Physicians & Prescribers

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.⁷

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.^8,11 DEA lab testing found that 60% of fake pills with fentanyl contained a potentially lethal dose.⁸

It only takes a very small dose of fentanyl (2mg) to be lethal.⁸
It’s difficult to distinguish between a fake pill and a real one.⁸
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®⁹ – 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.

Take Action

*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

Extremely potent, illegally-made synthetic opioids such as fentanyl and carfentanil are the most common drugs involved in overdose deaths in the United States.

Get the Facts

* 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

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

Learn the Signs

* 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®.

Download

See More Resources ›

References

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.
KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021.
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.
Your state PDMP may have built-in tools to help you assess a patient’s MME-associated risks.
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.
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.
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.
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.
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.
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.
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Important Safety Information and Indication for KLOXXADO® (naloxone HCl) NASAL SPRAY 8 mg

Warnings and Precautions

Risk of Recurrent Respiratory and CNS Depression
Due to the duration of action of naloxone relative to the opioid, keep patient under continued surveillance and administer repeat doses of naloxone using a new Nasal Spray for each dose, as necessary, while awaiting emergency medical assistance.

Important Safety Information and Indication for KLOXXADO® (naloxone HCl) NASAL SPRAY 8 mg

INDICATION AND USAGE

KLOXXADO® Nasal Spray is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, for adult and pediatric patients.

KLOXXADO® Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. KLOXXADO® Nasal Spray is not a substitute for emergency medical care.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Risk of Limited Efficacy with Partial Agonists or Mixed Agonist/Antagonists
Reversal of respiratory depression caused by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be necessary.

Precipitation of Severe Opioid Withdrawal
Use in patients who are opioid dependent may precipitate opioid withdrawal; the risk and severity of withdrawal increase as naloxone exposure increases. Opioid withdrawal is characterized by body aches, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal.

Risk of Cardiovascular (CV) Effects
Abrupt postoperative reversal of opioid depression may result in nausea, vomiting, sweating, tremulousness, tachycardia, hypotension, hypertension, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest. These events have primarily occurred in patients who had preexisting CV disorders or received other drugs that may have similar adverse cardiovascular (CV) effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone hydrochloride.

Contraindication

Hypersensitivity to naloxone hydrochloride or to any of the other ingredients in KLOXXADO® Nasal Spray.

Adverse Reactions

In two pharmacokinetic studies, a total of 47 healthy adult volunteers were exposed to a single dose of KLOXXADO® Nasal Spray, one spray in one nostril. The following adverse reactions were reported in two subjects each: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope.

The following most frequently reported events (in decreasing frequency) have been identified primarily during post-approval use of naloxone hydrochloride (all routes of administration): withdrawal syndrome, vomiting, non-responsiveness to stimuli, drug ineffective, agitation, somnolence, and loss of consciousness.

To report suspected Adverse Reactions, contact Hikma Specialty USA Inc. at: us.hikma@primevigilance.com, or call 1-877-845-0689 or 1-800-962-8364. You can also contact FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

For more information, please see accompanying full Prescribing Information for KLOXXADO® Nasal Spray.

Physicians & Prescribers

A simple step to help prevent accidental death by opioid overdose²

Is Naloxone right for your patient?