KLOXXADO® (naloxone HCl) Nasal Spray 8 mg Shelf-Life Extended from 24 months to 36 months

The FDA has recently announced the approval of the shelf-life extension of KLOXXADO® (naloxone HCl) Nasal Spray 8 mg from 24 to 36 months from date of manufacture. KLOXXADO® packaging has been updated with 36-month dating, starting with product manufactured in March 2024.

KLOXXADO® – a high dose option – is a ready-to-use nasal naloxone approved for the emergency treatment of known or suspected opioid overdose, providing an important treatment option in addressing the overdose epidemic. Naloxone has long been recognized as an important, safe and effective treatment in the fight against opioid overdose.

About Naloxone

Naloxone hydrochloride is a medicine that rapidly reverses an opioid overdose. It can quickly restore normal breathing in someone experiencing an opioid overdose and should be given to any person who shows signs of an opioid overdose or when an opioid overdose is suspected.

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

This product has been approved for marketing in the United States by the US FDA. This product approval does not confer the right on Hikma, or any other party, to market this product outside the United States.

Please see the Full Prescribing Information and Medication Guide for KLOXXADO® for complete product details.

NOTE: This article was not written by a medical professional and is not intended to substitute for the guidance of a physician. These are not Emergent’s recommendations, but rather facts and data collected from various reliable medical sources. For a full list of resources and their attributing links, see below.

Editor2025-05-22T04:44:47-04:00August 15, 2024|Community Groups, Healthcare Professionals, News, Patients & Caregivers|

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

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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.

Hikma

PP-KLOX-US-00024

July 2025

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

Contraindications