Healthcare Professional FAQs
Which of my patients may benefit from naloxone?
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
Who should not use KLOXXADO® (naloxone HCl) Nasal Spray 8 mg?
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 report negative side effects or adverse events?
You are encouraged to report negative side effects to the FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch. You can also contact Hikma Specialty USA Inc. at: us.hikma@primevigilance.com or call 1-877-845-0689 or 1-800-962-8364. ;
Is KLOXXADO® FDA-approved?
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?
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®?
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?
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?
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.
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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 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.
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.
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