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OPIOID EMERGENCIES

In the United States, opioid emergencies may happen more often than you think

  • >33,000 deaths due to opioids in 2015—more than half due to prescription opioid painkillers1
  • ~85% of deaths from prescription opioid painkillers are unintentional2
  • >560,000 opioid-related emergency department visits in 20143
  • >6,000 children 0–5 years of age experience unintentional opioid exposure each year4

TAKING OPIOIDS MAY PUT YOU OR OTHERS AT RISK FOR AN ACCIDENTAL OPIOID EMERGENCY

Know the risk factors

Opioid overdose does not just happen only to people who abuse or intentionally misuse opioid medications. People may be at increased risk of an opioid emergency for a variety of reasons, including:

Combining opioids with other medications, such as anxiety medication5-7
Consuming alcohol while taking opioids7
Taking any dose of opioids, taking extended release or long acting opioids, beginning opioid therapy, changing an opioid dosage, or switching to a different opioid8-11
Being a young child in the household of someone taking opioids, or being elderly or debilitated4,12
Having other conditions such as COPD or sleep apnea, liver or kidney problems, or substance use disorder including opioid use disorder7,12,13

Know the signs of an opioid emergency, which may include14

  • Unusual sleepiness or unresponsiveness
  • Breathing problems, from slow or shallow breathing to not breathing at all
  • Very small or “pinpoint” pupils
  • Slow heartbeat
  • Fingernails or lips turning blue/purple

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.

References 1. Rudd RA, Seth P, David F, Scholl L. Increases in drug and opioid-involved overdose deaths—2010-2015. MMWR. 2016;65(50-51):1445-1452. 2. Centers for Disease Control and Prevention. CDC Wonder: About multiple causes of death, 1999-2015. http:// wonder.cdc.gov/mcd-icd10.html. Accessed April 10, 2017. 3. Weiss AJ, Elixhauser A, Barrett ML, Steiner CA, Bailey MK, O’Malley L. Opioid-related inpatient stays and emergency department visits by state, 2009-2014. https://www.hcup-us. ahrq.gov/reports/statbriefs/sb219-Opioid-Hospital-Stays-ED-Visits-by-State.pdf. Accessed April 10, 2017. 4. Allen JD, Casavant MJ, Spiller HA, Thipalak C, Hodges NL, Smith GA. Prescription opioid exposures among children and adolescents in the United States: 2000-2015. Pediatrics. 2017:139(4):e20163382. 5. U.S. Food and Drug Administration. FDA warns about serious risks and death when combining opioid pain or cough medications with benzodiazepines; requires its strongest warning. August 31, 2016. https://www.fda.gov/Drugs/DrugSafety/ucm518473.htm. Accessed May 17, 2017. 6. SmIth HS. Opioid metabolism. Mayo Clin Proc. 2009;84(7):613-624. 7. Gudin JA, Mogali S, Jones JD, Comer SD. Risks, management, and monitoring of combination opioid, benzodiazepines, and/or alcohol use. Postgrad Med. 2013;125(4):115-130. 8. Dunn KM, Saunders KW, Rutter CM, et al. Overdose and prescribed opioids: associations among chronic non-cancer pain patients. Ann Intern Med. 2010;152(2):85-92. 9. Miller M, Barber CW, Leatherman S, et al. Prescription opioid duration of action and the risk of unintentional opioid overdose among patients receiving opioid therapy. JAMA Intern Med. 2015;175(4):608-615. 10. FDA Blueprint for prescriber education for extended-release and long-acting opioid analgesics 12/2014. http://www.fda.gov/downloads/Drugs/DrugSafety/InformationbyDrugClass/UCM277916.pdf. Accessed November 3, 2016. 11. Webster RL, Fine PG. Review and critique of opioid rotation practices and associated risks of toxicity. Pain Med. 2012;13(4):562-570. 12. Beaudoin FL, Merchant RC, Janicki A, McKaig DM, Babu KM. Preventing iatrogenic overdose: a review of in-emergency department opioid-related adverse drug events and medication errors. Ann Emerg Med. 2015;65(4):423-431. 13. Volkow ND, McLellan AT. Opioid abuse in chronic pain—misconceptions and mitigation strategies. N Engl J Med. 2016;374:1253-1263. 14. Substance Abuse and Mental Health Services Administration. SAMHSA Opioid Overdose Prevention Toolkit. HHS Publication No. (SMA) 16-4742. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2016.
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.

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  • All rights reserved.
  • PP-EVZ-US-1367
  • August 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 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.