Community Organizations2023-08-22T17:03:04-04:00

Community Organizations

Illicitly manufactured fentanyl and other synthetic opioids have taken over.1 Fight back with more naloxone: Kloxxado® (naloxone HCl) Nasal Spray 8 mg.2

Equip your community with Kloxxado®

Kloxxado® (naloxone HCl) 8 mg contains the most naloxone available in a nasal spray and works quickly to reverse an opioid overdose.2,3

  • 2x more naloxone per device as Narcan® (naloxone HCl) Nasal Spray 4 mg2,3
  • 2x medicine per box than Narcan®2,4
  • Effective counter to fentanyl overdose2
  • Community pricing and bulk orders available

The MORE 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.

Help reduce opioid overdose deaths

Illicitly-manufactured fentanyl is everywhere and in everything.1 One of the biggest risk factors is that people are often exposed unintentionally.1

Overdoses involving synthetic opioids and other drugs are a growing concern. Synthetic opioids were involved in:

  • 71% of cocaine-involved deaths4
  • 65% of benzodiazepine-involved deaths4
  • 49% of stimulant-involved deaths4
  • 43% of antidepressant-involved deaths4

Fentanyl is often laced into fake pills that are made to look like OxyContin®, Xanax®, Adderall® and other pharmaceuticals.1 In fact, DEA lab testing found that 60% of fake pills with fentanyl contained a potentially lethal dose.1

Community groups and harm-reduction organizations are at the front lines of this evolving epidemic, offering care and hope to hundreds of individuals.

To help improve access to naloxone and support the important work that you do, we offer special pricing on bulk orders of Kloxxado®. Contact us to learn more.

62% of all overdose deaths are attributed to fentanyl4

Get the facts about fentanyl ›

Overcoming opioid overdose takes stronger medicine

People Use More Naloxone

78% of opioid overdoses involve at least 8 mg of naloxone.5 Kloxxado® is the only nasal spray that contains a full 8 mg in a single dose.2
See the difference

Minutes Matter

Just four minutes without breathing during an opioid overdose can cause permanent brain damage, but EMS takes 7 minutes on average to arrive on scene.6,7 Kloxxado® ensures you deliver a full 8 mg in the first dose, leaving you another dose to spare just in case.2

Find out more

Keep Calm & Carry Kloxxado®

The DEA Laboratory found that 6 out of 10 fentanyl-laced fake prescription pills contained a potentially lethal dose of fentanyl.1 Err on the side of safety; get more naloxone with Kloxxado®.2

Explore more

Get community pricing on Kloxxado®

Kloxxado® naloxone nasal spray is available at a discounted price for qualified community-based organizations and public entities. It may already be available through your state program. Contact us to learn more about pricing, how to place an order, and how to work with your state to ensure Kloxxado® is available for your community.

Community Resources

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

Get more resources

Community FAQs

Find answers to questions about Kloxxado® for community partners.

See frequently asked questions

Community Factsheet

Find out why your community may need more naloxone.

See More Resources ›

References

  1. Fake Pills Fact Sheet. US Drug Enforcement Administration website. Available at: https://www.dea.gov/sites/default/files/2022-12/DEA-OPCK_FactSheet_December_2022.pdf. Accessed June 27, 2023.
  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. Drug Overdose Death Rates. National Institute on Drug Abuse website. Available at: https://nida.nih.gov/research-topics/trends-statistics/overdose-death-rates. Accessed June 27, 2023.
  5. 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.
  6. Non-Fatal Opioid Overdose and Associated Health Outcomes: Final Summary Report. ASPE website. Available at: https://aspe.hhs.gov/sites/default/files/migrated_legacy_files//190846/Nonfatal.pdf. Accessed June 25, 2023.
  7. Mell, Howard K et al., 2017. “Emergency Medical Services Response Times in Rural, Suburban, and Urban Areas.” JAMA Surgery, 152(10), 983–984. https://doi.org/10.1001/jamasurg.2017.2230.

* 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.

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