Community Group FAQs

Community Frequently Asked Questions2025-05-20T12:29:50-04:00

Community Group FAQs

Is public access pricing available for KLOXXADO®?2021-06-25T18:40:12-04:00

Qualified public entities such as government entities, first responders, community organizations, schools and universities can purchase KLOXXADO® at a discounted price through KLOXXADODirect™.

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?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 use for KLOXXADO® (naloxone HCl) Nasal Spray 8 mg?2025-04-01T16:31:09-04:00

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 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?2025-03-31T21:57:59-04:00

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 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?2021-06-24T20:45:45-04:00

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.

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 [email protected] 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., 2021

Opioid & Fentanyl FAQs

What is KLOXXADO® (naloxone HCl) Nasal Spray 8 mg?2021-06-24T18:00:24-04:00

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?2021-06-24T19:45:33-04:00

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?2023-04-27T14:06:18-04:00

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 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-00026

March 2025

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

Contraindications