A LONG-ACTING OPTION FOR OPIOID OVERDOSE REVERSAL¹*

The first and only nalmefene auto-injector¹

While the duration of action of nalmefene is as long as most opioids, a recurrence of respiratory depression is possible, even after an apparently adequate initial response to ZURNAI treatment.

Therefore, it is necessary to seek emergency medical assistance immediately after administration of the first dose of ZURNAI and to keep the patient under continued surveillance. A second dose may be necessary if there is recurrence of symptoms of opioid overdose.

Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.

*ZURNAI mean elimination half-life of 9.07 hours is based on a pharmacokinetic study of 24 healthy adult subjects given a single dose of intramuscular ZURNAI.

A woman's hand holding the ZURNAI auto-injector

Not actual size.

>80% of opioid receptors blocked within 5 minutes¹

>80% of opioid receptors blocked within 5 minutes¹

Following a 1 mg parenteral dose, nalmefene was rapidly distributed. In a pharmacology study of brain receptor occupancy, a 1 mg dose of nalmefene blocked more than 80% of brain opioid receptors within 5 minutes after administration.¹

ZURNAI (nalmefene injection) is designed to be used by anyone in the community

See important information
about administering ZURNAI.

Actor portrayals.

9-hour mean terminal
elimination half-life¹

ZURNAI mean terminal elimination half-life of 9.07 hours is based on a pharmacokinetic study of 24 healthy adult subjects given a single dose of intramuscular ZURNAI.

ZURNAI auto-injector without the cap

Not actual size.

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Opioid overdose crisis

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

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 .

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

Reference: 1. ZURNAI™ (nalmefene injection) Auto-Injector Full Prescribing Information. Purdue Pharma L.P.; 2024.