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      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.

      August 15, 2024 | News, Healthcare Professionals, Community Groups, Patients & Caregivers

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        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.

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        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.

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        Emergent BioSolutions

        KLOXXADO®️ is a registered trademark of Hikma Pharmaceuticals USA Inc.
        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.

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        February 2026