Frequently Asked Questions

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.¹

ZURNAI is contraindicated in patients known to be hypersensitive to nalmefene hydrochloride or to any other ingredients in the product.¹

ZURNAI is intended for immediate administration as emergency therapy in settings where opioids might be present, specifically when a patient is showing signs of an overdose such as respiratory and/or central nervous system depression. It is not a substitute for emergency medical care.¹

ZURNAI is for intramuscular or subcutaneous use only. The device is ready to use and no assembly is required. Inject ZURNAI into the anterolateral aspect of the thigh. ZURNAI can be administered through clothing. Step-by-step instructions for administering ZURNAI are included on the body of the auto-injector. Refer to Instructions for Use (opens in new window) (found in the Full Prescribing Information (opens in new window)) for additional administration details. In summary¹:

1. Twist blue cap then pull
2. Push needle end into outer thigh until click – then hold for 3 seconds
3. Injection complete when window is orange
4. Call 911 and watch the person. Stay until the ambulance arrives

The active ingredient in ZURNAI is nalmefene 1.5 mg (equivalent to 1.7 mg nalmefene hydrochloride) in 0.5 mL solution.¹

The inactive ingredients include: hydrochloric acid to adjust pH; magnesium chloride, 4.7mg; and water for injection¹

ZURNAI comes packaged as a single auto-injector within a carton. The prefilled, single-dose auto-injector contains 1.5 mg of nalmefene. It is intended for single use only and cannot be reused. After use, it should be discarded in a sharps container.¹

ZURNAI should be kept in the carton in a clean, dry place at controlled room temperature (68°F to 77°F), with excursions permitted between 59°F to 86°F.¹

• It needs to be protected from light, and you should not freeze or refrigerate it. Periodically check the expiration date and replace it as needed
• During storage, inspect the ZURNAI solution through the viewing window of the auto-injector every 30 days. The liquid should be clear, colorless to light yellow. If the ZURNAI solution is discolored, cloudy, or contains solid particles, replace it with a new ZURNAI Auto-Injector

ZURNAI is designed to work fast. In a pharmacodynamic study, the time to onset of reversing respiratory depression was observed to be between 2.5 to 5 minutes. Full recovery of respiratory drive was noted between 5 and 15 minutes after ZURNAI was administered. This pharmacodynamic study was conducted in an experimental setting where fentanyl was infused over an extended period and titrated to maintain consistent plasma concentrations. As such, the clinical implications of these findings for real-world overdose situations are unknown.¹

ZURNAI is a long-acting medication. In a pharmacokinetic study involving 24 healthy adult volunteers, ZURNAI demonstrated a mean terminal elimination half-life of 9.07 hours.¹ Pharmacokinetic studies are conducted in healthy subjects; as such, the clinical implications of these findings for real-world overdose situations are unknown.

The use of ZURNAI in opioid-dependent patients may precipitate opioid withdrawal, characterized by the following signs and symptoms: body aches, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea or vomiting, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure. Monitor patients closely for the development of the signs and symptoms of opioid withdrawal.¹

Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine, may be incomplete. In these cases, repeat doses of ZURNAI may be required.¹

ZURNAI is not a substitute for emergency medical care. Because a recurrence of respiratory depression is possible, patients must be kept under continued surveillance. If necessary, administer repeat doses of ZURNAI using a new auto-injector for each dose while awaiting emergency medical assistance.¹

The most common adverse reactions (occurring in > 5% of cases) are feeling hot, nausea, headache, dizziness, chills, vomiting, allodynia, palpitations, tinnitus, ear discomfort, feeling abnormal, burning sensation, hot flush, and irritability.¹

ZURNAI can be ordered through Knoa Pharma Authorized Distributors.

• NDC 59011-962-01
• More information is available at 1-800-877-5666