Evzio

Generic Name: naloxone hydrochloride injection
Date of Approval: April 3, 2014
Company: Kaleo Inc.

Treatment for: Known or suspected opioid (narcotic) overdose

Overview

The U.S. Food and Drug Administration (FDA) has approved Evzio (naloxone hydrochloride) as an emergency treatment for known or suspected opioid overdose. Naloxone is a medication that rapidly reverses the effects of an opioid (narcotic) overdose and is the standard treatment.

Evzio delivers a single naloxone dose via a hand-held auto-injector that can be carried in a pocket or stored at home. Existing naloxone drugs require administration by a trained medical personnel and are given by syringe. Because naloxone does not work as long as opioids, repeat doses may be needed. When Evzio is turned on, it provides verbal instructions to the user.

You and your caregivers should review this Patient Information leaflet BEFORE an opioid (narcotic) or narcotic analgesic combination overdose emergency occurs. You may be responsible for administering this medication and it is important you understand how to use it. This information does NOT take the place of consulting with your healthcare provider about your medical condition or treatment.

FDA Approves Evzio

The U.S. Food and Drug Administration (FDA) has approved Evzio (naloxone hydrochloride injection), an opioid antagonist in a handheld auto-injector indicated for the emergency treatment of a known or suspected opioid overdose.

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What is Evzio?

  • Evzio is a new, injectable drug used to reverse the effects from a known or suspected opioid (narcotic) overdose that may be accompanied by signs of difficult breathing, severe sleepiness or unresponsiveness. Evzio requires a prescription, and can be stored at home, at room temperature, after it is purchased.
  • Evzio is an autoinjector device that contain naloxone and can be given by right away by a caregiver but does NOT replace the need for emergency medical care. Get emergency medical help right away after the first dose of Evzio, even if the person wakes up. Additional medications, including Evzio, and other treatments may be required.

Examples of opioids that could result in an overdose and that could be reversed by Evzio include:

The reversal of depressed breathing by drugs known as partial agonists or mixed agonists/antagonists such as buprenorphine and pentazocine, may be incomplete.

Other opioids, partial agonists or mixed agonists/antagonists may be available that are not on this list.

Important information

Evzio is used to temporarily reverse the effects of opioid (narcotic) 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 because an opioid emergency can cause severe injury or death. Signs and symptoms of an opioid overdose 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 such as slow or shallow breathing in someone difficult to awaken. The person may 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. Go over all the directions in this form with anyone who may need to give Evzio.
  • Get emergency medical help right away after using the first dose of Evzio. Calling 911 is one option to get emergency 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 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. The active ingredient in Evzio is naloxone hydrochoride. Naloxone hydrochloride is also found in a brand product called Narcan.

Inactive ingredients in Evzio include sodium hydrochloride, hydrochloric acid to adjust pH, and water. Evzio is not made with natural rubber latex.

What should I tell my healthcare provider before using Evzio?

You should tell your healthcare provider about all of your medical conditions before you use Evzio. This might include if you:

  • have heart problems or take any medicines for your heart
  • 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?

You should use Evzio exactly as prescribed by your healthcare provider.

  • Each Evzio auto-injector contains only one 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” device with a separate “Trainer Instructions for Use” leaflet is included with the Evzio package labeling supplied by the manufacturer. The “Trainer for Evzio” does not contain a needle or medicine. It can be reused to practice your injection and to teach others. For additional training information and video instructions go to www.Evzio.com or call 1-855-773-8946.

Practice with the “Trainer for Evzio” device before an opioid emergency happens to make sure you are able to safely use the real Evzio in a true emergency.

A “Trainer for Evzio” device comes with each Evzio prescription so that you and your caregiver can practice and demonstrate how to use Evzio.

The red safety guard can be removed and replaced on the “Trainer for Evzio”. The “Trainer for Evzio” is in a white and black outer case. The real Evzio device that contains the medicine naloxone and a needle is in a purple and yellow outer case. In case of an opioid overdose or possible opioid overdose emergency, use the real Evzio device with medication and NOT the Trainer for Evzio.

Further instructions and detailed information about the correct way to use the Evzio device can be found at the end of this Patient Information leaflet under the section entitled “Instructions for Use”. The manufacturer’s package insert also contains additional graphics and Trainer Instructions for Use of the Evzio auto-injector and can be found at www.Evzio.com.

Evzio side effects

Like most drugs, Evzio may cause side effects, and some may be serious. These side effects may include:

  • sudden opioid withdrawal symptoms can occur quickly in some who has been using opioids on a regular basis and receives Evzio. Withdrawal symptoms can vary but 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 less than 4 weeks old who have been receiving opioids regularly, sudden opioid withdrawal can be life-threatening. Opioid withdrawal in a child of this age must be treated correctly. Signs and symptoms include: seizures, excessive crying, and increased reflexes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Are there drug interactions with Evzio?

Many drugs can interact with Evzio, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all medicines you use now and any medicine you start or stop using.

You can review specific drug interactions for naloxone, the generic name for Evzio, here in the drug interactions section.

How is Evzio stored?

  • Evzio should be stored at room temperature between 59 degrees F to 77 degrees F (15 degrees C to 25 degrees 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 with a new Evzio 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

For complete instructions with auto-injector pictures, refer to www.Evzio.com, call 1-855-773-8946 or refer to the patient information found with the Evzio auto-injector. You can also ask your pharmacist for this information.

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. 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.

Refer to the manufacturer's Patient Information for detailed instruction with pictures for correct use of the Evzio Auto-Injector.

Step 1.

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.

Step 2.

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.

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. 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.

Step 4.

After using Evzio, get emergency medical help right away (such as calling 911 in the U.S.) 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.

  • 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.

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.

Manufactured for kaleo, Inc., Richmond, VA, 23219

For more information, go to www.Evzio.com or call 1-855-773-8946.

Source: Patient Information Leaflet and Instructions for Use. Evzio; the U.S. Food and Drug Administration. Issued: 4/2014

Last Update: April 22nd, 2014
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