Physicians & Prescribers2025-04-29T17:11:02-04:00

Physicians & Prescribers

Accidental opioid overdose can happen anywhere, help your patients be prepared with KLOXXADO® Nasal Spray 8 mg.1

Kloxxado Inhaler

A simple step to help prevent accidental death by opioid overdose2

Naloxone is a critical tool in opioid overdose response.3 Discuss with your patients if KLOXXADO® is the right option for them.

  • 8 mg of naloxone is a higher dose for situations where more may be needed*
  • Safe, portable and easy to have on hand2

* The clinical significance of a higher dose is currently unknown.

Is Naloxone right for your patient?

Any patient prescribed an opioid may be at risk for an opioid overdose1, certain factors can increase a patient’s risk. Co-prescribing naloxone is recommended for your patients who are taking opioids, and:9,10

  • Have a history of overdose or a substance use disorder (SUD)
  • Have sleep apnea or other sleep-disordered breathing
  • Are taking higher dosages of opioids (e.g., ≥50 MME/day)
  • Are returning to a high dose after losing tolerance (e.g., patients undergoing tapering or recently released from prison)
  • Take benzodiazepines with opioids
  • Have kidney or liver failure
  • Are 65 years and older

How do I talk to my patients about KLOXXADO®?

Just like wearing a seat belt or keeping a fire extinguisher, carrying KLOXXADO® is an important safety measure for anyone who takes opioids. But starting the conversation around naloxone and opioid safety isn’t always easy.

Here are some helpful tips for talking to patients about their risk for accidental opioid overdose and how KLOXXADO® can help in case of an emergency.

Choose the Right Language

Stigma is often attached to opioid use, and many patients don’t believe they’re at risk for overdose.6

Try This:

“Our standard of care is to provide naloxone to any patient on opioids, no matter the dose.”

“Naloxone is a safe and effective antidote to opioid overdoses, including those involving fentanyl.”

“Accidental overdose could happen if someone in your home, like a child, takes the medication by accident. Or if you accidentally take double the dose.”

Explain the Benefits

Help patients understand how KLOXXADO® can help save a life from accidental overdose.2 Address any cost concerns.

Try This:

“Having KLOXXADO® Nasal Spray in the home is just a precaution. But in the event of an accidental overdose, it can save a life.”

“Let me check the price of KLOXXADO® Nasal Spray with your insurance.”

Help Patients Feel Prepared

Talk to patients about what an opioid overdose emergency looks like. Explain how to use and store KLOXXADO®.

Try This:

“KLOXXADO® Nasal Spray is easy to use. In the event of an opioid overdose emergency, follow these simple steps. Then call 911.”

“Let’s review how to recognize an opioid overdose.”

“I recommend keeping KLOXXADO® available in case of an emergency. Make sure your family and friends know where it’s stored and how to use it.”

The deadly risks of counterfeit pills.

Today, fentanyl is laced into fake pills that are made to look like OxyContin®, Xanax®, Adderall® and other pharmaceuticals.7,11 DEA lab testing found that 60% of fake pills with fentanyl contained a potentially lethal dose.7

  • It only takes a very small dose of fentanyl (2mg) to be lethal.7
  • It’s difficult to distinguish between a fake pill and a real one.7
  • Having naloxone on hand in case of an opioid overdose emergency is more critical than ever.

Synthetic fentanyl can impact us all. Help your patients be prepared with KLOXXADO®8 – a higher dose option for opioid overdose response.*2

* The clinical significance of a higher dose is currently unknown.

The Opioid Epidemic

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

*Drug Overdose Deaths Among Persons Aged 10-19 Years – United States, July 2019-December 2021. †Drug Overdose Deaths Rise, Disparities Widen. Centers for Disease Control and Prevention website. Available at: https://www.cdc.gov/vitalsigns/overdose-death-disparities/index.html. Accessed June 25, 2023.

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.*

* Fentanyl Facts. Centers for Disease Control and Prevention website. Available at: https://www.cdc.gov/stop-overdose/caring/fentanyl-facts.html. Accessed March 17, 2025.

Understanding Overdose

Understanding Overdose

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

* Humphreys et. Al. 2022, “Responding to the opioid crisis in North America and beyond: recommendations of the Stanford–Lancet Commission,” The Lancet, 399:10324, p555-604

Healthcare Resources

Access helpful online tools, videos, research studies, educational materials and more.

Get more resources

Healthcare FAQs

Find answers to questions about KLOXXADO® for healthcare professionals.

See frequently asked questions

KLOXXADO® Quick Use Instructions

Easy-to-follow instructions for administering KLOXXADO®.

See More Resources ›

References

  1. Preventing an Opioid Overdose Tip Card. US Centers for Disease Control and Prevention website. Available at: https://www.cdc.gov/overdose-resources/pdf/Preventing-an-Opioid-Overdose-Tip-Card-a_508.pdf. Accessed March 5, 2025.
  2. KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021.
  3. Access to Naloxone Can Save a Life During an Opioid Overdose. US Food and Drug Administration website. Available at: https://www.fda.gov/consumers/consumer-updates/access-naloxone-can-save-life-during-opioid-overdose#:~:text=Naloxone%20is%20a%20life%2Dsaving,including%20nasal%20sprays%20and%20injections.
  4. Your state PDMP may have built-in tools to help you assess a patient’s MME-associated risks.
  5. Naloxone: The Opioid Reversal Drug that Saves Lives. US Department of Health and Human Services website. Available at: https://www.hhs.gov/system/files/naloxone-coprescribing-guidance.pdf. Accessed June 25, 2023.
  6. Cheetham A, Picco L, Barnett A, Lubman DI, Nielsen S. The Impact of Stigma on People with Opioid Use Disorder, Opioid Treatment, and Policy. Subst Abuse Rehabil. 2022;13:1-12.
  7. One Pill Can Kill Fake Pills Fact Sheet. US Drug Enforcement Agency website. Available at: https://www.dea.gov/sites/default/files/2022-12/DEA-OPCK_FactSheet_December_2022.pdf. Accessed June 25, 2023.
  8. Opioid Crisis Affects All Americans, Rural and Urban. US Department of Agriculture website. Available at: https://www.usda.gov/about-usda/news/blog/opioid-crisis-affects-all-americans-rural-and-urban#:~:text=The%20effects%20of%20the%20opioid,olds%20and%20tripled%20for%20females. Accessed March 5, 2025.
  9. Centers for Disease Control and Prevention. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2022. MMWR Recomm Rep
    2022;71(3):1–88.
  10. CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. US Centers for Disease Control and Prevention website. Available at: https://www.cdc.gov/mmwr/volumes/71/rr/rr7103a1.htm#recommendations. Accessed April 29, 2025.
  11. All trademarks are the property of their respective owners.

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-00025

March 2025

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

Contraindications