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Now FDA-approved

Zurnai™ is the first and only auto-injector containing nalmefene, the longest-acting opioid antagonist approved for opioid overdose reversal1-3

The opioid epidemic is evolving—provisional data for the 12 months ending February 2024 show that approximately 90% of opioid overdose deaths were from synthetic opioids (primarily fentanyl).4 Zurnai was developed to meet the challenges of today's opioid crisis. Zurnai is designed to be easy to use, making it an important new opioid reversal tool that can be used by anyone in the community—from first responders to family members.

Zurnai will be available in 2025.

Read Zurnai Press Release
FDA=Food and Drug Administration.

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INDICATIONS AND USAGE

ZURNAI is indicated for the emergency treatment of known or suspected opioid overdose induced by natural or synthetic opioids in adults and pediatric patients aged 12 years and older, as manifested by respiratory and/or central nervous system depression.

ZURNAI is intended for immediate administration as emergency therapy in settings where opioids may be present.

ZURNAI is not a substitute for emergency medical care.

IMPORTANT SAFETY INFORMATION and INDICATIONS AND USAGE

CONTRAINDICATIONS

ZURNAI is contraindicated in patients known to be hypersensitive to nalmefene hydrochloride or to any other ingredients in the product.

WARNINGS AND PRECAUTIONS

Risk of Recurrent Respiratory and Central Nervous System Depression

A recurrence of respiratory depression is possible, therefore, keep the patient under continued surveillance and administer repeat doses of ZURNAI if necessary, using a new auto-injector with each dose while awaiting emergency medical assistance.

Risk of Limited Efficacy with Partial Agonists or Mixed Agonist/Antagonists

Reversal of respiratory depression by partial agonists or mixed agonists/antagonists such as buprenorphine and pentazocine, may be incomplete. Repeat doses of ZURNAI may be required.

Precipitation of Severe Opioid Withdrawal

The use of ZURNAI in patients who are opioid dependent may precipitate opioid withdrawal.

Abrupt postoperative reversal of opioid depression may result in adverse cardiovascular (CV) effects. These events have primarily occurred in patients who had preexisting CV disorders or received other drugs that may have similar adverse CV effects. Monitor these patients closely in an appropriate healthcare setting after use of ZURNAI.

In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated and may include the following signs and symptoms: convulsions, excessive crying, and hyperactive reflexes. Monitor the patient for the development of the signs and symptoms of opioid withdrawal.

Risk of Opioid Overdose from Attempts to Overcome the Blockade

Attempts to overcome opioid withdrawal symptoms caused by opioid antagonists with high or repeated doses of exogenous opioids may lead to opioid intoxication and death.

ADVERSE REACTIONS

Most common adverse reactions (>5%) are feeling hot, nausea, headache, dizziness, chills, vomiting, allodynia, palpitations, tinnitus, ear discomfort, feeling abnormal, burning sensation, hot flush, and irritability.

USE IN SPECIFIC POPULATIONS

Pregnancy

An opioid overdose is a medical emergency and can be fatal for the pregnant woman and fetus if left untreated. Treatment with ZURNAI for opioid overdose should not be withheld because of potential concerns regarding the effects of ZURNAI in the fetus.

Pediatric Use

The safety and effectiveness of ZURNAI for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression, have not been established in pediatric patients younger than 12 years of age.

Geriatric Use

Clinical studies of nalmefene hydrochloride injection did not include sufficient number of subjects aged 65 and over to determine whether they respond differently from younger subjects.


Please read Full Prescribing Information

To report SUSPECTED ADVERSE REACTIONS, contact Purdue Pharma L.P. at 1 888⁠-⁠726⁠-⁠7535, option 2, or FDA at 1⁠-⁠800⁠-⁠FDA⁠-⁠1088 or www.fda.gov/safety/medwatch.

Intended for healthcare professionals of the United States of America only.

References: 1. Zurnai™ (nalmefene injection) Auto-Injector Full Prescribing Information. Purdue Pharma L.P.; 2024. 2. Nalmefene HCl Injection Full Prescribing Information. Purdue Pharma L.P.; 2022. 3. OPVEE® Full Prescribing Information. Indivior Inc.; 2023. 4. Ahmad FB, Cisewski JA, Rossen LM, et al. Provisional drug overdose death counts. National Center for Health Statistics. Available at: https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm. Published July 7, 2024. Accessed July 30, 2024.