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The NARCAN® (naloxone HCl) Nasal Spray Starter Kit includes educational tools and resources to help start the conversation with patients about opioid overdose safety.

The NARCAN® Starter Kit does not contain medication.

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INDICATION AND USAGE

NARCAN® (naloxone HCl) Nasal Spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. NARCAN® Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. NARCAN® Nasal Spray is not a substitute for emergency medical care.

IMPORTANT SAFETY INFORMATION

NARCAN® Nasal Spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients.

Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance.

Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep the patient under continued surveillance and administer repeat doses of naloxone using a new nasal spray with each dose, as necessary, while awaiting emergency medical assistance.

Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.

Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid dependent may precipitate opioid withdrawal characterized by body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, and tachycardia. In some patients, there may be aggressive behavior upon abrupt reversal of an opioid overdose. Monitor for the development of opioid withdrawal.

In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may also include convulsions, excessive crying, and hyperactive reflexes.

Abrupt Postoperative Reversal of Opioid Depression: Abrupt postoperative reversal of opioid depression may result in nausea, vomiting, sweating, tremulousness, tachycardia, hypotension, hypertension, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest. Serious sequelae of these events, including coma and death, have been reported. These events have primarily occurred in patients who had pre-existing cardiovascular (CV) disorders or received other drugs that may have similar adverse CV effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone HCl.

Adverse Reactions: The following adverse reactions were observed in a NARCAN® Nasal Spray clinical study: increased blood pressure, constipation, toothache, muscle spasms, musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, nasal inflammation, rhinalgia, and xeroderma.

NNS HCP ISI 08/2020

Please see full Prescribing Information.

References: 1. Opioid overdose. Centers for Disease Control and Prevention website. https://www.cdc.gov/drugoverdose/index.html. Accessed April 12, 2021. 2. Wide-ranging online data for epidemiologic research (WONDER). Atlanta, GA: CDC, National Center for Health Statistics; 2020. 3. World Health Organization. Community management of opioid overdose. 2014:1-88. 4. 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 12, 2021. 5. NARCAN® Nasal Spray [prescribing information]. Plymouth Meeting, PA: Emergent BioSolutions Inc.; 2020. 6. Mell HK, Mumma SN, Hiestand B. Emergency medical services response times in rural, suburban, and urban areas. JAMA Surg. 2017;152(10):983-984. 7. Opioid overdose. World Health Organization website. http://www.who.int/substance_abuse/information-sheet/en. Updated August 28, 2020. Accessed April 12, 2021. 8. Calculating total daily dose of opioids for safer dosage. Centers for Disease Control and Prevention website. https://www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose­a.pdf. Accessed April 12, 2021. 9. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Chronic Pain — United States, 2016. Morb Mortal Wkly Rep. 2016;65(1):1-49. 10. National Safety Council. Prescription opioid pain killer public opinion poll. October 2017. 11. San Francisco Department of Public Health. Naloxone for opioid safety: a provider's guide to prescribing naloxone to patients who use opioids. January 2015. https://prescribetoprevent.org/wp2015/wp-content/uploads/CA.Detailing_Provider_final.pdf. Accessed April 12, 2021.

INDICATION AND USAGE

NARCAN® (naloxone HCl) Nasal Spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. NARCAN® Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. NARCAN® Nasal Spray is not a substitute for emergency medical care.

IMPORTANT SAFETY INFORMATION

NARCAN® Nasal Spray is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients.

Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance.

Risk of Recurrent Respiratory and CNS Depression: Due to the duration of action of naloxone relative to the opioid, keep the patient under continued surveillance and administer repeat doses of naloxone using a new nasal spray with each dose, as necessary, while awaiting emergency medical assistance.

Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists: Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required.

Precipitation of Severe Opioid Withdrawal: Use in patients who are opioid dependent may precipitate opioid withdrawal characterized by body aches, fever, sweating, runny nose, sneezing, piloerection, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, abdominal cramps, increased blood pressure, and tachycardia. In some patients, there may be aggressive behavior upon abrupt reversal of an opioid overdose. Monitor for the development of opioid withdrawal.

In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may also include convulsions, excessive crying, and hyperactive reflexes.

Abrupt Postoperative Reversal of Opioid Depression: Abrupt postoperative reversal of opioid depression may result in nausea, vomiting, sweating, tremulousness, tachycardia, hypotension, hypertension, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest. Serious sequelae of these events, including coma and death, have been reported. These events have primarily occurred in patients who had pre-existing cardiovascular (CV) disorders or received other drugs that may have similar adverse CV effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone HCl.

Adverse Reactions: The following adverse reactions were observed in a NARCAN® Nasal Spray clinical study: increased blood pressure, constipation, toothache, muscle spasms, musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, nasal inflammation, rhinalgia, and xeroderma.

NNS HCP ISI 08/2020

Please see full Prescribing Information.

References: 1. Opioid overdose. Centers for Disease Control and Prevention website. https://www.cdc.gov/drugoverdose/index.html. Accessed April 12, 2021. 2. Wide-ranging online data for epidemiologic research (WONDER). Atlanta, GA: CDC, National Center for Health Statistics; 2020. 3. World Health Organization. Community management of opioid overdose. 2014:1-88. 4. 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 12, 2021. 5. NARCAN® Nasal Spray [prescribing information]. Plymouth Meeting, PA: Emergent BioSolutions Inc.; 2020. 6. Mell HK, Mumma SN, Hiestand B. Emergency medical services response times in rural, suburban, and urban areas. JAMA Surg. 2017;152(10):983-984. 7. Opioid overdose. World Health Organization website. http://www.who.int/substance_abuse/information-sheet/en. Updated August 28, 2020. Accessed April 12, 2021. 8. Calculating total daily dose of opioids for safer dosage. Centers for Disease Control and Prevention website. https://www.cdc.gov/drugoverdose/pdf/calculating_total_daily_dose­a.pdf. Accessed April 12, 2021. 9. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Chronic Pain — United States, 2016. Morb Mortal Wkly Rep. 2016;65(1):1-49. 10. National Safety Council. Prescription opioid pain killer public opinion poll. October 2017. 11. San Francisco Department of Public Health. Naloxone for opioid safety: a provider's guide to prescribing naloxone to patients who use opioids. January 2015. https://prescribetoprevent.org/wp2015/wp-content/uploads/CA.Detailing_Provider_final.pdf. Accessed April 12, 2021.