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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.

What Is VIVITROL?1

VIVITROL is a once-monthly extended release injectable formulation of naltrexone for alcohol dependence

VIVITROL® packaging

VIVITROL is an extended-release, microsphere formulation of naltrexone designed to be administered by deep intramuscular (IM) 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
  • Compared to daily oral dosing with naltrexone 50 mg over 28 days, total naltrexone exposure is 3- to 4-fold higher following administration of a single dose of VIVITROL 380 mg. Steady state is reached at the end of the dosing interval following the first injection

The Development of Naltrexone from Oral to Extended-Release Injectable Formulation2-4

Timeline showing the development of naltrexone in 1963 through the approval of VIVITROL in 2006 for the treatment of alcohol dependence.

NIDA=National Institute on Drug Abuse.

VIVITROL Dosage and Administration1

  • VIVITROL must be prepared and administered by a healthcare provider and 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 the carton components provided
  • Pretreatment with oral naltrexone is not required before using VIVITROL
  • See full Prescribing Information for complete Directions for Use

Please see Dosing and Administration page for full Dosing Information.

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References: 1. VIVITROL [prescribing information]. Waltham, MA: Alkermes, Inc. 2. SAMHSA. A Treatment Improvement Protocol (TIP) 49. Incorporating Alcohol Pharmacotherapies into Medical Practice. Accessed June 19, 2023. https://store.samhsa.gov/sites/default/files/d7/priv/sma13-4380.pdf 3. Gastfriend D. Intramuscular extended-release naltrexone: current evidence. Ann N Y Acad Sci. 2011;1216:144-166. doi:10.1111/j.1749-6632.2010.05900.x 4. Alkermes. Alkermes initiates open-label pilot study of VIVITROL® to evaluate impact on re-arrest and re-incarceration in offenders with history of opioid dependence. Published January 31, 2012. Accessed December 2, 2022. https://investor.alkermes.com/news-releases/news-release-details/alkermes-initiates-open-label-pilot-study-vivitrolr-evaluate

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References: 1. VIVITROL [prescribing information]. Waltham, MA: Alkermes, Inc. 2. SAMHSA. A Treatment Improvement Protocol (TIP) 49. Incorporating Alcohol Pharmacotherapies into Medical Practice. Accessed June 19, 2023. https://store.samhsa.gov/sites/default/files/d7/priv/sma13-4380.pdf 3. Gastfriend D. Intramuscular extended-release naltrexone: current evidence. Ann N Y Acad Sci. 2011;1216:144-166. doi:10.1111/j.1749-6632.2010.05900.x 4. Alkermes. Alkermes initiates open-label pilot study of VIVITROL® to evaluate impact on re-arrest and re-incarceration in offenders with history of opioid dependence. Published January 31, 2012. Accessed December 2, 2022. https://investor.alkermes.com/news-releases/news-release-details/alkermes-initiates-open-label-pilot-study-vivitrolr-evaluate

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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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