How to Use KLOXXADO®

How to Use KLOXXADO®2025-03-20T23:19:20-04:00

Be ready to help save a life in an opioid emergency

With KLOXXADO® Nasal Spray, anyone can be prepared to reverse an opioid overdose. Once administered, it works in the brain, right at the opioid receptor, and has the ability to potentially reverse the deadly effects of the opioid causing the overdose.

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Key steps for administering KLOXXADO® Nasal Spray

KLOXXADO® is not a substitute for emergency medical care.

1. REMOVE

Remove KLOXXADO® Nasal Spray from the box. Peel off the back tab with the triangle to open the KLOXXADO® Nasal Spray blister.

2. HOLD

Hold it with your thumb on the bottom and your first and middle fingers on either side of the nozzle.

3. INSERT

Insert the tip of the nozzle into one nostril until your fingers are against the bottom of the person’s nose.

4. PRESS

Press the plunger firmly to give the dose of KLOXXADO® Nasal Spray.

5. CALL 911

After giving KLOXXADO® Nasal Spray to someone, call 911 and stay with them until emergency help arrives.

6. ADDITIONAL DOSES

If a person is given KLOXXADO® and does not respond after 2-3 minutes, administer another dose.

If a person responds then overdose symptoms continue, additional doses of KLOXXADO® may be given every 2-3 minutes until emergency medical assistance arrives.

Administrate in accordance with the Quick Instructions.

Use as directed.

  • If you’re experiencing an opioid overdose, you won’t be able to give KLOXXADO® Nasal Spray to yourself. Make sure those around you know about KLOXXADO® and where it’s stored, in case of an emergency.
  • KLOXXADO® is ready to use and contains 8 mg of naloxone per spray in a single dose. Do not prime or test the device before use, and discard device after use.

How to store KLOXXADO® Nasal Spray

  • Keep KLOXXADO® Nasal Spray in the blister and cartons provided until ready to use.
  • Store at 68°F to 77°F (20°C to 25°C) with excursions permitted to 104°F (40°C) and to 41°F (5°C).
  • Protect from light.
  • Do not freeze. Do not expose to temperatures below 41°F (5°C) or above 104°F (40°C).
  • Replace KLOXXADO® Nasal Spray before the expiration date on the box.

Keep KLOXXADO® Nasal Spray and all medicines out of the reach of children.

For more information, see complete prescribing information.

Kloxxado Inhaler

The Opioid Epidemic

With the spread of illegally-made, synthetic opioids like fentanyl, overdose deaths have grown across ages, races, ethnicities and communities.

Facts About Fentanyl

Facts About Fentanyl

Extremely potent, illegally-made synthetic opioids such as fentanyl and carfentanil are the most common drugs involved in overdose deaths in the United States.

Understanding Overdose

Understanding Overdose

More than a million Americans will die this decade of an opioid overdose. You could save someone.

KLOXXADO® Quick Use Instructions

Easy-to-follow instructions for administering KLOXXADO®.

See More Resources ›

Important Safety Information About KLOXXADO® (naloxone HCl) Nasal Spray 8 mg

Contraindications

Hypersensitivity to naloxone hydrochloride or to any of the other ingredients

Warnings and Precautions

  • Use KLOXXADO® right away if you suspect an opioid overdose emergency, even if you are not sure, because an opioid overdose emergency can cause severe injury or death. Signs and symptoms of an opioid overdose emergency may include:
    • Unusual sleepiness; you are not able to awaken the person with a loud voice or by 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.
  • Family members, caregivers or other people who may have to use KLOXXADO® in an opioid overdose emergency should know where KLOXXADO® is stored and how to give KLOXXADO® before an opioid overdose emergency happens.
  • Get emergency medical help right away after using the first dose of KLOXXADO®. Rescue breathing or CPR (cardiopulmonary resuscitation) may be needed while waiting for emergency medical help.
  • The signs and symptoms of an opioid overdose emergency can return after KLOXXADO® is given. If this happens, give another dose after 2 to 3 minutes, using a new KLOXXADO® device, alternating nostrils, and watch the person closely until emergency medical help arrives.
  • Do not use KLOXXADO® if you are allergic to naloxone hydrochloride or any of the ingredients in KLOXXADO®.
  • KLOXXADO® can cause sudden and severe opioid withdrawal, the symptoms of which may include body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, stomach cramps, weakness and 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.
  • Tell your doctor about all of your medical conditions before using KLOXXADO®, including if you have heart problems, are pregnant or plan to become pregnant, are breastfeeding or plan to breastfeed.
  • Tell your doctor about all of the medicines you take, including prescription drugs and over-the-counter medicines, drugs, vitamins and herbal supplements.

Side Effects

The following serious side effect is discussed in the full Prescribing Information for KLOXXADO®:

  • Sudden and Severe Opioid Withdrawal

Symptoms of sudden and severe opioid withdrawal resulting from the use of KLOXXADO® in someone regularly using opioids include: body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goosebumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, stomach cramps, weakness and increased blood pressure.

Infants may have seizures, cry more than normal and have increased reflexes.

Some people may become aggressive after abrupt reversal of opioid overdose.

In two clinical studies, a total of 47 healthy adult volunteers were exposed to a single dose of KLOXXADO®, one spray in one nostril. Side effects were reported in two subjects for each of the following: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope.

These are not all of the possible side effects of KLOXXADO®. Contact your doctor for medical advice about side effects.

Pregnancy, Infancy and Breastfeeding, Children

Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant and opioid dependent, use of KLOXXADO® may cause withdrawal symptoms in you and your unborn baby. A healthcare provider should monitor you and your unborn baby right away after you use KLOXXADO®.

There is no information regarding the presence of naloxone in human milk, the effects of naloxone on the breastfed infant or on milk production.

If the primary concern is an infant at risk of an overdose, consider whether other naloxone-containing products may be more appropriate.

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

Dosage and Administration

Do not attempt to prime or test-fire the device. Each KLOXXADO® Nasal Spray contains only 1 dose of medicine and cannot be reused. Read the “instructions for use” at the end of the Prescribing Information and Medication Guide for detailed information about the right way to use KLOXXADO® Nasal Spray.

Storage and Handling

Store KLOXXADO® at room temperature between 68°F to 77°F (20°C to 25°C). Do not expose to temperatures below 41°F (5°C) or above 104°F (40°C). Do not freeze KLOXXADO®. Keep KLOXXADO® in its box until ready to use. Protect from light. Replace KLOXXADO® before the expiration date on the box. Keep KLOXXADO® and all medicines out of the reach of children.

For more information, please see the full Prescribing Information and Medication Guide.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088.

This website is intended for U.S. audiences
Customer Service: Phone 1-800-631-2174 | Email

© Hikma Pharmaceuticals USA Inc. All rights reserved.

KLOXXADO®️ is a registered trademark of Hikma Pharmaceuticals USA Inc.
Better Health. Within Reach. Every Day.®️ is a registered trademark of Hikma Pharmaceuticals PLC.
Emergent Devices Inc. is wholly owned subsidiary of Emergent BioSolutions Inc.
KLOXXADO® is manufactured by Hikma Pharmaceuticals USA Inc. Columbus, OH 43228, and distributed by Emergent Devices Inc. Plymouth Meeting, PA 19462.

PP-KLOX-US-00024

March 2025

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Important Safety Information About KLOXXADO® (naloxone HCl) Nasal Spray 8 mg

Contraindications