Healthcare Professional FAQs

Healthcare Frequently Asked Questions2025-04-22T16:01:32-04:00

Healthcare Professional FAQs

Which of my patients may benefit from naloxone?2021-06-25T18:00:31-04:00

Co-prescribing naloxone is recommended for your patients who are taking opioids, and:*

  • 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

* 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.

Who should not use KLOXXADO® (naloxone HCl) Nasal Spray 8 mg?2021-06-25T18:15:27-04:00

KLOXXADO® is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients in KLOXXADO®.*

* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021

How do I stock and dispense KLOXXADO®?2021-06-25T18:45:58-04:00

KLOXXADO® is available from your regular wholesalers. Here’s the item number to find it. Need help? Contact us.

 

Product Image Strength Unit Size/Quantity NDC Number WAC Wholesaler Item #
8mg / 0.1mL Carton: 2-unit dose nasal spray devices 59467-679-01 $125.00 AmeriSource Bergen 10260066
Cardinal 5735550
McKesson 2342855
Morris & Dickson 104455

Product Description: Clear, colorless-to-yellow solution supplied in a single-dose spray device that consists of a stoppered glass vial encased in a container holder fitted with a spray actuator, cannula, and spray pin.

How do I report negative side effects or adverse events?2021-06-25T19:00:42-04:00

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.

Is KLOXXADO® FDA-approved?2021-06-25T19:15:08-04:00

Yes.*

* FDA 2021, “FDA Approves Higher Dosage of Naloxone Nasal Spray to Treat Opioid Overdose,” https://www.fda.gov/news-events/press-announcements/fda-approves-higher-dosage-naloxone-nasal-spray-treat-opioid-overdose, Accessed May 3, 2021.

What is the FDA-approved indication for KLOXXADO® (naloxone HCl) Nasal Spray 8 mg?2021-06-25T19:30:30-04:00

KLOXXADO® (naloxone HCl) Nasal Spray 8 mg 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® is intended for immediate administration as emergency therapy in settings where opioids may be present.*

KLOXXADO® is not a substitute for emergency medical care.*

* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021

What side effects or adverse events are most commonly reported with KLOXXADO®?2021-06-25T19:45:03-04:00

In two pharmacokinetic (PK) studies of 47 healthy adult volunteers, the following adverse reactions were reported in two subjects each: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope.

Common side effects may include: withdrawal syndrome, vomiting, non-responsiveness to stimuli, drug ineffective, agitation, somnolence, and loss of consciousness

Serious risks may include: recurrent respiratory and CNS depression; limited efficacy with partial agonists or mixed agonist/antagonists; precipitation of severe opioid withdrawal; and CV effects*

For more information, please see the full Prescribing Information and Important Safety Information.

* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021

My patient may be misusing opioids. What else should I be aware of?2021-06-25T20:00:20-04:00

If a patient obtains opioids from anywhere other than a pharmacy, they are at risk of acquiring counterfeit medications that contain illicitly manufactured synthetic opioids.* In these situations, your patient may not be able to tell the difference between a true prescription opioid and a counterfeit medication.*

Synthetic fentanyl can impact us all. Help your patients be prepared with KLOXXADO® – a higher dose option for opioid overdose response.*†‡

* 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.

‡ The clinical significance of a higher dose is currently unknown.

Can KLOXXADO® reverse an overdose on illicitly manufactured fentanyl or fentanyl analogs?2023-07-17T07:58:42-04:00

KLOXXADO® contains 8 mg of naloxone HCl, a medicine that can reverse the effects of opioids including fentanyl and fentanyl analogs.*† Synthetic fentanyl can impact us all. Help your patients be prepared with KLOXXADO® – a higher dose option for opioid overdose response.‡

* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021.
† Stop Overdose – Naloxone. CDC, https://www.cdc.gov/stopoverdose/naloxone/index.html, Accessed June 22, 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.

¶ The clinical significance of a higher dose is currently unknown.

Don’t see an answer to your question? Contact us

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.

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

© Hikma Pharmaceuticals USA Inc. All rights reserved.

KLOXXADO®️ is a registered trademark of Hikma Pharmaceuticals USA Inc.
Better Health. Within Reach. Every Day.®️ is a registered trademark of Hikma Pharmaceuticals PLC.
Emergent Devices Inc. is wholly owned subsidiary of Emergent BioSolutions Inc.
KLOXXADO® is manufactured by Hikma Pharmaceuticals USA Inc. Columbus, OH 43228, and distributed by Emergent Devices Inc. Plymouth Meeting, PA 19462.

PP-KLOX-US-00025

March 2025

This website uses cookies and third party services. Please see our cookie policy and privacy policy for more information. OK
Go to Top
Read More...

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

Contraindications