Welcome to the newest installment of our Guidelines+ Monographs Series. Today, we will be exploring the medication naltrexone, specifically the injectable form marketed under the brand name Vivitrol by Alkermes, Inc. Vivitrol is an opioid antagonist that was first approved in 2006. It is prescribed for the treatment of alcohol dependence and to block the effects of externally administered opioids, helping to prevent relapse after detoxification.
In the following sections, we will provide a comprehensive overview of naltrexone and analyze its positioning across various guidelines for its approved indications.
Note* – This Guidelines+ Monographs for naltrexone (Vivitrol) is current as of October 2024. Consult our clinical guidelines library and/or or medication information lookup tool to ensure you are always accessing the most current information.
Medication Overview:
- Brand name: Vivitrol
- Generic name: naltrexone for extended-release injectable suspension
- Manufacturer(s): Alkermes, Inc
- Initial FDA Approval: 2006
Indications and FDA Approval Details
| Indicated Condition | Indication | Age | Date Approved |
|---|---|---|---|
Alcohol Dependence | 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. | Adult | April 2006 |
Opioid Dependence | For the prevention of relapse to opioid dependence, following opioid detoxification. | Adult | October 2010 |
Dosage and Administration
Alcohol dependence and opioid use disorder: The recommended dose is naltrexone 380 mg delivered intramuscularly (IM) as a gluteal injection every 4 weeks or once a month, alternating buttocks for each subsequent injection.
Warnings and Precautions
- Vulnerability to Opioid Overdose: Following VIVITROL treatment opioid tolerance is reduced from pretreatment baseline, and patients are vulnerable to potentially fatal overdose at the end of a dosing interval, after missing a dose, or after discontinuing VIVITROL treatment. Attempts to overcome blockade may also lead to fatal overdose. Strongly consider prescribing naloxone for the emergency treatment of opioid overdose.
- Injection Site Reactions: VIVITROL must be prepared and administered by a healthcare provider. In some cases, injection site reactions may be very severe. Some cases of injection site reactions required surgical intervention.
- Precipitation of Opioid Withdrawal: Opioid-dependent and opioid-using patients, including those being treated for alcohol dependence, should be opioid-free before starting VIVITROL treatment, and should notify healthcare providers of any recent opioid use. 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.
- Hepatotoxicity: Cases of hepatitis and clinically significant liver dysfunction were observed in association with VIVITROL treatment during the clinical development program and in the postmarketing period. Discontinue use of VIVITROL in the event of symptoms or signs of acute hepatitis.
- Depression and Suicidality: Monitor patients for the development of depression or suicidal thinking.
- When Reversal of VIVITROL Blockade Is Required for Pain Management: In an emergency situation in patients receiving VIVITROL, suggestions for pain management include regional analgesia or use of non-opioid analgesics.
- Eosinophilic Pneumonia: Patients who develop dyspnea and hypoxemia should seek medical attention immediately. Consider the possibility of eosinophilic pneumonia in patients who do not respond to antibiotics.
- Hypersensitivity Reactions Including Anaphylaxis: Cases of urticaria, angioedema, and anaphylaxis have been observed with the use of VIVITROL.
Adverse Reactions
The adverse events seen most frequently in association with VIVITROL therapy for alcohol dependence (i.e., those occurring in ≥5% and at least twice as frequently with VIVITROL than placebo) include nausea, vomiting, injection site reactions (including induration, pruritus, nodules and swelling), muscle cramps, dizziness or syncope, somnolence or sedation, anorexia, decreased appetite or other appetite disorders (6). The adverse events seen most frequently in association with VIVITROL therapy in opioid-dependent patients (i.e., those occurring in ≥2% of patients treated with VIVITROL and at least twice as frequently with VIVITROL than placebo) were hepatic enzyme abnormalities, injection site pain, nasopharyngitis, insomnia, and toothache.
Now that we’ve covered the basic monograph information for naltrexone, let’s take a closer look at how Vivitrol is currently recommended in various clinical practice guidelines.
Specific Inclusions of Naltrexone in Clinical Guidelines
- Management of Substance Use Disorder
- Authoring Societies: Veteran Health Administration/Department of Defense (VA/DoD)
- Publication: January 01, 2015
- For patients diagnosed with moderate to severe alcohol use disorder, it is recommended to prescribe one of the following medications:
- Acamprosate
- Disulfiram
- Naltrexone (oral or extended release)
- Topiramate
- In cases where patients have opioid use disorder and are unable to undergo opioid agonist treatment due to contraindications, unavailability, or discontinuation, and have successfully maintained abstinence for a significant period of time, the recommended course of action is to offer extended-release injectable naltrexone.
- For patients diagnosed with moderate to severe alcohol use disorder, it is recommended to prescribe one of the following medications:
- Pharmacological Treatment of Patients with Alcohol Use Disorder
- Authoring Society: American Psychiatric Association (APA)
- Publication: January 01, 2018
- According to the American Psychological Association (APA), patients with moderate to severe alcohol use disorder should be considered for treatment with naltrexone or acamprosate if they have a goal of reducing alcohol consumption or achieving abstinence. This recommendation applies to individuals who prefer pharmacotherapy or have not seen improvement with nonpharmacological treatments alone. Additionally, patients must have no contraindications to the use of these medications in order to be eligible for this treatment approach.
- Treatment of Opioid Use Disorder
- Authoring Society: American Society of Addiction Medicine (ASAM)
- Publication: March 20, 2020
- All FDA approved medications for the treatment of opioid use disorder should be available to all patients. Clinicians should consider the patient’s preferences, past treatment history, current state of illness, and treatment setting when deciding between the use of methadone, buprenorphine, and naltrexone.
- Management of Stimulant Use Disorder
- Authoring Society: ASAM/American Academy of Addiction Psychiatry (AAAP)
- Publication: November 08, 2023
- For patients diagnosed with ATS use disorder, clinicians may consider prescribing a combination of bupropion and naltrexone to help reduce the use of ATS. This recommendation comes with a moderate level of certainty and is considered a conditional recommendation.
- Furthermore, clinicians should give special consideration to this combination for patients who also have co-occurring AUD, as naltrexone has been shown to be effective in reducing alcohol consumption. This recommendation also comes with a moderate level of certainty and is considered a conditional recommendation.
- In summary, the use of bupropion in combination with naltrexone can be a valuable treatment option for patients struggling with ATS use disorder, especially those with co-occurring AUD.
- Mental, Neurological and Substance Use Disorders
- Authoring Society: World Health Organization
- Publication: November 20, 2023
- It is recommended that adults with alcohol dependence receive a combination of psychosocial and pharmacological interventions. Among the various medications available, research has shown that the combination of naltrexone and psychosocial treatment is more effective than either psychosocial or pharmacological interventions alone. This combination has been found to produce better outcomes at the end of treatment with moderate to high certainty.
This concludes our Guidelines+ Monographs for naltrexone (Vivitrol). This list is current as of October 2024 and may be updated over time as new indications are approved and/or new guidelines published or updated. Sign up for alerts and stay informed on the latest published guidelines and articles.
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