does not contain a needle or medicine
  • can be reused (the Red safety guard can be placed back on the Black base after use)
  • has no expiration date

EVZIO:

  • is inside a purple and yellow outer case
  • contains a needle and medicine
  • cannot be reused (the Red safety guard cannot be placed back on the Black base after it is removed)
  • has an expiration date

In case of an opioid overdose or possible opioid overdose emergency, use the real EVZIO and not the TRAINER for EVZIO.

Who should practice using the Trainer for EVZIO?

Anyone who may need to help you with EVZIO in case of an opioid overdose or possible overdose emergency should practice using the Trainer for EVZIO.

Have them practice using the Trainer for EVZIO and review the Patient Information leaflet included in the packaging with your prescription of EVZIO.

For more information and video instructions on the use of EVZIO, go to http://www.EVZIO.com or call 1-855-77-EVZIO.

Practicing with the Trainer for EVZIO

  • Practice with the Trainer for EVZIO before an opioid emergency happens to make sure you are able to safely use the real EVZIO in the case of an opioid overdose or possible overdose emergency.
  • You and your caregivers should practice every day for the first week after you receive your Trainer for EVZIO, and then at least 1 time each week, to help you feel familiar with using EVZIO quickly and safely during an opioid overdose or possible opioid overdose emergency. Even when you are familiar with using the Trainer for EVZIO, continue to practice using it often.

How to use the Trainer for EVZIO

  • Even though the Trainer for EVZIO does not have a needle and contains no medicine, it works the same way as the real EVZIO.
  • Just like the real EVZIO, the Trainer for EVZIO contains an electronic voice instruction system to help guide you through each step of the injection. If the voice instructions do not work for any reason, you can still use the Trainer for EVZIO to practice using the instructions below and following the written instructions on the Trainer for EVZIO.
  • The Trainer for EVZIO has the same blinking red and green lights as the real EVZIO. These blinking lights help provide visual cues for each voice instruction and step.

Follow these steps to practice using the Trainer for EVZIO

1. Pull the Trainer for EVZIO from the outer case. See Figure B.

2. Pull off Red safety guard. See Figure C.

Figure B

Pull the Trainer for EVZIO from the outer case - Illustration

Figure C

Pull off Red safety guard - Illustration

Note: The Red safety guard is made to fit tight similar to the safety guard on EVZIO. Pull firmly to remove.

3. Place Black end of the Trainer for EVZIO against the middle of the outer thigh (through clothing, if needed), then press firmly, and hold in place for 5 seconds. See Figure D.

Figure D

Press firmly, and hold in place for 5 seconds - Illustration

Only practice using the middle of the outer thigh. The outer thigh is where you would inject with the real EVZIO.

Note: The Trainer for EVZIO makes a distinct sound (click and hiss) when you press it against the outer thigh. This is the same sound that is made with the real EVZIO. This is normal, and indicates EVZIO is working correctly. Do not pull the Trainer for EVZIO away from the leg when you hear the click and hiss sound.

4. After practicing, reset the Trainer for EVZIO:

a. Replace the Red safety guard. See Figure E.

b. Slide the Trainer for EVZIO all the way back into the white outer case to reset the electronic voice system. See Figure F.

Figure E

Replace the Red safety guard - Illustration

Figure F

Slide the Trainer for EVZIO all the way back - Illustration

Note: Do not hold the Black base when replacing the Red safety guard. If you do this, the Black base may not reset properly and may prevent you from inserting the Red safety guard into the Black base. If this happens, remove the Red safety guard and repeat Step 4 above.

Leave the Trainer for EVZIO in its outer case for at least 5 seconds between each time you practice to allow the electronic voice system to reset.

How should I dispose of the Trainer for EVZIO?

The Trainer for EVZIO 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

For more information or questions about the Trainer for EVZIO, go to www.EVZIO.com or call 1-855-773-8946.

How should I store the Trainer for EVZIO?

  • Store the Trainer for EVZIO at room temperature between 59°F to 77°F (15°C to 25°C).
  • Store the Trainer for EVZIO in its outer case.

This Instructions for Use has been approved by the U.S. Food and Drug Administration.

Last reviewed on RxList: 4/14/2014
This monograph has been modified to include the generic and brand name in many instances.

A A A

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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