ZIMHI(naloxone HCI Injection)5mg/0.5mL

ZIMHI 5mg high-dose naloxone prefilled syringe intramuscular or subcutaneous injection device The ZIMHI device can be injected through clothing, if necessary.1

NEW ZIMHI delivers a 5mg intramuscular or subcutaneous dose of naloxone1

Reaches the Cmax for 4mg intranasal naloxone in ≈3.5 minutes, vs ≈20 minutes1-5,*

Achieves a
>3x higher Cmax than 4mg intranasal naloxone1-5,*

Maintains
>50% greater concentrations than 4mg intranasal naloxone at 1 hour1-4,*

*Note: Pharmacokinetic data were compiled from multiple sources and do not account for interpatient variability.1-5

AVAILABLE first quarter of 2022

NEW ZIMHI delivers a 5mg intramuscular or subcutaneous dose of naloxone1

Reaches the Cmax for 4mg intranasal naloxone in ≈3.5 minutes, vs ≈20 minutes1-5,*

Achieves a
>3x higher Cmax than 4mg intranasal naloxone1-5,*

Maintains
>50% greater concentrations than 4mg intranasal naloxone at 1 hour1-4,*

*Note: Pharmacokinetic data were compiled from multiple sources and do not account for interpatient variability.1-5

Available for as little as $0 if eligible†

†Offer is not insurance and is not valid for patients enrolled in Medicaid, Medicare, TRICARE, or any other similar state-funded or federally funded programs. Patients must visit a participating pharmacy for savings or rebates on their ZIMHI prescriptions. Maximum benefits may apply.

The actual savings on out-of-pocket costs for ZIMHI will vary according to quantity, personal healthcare insurance coverage, and adherence to FDA dosing guidelines.

INDICATION

ZIMHI is an opioid antagonist indicated for the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression in adult and pediatric patients. ZIMHI is intended for immediate administration as emergency therapy in settings where opioids may be present. ZIMHI is not a substitute for emergency medical care.

IMPORTANT SAFETY INFORMATION

As the duration of action of naloxone hydrochloride is shorter than many opioids, keep the patient under continued surveillance and administer repeated doses of naloxone using a new ZIMHI device, as necessary, while awaiting emergency medical assistance.

Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine may be incomplete. Larger or repeat doses of ZIMHI may be required.

Use in patients who are opioid dependent may precipitate opioid withdrawal. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. Monitor for the development of signs and symptoms of opioid withdrawal.

Abrupt postoperative reversal of opioid depression may result in adverse cardiovascular (CV) effects. These events have primarily occurred in patients who had pre-existing 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 naloxone hydrochloride.

After use, the ZIMHI needle is exposed until the safety guard is deployed. A needlestick injury could occur during use in emergency situations. In the event of accidental needlestick injury, medical attention should be sought.

The following adverse reactions were most commonly observed in ZIMHI clinical studies: dizziness, lightheadedness, and elevated bilirubin.

To report SUSPECTED ADVERSE REACTIONS, contact Adamis Pharmaceuticals Corporation at 1-800-230-3935 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Cmax, maximum concentration.

References: 1. ZIMHI. Prescribing information. Adamis Pharmaceuticals Corporation; 2021. 2. Moss RB, Carleton F, Lollo, CP, Carlo DJ. Comparative pharmacokinetic analysis of community use naloxone formulations for acute treatment of opioid overdose. J Addict Res Adolesc Behav. 2019;2(2):1-4. doi:10.31579-007/2688-7517/012 3. United States Food and Drug Administration. Cross-discipline team leader review. 2015. 4. Moss RB, Carleton F, Lollo, CP, Carlo DJ. An open-label, randomized, single-dose, two-period, two-treatment crossover bioavailability study comparing 5 mg/0.5 mL of intramuscular naloxone hydrochloride to 2 mg/0.4 mL intramuscular naloxone hydrochloride autoinjector in healthy subjects. J Opioid Manag. 2020;16(3):209-214. doi:10.5055/jom.2020.0569 5. FDA Advisory Committee on the most appropriate dose or doses of naloxone to reverse the effects of life-threatening opioid overdose in the community settings. Adapt Pharma Operations Limited; 2016.

Tap here to view Indication and Important Safety Information

IMPORTANT SAFETY INFORMATION

As the duration of action of naloxone hydrochloride is shorter than many opioids, keep the patient under continued surveillance and administer repeated doses of naloxone using a new ZIMHI device, as necessary, while awaiting emergency medical assistance.

Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists, such as buprenorphine and pentazocine may be incomplete. Larger or repeat doses of ZIMHI may be required.