What Is NARCAN® Nasal Spray

NARCAN® (naloxone HCl) Nasal Spray, the first nasal formulation of naloxone, is FDA approved for the treatment of known or suspected opioid overdose.

Designed for use in the community, NARCAN® Nasal Spray is needle-free and ready to use. Since most accidental overdoses occur in a home setting, it was developed for first responders, as well as family, friends, and caregivers, with no specialized training required.9

NARCAN® Nasal Spray counteracts the life-threatening effects of an opioid overdose.9

Administer in accordance with the Instructions for Use. Repeat doses may be necessary.

NARCAN® Nasal Spray is not a substitute for emergency medical care. Repeat doses may be necessary. Always get help immediately, even if the person wakes up, because they may relapse into respiratory depression. The use of NARCAN® may result in symptoms of acute opioid withdrawal.

FOR QUALIFYING PUBLIC SERVICE ENTITIES

To expand community access, NARCAN® Nasal Spray is available to public service entities for $37.50 per 4 mg dose ($75 per carton of 2 doses, a 40% discount off of list price).

This pricing is available for public service entities, such as first responders (EMS, Fire Department, Police), community organizations, and Departments of Health, regardless of size.*

If you would like to make a qualified purchase, click here.

*Subject to approval by Emergent BioSolutions.

INDICATION AND IMPORTANT SAFETY INFORMATION

WHAT IS NARCAN® NASAL SPRAY?

  • NARCAN® Nasal Spray is a prescription medicine used for the treatment of a known or suspected opioid overdose emergency with signs of breathing problems and severe sleepiness or not being able to respond.
  • NARCAN® Nasal Spray is to be given right away and does not take the place of emergency medical care. Get emergency medical help right away after giving the first dose of NARCAN® Nasal Spray, even if the person wakes up.

NARCAN® Nasal Spray is safe and effective in children for known or suspected opioid overdose.

IMPORTANT SAFETY INFORMATION

Who should not use NARCAN® Nasal Spray?

Do not use NARCAN® Nasal Spray if you are allergic to naloxone hydrochloride or any of the ingredients in NARCAN® Nasal Spray.

What is the most important information I should know about NARCAN® Nasal Spray?
NARCAN® Nasal Spray is used to temporarily reverse the effects of opioid medicines. The medicine in NARCAN® Nasal Spray has no effect in people who are not taking opioid medicines. Always carry NARCAN® Nasal Spray with you in case of an opioid overdose.

  • Use NARCAN® Nasal Spray right away if you or your caregiver think signs or symptoms of an opioid overdose are present, even if you are not sure, because an opioid overdose can cause severe injury or death. Signs and symptoms of an opioid overdose may include:
    • unusual sleepiness and you are not able to awaken the person with a loud voice or by rubbing firmly on the middle of their chest (sternum)
    • breathing problems including slow or shallow breathing in someone difficult to awaken or who looks 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 NARCAN® Nasal Spray in an opioid overdose should know where NARCAN® Nasal Spray is stored and how to give NARCAN® Nasal Spray before an opioid overdose happens.
  • Get emergency medical help right away after giving the first dose of NARCAN® Nasal Spray. Rescue breathing or CPR (cardiopulmonary resuscitation) may be given while waiting for emergency medical help.
  • The signs and symptoms of an opioid overdose can return after NARCAN® Nasal Spray is given. If this happens, give another dose after 2 to 3 minutes using a new NARCAN® Nasal Spray device and watch the person closely until emergency help is received.

What should I tell my healthcare provider before using NARCAN® Nasal Spray?
Before using NARCAN® Nasal Spray, 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 NARCAN® Nasal Spray may cause withdrawal symptoms in your unborn baby. Your unborn baby should be examined by a healthcare provider right away after you use NARCAN® Nasal Spray.
  • are breastfeeding or plan to breastfeed. It is not known if NARCAN® Nasal Spray passes into your breast milk.
Tell your healthcare provider about the medicines you take, including prescription and over-the-counter medicines, drugs, vitamins, and herbal supplements.

What are the possible side effects of NARCAN® Nasal Spray?
NARCAN® Nasal Spray may cause serious side effects, including:
Sudden opioid withdrawal symptoms which can be severe. In someone who has been using opioids regularly, opioid withdrawal symptoms can happen suddenly after receiving NARCAN® Nasal Spray and may include:

  • body aches
  • diarrhea
  • increased heart rate
  • fever
  • runny nose
  • sneezing
  • goose bumps
  • sweating
  • yawning
  • nausea or vomiting
  • nervousness
  • restlessness or irritability
  • shivering or trembling
  • stomach cramping
  • weakness
  • increased blood pressure

Some patients may show aggressive behavior upon abrupt reversal of an opioid overdose.

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 NARCAN® Nasal Spray. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

NNS CON ISI 08/2020

Please see full Prescribing Information.

References: 1. U.S. Surgeon General's advisory on naloxone and opioid overdose. U.S. Department of Health and Human Services website. https://www.surgeongeneral.gov/priorities/opioid-overdose-prevention/naloxone-advisory.html. Accessed April 14, 2020. 2. Rudd RA, Seth P, David F, Scholl L. Increases in drug and opioid-involved overdose deaths — United States, 2010–2015. Morb Mortal Wkly Rep. 2016;65(50-51):1445–1452. 3. Elzey MJ, Barden SM, Edwards ES. Patient characteristics and outcomes in unintentional, non-fatal prescription opioid overdoses: a systematic review. Pain Physician. 2016;19:215-228. 4. 7 staggering statistics about America's opioid epidemic. ChoosePT website. https://www.choosept.com/resources/detail/7-staggering-statistics-about-america-s-opioid-epi. Accessed April 28, 2020. 5. Results from the 2016 national survey on drug use and health: detailed tables. Substance Abuse and Mental Health Services Administration website. https://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-2016/NSDUH-DetTabs-2016.pdf. Accessed April 14, 2020. 6. Sun EC, Jena AB. Distribution of prescription opioid use among privately insured adults without cancer: United States, 2001 to 2013. Ann Intern Med. 2017;167(9):684-686. 7. The next gateway drug: how prescription drugs have started a new epidemic, March 19, 2018. DISA Global Solutions website. https://disa.com/blog/the-next-gateway-drug-how-prescription-drugs-have-started-a-new-epidemic. Accessed April 28, 2020. 8. McCance-Katz EF. The National Survey on Drug Use and Health: 2017. Substance Abuse and Mental Health Services Administration website. https://www.samhsa.gov/data/sites/default/files/nsduh-ppt-09-2018.pdf. Accessed April 15, 2020. 9. NARCAN® Nasal Spray [prescribing information]. Plymouth Meeting, PA: ADAPT Pharma, Inc.; 2020.

INDICATION AND IMPORTANT SAFETY INFORMATION

WHAT IS NARCAN® NASAL SPRAY?

  • NARCAN® Nasal Spray is a prescription medicine used for the treatment of a known or suspected opioid overdose emergency with signs of breathing problems and severe sleepiness or not being able to respond.
  • NARCAN® Nasal Spray is to be given right away and does not take the place of emergency medical care. Get emergency medical help right away after giving the first dose of NARCAN® Nasal Spray, even if the person wakes up.

NARCAN® Nasal Spray is safe and effective in children for known or suspected opioid overdose.

IMPORTANT SAFETY INFORMATION

Who should not use NARCAN® Nasal Spray?

Do not use NARCAN® Nasal Spray if you are allergic to naloxone hydrochloride or any of the ingredients in NARCAN® Nasal Spray.

What is the most important information I should know about NARCAN® Nasal Spray?
NARCAN® Nasal Spray is used to temporarily reverse the effects of opioid medicines. The medicine in NARCAN® Nasal Spray has no effect in people who are not taking opioid medicines. Always carry NARCAN® Nasal Spray with you in case of an opioid overdose.

  • Use NARCAN® Nasal Spray right away if you or your caregiver think signs or symptoms of an opioid overdose are present, even if you are not sure, because an opioid overdose can cause severe injury or death. Signs and symptoms of an opioid overdose may include:
    • unusual sleepiness and you are not able to awaken the person with a loud voice or by rubbing firmly on the middle of their chest (sternum)
    • breathing problems including slow or shallow breathing in someone difficult to awaken or who looks 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 NARCAN® Nasal Spray in an opioid overdose should know where NARCAN® Nasal Spray is stored and how to give NARCAN® Nasal Spray before an opioid overdose happens.
  • Get emergency medical help right away after giving the first dose of NARCAN® Nasal Spray. Rescue breathing or CPR (cardiopulmonary resuscitation) may be given while waiting for emergency medical help.
  • The signs and symptoms of an opioid overdose can return after NARCAN® Nasal Spray is given. If this happens, give another dose after 2 to 3 minutes using a new NARCAN® Nasal Spray device and watch the person closely until emergency help is received.

What should I tell my healthcare provider before using NARCAN® Nasal Spray?
Before using NARCAN® Nasal Spray, 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 NARCAN® Nasal Spray may cause withdrawal symptoms in your unborn baby. Your unborn baby should be examined by a healthcare provider right away after you use NARCAN® Nasal Spray.
  • are breastfeeding or plan to breastfeed. It is not known if NARCAN® Nasal Spray passes into your breast milk.
Tell your healthcare provider about the medicines you take, including prescription and over-the-counter medicines, drugs, vitamins, and herbal supplements.

What are the possible side effects of NARCAN® Nasal Spray?
NARCAN® Nasal Spray may cause serious side effects, including:
Sudden opioid withdrawal symptoms which can be severe. In someone who has been using opioids regularly, opioid withdrawal symptoms can happen suddenly after receiving NARCAN® Nasal Spray and may include:

  • body aches
  • diarrhea
  • increased heart rate
  • fever
  • runny nose
  • sneezing
  • goose bumps
  • sweating
  • yawning
  • nausea or vomiting
  • nervousness
  • restlessness or irritability
  • shivering or trembling
  • stomach cramping
  • weakness
  • increased blood pressure

Some patients may show aggressive behavior upon abrupt reversal of an opioid overdose.

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 NARCAN® Nasal Spray. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

NNS CON ISI 08/2020

Please see full Prescribing Information.

References: 1. U.S. Surgeon General's advisory on naloxone and opioid overdose. U.S. Department of Health and Human Services website. https://www.surgeongeneral.gov/priorities/opioid-overdose-prevention/naloxone-advisory.html. Accessed April 14, 2020. 2. Rudd RA, Seth P, David F, Scholl L. Increases in drug and opioid-involved overdose deaths — United States, 2010–2015. Morb Mortal Wkly Rep. 2016;65(50-51):1445–1452. 3. Elzey MJ, Barden SM, Edwards ES. Patient characteristics and outcomes in unintentional, non-fatal prescription opioid overdoses: a systematic review. Pain Physician. 2016;19:215-228. 4. 7 staggering statistics about America's opioid epidemic. ChoosePT website. https://www.choosept.com/resources/detail/7-staggering-statistics-about-america-s-opioid-epi. Accessed April 28, 2020. 5. Results from the 2016 national survey on drug use and health: detailed tables. Substance Abuse and Mental Health Services Administration website. https://www.samhsa.gov/data/sites/default/files/NSDUH-DetTabs-2016/NSDUH-DetTabs-2016.pdf. Accessed April 14, 2020. 6. Sun EC, Jena AB. Distribution of prescription opioid use among privately insured adults without cancer: United States, 2001 to 2013. Ann Intern Med. 2017;167(9):684-686. 7. The next gateway drug: how prescription drugs have started a new epidemic, March 19, 2018. DISA Global Solutions website. https://disa.com/blog/the-next-gateway-drug-how-prescription-drugs-have-started-a-new-epidemic. Accessed April 28, 2020. 8. McCance-Katz EF. The National Survey on Drug Use and Health: 2017. Substance Abuse and Mental Health Services Administration website. https://www.samhsa.gov/data/sites/default/files/nsduh-ppt-09-2018.pdf. Accessed April 15, 2020. 9. NARCAN® Nasal Spray [prescribing information]. Plymouth Meeting, PA: ADAPT Pharma, Inc.; 2020.