Patient information: uses, side effects, how to take - Opvee

What is the most important information I should know about OPVEE nasal spray?

OPVEE nasal spray is used to temporarily reverse the effects of opioid medicines. The medicine in OPVEE nasal spray is not expected to have an effect in people who are not taking opioid medicines. Always carry OPVEE nasal spray with you in case of an opioid emergency.

1.
Use OPVEE 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 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 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
2. Family members, caregivers, or other people who may have to use OPVEE nasal spray in an opioid emergency should know where OPVEE nasal spray is stored and how to give it before an opioid emergency happens.
3. Call 911 or get emergency medical help right away after giving the first dose of OPVEE nasal spray.Rescue breathing or CPR (cardiopulmonary resuscitation) may be given while waiting for emergency medical help.
4. The signs and symptoms of an opioid emergency can return after OPVEE nasal spray is given. If this happens, give another dose every 2 to 5 minutes using a new OPVEE nasal spray and watch the person closely until emergency help is received.

What is OPVEE nasal spray?

OPVEE nasal spray is a prescription medicine used in adults and children 12 years of age and older 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.
OPVEE nasal spray is to be given right away and does not take the place of emergency medical care. Get emergency medical help right way after giving the first dose of OPVEE nasal spray, even if the person wakes up.

It is not known if OPVEE nasal spray is safe and effective in children younger than 12 years of age.

Do not use OPVEE nasal spray if youare allergic to nalmefene or any of the ingredients in OPVEE nasal spray. See the end of this leaflet for a complete list of ingredients in OPVEE nasal spray.

Before using OPVEE 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 OPVEE 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 OPVEE nasal spray.
are breastfeeding or plan to breastfeed. It is not known if OPVEE 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 should I use OPVEE nasal spray?

Read the "Instructions for Use" at the end of this Patient Information leaflet for detailed information about how to use OPVEE nasal spray.

Use OPVEE nasal spray exactly as prescribed by your healthcare provider.
Each OPVEE nasal spray only contains 1 dose of medicine and cannot be reused.
Do not test or prime OPVEE nasal spray before use.
Lay the person on their back. Use your hand to support behind their neck and allow the head to tilt back before giving OPVEE nasal spray.
OPVEE nasal spray should be given into one nostril.
If additional doses are needed, give OPVEE nasal spray in the other nostril.

What are the possible side effects of OPVEE nasal spray?

OPVEE 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 OPVEE 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

Risk of opioid overdose.OPVEE nasal spray blocks the effects of opioids and may cause opioid withdrawal in someone who has been using opioids regularly. Do nottake large amounts of opioids to try to overcome the opioid-blocking effects of OPVEE nasal spray. This could lead to an opioid overdose and death. Call 911 or get emergency medical help right away after using OPVEE nasal spray.

The most common side effects of OPVEE nasal spray include:

nose (nasal) discomfort
headache
nausea
dizziness
hot flush

vomiting
anxiety
tiredness
nasal congestion
throat irritation

pain in the nose
decreased appetite
changes in the sense of taste
skin redness
increased sweating

These are not all of the possible side effects of OPVEE nasal spray.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store OPVEE nasal spray?

Store OPVEE nasal spray at room temperature between 59°F to 77°F (15°C to 25°C).
Do not freeze OPVEE nasal spray.
Keep OPVEE nasal spray in its box until ready to use.
Protect from light.
Replace OPVEE nasal spray before the expiration date on the box.

Keep OPVEE nasal spray and all medicines out of the reach of children.

General information about the safe and effective use of OPVEE nasal spray.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use OPVEE nasal spray for a condition for which it was not prescribed. You can ask your pharmacist or healthcare provider for information about OPVEE nasal spray that is written for health professionals.

What are the ingredients in OPVEE nasal spray?

Active ingredient: nalmefene

Inactive ingredients:benzalkonium chloride, disodium ethylenediaminetetraacetate, dodecyl maltoside, sodium chloride, and purified water.

OPVEE nasal spray is not made with natural rubber latex.

OPVEE ^®is a registered trademark of Indivior Inc.

Manufactured for: Indivior Inc., North Chesterfield, VA, 23235, USA

For more information, visit www.OPVEE.com or call 1-877-782-6966

INSTRUCTIONS FOR USE

OPVEE (op vee)

(nalmefene)

nasal spray

The Instructions for Use contains information on how to give OPVEE nasal spray in response to a known or suspected opioid overdose in adults and children 12 years of age and older. You and your family members or caregivers should read the Instructions for Use that comes with OPVEE nasal spray before using it. Talk to your healthcare provider if you and your family members or caregivers have any questions about the use of OPVEE nasal spray.

Important Information You Need to Know Before Giving OPVEE nasal spray

For use in the nose only.
Do not remove or test the OPVEE nasal spray before use.
Each OPVEE nasal spray has 1 dose and cannot be reused.
You do not need to prime OPVEE nasal spray.

Check for response

Step 1. Shout"wake up" and shakethe person gently.

If there is no response, slow breathing, or no breathing, lay the person flat on their back ( Figure A).

Figure A

Prepare to give OPVEE nasal spray

Step 2. Remove OPVEE nasal spray from the box. Peel off the back from the top corner to open the OPVEE nasal spray blister ( Figure B).

Step 3. Hold the OPVEE nasal spray with your fingers on both sides of the nozzle and your thumb on the white plunger ( Figure C).

Do not press the plunger yet.

Figure B

Figure C

Give OPVEE nasal spray

Step 4.Provide support behind the neck with your hand and tilt the person's head back ( Figure D).

Step 5.Gently insert the nozzle into one nostril until your fingers on either side of the nozzle are against the bottom of the person's nose. (Figure D).

Step 6.Press the plunger firmly to give the dose of OPVEE nasal spray in the nose.

The dose has been delivered when the white plunger has been pushed all the way down until it stops.

Step 7.Remove the OPVEE nasal spray from the nostril after the dose has been given.

Figure D

After giving OPVEE nasal spray

Step 8. Call 911or get emergency medical help right away ( Figure E).

Step 9. Move the person on their side (recovery position)( Figure F):

Hand is supporting their head.
Bend their knee.
Turn their face to the side.

Step 10. Wait for 2 to 5 minutesto see if the person wakes up. If the person does not respond by waking up, to voice or touch, or start breathing normally, another dose may be given ( Figure G).

Get a new OPVEE nasal sprayfrom the box.
Repeat Steps 1 through 7 to give another dose of OPVEE in the other nostril.
If more OPVEE nasal sprays are available, repeat Steps 1 through 7 every 2 to 5 minutes, alternating nostrils, until the person wakes up or medical help arrives.

Stay with the person until medical help arrives.

Step 11.After OPVEE nasal spray has been used, put it back into its box. Throw away (dispose of) the used OPVEE nasal spray in a place that is away from children.

Figure E

Figure F

Figure G

Storing OPVEE nasal spray

Store OPVEE nasal spray at room temperature between 59°F to 77°F (15°C to 25°C).
Do not freeze OPVEE nasal spray.
Keep OPVEE nasal spray in its box until ready to use.
Protect from light.
Replace OPVEE nasal spray before the expiration date on the box.