Healthcare Professional Resources

Healthcare Resources2024-03-22T12:09:38-04:00

Product information

Kloxxado® Co-Rx Guide

Kloxxado® Co-Rx Guide

Download a quick guide to co-prescribing Kloxxado®.

Kloxxado® Patient Information

View Kloxxado® Patient Information online.

Kloxxado® Quick Use Instructions

Easy-to-follow instructions for administering Kloxxado®.

Kloxxado® Quick Use Instructions – Spanish

En español: instrucciones fáciles de seguir para administrar Kloxxado®.

Kloxxado® Savings Card

Help your patients pay as little as $0* for naloxone.

Visit savings card page ›

Who Should Carry Kloxxado®

Wondering if naloxone should be part of your first aid kit? This checklist will help you decide.

Talking to Patients About Substance Use

Helpful tips for talking to your patients about substance use. Brought to you by the National Institutes of Health and the National Institute on Drug Use.

Talking to Patients About Naloxone

Helpful tips for talking to your patients about naloxone. Brought to you by the American Medical Association.

3 Things to Consider When Co-Prescribing Naloxone

Prescribing naloxone is about more than just your patient. Brought to you by the American Medical Association.

The MORE study

Life Saving Confidence

Listen to the voices of real people who participated in The MORE Study as they recount their experience using naloxone HCI nasal spray 4 mg.1

Real-world study of multiple naloxone administration for opioid overdose reversal among bystanders

Known as The MORE Study, this recent study published in the Harm Reduction Journal 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

Read the study

Guidance & recommendations

AMA Supports Kloxxado® Approval

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

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AT Forum Explains Kloxxado®

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

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APhA Motion

American Pharmacists Association supports policies and practices that increase the availability of naloxone.5

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AMA Statement

“Now, we must make sure that the new version of naloxone is placed on the lowest cost-sharing tier with low or no cost-sharing and also available in pharmacies.”7

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FDA on Kloxxado® Approval

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

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FDA Recommendations

The FDA urges healthcare professionals to discuss naloxone with their patients.6
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FDA Statement on Naloxone

Learn why the FDA is expanding access to naloxone.

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Around the practice: Education on the importance of naloxone

Presented by Psychiatric Times
Moderator: Matthew A. Torrington, MD
Panelists: Daniel E. Buffington PharmD, MBA, Thomas R. Kosten, MD, and Bill H. McCarberg, MD

The following videos are used with permission from Psychiatric Times. Psychiatric Times is a copyright publication of MultiMedia Medical, LLC. All rights reserved.
The views of the participants are independently created are not necessarily those of Hikma Pharmaceuticals.

EP1: The Opioid Epidemic and Fentanyl

Episode 1 explores the current state of the opioid epidemic and the role of naloxone in the emergency treatment of patients with a known or suspected overdose.

EP2: Approaches to Pain Management

Episode 2 explores how the opioid overdose epidemic has changed how clinicians manage pain.

EP3: Challenges With Opioid Use

Episode 3 explores the difficulties practitioners face prescribing opioid therapies to patients for pain management.

EP4: Using Naloxone Against Opioid Use

Episode 4 explores the prescribing and use of naloxone, an opioid antagonist, as a response to the opioid epidemic.

 

EP5: Dealing With a Fentanyl Overdose

Episode 5 explores how naloxone is used to reverse fentanyl overdose.

EP6: Educating Family on Naloxone and Overdoses

Episode 6 explores the importance of educating patients and their loved ones about fentanyl, overdose and naloxone.

EP7: Patient Case #1 Introduction

Episode 7 introduces the patient case of a 27 year old man presented with extreme pain in his right ankle, ribs, and arm from getting into a car accident.

 

EP8: Patient Case #1 Discussion

Episode 8 examines the case of the 27 year old man with car accident injuries.

EP9: Patient Case #2 Introduction

Episode 9 introduces the patient case of a 49 year old man found semi-responsive to commands with suspected opioid overdose.

 

EP10: Patient Case #2 Discussion

Episode 10 examines the case of the 49 year old man with suspected opioid overdose.

EP11: The Role of Healthcare Professionals and Future Direction

Episode 11 discusses the future of pain management and explores why the risk of opioid overdose necessitates patient education on the use of naloxone.

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 1-877-259-6893 | 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.

HK-1266-v3

June 2023

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

Contraindications