Vivitrol for Alcohol Use Disorder

Required labs prior to injection:

1. Liver function tests

2. Urine toxicology

3. BUN/creatinine
 
Contraindications:

1. Reported history of opioid use (including tramadol) within 7 to 10 days of injection, with the exception of methadone and buprenorphine, which require a minimum of 14 drug-free days

2. Failure to tolerate oral naloxone

3. Positive urine screen for opioids

4. Hypersensitivity to naltrexone or any component of the formulation

5. Pregnancy

6. Breast feeding

7. Severe renal failure, as Vivitrol has not been studied in this population

8. Severe hepatic impairment, as Vivitrol has not been studied in this population

Use with caution:

1. Bleeding disorders: Use IM injection with caution in patients thrombocytopenia or any bleeding disorder (including hemophilia and severe hepatic failure), or patients on anticoagulant therapy; bleeding/hematoma may occur from IM administration.

2. Hepatocellular injury: Dose-related hepatocellular injury is possible; the margin of separation between the apparent safe and hepatotoxic doses appears to be ≤5-fold. Discontinue therapy if signs/symptoms of acute hepatitis develop. Clinicians should note that elevated transaminases may be a result of pre-existing alcoholic liver disease, hepatitis B and/or C infection, or concomitant use of other hepatotoxic drugs; abrupt opioid withdrawal may also lead to acute liver injury.

Administration Instructions:

IM: Vivitrol: Administer IM into the upper outer quadrant of the gluteal area; must inject dose using one of the provided needles for administration. Use either the 1.5-inch needle (for very lean patients) or the 2-inch needle (for patients with a larger amount of subcutaneous tissue overlying the gluteal muscle). Either needle may be used for patients with average body habitus. Avoid inadvertent injection into a blood vessel; do not administer IV, SubQ, or into fatty tissue (the risk of serious injection site reaction is increased if given incorrectly as a SubQ injection or into fatty tissue instead of the gluteal muscle). Injection should alternate between the 2 buttocks. Do not substitute any components of the dose-pack

Informed Consent:

Please provide informed consent, including warning that opiate use after Vivitrol can cause fatal overdose, as the opiate receptors may be sensitized. Please give the following handout per FDA regulations: http://www.fda.gov/downloads/Drugs/DrugSafety/UCM206669.pdf