Generic Name and Formulations:
Naltrexone 380mg/vial; ext-rel susp for IM inj; contains polylactide-co-glycolide (PLG).

Company:
Alkermes

Indications for VIVITROL:
Alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting, in conjunction with psychosocial support (eg, counseling or group therapy). Prevention of relapse to opioid dependence following opioid detoxification.

Adult:
Give by IM inj into alternating buttocks. 380mg once every 4 weeks. Switching from buprenorphine, buprenorphine/naloxone, or methadone: monitor for precipitation of withdrawal symptoms and treat with non-opioid drugs.

Children:
Not established.

Pharmacological Class:
Opioid antagonist.

Contraindications:
Concomitant opioids. Current physiologic opioid dependence. Acute opiate withdrawal. Failed naloxone challenge test. Positive urine test for opioids. Previous hypersensitivity to PLG or carboxymethylcellulose (in diluent).

Warnings/Precautions:
Vulnerability to opioid overdose (eg, at end of a dosing interval, after missing a dose, or after discontinuing treatment). Precipitation of opioid withdrawal: consider naloxone challenge test before treating to exclude recent (7–10 days) opioid use. Moderate to severe renal dysfunction. Risk of hepatic injury; discontinue if acute hepatitis develops. Risk of eosinophilic pneumonia; follow-up if respiratory symptoms occur. Monitor for depression and/or suicidality. Advise patient of reduced post-treatment opioid tolerance and of danger of attempting to overcome opioid blockade; advise use of medication alert documentation. Coagulation disorders. Discontinue if hypersensitivity reactions develop. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions:
See Contraindications. Antagonizes opioids (eg, antitussives, antidiarrheals, analgesics); use non-opioids, and/or anesthesia if pain management is necessary. May interfere with urine opioid tests.

Adverse Reactions:
Nausea, vomiting, muscle cramps, somnolence/sedation, fatigue, headache, dizziness, decreased appetite, inj site reactions (may be serious; eg, induration, cellulitis, hematoma, abscess, sterile abscess, necrosis), hepatotoxicity; rare: allergic (eosinophilic) pneumonia.

REMS:
YES

How Supplied:
Vial—1 (w. supplies)