What is Kloxxado®?2025-01-31T18:27:52-05:00

What is Kloxxado®?

Kloxxado® is a naloxone nasal spray that can reverse the effects of an opioid overdose, potentially saving someone’s life.1

hand holding kloxxado inhaler device

One thumb press can save a life1

Kloxxado® with 8 mg of naloxone can quickly reverse an opioid overdose.1

Anyone taking opioids could be at risk for accidental opioid overdose. You can be ready with Kloxxado®.1

  • 2x naloxone per device as Narcan®1,2
  • Powerful enough to counteract fentanyl1
  • Safe, portable and easy to have on hand1
  • Pay $0 if eligible*
  • No generic equivalent – ask for Kloxxado® by name

Lifesaving power at your fingertips

People Use More Naloxone

78% of opioid overdoses involve at least 8 mg of naloxone.3 Kloxxado® is the only nasal spray that contains a full 8 mg in a single dose.

See the difference

Every Minute Matters

Just four minutes without breathing during an opioid overdose can cause permanent brain damage.4 Fortunately, Kloxxado® makes it easy to respond quickly.1 It’s compact, easy-to-use and works fast to reverse the effects of opioid overdose.1

Find out more

An Affordable Choice

Don’t let cost get in the way of saving a life. With the Kloxxado® Savings Card, eligible patients may pay as little as $0* for Kloxxado® naloxone nasal spray.

Get your card

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/stopoverdose/fentanyl/index.html. Accessed March 21, 2023.

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

Kloxxado® Savings Card

Kloxxado® Savings Card

Eligible patients may pay as little as $0* with the first manufacturer’s savings card for a naloxone nasal spray.

*Maximum value of $40 per box, up to 2 boxes per redemption, up to 4 boxes per month. No activation is necessary. See eligibility and restrictions.

Kloxxado® Patient Brochure

Read about the key benefits of Kloxxado® nasal spray.

See More Resources ›

References

  1. KLOXXADO® (Naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA, Inc.; 2021
  2. NARCAN® (Naloxone HCl) Nasal Spray [prescribing information]. Plymouth Meeting, PA: Adapt Pharma, Inc.; 2020
  3. 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
  4. CPR – adult and child after onset of puberty. Medline Plus website. Available at: https://medlineplus.gov/ency/article/000013.htm. Accessed Sep. 11, 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 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.

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.

HK-2308-v1

September 2023

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

Contraindications