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HEALTHCARE PROVIDERS / NEED FOR HIGH DOSE

Opioid overdoses are becoming

INCREASINGLY
CHALLENGING

THE RISK FOR SYNTHETIC OPIOID
OVERDOSE HAS NEVER BEEN HIGHER.
vials depicting a lethal dose of heroin, fentanyl, and carfentanil

Representative of respective lethal doses.

Opioid overdoses are becoming

INCREASINGLY
CHALLENGING

THE RISK FOR
SYNTHETIC OPIOID
OVERDOSE HAS NEVER
BEEN HIGHER.
vials depicting a lethal dose of heroin, fentanyl, and carfentanil

Representative of respective lethal doses.

FENTANYL:

100x

more potent

than morphine with a faster onset of action1,2

CARFENTANIL:

10,000x

more potent

than morphine—the most potent fentanyl analog in the United States3

85%

OF OPIOID OVERDOSE DEATHS
were due to synthetic opioids from April 2020 to April 20214

FENTANYL:

100x

more potent

than morphine with a faster onset of action1,2

CARFENTANIL:

10,000x

more potent

than morphine—the most potent fentanyl analog in the United States3

85%

OF OPIOID OVERDOSE DEATHS
were due to synthetic opioids from April 2020 to April 20214

THE NUMBER OF SEIZED COUNTERFEIT PILLS CONTAINING FENTANYL
DURING AN 8-WEEK PERIOD IN 2021 WAS ENOUGH TO POTENTIALLY KILL
>700,000 PEOPLE5

THE NUMBER OF SEIZED
COUNTERFEIT PILLS
CONTAINING FENTANYL
DURING AN 8-WEEK PERIOD IN
2021 WAS ENOUGH TO
POTENTIALLY KILL >700,000
PEOPLE5

GREATER ASSURANCE DURING AN OPIOID
OVERDOSE EMERGENCY RESCUE SITUATION

There is no way to know how much naloxone will be needed to restore normal respiration during an opioid overdose
emergency. When you consider all the uncertainties associated with an overdose—such as how much a patient has
taken or how long they haven’t been breathing—having a wider safety net could be beneficial.6

High-dose intramuscular naloxone administration could be the difference.

≈50%

OF OPIOID REVERSALS

are estimated to require more
than 1 dose of naloxone7

44%

4-mg INTRANASAL DOSE

of naloxone has only 44% of the
relative bioavailability* compared with
a 0.4-mg intramuscular injection8

GREATER ASSURANCE
DURING AN OPIOID
OVERDOSE
EMERGENCY RESCUE
SITUATION

There is no way to know how much
naloxone will be needed to restore
normal respiration during an opioid
overdose emergency. When you
consider all the uncertainties associated
with an overdose—such as how much a
patient has taken or how long they
haven’t been breathing—having a wider
safety net could be beneficial.6

High-dose intramuscular
naloxone administration
could be the difference.

≈50%

OF OPIOID REVERSALS

are estimated to require more than 1 dose
of naloxone7

44%

4-mg INTRANASAL DOSE

of naloxone has only 44% of the
relative bioavailability* compared
with a 0.4-mg intramuscular
injection7

EVEN WITH INTRAMUSCULAR ADMINISTRATION OF
NALOXONE, FENTANYL POTENCY DEMANDS GREATER
STRENGTH

As noted in a 2016 FDA Advisory Report, reducing opioid receptor occupancy to 50%
is estimated to be the threshold for successful overdose recovery6,9

Modeled simulation for rate of opioid receptor occupancy reduction of
fentanyl (50ng/mL) for 5-mg IM naloxone vs 2-mg IM naloxone10

line graph of a modeled simulation rate of opioid receptor occupancy reduction of fentanyl (50ng/mL) for 5-mg intramuscular naloxone vs 2-mg intramuscular naloxone. At 4 minutes, 5-mg intramuscular naloxone reduced opioid receptor occupancy to 50% compared to 10 minutes with 2-mg intramuscular naloxone

IM=intramuscular.

*Dose normalized.

EVEN WITH INTRAMUSCULAR ADMINISTRATION OF
NALOXONE, FENTANYL POTENCY DEMANDS GREATER STRENGTH

As noted in a 2016 FDA Advisory Report, reducing opioid receptor occupancy to 50%
is estimated to be the threshold for successful overdose recovery6,9

Modeled simulation for rate of opioid receptor
occupancy reduction of fentanyl (50ng/mL) for
5-mg IM naloxone vs 2-mg IM naloxone10

line graph of a modeled simulation rate of opioid receptor occupancy reduction of fentanyl (50ng/mL) for 5-mg intramuscular naloxone vs 2-mg intramuscular naloxone. At 4 minutes, 5-mg intramuscular naloxone reduced opioid receptor occupancy to 50% compared to 10 minutes with 2-mg intramuscular naloxone

IM=intramuscular.

*Dose normalized.

“…if a patient is experiencing profound respiratory depression that could lead to death, the risks of precipitated withdrawal are outweighed by the need to restore respiration quickly before brain injury or death occur.”11

—FDA Spokesperson

FAST ABSORPTION WITH ZIMHI

HELPFUL TIPS FOR TALKING TO
PATIENTS ABOUT ZIMHI

HELP PATIENTS SAVE

In an opioid overdose emergency,

ZIMHI MAY MAKE ALL
THE DIFFERENCE

REQUEST A TRAINING DEVICE

In an opioid overdose emergency,

ZIMHI MAY
MAKE ALL THE
DIFFERENCE

REQUEST A TRAINING DEVICE

In an opioid overdose emergency,

ZIMHI MAY
MAKE ALL THE
DIFFERENCE

REQUEST A TRAINING DEVICE

References: 1. Fentanyl. United States Drug Enforcement Administration. Accessed October 28, 2020. https://www.dea.gov/factsheets/fentanyl 2. Stanley TH. The fentanyl story. J Pain. 2014;15(12):1215-1226. doi:10.1016/j.jpain.2014.08.010 3. Synthetic opioid overdose data. Centers for Disease Control and Prevention. Updated March 25, 2021. Accessed November 30, 2021. https://www.cdc.gov/drugoverdose/deaths/synthetic/index.html 4. Provisional drug overdose death counts. Centers for Disease Control and Prevention. Updated October 13, 2021. Accessed December 9, 2021. https://www.cdc.gov/nchs/nvss/vsrr/drug-overdose-data.htm 5. Department of Justice announces DEA seizures of historic amounts of deadly fentanyl-laced fake pills in public safety surge to protect U.S. communities. Department of Justice. Published September 30, 2021. Accessed December 22, 2021. justice.gov/opa/pr/department-justice-announces-dea-seizures-historic-amounts-deadly-fentanyl-laced-fake-pills 6. 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. 7. CT EMS SWORD: Statewide Opioid Reporting Directive Newsletter. Connecticut Dept of Health. Accessed October 20, 2021. https://portal.ct.gov/-/media/Departments-and-Agencies/DPH/dph/ems/pdf/SWORD/SWORD-newsletters/2021/SWORDSept2021NL_FINAL.pdf 8. Narcan. Prescribing Information. Adapt Pharma Operations Limited; Rev 08/2020. 9. Melichar JK, Nutt DJ, Malizia AL. Naloxone displacement at opioid receptor sites measured in vivo in the human brain. Eur J Pharmacol. 2003:459(2-3);217-219. doi: 10.1016/s0014-2999(02)02872-8 10. Moss RB, Pryor MM, Baillie R, et al. Higher naloxone dosing in a quantitative systems pharmacology model that predicts naloxone-fentanyl competition at the opioid mu receptor level. PLoS one. 2020;15(6):e0234683. doi:10.1371/journal.pone.0234683 11. Farah, T. How much naloxone is needed to reverse an opioid overdose? New high-dose treatments are raising questions. STAT. Published December 15, 2021. Accessed January 27, 2022. https://www.statnews.com/2021/12/15/naloxone-opioid-overdose-zimhi-kloxxado

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. 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

IMPORTANT SAFETY INFORMATION and INDICATION for ZIMHI™

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. Repeat doses of ZIMHI may be required.

More
+

IMPORTANT SAFETY INFORMATION and INDICATION for ZIMHI™

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.

More
+
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