VIVITROL
Vivitrol has been available on the market since June of 2006. This medication is manufactured by Alkermes, Inc/Cephalon, Inc. Vivitrol provides an alternative relapse prevention strategy for the treatment of alcohol dependency.
Prior to its availability on the market, clinical trials with Vivitrol were done on patients who were abstinent from alcohol.
Vivitrol is one therapy in a comprehensive program of treatment for recovering alcohol dependent patients. No relapse prevention medication is effective without ongoing counseling and psychosocial support.
Vivitrol is an injectable form of Naltrexone. Oral Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses. Naltrexone is contraindicated in acute hepatitis and liver failure. Its use in patients with active liver disease must be carefully considered secondary to the hepatotoxic effects of Naltrexone. Clinical trials have demonstrated Vivitrol's safety profile and this medication does not seem to adversely affect the liver in recommended doses as this medication is administered intramuscularly, therefore, bypassing the first pass liver effect that occurs with standard oral medication administration. Although Vivitrol does not appear to be hepatotoxic in clinical trials, patients should be warned of the signs and symptoms of acute hepatitis. The medication should be discontinued immediately should any patient develop such signs and symptoms.
Vivitrol is contraindicated in patients receiving or dependent on opioids or patients who are in acute opioid withdrawal.
A diagnosis of eosinophilic pneumonia should be considered if patients develop progressive dyspnea and hypoxemia. Injection site reactions not improving require prompt medical attention. Alcohol dependent patients, including those taking Vivitrol, should be monitored for the development of depression or suicidal thinking. Caution is recommended in administering Vivitrol to patients with moderate to severe renal impairment.
The most common adverse events associated with Vivitrol in clinical trials were:
Nausea
Vomiting
Headache
Dizziness
Asthenic conditions (weakness, lack of strength)
Injection site reactions
The standard dose of Vivitrol is 380 milligrams administered deep intramuscularly in the gluteal region on a once monthly basis. Patients generally remain on this medication for around a 6 month time period. The medication is only administered after the patient has been abstinent from alcohol. The dose of Naltrexone, when administered orally, is 50 milligrams once daily at bedtime. This daily oral dosing of Naltrexone translates to 1,500 milligrams monthly compared to the Vivitrol 380 milligram once monthly dose. This perhaps further explains why Vivitrol is less hepatotoxic compared to oral Naltrexone.
Patients need to be assessed to see if they are appropriate candidates for Vivitrol therapy. Liver enzymes should be monitored prior to administration of this medication. The prescribing clinician writes a prescription which is sent to the pharmaceutical firm that manufactures Vivitrol. The pharmaceutical firm will work with the patient's insurance carrier to seek approval. Some insurance plans require an oral Naltrexone challenge. Once insurance approval is received, the pharmaceutical firm will coordinate an addictions treatment site and provider for the patient for the once monthly administration of the injection. The easiest way to enroll a patient for Vivitrol therapy is to download a VIP enrollment form from the pharmaceutical firm (http://www.vivitrol.com/).