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IMPORTANT SAFETY INFORMATION FOR VIVITROL® (naltrexone for extended-release injectable suspension) INDICATIONS
VIVITROL is indicated for:
Treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting. Patients should not be actively drinking at the time of initial VIVITROL administration.
Prevention of relapse to opioid dependence, following opioid detoxification.
VIVITROL should be part of a comprehensive management program that includes psychosocial support.
VIVITROL is contraindicated in patients:
With current physiologic opioid dependence
Who have failed the naloxone challenge test or have a positive urine screen for opioids
Who have exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose, or any other components of the diluent
WARNINGS/PRECAUTIONS Vulnerability to Opioid Overdose:
Because VIVITROL blocks the effects of exogenous opioids for approximately 28
days after administration, patients are likely to have a reduced tolerance to opioids after opioid detoxification. As the
blockade dissipates, use of previously tolerated doses of opioids could result in potentially life-threatening opioid
intoxication (respiratory compromise or arrest, circulatory collapse, etc). Cases of opioid overdose with fatal
outcomes have been reported in patients who used opioids at the end of a dosing interval, after missing a scheduled
dose, or after discontinuing treatment. Patients and caregivers should be told of this increased sensitivity to opioids
and the risk of overdose.
Any attempt by a patient to overcome the VIVITROL blockade by taking opioids may lead to fatal overdose. Patients
should be told of the serious consequences of trying to overcome the opioid blockade. Injection Site Reactions:
VIVITROL injections may be followed by pain, tenderness, induration, swelling, erythema,
bruising, or pruritus; however, in some cases injection site reactions may be very severe. Injection site reactions not
improving may require prompt medical attention, including, in some cases, surgical intervention. Inadvertent
subcutaneous/adipose layer injection of VIVITROL may increase the likelihood of severe injection site reactions.
Select proper needle size for patient body habitus, and use only the needles provided in the carton. Patients should
be informed that any concerning injection site reactions should be brought to the attention of their healthcare
provider. Precipitation of Opioid Withdrawal:
Withdrawal precipitated by administration of VIVITROL may be severe. Some
cases of withdrawal symptoms have been severe enough to require hospitalization and management in the ICU. To
prevent precipitated withdrawal, patients, including those being treated for alcohol dependence:
Should be opioid-free (including tramadol) for a minimum of 7–10 days before starting VIVITROL.
Patients transitioning from buprenorphine or methadone may be vulnerable to precipitated withdrawal for as long as two weeks.
Patients should be made aware of the risk associated with precipitated withdrawal and be encouraged to give an
accurate account of last opioid use.
Cases of hepatitis and clinically significant liver dysfunction have been observed in association with
VIVITROL. Warn patients of the risk of hepatic injury; advise them to seek help if experiencing symptoms of acute
hepatitis. Discontinue use of VIVITROL in patients who exhibit acute hepatitis symptoms.
Depression and Suicidality:
Alcohol- and opioid-dependent patients taking VIVITROL should be monitored for
depression or suicidal thoughts. Alert families and caregivers to monitor and report the emergence of symptoms of
depression or suicidality. When Reversal of VIVITROL Blockade Is Required for Pain Management:
For VIVITROL patients in emergency
situations, suggestions for pain management include regional analgesia or use of non-opioid analgesics. If opioid
therapy is required to reverse the VIVITROL blockade, patients should be closely monitored by trained personnel in a
setting staffed and equipped for CPR. Eosinophilic Pneumonia:
Cases of eosinophilic pneumonia requiring hospitalization have been reported. Warn
patients of the risk of eosinophilic pneumonia and to seek medical attention if they develop symptoms of pneumonia.
Patients should be warned of the risk of hypersensitivity reactions, including
anaphylaxis. Intramuscular Injections:
As with any IM injection, VIVITROL should be administered with caution to patients with
thrombocytopenia or any coagulation disorder. ADVERSE REACTIONS
Serious adverse reactions that may be associated with VIVITROL therapy in clinical use include severe injection site
reactions, eosinophilic pneumonia, serious allergic reactions, unintended precipitation of opioid withdrawal, accidental
opioid overdose, and depression and suicidality. The adverse events seen most frequently in association with
VIVITROL therapy for alcohol dependence include nausea, vomiting, injection site reactions (including induration,
pruritus, nodules, and swelling), muscle cramps, dizziness or syncope, somnolence or sedation, anorexia, decreased
appetite or other appetite disorders. The adverse events seen most frequently in association with VIVITROL in opioid-
dependent patients also include hepatic enzyme abnormalities, injection site pain, nasopharyngitis, insomnia, and
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