Healthcare Professionals

Important Safety Information and Indication for KLOXXADO® (naloxone HCl) NASAL SPRAY 8 mg

INDICATION AND USAGE

KLOXXADO® Nasal Spray 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, for adult and pediatric patients.

KLOXXADO® Nasal Spray is intended for immediate administration as emergency therapy in settings where opioids may be present. KLOXXADO® Nasal Spray is not a substitute for emergency medical care.

IMPORTANT SAFETY INFORMATION

Warnings and Precautions

Risk of Recurrent Respiratory and CNS Depression
Due to the duration of action of naloxone relative to the opioid, keep patient under continued surveillance and administer repeat doses of naloxone using a new Nasal Spray for each dose, as necessary, while awaiting emergency medical assistance.

Risk of Limited Efficacy with Partial Agonists or Mixed Agonist/Antagonists
Reversal of respiratory depression caused by partial agonists or mixed agonist/antagonists, such as buprenorphine and pentazocine, may be incomplete. Larger or repeat doses may be necessary.

Precipitation of Severe Opioid Withdrawal
Use in patients who are opioid dependent may precipitate opioid withdrawal; the risk and severity of withdrawal increase as naloxone exposure increases. Opioid withdrawal is characterized by 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. In neonates, opioid withdrawal may be life-threatening if not recognized and properly treated. Monitor for the development of opioid withdrawal.

Risk of Cardiovascular (CV) Effects
Abrupt postoperative reversal of opioid depression may result in nausea, vomiting, sweating, tremulousness, tachycardia, hypotension, hypertension, seizures, ventricular tachycardia and fibrillation, pulmonary edema, and cardiac arrest. These events have primarily occurred in patients who had preexisting CV disorders or received other drugs that may have similar adverse cardiovascular (CV) effects. Monitor these patients closely in an appropriate healthcare setting after use of naloxone hydrochloride.

Contraindication

Hypersensitivity to naloxone hydrochloride or to any of the other ingredients in KLOXXADO® Nasal Spray.

Adverse Reactions

In two pharmacokinetic studies, a total of 47 healthy adult volunteers were exposed to a single dose of KLOXXADO® Nasal Spray, one spray in one nostril. The following adverse reactions were reported in two subjects each: abdominal pain, asthenia, dizziness, headache, nasal discomfort, and presyncope.

The following most frequently reported events (in decreasing frequency) have been identified primarily during post-approval use of naloxone hydrochloride (all routes of administration): withdrawal syndrome, vomiting, non-responsiveness to stimuli, drug ineffective, agitation, somnolence, and loss of consciousness.

To report suspected Adverse Reactions, contact Hikma Specialty USA Inc. at: us.hikma@primevigilance.com, or call 1-877-845-0689 or 1-800-962-8364. You can also contact FDA at: 1-800-FDA-1088 or www.fda.gov/medwatch.

For more information, please see accompanying full Prescribing Information for KLOXXADO® Nasal Spray.