(BPT) - The opioid epidemic is on the rise. According to the Centers for Disease Control and Prevention, 91 Americans die every day from an opioid overdose -- that includes prescription drugs and heroin --and more than 6,000 children (0-5 years of age) experience unintentional opioid exposure each year. 1,2 As greater national attention turns to tackling this serious and growing public health crisis, it is important to understand the role you can play in helping your family, loved ones and community act in an opioid emergency.

Seconds count

In an opioid overdose emergency, SECONDS COUNT. If you think a loved one is at risk for an opioid overdose emergency, it is important to know the signs and symptoms and have a plan in place because lack of oxygen may lead to severe and permanent brain damage in as little as 4 minutes.3 Most life-threatening opioid overdose emergencies happen in the home and the National EMS Information System estimates the average EMS response time is 9.4 minutes, so you may be in the best position to help your loved one. 3,4

Signs and symptoms of an opioid overdose emergency may include extreme or unusual sleepiness or unresponsiveness, breathing problems, very small or pinpoint pupils, slow heartbeat or low blood pressure and fingernails or lips turning blue/purple.5

Take action

Take action by arming yourself with a potentially life-saving product, take-home naloxone, like EVZIO® (naloxone HCl injection) - 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 is available by prescription and can temporarily reverse the effects of opioids. Ask your healthcare provider about take-home naloxone options, including EVZIO. EVZIO is not a substitute for emergency medical care and it's important to get emergency medical help right away after the first dose of EVZIO, even if your loved one wakes up.

Are you at risk?

Understanding if you or a loved one is at risk for an opioid overdose emergency is the first step. Taking an opioid or having them in your home may put you and your family at risk for an unintentional opioid overdose emergency. Other factors may increase that risk including6-12: combining opioids with other medications, taking extended-release or long acting opioid medication, drinking alcohol while taking opioids, having young children or the elderly in your home while opioids are there, and certain other conditions including opioid use disorder.

Take the next step. Talk to your healthcare provider to understand if a take-home naloxone product, like EVZIO, is right for you and what type of patient access plans may be available.

'At kaléo, our number one priority is saving lives,' explains Dr. Eric Edwards, co-founder of kaléo. 'We believe removing barriers for patients to obtain take-home naloxone, the drug that can help reverse the effects of an opioid overdose, is critical to help those who might be at risk.'

Through the EVZIO2YOU direct delivery service, all commercially insured individuals pay absolutely nothing out of pocket for EVZIO*, regardless of coverage, copays, or deductible payments.

With the opioid crisis showing no signs of slowing, if you or a loved one have opioids in your home, or know someone struggling with an opioid use disorder, it's important to know how to act in the event of an opioid overdose emergency. When every second counts, having take-home naloxone - like EVZIO - may help save a life.

More About EVZIO (naloxone HCl injection)14

EVZIO is a prescription medicine used in adults and children for the treatment of an opioid emergency such as an overdose or possible opioid overdose with signs of breathing problems and severe sleepiness or not being able to respond. EVZIO is not a substitute for emergency medical care, so you should get medical help right away after the first dose of EVZIO, even if the person wakes up.

EVZIO is prefilled, durable, and portable-small enough to fit in most pockets and is administered intramuscularly or subcutaneously into the outer thigh, through clothing if needed. 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 911.15

Each EVZIO prescription includes a Trainer for EVZIO, allowing patients and caregivers to practice. EVZIO can temporarily reverse the effects of opioids and help keep a patient breathing until emergency medical assistance is available.

You should ask your healthcare provider about take-home naloxone or visit EVZIO.com to learn more. For more information on EVZIO, including full Prescribing Information, visit www.EVZIO.com.

*Terms and Conditions apply. Maximum reimbursement limits apply. Only applies to patients with commercial insurance; patients covered by government programs are not eligible.

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?

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 see full Prescribing Information at EVZIO.com.

  1. Rudd RA, Seth P, David F, Scholl L. Increases in drug and opioid-involved overdose deaths-United States, 2010-2015. MMWR Morb Mortal Wkly Rep. ePub: 16 December 2016. doi: http://dx.doi.org/10.1558/mmqr.mm655051e1.
  2. 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.
  3. Fine PG, Webster LR. Preparing for life-threatening opioid emergencies in nonmedical pain settings. Pain Medicine News. August 14, 2015. http://www.painmedicinenews.com/download/SR1534_Kaleo_WM.pdf. Accessed October 26, 2017.
  4. World Health Organization. Community management of opioid overdose. http://www.who.int/substance_abuse/ publications/management_opioid_overdose/en/. Accessed October 26, 2017.
  5. 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 Administration, 2016.
  6. 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.
  7. 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.
  8. Webster RL, Fine PG. Review and critique of opioid rotation practices and associated risks of toxicity. Pain Med. 2012;13(4):562-570
  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. 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.
  12. Volkow ND, McLellan AT. Opioid abuse in chronic pain-misconceptions and mitigation strategies. N Engl J Med. 2016;374:1253-1263.
  13. EVZIO (naloxone HCI injection) Prescribing Information. 2016.
  14. Data on file. Richmond, VA; kaleo, Inc.
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