VIVITROL (naltrexone for extended-release injectable suspension) VIVITROL: A Treatment Option For The Daily Struggle Against Alcohol Dependence. One dose all month long.
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About VIVITROL
My Path to Recovery
Overview


Mechanism of action


Efficacy


Dosage/Administration


Adherence


Safety Considerations


VIVITROL Preparation and Administration
What is VIP3?


How do I start a patient on therapy?

Adherence

A month of medication provided in a single dose

Adherence to any treatment program is essential for a successful outcome.6

VIVITROL overcomes the limitations of daily oral dosing

VIVITROL is administered once monthly or every 4 weeks, which means your patients don't have to remember to take daily oral medications to treat their alcohol dependence.

As a once-a-month treatment, VIVITROL relieves your patients of the burden of daily adherence decisions by shifting daily dosing responsibility from your patients to the unique drug-delivery system.

It is important to recognize that a long-term commitment is a critical component of recovery. This commitment requires your patients' regular participation in your counseling and/or treatment program.

Figure 1 compares VIVITROL 380 mg to daily dosing with oral naltrexone.

Figure 1.

Mean steady state naltrexone concentration following monthly VIVITROL 380mg compared to daily oral dosing

*Data for oral naltrexone beyond day 5 have been extrapolated from a study of normal healthy volunteers (n=14) given oral naltrexone 50 mg daily for days.2

This was a head-to-head study comparing the pharmacokinetics of oral naltrexone to VIVITROL.2

  • The peaks and troughs associated with daily oral naltrexone administration may diminish efficacy, increase adverse effects, and reduce compliance1
  • In contrast, VIVITROL provides more consistent and measurable naltrexone plasma levels over a one month period, as shown above in Figure 1
  • With VIVITROL 380 mg, naltrexone plasma concentrations reach a transient initial peak approximately 2 hours after injection, followed by a second peak approximately 2 to 3 days later. Beginning approximately 14 days after dosing, concentrations slowly decline, with measurable levels for greater than 1 month
  • Steady state is achieved by the second dose7
Important Safety Information
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 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.