WHAT IS
`NARCAN® NASAL SPRAY?
`NARCAN® Nasal Spray 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.
`
`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 because symptoms may return. Repeat doses may be necessary.
`
`NARCAN® Nasal Spray is safe and effective in children for known or suspected opioid overdose.
`
`WHEN SHOULD
`NARCAN® NASAL SPRAY BE USED?
`Use NARCAN® Nasal Spray 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 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 by rubbing firmly
`on the middle of his/her chest (sternum).
`
`• Breathing problems including slow or shallow breathing in someone difficult to awaken or who looks
`like he/she is 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.
`
`Get emergency medical help right away in any cases of known or suspected overdose. NARCAN®
`Nasal Spray is not a substitute for emergency medical care. Administer in accordance with the
`Instructions for Use.
`
`WHO SHOULD NOT USE
`NARCAN® NASAL SPRAY?
`Do not use NARCAN® Nasal Spray if you are allergic to naloxone hydrochloride (HCl) or any of the
`ingredients in NARCAN® Nasal Spray, which include:
`
`• Benzalkonium chloride (preservative)
`• Disodium ethylenediaminetetraacetate (stabilizer)
`• Sodium chloride
`• Hydrochloric acid (to adjust pH)
`• Sterile water
`
`Use in infants with extreme caution.
`Please see Important Safety Information and full Prescribing Information.
`
`Opiant Exhibit 2120
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00688
`Page 1
`
`

`

`HOW SHOULD I USE
`NARCAN® NASAL SPRAY?
`Read the Instructions for Use at the end of the Patient Information leaflet for detailed
`information about the right way to use NARCAN® Nasal Spray.
`
`
`
`• Use NARCAN® Nasal Spray exactly as prescribed by your healthcare provider.
`
`• Each NARCAN® Nasal Spray contains only 1 dose of medicine and cannot be reused.
`
`• Lay the person on their back. Support their neck with your hand and allow the head to tilt back before
` giving NARCAN® Nasal Spray.
`
`• NARCAN® Nasal Spray should be given into one nostril.
`
`If additional doses are needed, give NARCAN® Nasal Spray in the other nostril.
`
`DOES NARCAN® NASAL SPRAY
`ONLY WORK IN THE NOSE?
`Yes, NARCAN® Nasal Spray is for intranasal (in the nose/nostril) use only.
`
`BEFORE I USE NARCAN® NASAL SPRAY, DO I NEED TRAINING?
`DO I NEED TO ASSEMBLE NARCAN® OR MEASURE THE MEDICINE?
`There is no special training, measuring or assembly required to use NARCAN® Nasal Spray.
`
`NARCAN® Nasal Spray comes as a ready-to-use device that contains a single, pre-filled, pre-measured
`dose of naloxone.
`
`NARCAN® Nasal Spray should be used in accordance with the Instructions for Use contained in the
`full Prescribing Information. The caregiver should familiarize her/himself with these instructions in
`order to be sure to administer NARCAN® Nasal Spray properly.
`
`CAN I GIVE MYSELF
`NARCAN® NASAL SPRAY?
`No, treatment of suspected opioid overdose must be performed by someone other than the affected
`person. If you have or are prescribed NARCAN® Nasal Spray, it’s important to tell family, roommates,
`caregivers, friends, and others around you where you keep NARCAN® Nasal Spray (at home, on your
`person, in your car, etc.) and how and when to use it. Also, inform them that NARCAN® Nasal Spray
`should always be given in accordance with the Instructions for Use, which are included in the package.
`
`HOW DOES
`NARCAN® NASAL SPRAY WORK?
`NARCAN® Nasal Spray is administered in the nostril and does not require evidence of breathing through
`the nose during administration.
`
`When someone takes an overdose of opioids, the opiates overwhelm certain areas in the brain and
`interrupt a key part of the body’s impulse to breathe. Breathing slows dangerously or stops. Quickly
`rescuing this person is crucial because prolonged, severe breathing problems can lead to brain injury
`or death.
`
`Opiant Exhibit 2120
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00688
`Page 2
`
`

`

`HOW DOES
`NARCAN® NASAL SPRAY WORK? (continued)
`Naloxone, the active ingredient in NARCAN® Nasal Spray, competes with opioids to bind with the same
`receptors in the brain. Usually, it reverses the effects of opioid overdose in 2 to 3 minutes. This buys the
`opioid-poisoned person time for emergency medical help to arrive. If necessary, a bystander can give
`an additional dose of NARCAN® Nasal Spray if the patient doesn’t respond, doesn’t respond enough or
`relapses into breathing problems while awaiting additional help.
`
`Get emergency medical help right away in any cases of known or suspected overdose emergency.
`NARCAN® Nasal Spray is not a substitute for emergency medical care. Administer in accordance with the
`Instructions for Use.
`
`HOW LONG DOES
`NARCAN® NASAL SPRAY TAKE TO WORK?
`If the patient does not respond in 2 to 3 minutes or responds and then relapses into respiratory
`depression, additional doses of NARCAN® Nasal Spray may be given every 2 to 3 minutes until
`emergency medical assistance arrives.
`
`
`
`Each device is a single dose. If an additional dose is needed, you must use another device.
`Get emergency medical help right away in any cases of known or suspected overdose emergency.
`NARCAN® Nasal Spray is not a substitute for emergency medical care. Administer in accordance with the
`Instructions for Use.
`
`CAN I REUSE
`NARCAN® NASAL SPRAY?
`No, you cannot reuse NARCAN® Nasal Spray. Each device is single-use, single-dose only. It is intended to
`be sprayed once, in a nostril, and then discarded.
`
`IS IT POSSIBLE TO USE
`ONLY HALF THE CONTENTS?
`No, the device is designed and FDA-approved to provide a single 4 mg dose of naloxone. It is intended to
`be sprayed once, in a nostril, and then discarded.
`
`HOW LONG DOES NARCAN® NASAL SPRAY WORK?
`WILL A SECOND DOSE BE NEEDED?
`NARCAN® Nasal Spray has been shown in studies to stay in the body for about 2 hours.
`
`A second dose of NARCAN® Nasal Spray may be necessary. One dose of naloxone may not be enough to
`reverse the effects of an opioid overdose that involves strong opioids or more. Or, sometimes, the nalox-
`one dose can wear off before the opioids—necessitating another dose.
`
`Opiant Exhibit 2120
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00688
`Page 3
`
`

`

`HOW LONG DOES NARCAN® NASAL SPRAY WORK?
`WILL A SECOND DOSE BE NEEDED? (continued)
`Emergency medical services (EMS) will have been called immediately and will hopefully arrive before a
`second dose is needed. But if help hasn’t arrived, bystanders can administer additional doses of
`NARCAN® Nasal Spray every 2 to 3 minutes in alternating nostrils if the patient doesn’t respond, responds
`insufficiently or relapses back into respiratory depression.
`
`Get emergency medical help right away in any cases of known or suspected overdose emergency.
`NARCAN® Nasal Spray is not a substitute for emergency medical care. Administer in accordance with the
`Instructions for Use.
`
`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, vitamins, and herbal supplements.
`
`
`
`HOW DO YOU ADMINISTER
`NARCAN® NASAL SPRAY?
`Key steps to administering NARCAN® Nasal Spray:
`
`• PEEL back the package to remove the device. Hold the device with your thumb on the bottom of the
`
` plunger and 2 fingers on the nozzle.
`
`
`
`• PLACE the tip of the nozzle in either nostril until your fingers touch the bottom of the patient’s nose.
`
`• PRESS the plunger firmly to release the dose into the patient’s nose.
`
`Remove the device from the nostril and, if you haven’t already done so, get emergency help right away.
`Continue to watch the patient. Most patients respond within 2 to 3 minutes.
`
`If help hasn’t arrived yet and the patient is not responding after 2 to 3 minutes, or responds and then re-
`lapses back into respiratory depression, give another dose. Make sure to use another device, as each
`device contains only one dose.
`
`Get emergency medical help right away in any cases of known or suspected overdose emergency.
`NARCAN® Nasal Spray is not a substitute for emergency medical care. Administer in accordance with the
`Instructions for Use.
`
`These steps are not comprehensive. See the Instructions for Use for more information.
`Administer in accordance with the Instructions for Use.
`
`Opiant Exhibit 2120
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00688
`Page 4
`
`

`

`IS NARCAN® NASAL SPRAY
`ADDICTIVE?
`No, naloxone has no potential for abuse or overdose. It does not work in the absence of opioids.
`
`WHAT ARE THE POSSIBLE SIDE EFFECTS
`OF NARCAN® NASAL SPRAY?
`NARCAN® Nasal Spray 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 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
`
`In infants less than 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.
`
`
`
`View full Prescribing Information.
`
`WHAT ARE THE INGREDIENTS
`IN NARCAN® NASAL SPRAY?
`Active ingredient: naloxone hydrochloride
`Inactive ingredients: benzalkonium chloride (preservative), disodium ethylenediametetraacetate
`(stabilizer), sodium chloride, hydrochloric acid to adjust pH and sterile water
`
`NARCAN® Nasal Spray is not made with natural rubber latex.
`
`HOW SHOULD I STORE
`NARCAN® NASAL SPRAY?
`• Store NARCAN® Nasal Spray at room temperature between 59°F to 77°F (15°C to 25°C).
` NARCAN® Nasal Spray may be stored for short periods up to 104°F (40°C).
`• Do not freeze NARCAN® Nasal Spray.
`• Keep the NARCAN® Nasal Spray in its box until ready to use. Protect from light.
`• Replace NARCAN® Nasal Spray before the expiration date on the box.
`Keep NARCAN® Nasal Spray and all medicines out of the reach of children.
`
`
`
`
`
`Opiant Exhibit 2120
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00688
`Page 5
`
`

`

`HOW DO I PURCHASE
`NARCAN® NASAL SPRAY?
`NARCAN® Nasal Spray is a prescription product. However, every state allows direct access to naloxone
`for patients and their carergivers (family, friends) through retail pharmacies, without a prescription from
`your doctor. Plus, NARCAN® is covered by most major insurance plans. Please check with your
`pharmacist for your particular state’s laws on obtaining NARCAN® from your pharmacy.
`
`ADAPT Pharma is committed to ensure people can access NARCAN®. We have collaborated with major
`Pharmacy Benefits Managers and insurance companies (including Medicaid), to help make sure the cost
`of NARCAN® Nasal Spray to insured patients and caregivers is reasonable and affordable.
`
`WHERE DO I PURCHASE
`NARCAN® NASAL SPRAY?
`Anyone can purchase NARCAN® Nasal Spray directly from a pharmacist, without a doctor’s
`prescription, in accordance with the particular laws of each state. NARCAN® Nasal Spray can be
`obtained at retail pharmacies across the country. All major pharmacy and grocery chains stock
`NARCAN®, so it is convenient for you to obtain.
`
`If you are going to a local/independent pharmacy, please call in advance to ensure is has the product.
`The pharmacy can usually order it from its supplier within 2 days.
`
`DOES INSURANCE COVER
`NARCAN® NASAL SPRAY?
`ADAPT Pharma is committed to ensure people can access NARCAN®. We have collaborated with major
`Pharmacy Benefits Managers and insurance companies (including Medicaid), to help make sure the cost
`of NARCAN® Nasal Spray to insured patients and caregivers is reasonable and affordable.
`NARCAN® Nasal Spray has extensive public and private insurance coverage. 97% of U.S. insured lives
`have access to NARCAN® Nasal Spray.*
`
`• 38% of prescriptions for NARCAN® Nasal Spray have a co-pay of $0†
`• 76% have a co-pay of $10 or less†
`• 81% have a co-pay of $20 or less†
`
`Please contact your health insurance provider to find out your coverage and co-pay for
`NARCAN® Nasal Spray.
`
`*MMIT Formulary Analytics, AUG 2018.
`†IMS Health, NPA Extended Insights Audit, AUG 2017 - JUL 2018.
`
`Opiant Exhibit 2120
`Nalox-1 Pharmaceuticals, LLC v. Opiant Pharmaceuticals, Inc.
`IPR2019-00688
`Page 6
`
`