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Vivitrol Prescribing Requirements

Vivitrol is a form of naltrexone, an opioid antagonist that is used to help people who are working to avoid relapse in opioid or alcohol addiction recovery.[1] 

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It is important that those who are prescribed the medication fit the appropriate criteria. That is, they need to have a history of substance abuse, the substance of choice must be either alcohol or opioids, and the person must be at a certain place in their medication-assisted treatment (MAT) process.[2]

Vivitrol is not a drug that will work in every situation, and it’s also not a solution to addiction on its own. It’s recommended that those who take Vivitrol also take part in therapy, holistic treatment, support groups, and other resources that promote a whole new way of life without substance use. 

What Are the General Prescribing Requirements for Vivitrol?

Vivitrol is a prescribed medication. Doctors examine patients, including taking a medical history, to determine whether they will benefit from the medication before getting started. 

Patients must fit the prescribing criteria. They must fully understand the effects of Vivitrol and consent to take the drug since it stays in one’s system for a month. It can cause serious effects if the person drinks alcohol or takes opioids while on Vivitrol.[3]

In some cases, the details of the requirements for a Vivitrol prescription will vary based on the doctor or clinic, but in general, patients seeking a Vivitrol prescription can expect the following:

Evaluation & Assessment

Before prescribing Vivitrol, a doctor will perform a thorough evaluation and assessment that looks at the person’s medical history, substance use history, current medications, and overall health and wellness. Additionally, the doctor will talk to the patient about their past and their goals for the future. 

Diagnosis of AUD or OUD

Vivitrol is only prescribed for the treatment of alcohol use disorder (AUD) or opioid use disorder (OUD). Therefore, the patient must have a confirmed diagnosis of one of these substance use disorders to be considered a viable candidate for a Vivitrol prescription. 

If the person does not have a current diagnosis in their medical file, the doctor may use guidelines provided by the Diagnostic and Statistical Manual of Mental Disorders (DSM 5) to officially give a diagnosis.[4]

Confirmation of Opioid Abstinence

For patients who are living with OUD, it is generally recommended that they undertake a period of abstinence before starting Vivitrol treatment.[5] This period of abstinence should last at least seven to 10 days, and it helps to minimize the risk of triggering a sudden onset of opioid withdrawal symptoms when starting Vivitrol therapy.[1] At the doctor’s office, the levels of opioids in a person’s system may be confirmed with a drug test to make sure they are in the safe zone.

Alcohol Abstinence

People taking Vivitrol should commit to abstinence from alcohol even if their drug of choice is an opioid. Alcohol can subvert the positive effects of Vivitrol and potentially put a person at risk of accidents, risky behaviors and their consequences, and medical emergency.[6]

For those who abuse alcohol, drinking is a relapse. This requires that the person check back in with their treatment team and address whatever is missing in their program to help them get back on track. 

For those who are dependent on opioids, drinking alcohol can cause Vivitrol to no longer bind to opioid receptors and be less effective at blocking the use of opioids. This means that use of opioids in too large of a dose can trigger an overdose.

Patient Education & Informed Consent

Prescribing physicians are required to provide comprehensive patient education about how Vivitrol works, the potential benefits and risks, the side effects that can occur with use, and what can happen if relapse occurs while taking the medication.

Patients need to understand that it is a once-a-month shot that they cannot undo until it wears off. There are other MAT options, such as daily tablets or film strips, if they choose. Those options are not necessarily better or worse, but patients must have a solid understanding of the choices available to them and have the chance to ask questions, so they can make an informed decision. 

Consent is required prior to the start of treatment.[7]

Monitoring & Follow-Up Care

Just as patients should begin treatment with the support and assistance of a medical professional, they should also have ongoing access to their prescribing physician, so they can effectively address any questions or concerns that arise during treatment. 

Before they leave the office after their first Vivitrol shot, patients should have a plan in place for monitoring over the coming months as well as an appointment for their next shot. This plan may include regular assessments, a standardized way to check in on adverse effects, and the option to adjust treatment as needed. 

For example, it is recommended that patients take 380 mg of Vivitrol per dose. That dose should be delivered as an intramuscular injection in the gluteus, and every month, the site of injection should switch to the opposite side.[1] If the dose needs to be adjusted or the person has a reaction at the injection site, the doctor should be able to help.

There should also be a plan in place for what to do if the person drinks, experiences a naltrexone reaction, and needs medical care.[8]

Comprehensive Treatment Approach

Vivitrol is not a silver bullet when it comes to overcoming OUD or AUD—no medication is. Vivitrol is most effective when it is used as a part of a comprehensive treatment program that includes therapies that fit the needs of the individual. Full addiction treatment programs should also include counseling, behavioral therapy, holistic treatment, and other support services.[9]

Who Is a Good Candidate for Vivitrol?

A good candidate for Vivitrol treatment will meet the following criteria:[1,10,11]

  • Currently be in treatment for OUD or AUD
  • Be free from opioids for at least one week 
  • Not be under the influence of alcohol 
  • Fully understand the nature of Vivitrol treatment 
  • Consent to Vivitrol treatment 
  • Engage in behavioral therapy, support groups, and holistic treatments that also address addiction issues
  • Not be allergic to naltrexone
  • Be stable medically and mentally
  • Have no liver dysfunction 

If any of these criteria are not met, Vivitrol will not be an appropriate choice for the individual. There are other medication options that may be a better choice. In some cases, it might just not be the appropriate time for Vivitrol treatment, and the person may be able to come back in the future and initiate this treatment. 

It’s important to note that the decision to take Vivitrol should be made on a case-by-case basis, taking into account the specific needs, preferences, and circumstances of each person. By working together with your treatment team, you can ensure you have guidance on every step of this process.

Updated April 11, 2024
Resources
  1. Vivitrol highlights of prescribing information. Vivitrol. Accessed March 27, 2024.
  2. Medication Assisted Treatment. Pennsylvania Department of Corrections. Published 2019. Accessed March 27, 2024.
  3. An introduction to extended-release injectable naltrexone for the treatment of people with opioid dependence. Substance Abuse and Mental Health Services.  Published 2012. Accessed March 27, 2024.
  4. Hasin DS, O’Brien CP, Auriacombe M, et al. DSM-5 criteria for substance use disorders: Recommendations and rationale. American Journal of Psychiatry. 2013;170(8):834-851.
  5. Ndegwa S;Pant S;Pohar S;Mierzwinski-Urban M. Injectable extended-release naltrexone to treat opioid use disorder. CADTH Issues in Emerging Health Technologies. Published August 2017. Accessed March 27, 2024.
  6. Medications for the treatment of alcohol use disorder. New York State Office of Addiction Services and Supports. Accessed March 27, 2024.
  7. Vivitrol treatment consent and agreement I. Vivitrol medication guide. Indian Health Services. Accessed March 27, 2024.
  8. Heck J, Burda K, Hillemacher T, Bleich S, Stichtenoth DO, Groh A. Naltrexone‐induced drug eruption. Clinical Case Reports. 2020;8(10):2049-2050.
  9. Volkow ND. Personalizing the treatment of substance use disorders. American Journal of Psychiatry. 2020;177(2):113-116.
  10. Clinical use of extended-release injectable naltrexone in the treatment of opioid use disorder: A brief guide. U.S. Department of Health and Human Services. Published 2015. Accessed March 27, 2024.
  11. Ayyala D, Bottyan T, Tien C, et al. Naltrexone for alcohol use disorder: Hepatic safety in patients with and without liver disease. Hepatology Communications. 2022;6(12).
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