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Get to Know EVZIO

The first and only naloxone auto-injector

EVZIO is a take-home, hand-held, single-use naloxone auto-injector that may be used wherever an opioid overdose occurs. If you accidentally overdose on your opioid medication, a family member, friend, or other caregiver can administer EVZIO to temporarily reverse the effects of the overdose and help keep you breathing until emergency medical assistance is available.

EVZIO should 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.

If you have an opioid overdose, you are likely to be unconscious and unable to use EVZIO yourself. That's why it's so important to have a caregiver, such as a family member or friend, who is always prepared to administer EVZIO for you, just in case.

User-friendly features guide the way

EVZIO contains the Intelliject® Prompt System (IPS™). This system makes EVZIO easy to use, even for people who don't have medical training.

See How EVZIO Works

Click on each to take a closer look.

The outer case protects EVZIO until it is ready to use. Voice instructions begin after the outer case is removed.

EVZIO delivers a single 0.4 mg (0.4 mL) dose of naloxone. Each prescription comes with 2 EVZIO auto-injectors, just in case you need more than one dose, and a Trainer that you can use for practice.

After the outer case is removed, voice instructions help guide the user through the injection process. The voice instructions count down (5...4...3...2...1), then say, "Injection complete. Seek emergency medical attention."

Step-by-step administration instructions are printed on EVZIO. If the voice instructions do not work for any reason, EVZIO will still work when used according to the written instructions.

The viewing window lets you make sure the naloxone medication in EVZIO is clear. EVZIO should not be used if the medication is discolored, cloudy, or contains particles. Instead, take EVZIO to your doctor for proper disposal and ask for a new prescription.

Red and green lights provide additional guidance for correctly using EVZIO.

The retractable needle system helps prevent against accidental needle sticks. The needle is not visible before, during, or after an injection.

When the black base is pressed firmly against the outer thigh, through clothing (pants, jeans, etc) if necessary, a countdown begins (5...4...3...2...1) and the injection occurs. Post-injection, the needle retracts fully into its housing, the black base locks in place, a red indicator appears in the viewing window, and voice instructions say, "Injection complete. Seek emergency medical attention."

The red safety guard helps keep the needle inside EVZIO clean and free from germs. Once the red safety guard has been removed, it should not be replaced. EVZIO should be used immediately or taken to your healthcare provider for proper disposal in a sharps container.

Note: the red safety guard on the Trainer can be replaced.

Healthcare providers have used naloxone for more than 40 years to help treat people who have had an opioid overdose. EVZIO is approved to be the first and only naloxone auto-injector to be administered by family members and caregivers.
INDICATION

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.
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.

  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.

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 use 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.

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.

For more information about EVZIO, call 1-855-77-EVZIO (1-855-773-8946).

  • ©2016 kaleo, Inc.
  • All rights reserved.
  • PP-EVZ-US-0861
  • February 2016
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 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.

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.

  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.
  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.

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 use 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.

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.