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

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

REZENOPY nasal spray is used to temporarily reverse the effects of opioid medicines. The medicine in REZENOPY nasal spray has no effect in people who are not taking opioid medicines. Always carry REZENOPY nasal spray with you in case of an opioid emergency.

1. Use REZENOPY 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 REZENOPY nasal spray in an opioid emergency should know where REZENOPY 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 REZENOPY 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 REZENOPY nasal spray is given. If this happens, give another dose every 2 to 3 minutes using a new REZENOPY nasal spray and watch the person closely until emergency help is received.

What is REZENOPY nasal spray?

REZENOPY nasal spray is a prescription medicine used in adults and children 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.

REZENOPY 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 REZENOPY nasal spray, even if the person wakes up.

REZENOPY nasal spray is safe and effective in children for known or suspected opioid overdose.

Do not use REZENOPY nasal spray if you are allergic to naloxone hydrochloride or any of the ingredients in REZENOPY nasal spray. See the end of this leaflet for a complete list of ingredients in REZENOPY nasal spray.

Before using REZENOPY nasal spray, tell your healthcare provider about all your medical conditions, including if you:

have heart problems
are breastfeeding or plan to breastfeed. It is not known if REZENOPY 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 REZENOPY nasal spray?

Read the “Instructions for Use” at the end of this Patient Information leaflet for detailed information about the right way to use REZENOPY nasal spray.

Use REZENOPY nasal spray exactly as prescribed by your healthcare provider.

Each REZENOPY nasal spray contains 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 REZENOPY nasal spray.
REZENOPY nasal spray should be given into one nostril.

If additional doses are needed, give REZENOPY nasal spray in the other nostril.

What are the possible side effects of REZENOPY nasal spray?

REZENOPY 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 REZENOPY 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 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.

The most common side effects of REZENOPY nasal spray include: upperstomach-area (abdominal) pain, the common cold, and changes in sense of taste.

These are not all the possible side effects of REZENOPY 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 REZENOPY nasal spray?

Store REZENOPY nasal spray between 2°C to 25°C (36°F to 77°F).

Do not freeze. Do not expose to excessive heat above 40°C (104°F).
Keep REZENOPY nasal spray in its box until ready to use. Protect from light.
Replace REZENOPY nasal spray before the expiration date on the box.

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

General Information about the safe and effective use of REZENOPY nasal spray.

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

What are the ingredients in REZENOPY nasal spray?

Active ingredients: naloxone hydrochloride

Inactive ingredients: glycerin, trisodium citrate dihydrate, hydrochloric acid and sodium hydroxide to adjust pH, and purified water.

REZENOPY nasal spray is not made with natural rubber latex.

Manufactured for: Scienture, LLC, Commack, NY 11725.

For more information, go to www.rezenopy.com or call 1-833-754-4917.

This Patient Information has been approved by the U.S. Food and Drug Administration Issued: 04/2024

INSTRUCTIONS FOR USE

REZENOPY™ (reh zeh' noe pee)

(naloxone HCl) nasal spray

10 mg

You and your family members or caregivers should read the Instructions for Use that comes with REZENOPY 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 REZENOPY nasal spray.

Use REZENOPY nasal spray for known or suspected opioid overdose in adults and children. Use REZENOPY nasal spray exactly as prescribed by your healthcare provider.

Important Information You Need to Know Before Giving REZENOPY nasal spray:

For use in the nose only.
Do not remove REZENOPY nasal spray from package until ready to use.
Each REZENOPY nasal spray device has 1 dose and cannot be reused.
Do not test or prime REZENOPY nasal spray before use.

REZENOPY nasal spray Parts (Figure A)

Step 1. Check person for signs of suspected opioid overdose Shout “wake up” and shake the person gently. Check for the following (Figure B): unresponsive unconscious or unable to wake up slow, shallow, irregular breathing fingernails or lips turning blue or purple
Step 2. Position Person Lay the person flat on their back (Figure C).
Step 3. Remove REZENOPY nasal spray from the box Peel back from either corner at the top of the package. Then removeREZENOPY nasal spray from package (Figure D).
Step 4. Hold REZENOPY nasal spray Hold with your index and middle fingers on either side of the nozzle and your thumb on the bottom of the plunger (Figure E). Do not apply any pressure until you are ready to give the dose.
Step 5. Prepare to give REZENOPY nasal spray Provide support behind the neck with your hand and tilt the person’s head back. (Figure F). Gently insert the nozzle tip all the way into one nostril (Figure G).
Step 6. Give REZENOPY nasal spray Push the plunger hard and all the way in to give the dose (Figure H). Remove REZENOPY nasal sprayfrom nostril after dose has been given.
Step 7. Call 911 or get emergency help Call for emergency help right away (Figure I).
Step 8. Turn person to recovery position and monitor Put the person into the recovery position by turning them on their side (Figure J). Watch the person closely for 2 to 3 minutes (Figure J).
Step 9. Give another dose if needed and monitor If the person does not respond by waking up, to voice or touch, or start breathing normally, another dose may be given. Get a new REZENOPY nasal spray from the box. Repeat Steps 2 through 6 to give another dose of REZENOPY nasal spray in the other nostril (Figure K). If more REZENOPY nasal spray is available, repeat Steps 2 through 6 every 2 to 3 minutes, alternating nostrils, until the person wakes up or medical help arrives. Stay with the person until medical help arrives. Return the person to a recovery position (Figure L).
Step 10. Disposing of REZENOPY nasal spray Throw away (dispose of) the used REZENOPY nasal spray in a place away from children (Figure M).

Storage Information

Storing REZENOPY nasal spray

Store REZENOPY nasal spray between 2°C to 25°C (36°F to 77°F). Excursions permitted up to 40°C (104°F).
Do not freeze. Do not expose to excessive heat above 40°C (104°F).
Keep REZENOPY nasal spray in its box until ready to use. Protect from light.
Replace REZENOPY nasal spray before the expiration date on the box.