safety_and_tolerability :: VIVITROL Information

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VIVITROL—generally well tolerated with a demonstrated safety profile

VIVITROL was generally well tolerated in clinical trials1

Discontinuation rates due to adverse events were 9% in patients treated with VIVITROL and 7% in patients treated with placebo

Adverse events occurring in ≥10% of patients and > placebo1

	VIVITROL %	PLACEBO %
Injection site reaction	69	50
Nausea	33	11
Headache	25	18
Asthenic conditions	23	12
Insomnia, sleep disorder	14	12
Vomiting	14	6
Anorexia, appetite decreased NOS, appetite disorder NOS	14	3
Diarrhea	13	10
Dizziness	13	4
Anxiety	12	8
Pharyngitis	11	11
Abdominal pain	11	8

NOS=not otherwise specified.

Injection site reaction

VIVITROL injections may be followed by pain, tenderness, induration, abscess, sterile abscess, and pruritus. Cases of serious injection site reactions, some of which involved surgical intervention, have been reported. VIVITROL should only be administered intramuscularly using the specially designed needle provided. Please see FDA Alert regarding VIVITROL and Injection Site Reactions available on the FDA website and from your VIVITROL Addiction Recovery Associate

Nausea

Mild in the majority of reports
Occurred in the first month in the majority of cases
Median duration of a few days
Trial dropout rate attributed to nausea was 2%

The safety profile of VIVITROL has been established1

VIVITROL is non-addictive with no physical or psychological dependence

The CYP450 system is not involved in VIVITROL metabolism

The safety profile of patients treated with VIVITROL concomitantly with antidepressants was similar to that of patients taking VIVITROL without antidepressants
VIVITROL is not aversive therapy

IM administration of VIVITROL reduces first-pass hepatic metabolism compared with oral naltrexone
No significant increase in mean AST or ALT levels
Patients should be warned of the risk of hepatic injury. VIVITROL does not appear to be a hepatotoxin at recommended doses

Indication1

VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL.

Patients should not be actively drinking at the time of initial VIVITROL administration.

Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support.

Important Safety Information1

Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses.
Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects.
The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only five-fold or less. VIVITROL does not appear to be a hepatotoxin at the recommended doses.
Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis. Use of VIVITROL should be discontinued in the event of symptoms and/or signs of acute hepatitis.

VIVITROL is contraindicated in patients receiving or dependent on opioids, in acute opioid withdrawal, and in those who have failed the naloxone challenge test or have a positive urine screen for opioids; and in those with previous hypersensitivity to naltrexone, PLG, carboxymethylcellulose, or any other components of the diluent.

Patients must be opioid free for a minimum of 7-10 days before treatment. Attempts to overcome opioid blockade due to VIVITROL may result in fatal overdose. In prior opioid users, use of opioids after discontinuing VIVITROL may result in fatal overdose because patients may be more sensitive to lower doses of opioids. Patients requiring reversal of the VIVITROL blockade for pain management should be monitored by appropriately trained personnel in a setting equipped for cardiopulmonary resuscitation.

Consider the diagnosis of eosinophilic pneumonia if patients develop progressive dyspnea and hypoxemia. Injection site reactions not improving may 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, and injection site reactions.