FDA

Zimhi

Approved 15 Oct 2021Intramuscular, SubcutaneousSolution

Indications

1. INDICATIONS AND USAGE ZIMHI is indicated in adults and pediatric patients for: the emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression. 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. 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.

( 1 ) ZIMHI is intended for immediate administration as emergency therapy in settings where opioids may be present. ( 1 ) ZIMHI is not a substitute for emergency medical care. ( 1 )

Contraindications

4. CONTRAINDICATIONS ZIMHI is contraindicated in patients known to be hypersensitive to naloxone hydrochloride or to any of the other ingredients. Hypersensitivity to naloxone hydrochloride or to any of the other ingredients in ZIMHI. ( 4 )

Warnings and precautions

5. WARNINGS AND PRECAUTIONS Risk of Recurrent Respiratory and CNS Depression : Due to the duration of action of naloxone relative to the opioid, respiratory and CNS depression may recur after the first dose of naloxone. Seek emergency medical assistance immediately after the first dose, keep the patient under continued surveillance, and administer repeated doses of naloxone using a new ZIMHI, as necessary, while awaiting emergency medical assistance.

( 5.1 ) Risk of Limited Efficacy with Partial Agonists or Mixed Agonists/Antagonists : Reversal of respiratory depression caused by partial agonists or mixed agonists/antagonists such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be required. ( 5.2 ) Precipitation of Severe Opioid Withdrawal : Use in patients who are opioid dependent results in rapid onset of opioid withdrawal. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated.

Monitor for the development of opioid withdrawal. ( 5.3 ) Risk of Cardiovascular (CV) Effects : Abrupt postoperative reversal of opioid depression may result in adverse CV effects. These events have primarily occurred in patients who had pre-existing CV disorders or received other drugs that may have similar CV effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone hydrochloride.

( 5.3 ) Risk of Accidental Needlestick Injury : After use, the ZIMHI needle is exposed until the safety guard is deployed. Stress to patients the importance of familiarizing themselves with the device and its operation prior to experiencing an emergency situation, and to immediately seek medical attention should a needlestick occur. ( 5.4 )

At a glance

Brand name: Zimhi
Active substance: naloxone hydrochloride
Route: Intramuscular, Subcutaneous
Dosage form: Solution
Applicant: Zmi Pharma
Status: Prescription
FDA approval: 15 Oct 2021
Application: NDA212854-001

Indications

( 1 ) ZIMHI is intended for immediate administration as emergency therapy in settings where opioids may be present. ( 1 ) ZIMHI is not a substitute for emergency medical care. ( 1 )

Warnings and precautions

Adverse reactions

6. ADVERSE REACTIONS The following serious adverse reactions are discussed elsewhere in the labeling: Precipitation of Severe Opioid Withdrawal [ see Warnings and Precautions ( 5.3 )] Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice.

The following adverse reactions were observed in ZIMHI clinical studies in healthy volunteers without opioid dependence: nausea, dizziness, lightheadedness, and elevated bilirubin. The following adverse reactions have been identified during post-approval use of naloxone hydrochloride in the post-operative setting. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure: Hypotension, hypertension, ventricular tachycardia and fibrillation, dyspnea, pulmonary edema, and cardiac arrest.

Death, coma, and encephalopathy have been reported as sequelae of these events. Excessive doses of naloxone hydrochloride in post-operative patients have resulted in significant reversal of analgesia and have caused agitation [ see Warnings and Precautions ( 5.3 ) ]. Other events that have been reported in post-marketing use of naloxone hydrochloride include agitation, disorientation, confusion, and anger. Abrupt reversal of opioid effects in persons who were opioid dependent resulted in opioid withdrawal characterized by rapid onset of severe body aches, vomiting, diarrhea, tachycardia, fever, runny nose, sneezing, piloerection, sweating, yawning, nausea, nervousness, restlessness or irritability, shivering or trembling, abdominal cramps, weakness, and increased blood pressure.

In some patients, aggressive behavior has occurred in the context of abrupt reversal of an opioid overdose. In the neonate, opioid withdrawal signs and symptoms also included: convulsions, excessive crying, and hyperactive reflexes [ see Warnings and Precautions ( 5.3 ) ]. The following adverse reactions were most commonly observed in ZIMHI clinical studies: dizziness and injection site erythema. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact ZMI Pharma Corporation at 1-800-230-3935 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Zimhi

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

Zimhi

Indications

Contraindications

Warnings and precautions

At a glance

Two medicines in one question?

5.1Risk of Recurrent Respiratory and Central Nervous System Depression

5.2Risk of Limited Efficacy with Partial Agonists or Mixed Agonist/Antagonists Reversal

5.3Precipitation of Severe Opioid Withdrawal

Pregnancy and breastfeeding

8.1Pregnancy Risk Summary

Adverse reactions

Composition

Official product information