Physicians & Prescribers2024-02-22T21:49:03-05:00

Physicians & Prescribers

Opioid overdose can happen to anyone.
Help your patients be ready with Kloxxado® (naloxone HCl) nasal spray 8 mg.

Prescribe a lifeline with twice the naloxone

78% of opioid overdoses involve at least 8 mg of naloxone.1 Kloxxado® is the only nasal spray that contains a full 8 mg in a single dose.2

  • 2x more naloxone per device as Narcan®2,3
  • Safe, portable and easy to have on hand2
  • A simple step to prevent accidental death by opioid overdose2

Study: A case for higher-dose naloxone

This recent study found that 78% of opioid overdose reversals required multiple doses of Narcan® Nasal Spray 4 mg, which suggests the need for a naloxone nasal spray that contains 8 mg of naloxone in a single dose.1

The increasing prevalence of highly potent, illicitly manufactured fentanyl and its analogues (IMF) in the USA is exacerbating the opioid epidemic which has worsened during the COVID-19 pandemic. Narcan® (naloxone HCl) Nasal Spray has been approved by the US Food and Drug Administration as a treatment for opioid-related overdoses. Due to the high potency of IMF, multiple naloxone administrations (MNA) may be needed per overdose event. It is essential to determine the patterns of naloxone use, including MNA, and preferences among bystanders who have used naloxone for opioid overdose reversal.

A cross-sectional web-based survey was administered to 125 adult US residents who administered 4 mg Narcan® Nasal Spray during an opioid overdose in the past year. The survey asked about the most recent overdose event, the use of Narcan® during the event and the associated withdrawal symptoms, and participant preferences regarding dosages of naloxone nasal spray. An open-ended voice survey was completed by 35 participants.

Most overdose events (95%) were successfully reversed, with 78% using ≥ 2 doses and 30% using ≥ 3 doses of Narcan® Nasal Spray. Over 90% were worried that 1 Narcan® box may not be enough for a successful future reversal. Reported withdrawal symptoms were similar in overdose events where 1 versus ≥ 2 sprays were given. Eighty-six percent of participants reported more confidence in an 8 mg versus a 4 mg naloxone nasal spray and 77% reported a stronger preference for 8 mg over 4 mg.

MNA occurred in most overdose events, often involving more sprays than are provided in one Narcan® nasal spray box, and participants predominantly expressed having a stronger preference for and confidence in an 8 mg compared to a 4 mg nasal spray. This suggests the need and desire for a higher dose naloxone nasal spray formulation option. Given that bystanders may be the first to administer naloxone to someone experiencing an opioid overdose, ensuring access to an adequate naloxone supply is critical in addressing the opioid overdose epidemic.

Life Saving Confidence

The following video captures voices of real people who have experience using naloxone HCl nasal spray 4 mg.1 Watch now.

What do the experts say about naloxone?

FDA on Kloxxado® Approval

The FDA describes the approval of Kloxxado® as meeting “another critical need in combatting opioid overdose.”

Read more

AMA Supports Kloxxado® Approval

The AMA commended the FDA approving new high-dose tools to addressing the evolving opioid landscape.

Read more

AT Forum Explains Kloxxado®

The Addiction Treatment Forum describes how the opioid epidemic has evolved and why patients need Kloxxado®.

Read more
Kloxxado® Co-Rx Guide

Kloxxado® Co-Rx Guide

Download a quick guide to co-prescribing Kloxxado®.

See More Resources ›

Which patients need Kloxxado®?

Certain factors can increase a patient’s risk for opioid overdose. Co-prescribing naloxone is recommended for patients who are taking opioids and meet any of the following criteria:4

  • Taking opioids at a high strength (≥50MME/day)* or as a long-term therapy4
  • Taking a benzodiazepine4
  • Have certain respiratory conditions, like COPD or sleep apnea4
  • Have a mental health disorder4
  • Have a history of overdose or substance use disorder, including PWUD and patients in recovery4

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

A stigma is often attached to opioid use, and many patients don’t believe they’re at risk for overdose.5

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. Address any cost concerns.2

Try This:

“Having Kloxxado® nasal spray in the home is just a precaution. It’s like an EpiPen. But in the event of an accidental overdose, it could save a life.”

“Let me check the price of Kloxxado® nasal spray with your insurance or the Kloxxado® savings card.”

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 four simple steps. Then call 911.”

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

“I recommend keeping Kloxxado® in your home in case of an emergency. Make sure family and friends know where it’s stored.”

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.6 DEA lab testing found that 60% of fake pills with fentanyl contained a potentially lethal dose.6

  • It only takes a very small dose of fentanyl (2mg) to be lethal.6
  • It’s difficult to distinguish between a fake pill and a real one.6
  • Having naloxone on hand in case of an opioid overdose emergency is more critical than ever.7

More potent opioids, like fentanyl, may require more naloxone to counteract.7 That’s why Kloxxado® contains 8 mg of naloxone per device – the highest dose of naloxone available as a nasal spray.2

Relapse should be a learning experience, not a death sentence.

Kloxxado® is an important safety net for your patients who may have a substance use disorder (SUD).

SUD patients are at a high risk of overdose due to a diminished tolerance to opioids.8

  • 40-60% of SUD patients in recovery will experience a relapse.8
  • If they relapse on their previously “normal” opioid dose, they could be more likely to experience an overdose.8
  • Fentanyl is particularly dangerous for someone with less tolerance to opioids.9 It can be mixed with other drugs like pills, heroin, cocaine and meth without the user’s knowledge.9

Talk to your patients about their risks and prescribe Kloxxado® so they can be prepared.

Request a Kloxxado® Training Kit

The Kloxxado® Training Kit includes helpful resources for your patients, including a training device and Kloxxado® Savings Cards.

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® Co-Rx Guide

Kloxxado® Co-Rx Guide

Download a quick guide to co-prescribing Kloxxado®.

See More Resources ›

References

  1. Abdelal R, Banerjee A, Carlberg-Racich S, Darwaza N, Ito D, Shoaff J, Epstein J. Real-World Study of Multiple Naloxone Administration for Opioid Overdose Reversal Among Bystanders. JMCP. 2021;27(10-a):S54.
  2. KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021.
  3. NARCAN® (naloxone HCl) Nasal Spray [prescribing information]. Plymouth Meeting, PA: Emergent BioSolutions, 2020.
  4. 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.
  5. 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.
  6. 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.
  7. Naloxone DrugFacts. National Institute on Drug Abuse website. Available at: https://nida.nih.gov/publications/drugfacts/naloxone. Accessed June 25, 2023.
  8. Drugs, Brains, and Behavior: The Science of Addiction/Treatment and Recovery. National Institute on Drug Abuse website. Available at: https://nida.nih.gov/publications/drugs-brains-behavior-science-addiction/treatment-recovery. Accessed June 26, 2023.
  9. Fentanyl DrugFacts. National Institute on Drug Abuse website. Available at: https://nida.nih.gov/publications/drugfacts/fentanyl. Accessed June 26, 2023.

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 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.

Distributed by: Hikma Specialty USA Inc., Columbus, OH 43228.

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

© Hikma Specialty USA Inc. All rights reserved.
NARCAN® is a registered trademark of Emergent Operations Ireland Limited.

KLOXXADO®️ is a registered trademark of Hikma Pharmaceuticals USA Inc.
The brand statement “Better Health. Within Reach. Every Day.” is a registered trademark of Hikma Pharmaceuticals PLC.

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June 2023

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

Contraindications