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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.
  • The prevention of relapse to opioid dependence, following opioid detoxification.

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


VIVITROL—a once-monthly treatment option1

VIVITROL is an extended-release, microsphere formulation of naltrexone designed to be administered by deep gluteal injection every 4 weeks or once a month.

  • Approximately 2 hours after injection, a transient initial naltrexone plasma concentration peak occurs, followed by a second peak approximately 2-3 days later
  • Beginning approximately 14 days after dosing, concentrations slowly decline, with measurable levels for greater than 1 month

Plasma naltrexone concentration2,3

Mean naltrexone concentration over 30 days

*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 5 days. Plasma concentrations do not necessarily correlate with clinical efficacy.

Dosage and administration1

  • VIVITROL must be prepared and administered by a healthcare provider
  • VIVITROL must ONLY be administered as a deep intramuscular gluteal injection
  • Prior to initiation of VIVITROL, an opioid-free duration of a minimum of 7-10 days is recommended for patients, to avoid precipitation of opioid withdrawal that may be severe enough to require hospitalization
  • The recommended dose of VIVITROL is 380 mg delivered intramuscularly (deep) as a gluteal injection every 4 weeks or once a month, alternating buttocks for each subsequent injection, using carton components provided
  • Pre-treatment with oral naltrexone is not required before using VIVITROL
  • See Section 2.6 in Prescribing Information for complete directions for use.

Injection site reactions1

  • 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
  • VIVITROL is administered as a deep intramuscular gluteal injection, and inadvertent subcutaneous 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

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References: 1. VIVITROL [prescribing information]. Waltham, MA: Alkermes, Inc. 2. Dean RL. The preclinical development of Medisorb naltrexone, a once a month long-acting injection, for the treatment of alcohol dependence. Front Biosci. 2005;10:643-655. 3. Dunbar JL, Turncliff RZ, Dong Q, Silverman BL, Ehrich EW, Lasseter KC. Single- and multiple-dose pharmacokinetics of long-acting injectable naltrexone. Alcohol Clin Exp Res. 2006;30(3):480-490.

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References: 1. VIVITROL [prescribing information]. Waltham, MA: Alkermes, Inc. 2. Dean RL. The preclinical development of Medisorb naltrexone, a once a month long-acting injection, for the treatment of alcohol dependence. Front Biosci. 2005;10:643-655. 3. Dunbar JL, Turncliff RZ, Dong Q, Silverman BL, Ehrich EW, Lasseter KC. Single- and multiple-dose pharmacokinetics of long-acting injectable naltrexone. Alcohol Clin Exp Res. 2006;30(3):480-490.

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We have updated our Privacy Policy. Please review our Privacy Policy. This website uses cookies. By using our website without changing your cookie settings, you agree to our use of cookies as described in our Privacy Policy.

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