The FIRST and ONLY
`FDA-Approved intranasal
`naloxone for emergency
`treatment of opioid overdose1
`Please see Indications and
`Important Safety Information below
`Not a substitute for emergency medical care
`
`Prefilled 4 mg unit dose:
`No assembly needed
`
`No needles
`
`No special training
`required.
`Administer in accordance
`with Instructions for Use
`
`Provide the right treatment...
`at the right place…at the right time.
`
`Order Today. Call 1-844-4-NARCAN or 1-844-462-7226
`For more information go to NarcanNasalSpray.com
`
`INDICATIONS AND IMPORTANT SAFETY INFORMATION
`INDICATIONS
`NARCAN® (naloxone hydrochloride) 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.
`Seek emergency medical assistance immediately after initial use, keeping the patient under continued surveillance.
`Please see additional Important Safety Information on reverse side.
`
`Opiant Exhibit 2115
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 1
`
`

`

`The majority of opioid overdose related deaths occur
`outside the medical setting.2 NARCAN® Nasal Spray
`requires no specialized training and can be
`administered by anyone.
`Administer in accordance with Instructions for Use
`Current Partnerships
`In response to the growing opioid overdose crisis
`in communities across the nation, Adapt Pharma partners
`with state and local communities and organizations
`support efforts to:
` Educate on curbing opiate abuse
`and the appropriate use of opioid prescription
`medications
`Implement scaled-up naloxone access
`and distribution policies
`
`•
`
`•
`
`Ordering Information
`
`NARCAN® Nasal Spray
`
`NDC# 69547-0353-02
`
`Wholesaler
`
`Item#
`
`Amerisource Bergen
`
`10162640
`
`Cardinal
`
`H.D. Smith
`
`McKesson
`
`5204037
`
`5525191
`
`3519402
`
`IMPORTANT SAFETY INFORMATION (continued)
`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, diarrhea, increased heart rate (tachycardia), fever, runny nose, sneezing, goose bumps
`(piloerection), sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling,
`abdominal cramps, weakness, and increased blood pressure. In neonates, opioid withdrawal may be life-threatening
`if not recognized and properly treated and may be characterized by convulsions, excessive crying, and hyperactive
`reflexes. Monitor for the development of opioid withdrawal.
`Risk of Cardiovascular (CV) Effects: Abrupt postoperative reversal of opioid depression may result in adverse CV
`effects. These events have primarily occurred in patients who had pre-existing 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 hydrochloride.
`The following adverse reactions were observed in a NARCAN® Nasal Spray clinical study: increased blood pressure,
`musculoskeletal pain, headache, nasal dryness, nasal edema, nasal congestion, and nasal inflammation.
`Please see accompanying full Prescribing Information.
`For more information about NARCAN® Nasal Spray, please visit www.NarcanNasalSpray.com. You are encouraged
`to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch
`or call 1-800-FDA-1088.
`Reference: 1. Adapt Pharmaceuticals. Prescribing Information for NARCAN® Nasal Spray. Revised April, 2016. 2. CDC Wonder Database Multiple Cause of Death MCD -
`ICD-10 Codes: T40.1 (Heroin), T40.2 (Other opioids), T40.3 (Methadone), T40.4 (Other synthetic narcotics) 2013.
`
`Find us on YouTube
`
`Download the NARCAN® Now App
`
`Visit NarcanNasalSpray.com
`
`© 2016 ADAPT Pharma, Inc. NARCAN® is a registered trademark licensed to ADAPT Pharma Operations Limited. NAR4-45-16
`Adapt Pharma, Inc. Radnor, PA
`
`Opiant Exhibit 2115
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00694
`Page 2
`
`