Naloxone HCL injection (Evzio)

SELF INJECTION

Indications for Prior Authorization:
  • Emergency treatment of known or suspected opioid overdose, as manifested by respiratory and/or central nervous system depression.
Patients must meet the following criteria for the indications above:


Opioid Overdose

  • The patient may have access to opioids AND
  • Medical justification supported by chart note documentation why the patient cannot use Narcan (naloxone nasal spray) AND naloxone injection (non-auto-injector formulation for use with a standard syringe)

The following indications do not meet the criteria for use established by the Western Health Advantage Pharmacy and Therapeutics Committee:

  • Non-FDA approved indications, which are not listed in the Approved Indications section, unless there is sufficient documentation of efficacy and safety in the published literature (2 peer reviewed sources required).
General Information:
  • Evzio is intended for immediate administration as emergency therapy in settings where opioids may be present.
  • Evzio is not a substitute for emergency medical care.  If the desired response is not obtained after 2 or 3 minutes, another Evzio dose may be administered.  If there is still no response and additional doses are available, additional Evzio doses may be administered every 2 to 3 minutes until emergency medical assistance arrives.  If no response is observed after 10 mg of naloxone hydrochloride have been administered, the diagnosis of narcotic-induced or partial narcotic induced toxicity should be questioned.  Additional supportive and/or resuscitative measures may be helpful while awaiting emergency medical assistance.
  • Clinical efficacy studies were not conducted for Evzio.  In one pharmacokinetic study of 30 patients, a single Evzio injection provided equivalent naloxone compared to a single dose of naloxone injection using a standard syringe.
Therapeutic Alternatives (Prior authorization not required):
 

Drug

Dosing Regimen

Dose Limit/ Maximum Dose

Narcan (naloxone nasal spray)

Known or Suspected Opioid Overdose

4 mg intranasally as a single spray in one nostril. Repeat as needed every 2 to 3 minutes with a new nasal spray in alternate nostrils.

Two cartons (4 single dose nasal sprays) per prescription.

 

 
Therapeutic Alternatives (Prior authorization required, approvable for diagnosis of opioid overdose):
 

Drug

Dosing Regimen

Dose Limit/ Maximum Dose

Naloxone for injection (with standard syringe)

Known or Suspected Opioid Overdose

IV, IM, SubQ: Initial: 0.4 to 2 mg; may need to repeat doses every 2 to 3 minutes. A lower initial dose (0.1 to 0.2 mg) should be considered for patients with opioid dependence to avoid acute withdrawal or if there are concerns regarding concurrent stimulant overdose. After reversal, may need to readminister dose(s) at a later interval (i.e., 20 to 60 minutes) depending on type/duration of opioid.

If no response is observed after 10 mg total, consider other causes of respiratory depression

Generic: 0.4 mg/mL(1 mL); 4 mg/10 mL (10 mL)



 

 
Evzio Requires Prior Authorization

Recommended Dosing Regimen and Authorization Limit:

Drug

Dosing Regimen

Authorization Limit

Evzio 0.4 mg/0.4 mL

Known or Suspected Opioid Overdose

Place the Black end of Evzio against the outer thigh, through clothing, if needed. Press firmly and hold in place for 5 seconds.
Repeat doses of Evzio may be required depending upon the amount, type, and route of administration of the opioid being antagonized.

If there is still no response and additional doses are available, additional Evzio doses may be administered every 2 to 3 minutes until emergency medical assistance arrives.

Two boxes (4 autoinjectors) per prescription.

Approval for six month including initial and renewal requests.

 
Product Availability:
  • Evzio Autoinjector containing a single dose of naloxone 0.4 mg/0.4mL
  • Narcan Nasal Spray 4mg, supplied as a carton containing two blister packages, each with a single dose
Coverage Period:

Six months

Last review date: November 13, 2018