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Reach for voice guidance

EVZIO is the first and only intelligent take-home naloxone auto-injection system with voice and visual guidance—designed to help caregivers take fast, confident action administering naloxone in an opioid emergency.

  • EVZIO can temporarily reverse the effects of opioids and help keep a patient breathing until emergency medical assistance is available
  • Get emergency medical help right away after the first dose of EVZIO, even if the person wakes up
  • If symptoms return after an injection with EVZIO, an additional injection using another EVZIO may be needed

Seconds count in an opioid emergency—have a plan in place

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  • Most life-threatening opioid emergencies occur in the home, witnessed by friends or family
  • Lack of oxygen from an opioid emergency may lead to severe and permanent brain damage in as little as 4 minutes, yet the average EMS response time is 9.4 minutes according to the National EMS Information System

Voice and visual guidance may help friends, family, or other caregivers without medical training correctly use EVZIO when they are the first to respond.

Get to know EVZIO

INTELLIGENT VOICE GUIDANCE: Simple, on-the-spot voice and visual guidance helps caregivers take fast, confident action administering naloxone during an opioid emergency and reminds the user to call 911

  • Each prescription includes a Trainer for EVZIO, allowing patients and caregivers to practice

EASY TO USE: Studies show 94% of users correctly administered EVZIO without training, and 100% with training*

SELF-CONTAINED SYSTEM: Prefilled, durable, and portable—small enough to fit in most pockets

  • Is administered intramuscularly or subcutaneously into the outer thigh, through clothing if needed

*Based on the averaged results from 2 adequate and well-controlled usability studies.


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Does your EVZIO look different than this? Learn More

FREQUENTLY ASKED QUESTIONS

Why is my EVZIO yellow and purple?

The EVZIO 0.4 mg device and carton are yellow and purple and are no longer being manufactured. The EVZIO 2 mg device and carton are blue and purple and are now available. Although EVZIO 0.4 mg, with the yellow and purple packaging, is no longer available for prescribing, it remains a safe and effective treatment for opioid emergencies. Always carry your EVZIO with you in case of an opioid emergency.

Does the 0.4 mg dose not work?

EVZIO 0.4 mg remains a safe, effective option for treatment of an opioid emergency.

Can I still use EVZIO 0.4 mg?

Yes—EVZIO 0.4 mg remains a safe, effective option for treatment of an opioid emergency until the expiration date.

Can I still get EVZIO 0.4 mg from my doctor?

EVZIO 0.4 mg is no longer being manufactured. When you need to refill your EVZIO prescription, ask your doctor if EVZIO 2 mg is right for you.

Where do I go for more information on EVZIO 2 mg?

For more information on EVZIO 2 mg, review this website or call 1-855-77-EVZIO (1-855-773-8946). You should speak with your healthcare provider to see if EVZIO 2 mg is right for you.

Using EVZIO

You should use EVZIO exactly as prescribed by your healthcare provider and as described in the Patient Instructions for Use. Each EVZIO auto-injector contains only one dose of medicine.

As part of your opioid emergency plan, practice using the Trainer for EVZIO. Make sure your family and caregiver also practice using the Trainer for EVZIO.

Administration steps

Pull EVZIO from the outer case.

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.

Pull off the red safety guard.

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 tightly. Pull firmly to remove.

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

Place the black end against the middle of the patient's outer thigh, through clothing (pants, jeans, etc.) if necessary, then press firmly and hold in place for 5 seconds.

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.

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.

After using EVZIO, get emergency medical help immediately.

For more detailed information on how to use EVZIO, click here.

If a family member, friend, or other caregiver thinks the patient is having an opioid emergency—even if they are not sure—they should still use EVZIO and call 911 or seek emergency medical assistance.

A Trainer for Evzio is included with every prescription for practice

Each EVZIO prescription comes with a black-and-white Trainer that can be used for practice. Unlike EVZIO, the Trainer for EVZIO:

Does not have a needle
Does not have an expiration date
Does not contain medicine or any liquid
Can be reused (more than 1,000 times)

To be prepared in an opioid emergency, patients, family members, caregivers, and other individuals who may have to administer EVZIO should practice using the Trainer for EVZIO to become familiar with the injection process. After practicing with the Trainer for EVZIO, the electronic voice system should be reset by:

  • Replacing the red safety guard
  • Sliding the Trainer for EVZIO all the way back into the outer case

The Trainer for EVZIO should be left in its outer case for at least 5 seconds between each practice to allow the electronic voice system to reset properly. For more information on the Trainer for EVZIO, view the Trainer Information.

TALK TO YOUR HEALTHCARE PROVIDER TO LEARN MORE ABOUT EVZIO.

YOU ALSO CAN CALL 1-855-77-EVZIO (1-855-773-8946)
FOR MORE INFORMATION ABOUT EVZIO.

INDICATION

What is EVZIO?

EVZIO is a prescription medicine used in adults and children 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 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.

EVZIO is safe and effective in children for known or suspected opioid overdose.

IMPORTANT SAFETY INFORMATION

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.

  • Use EVZIO right away if you or your caregiver think signs or symptoms of an opioid emergency are present, even if you are not sure, 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
  • 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.
  • Get emergency medical help right away after using the first dose of EVZIO. Rescue breathing or CPR (cardiopulmonary resuscitation) may be given while waiting for emergency medical help.
  • The signs and symptoms of an opioid emergency can return within several minutes after EVZIO is given. If this happens, give additional injections using new EVZIO auto-injectors every 2 to 3 minutes and continue to closely watch the person until emergency help is received.

Who should not use EVZIO?

Do not use EVZIO if you are allergic to naloxone hydrochloride or any of the ingredients in EVZIO.

What are the ingredients in EVZIO?

Active ingredient: naloxone hydrochloride
Inactive ingredients: sodium chloride, hydrochloric acid to adjust pH, and water

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 are given EVZIO.

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

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.

Common side effects of EVZIO include dizziness and injection site redness.

These are not all of the possible side effects of EVZIO. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for full Prescribing Information.

  • ©2017 kaleo, Inc.
  • All rights reserved.
  • PP-EVZ-US-1299
  • April 2017
IMPORTANT SAFETY INFORMATION

INDICATION

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.

INDICATION

What is EVZIO?

EVZIO is a prescription medicine used in adults and children 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 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.

EVZIO is safe and effective in children for known or suspected opioid overdose.

IMPORTANT SAFETY INFORMATION

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.

  • Use EVZIO right away if you or your caregiver think signs or symptoms of an opioid emergency are present, even if you are not sure, 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
  • 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.
  • Get emergency medical help right away after using the first dose of EVZIO. Rescue breathing or CPR (cardiopulmonary resuscitation) may be given while waiting for emergency medical help.
  • The signs and symptoms of an opioid emergency can return within several minutes after EVZIO is given. If this happens, give additional injections using new EVZIO auto-injectors every 2 to 3 minutes and continue to closely watch the person until emergency help is received.

Who should not use EVZIO?

Do not use EVZIO if you are allergic to naloxone hydrochloride or any of the ingredients in EVZIO.

What are the ingredients in EVZIO?

Active ingredient: naloxone hydrochloride
Inactive ingredients: sodium chloride, hydrochloric acid to adjust pH, and water

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 are given EVZIO.

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

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.

Common side effects of EVZIO include dizziness and injection site redness.

These are not all of the possible side effects of EVZIO. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for full Prescribing Information.