Community Group FAQs
Is public access pricing available for KLOXXADO®?
Qualified public entities such as government entities, first responders, community organizations, schools and universities can purchase KLOXXADO® at a discounted price through NARCANDirect™.
Contact us to learn more about pricing, how to place an order, or if interested in learning more about the distribution program that will fit best for your entity.
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 use 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 adults and children.*
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
Does KLOXXADO® work to reverse overdoses from illicit 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 community 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.
What are the possible side effects from using KLOXXADO® Nasal Spray?
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.
The most common side effects in adults include: stomach-area (abdomen) pain, weakness, dizziness, headache, nose (nasal) discomfort, and a feeling like you are going to faint.*
Serious side effects include sudden opioid withdrawal symptoms. In someone who has been using opioids regularly, opioid withdrawal symptoms can happen suddenly after receiving KLOXXADO® Nasal Spray and may include body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, stomach cramping, weakness, or increased blood pressure.*
For more information, please see the full Prescribing Information and Important Safety Information.
To report an adverse event or product complaint, please contact us at us.hikma@primevigilance.com or call 1-877- 845-0689 or 1-800-962-8364. Adverse events may also be reported to the FDA directly at 1-800-FDA-1088 or www.fda.gov/medwatch.
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021Opioid & Fentanyl FAQs
What is KLOXXADO® (naloxone HCl) Nasal Spray 8 mg?
KLOXXADO® provides an option for 8 mg of naloxone HCl per spray in a single dose.* KLOXXADO® can be used by anyone to reverse the effects of an opioid overdose until medical help arrives.* Each box of KLOXXADO® contains two individually packaged single-spray devices.*
Always carry KLOXXADO® with you in case of an opioid emergency.
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021
How does KLOXXADO® Nasal Spray work?
Opioids work by attaching to specific receptors found in the brain and in the nervous system.‡ This includes the nerves that sense pain, as well as the nerves that control breathing.† Taking too many opioids can lead to an overdose and that can stop someone from breathing.‡
Naloxone, the active ingredient in KLOXXADO®, stops the opioids from attaching to the receptors on the nerves.* This reverses the effects and symptoms of the overdose.*†
KLOXXADO® Nasal Spray is administered in the nostril and does not require evidence of breathing through the nose during administration.*
Get emergency medical help right away in any case of known or suspected overdose emergency. KLOXXADO® Nasal Spray is not a substitute for emergency medical care.* Administer in accordance with the instructions provided in the KLOXXADO® Quick Instructions resource.
Each device is a single dose.* If an additional dose is needed, you must use another device.*
* KLOXXADO® (naloxone HCl) Nasal Spray [prescribing information]. Columbus, OH: Hikma Specialty USA Inc., 2021.† NIDA 2021. “Naloxone DrugFacts,” National Institute on Drug Abuse, https://www.drugabuse.gov/publications/drugfacts/naloxone, Accessed May 3, 2021.
‡ White JM & Irvine RJ. 1999, “New Horizons/Mechanisms of fatal opioid overdose,” Addiction, 94(7):961–972.
What happens if you give KLOXXADO® to someone who is not on opioids?
Naloxone, the medicine in KLOXXADO®, works only if a person has opioids in their system.*† It is safe to use even if opioids aren’t present.† Administering naloxone is unlikely to harm someone, but it could save their life if they are experiencing an opioid overdose.†
* 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. Accessed March 5, 2023.
Don’t see an answer to your question? Contact us
Important Safety Information and Indication for KLOXXADO® (naloxone HCl) NASAL SPRAY 8 mg
What is the most important information I should know about KLOXXADO® Nasal Spray?
Get emergency medical help right away after giving the first dose of KLOXXADO® Nasal Spray. The signs and symptoms of an opioid emergency can return after KLOXXADO® Nasal Spray is given. If this happens, give another dose after 2 to 3 minutes using a new KLOXXADO® Nasal Spray and watch the person closely until emergency help is received.
Important Safety Information and Indication for KLOXXADO® (naloxone HCl) NASAL SPRAY 8 mg
What is KLOXXADO® Nasal Spray?
- KLOXXADO® Nasal Spray is a prescription medicine used for the treatment of an opioid emergency such as an overdose or a possible opioid overdose in adults and children with signs of breathing problems and severe sleepiness or not being able to respond.
- KLOXXADO® Nasal Spray is to be given right away and does not take the place of emergency medical care.
- Get emergency medical help right away after giving the first dose of KLOXXADO® Nasal Spray, even if the person wakes up.
What is the most important information I should know about KLOXXADO® Nasal Spray?
Get emergency medical help right away after giving the first dose of KLOXXADO® Nasal Spray. The signs and symptoms of an opioid emergency can return after KLOXXADO® Nasal Spray is given. If this happens, give another dose after 2 to 3 minutes using a new KLOXXADO® Nasal Spray and watch the person closely until emergency help is received.
The medicine in KLOXXADO® Nasal Spray is safe to use in people who are not taking opioids. KLOXXADO® Nasal Spray is not intended for self-administration.
What should I tell my healthcare provider (pharmacist or prescriber) before using?
Before using KLOXXADO® Nasal Spray, tell your healthcare provider about all of your medical conditions, including if you:
- have heart problems
- are pregnant or plan to become pregnant. Use of KLOXXADO® Nasal Spray may cause withdrawal symptoms in your unborn baby. Your unborn baby should be examined by a healthcare provider right away after you use KLOXXADO® Nasal Spray.
- are breastfeeding or plan to breastfeed. It is not known if KLOXXADO® Nasal Spray passes into your breast milk.
What are the possible serious side effects of KLOXXADO® Nasal Spray?
KLOXXADO® Nasal Spray may cause sudden opioid withdrawal symptoms including body aches, diarrhea, increased heart rate, fever, runny nose, sneezing, goose bumps, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, stomach cramping, 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.
Who should not use KLOXXADO® Nasal Spray?
Do not use KLOXXADO® Nasal Spray if you are allergic to naloxone hydrochloride or any of the ingredients in KLOXXADO® Nasal Spray.
What are the most common side effects of KLOXXADO® nasal spray?
The most common side effects of KLOXXADO® Nasal Spray in adults include stomach-area (abdomen) pain, weakness, dizziness, headache, nose (nasal) discomfort, and a feeling like you are going to faint.
These are not all of the possible side effects of KLOXXADO® Nasal Spray. Please click here for the accompanying full Prescribing Information, including Patient Information, which includes a more complete discussion of the risks associated with KLOXXADO® Nasal Spray. Always contact your healthcare provider (pharmacist or prescriber) if you have questions or experience any side effects.
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.
