If you are ready to treat your alcohol dependence, there are different approaches to managing your drinking. These include counseling, behavioral treatments, self-help groups, and medication. Work with your healthcare provider to determine your treatment goals and approach, and if medication is part of your plan, consider VIVITROL.

THINGS TO KNOW ABOUT VIVITROL1:

  • Opioid blocker
  • Must be administered by a healthcare provider
  • Once-monthly injection
  • Used with counseling
  • Non-addictive and not a narcotic
  • Requires opioid detox of 7–14 days prior to start of treatment

Anyone who receives a VIVITROL injection must not use any type of opioid (must be opioid-free) including street drugs, prescription pain medicines, cough, cold, or diarrhea medicines that contain opioids, or opioid dependence treatments, buprenorphine or methadone, for at least 7 to 14 days before starting VIVITROL. Using opioids in the 7 to 14 days before you start receiving VIVITROL may cause you to suddenly have symptoms of opioid withdrawal when you get the VIVITROL injection.

Sudden opioid withdrawal can be severe, and you may need to go to the hospital.

You must be opioid-free before receiving VIVITROL, unless your healthcare provider decides that you don’t need to go through detox first. Instead, your doctor may decide to give your VIVITROL injection in a medical facility that can treat you for sudden opioid withdrawal.

  • VIVITROL is injected by a healthcare provider, about 1 time each month.
  • VIVITROL must be injected by a healthcare provider. Do not attempt to inject yourself with VIVITROL. Serious reaction, some that may require hospitalization, might happen.
  • VIVITROL is given as an injection into a muscle in your buttocks using a special needle that comes with VIVITROL.

See Med Guide for more information.

TREATING ALCOHOL DEPENDENCE
WITH VIVITROL AND COUNSELING1-3

When used as part of a treatment plan that includes counseling, VIVITROL can help reduce heavy drinking days.

A 6-month, double-blind, placebo-controlled, randomized clinical study compared alcohol-dependent outpatients treated with VIVITROL and counseling (n=205) with patients who received placebo and counseling (n=209).2

PRIMARY ENDPOINT

Outpatients on VIVITROL experienced a 25% greater reduction in days of heavy drinking* than those treated with placebo, P=0.022

SUBSET POPULATION

This study included a prespecified subset of VIVITROL and placebo patients (n=53 or 8% of the total study population) who abstained from alcohol completely during the week prior to their first dose. In this population1:

  • 17 patients on VIVITROL had 0.2 heavy drinking days compared to 2.5 heavy drinking days for 19 patients on placebo.3
  • This amounts to 92% fewer heavy drinking days for VIVITROL patients.3

The same results were not seen in the subset of patients (n=571, or 92% of the total study population) who were actively drinking at the time of starting treatment.1


*Heavy drinking was defined as a self-report of 5 or more standard drinks consumed on a given day for male patients and 4 or more drinks for female patients.

Is there a risk of opioid overdose with VIVITROL?

Yes. One serious side effect of VIVITROL is the risk of opioid overdose. Using opioids, even in amounts that you used before VIVITROL treatment, can lead to accidental overdose, serious injury, coma, or death.

  • Do not take large amounts of opioids or try to overcome the opioid-blocking effects of VIVITROL.
  • Do not use opioids in amounts that you used before VIVITROL treatment. You may even be more sensitive to lower amounts of opioids:
  • After detox
  • When your next VIVITROL dose is due
  • If you miss a dose of VIVITROL
  • After you stop VIVITROL treatment

Get emergency medical help right away if you:

  • have trouble breathing
  • become very drowsy with slowed breathing
  • have slow, shallow breathing (little chest movement with breathing)
  • feel faint, dizzy, confused or have other unusual symptoms.

It is important that you tell your family and the people closest to you of this increased sensitivity to opioids and the risk of overdose.

Is there a risk of severe reactions at the injection site with VIVITROL?

Yes. One serious side effect of VIVITROL is severe reactions at the site of the injection, including tissue death. Some injection site reactions have required surgery. Call your healthcare provider right away if you notice any of the following at your injection site:

  • Intense pain
  • The area feels hard
  • Swelling
  • Lumps
  • Blister
  • An open wound
  • A dark scab

Tell your healthcare provider about any injection site reaction that concerns you, gets worse over time, or does not get better by two weeks after the injection.

Is there a risk of a sudden opioid withdrawal when starting VIVITROL?

Yes. One serious side effect of VIVITROL is sudden opioid withdrawal. You must stop taking any opioids or opioid-containing medications, including buprenorphine or methadone, for at least 7 to 14 days before starting VIVITROL. If your healthcare provider decides that you don’t need to complete detox first, he or she may give you VIVITROL in a medical facility that can treat sudden opioid withdrawal. Sudden opioid withdrawal can be severe and may require hospitalization.

Can VIVITROL cause liver damage or hepatitis?

Yes. One serious side effect of VIVITROL is liver damage or hepatitis. Naltrexone, the active ingredient in VIVITROL, can cause liver damage or hepatitis. Tell your healthcare provider if you have any of the following symptoms of liver problems during VIVITROL treatment:

  • Stomach area pain lasting more than a few days
  • Yellowing of the whites of your eyes
  • Dark urine
  • Tiredness

Your healthcare provider may need to stop treating you with VIVITROL if you get signs or symptoms of a serious liver problem.

If my healthcare provider is considering VIVITROL treatment for my alcohol dependence, do I need to tell my healthcare provider that I take opioids?

Yes. If you are being treated for alcohol dependence but also use or are addicted to opioid-containing medicines or illicit opioids, it is important that you tell your healthcare provider before starting VIVITROL to avoid having sudden opioid withdrawal symptoms when you start VIVITROL treatment. Know the medications you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

VIVITROL is not right for everyone. There are significant risks from VIVITROL treatment, including risk of opioid overdose, severe reaction at the injection site and sudden opioid withdrawal.
See Important Safety Information below. Discuss all benefits and risks with a healthcare provider. See Prescribing Information and Medication Guide.


References:

  1. VIVITROL [prescribing information]. Waltham, MA: Alkermes, Inc; rev March 2021.
  2. Garbutt JC, Kranzler HR, O'Malley SS, et al. Efficacy and tolerability of long-acting injectable naltrexone for alcohol dependence: a randomized controlled trial. JAMA. 2005;293(13):1617-1625.
  3. Data on file. Alkermes, Inc. Waltham, MA.

*Terms and Conditions

Eligibility for Alkermes-Sponsored Co-pay Savings. This offer is only available to patients 18 years or older, with a prescription consistent with the Prescribing Information and the patient is not enrolled in, or covered by, any local, state, federal or other government program that pays for any portion of medication costs, including but not limited to Medicare, including Medicare Part D or Medicare Advantage plans; Medicaid, including Medicaid Managed Care and Alternative Benefit Plans under the Affordable Care Act; Medigap; VA; DOD; TRICARE; or a residential correctional program.
Additional Terms of Use: This offer is not conditioned on any past, present, or future purchase, including refills. Alkermes reserves the right to rescind, revoke, or amend this offer, program eligibility, and requirements at any time without notice. This offer is limited to one per patient, may not be used with any other offer, is not transferable and may not be sold, purchased or traded, or offered for sale, purchase or trade. Void where prohibited by law. Program Administrator or its designee will have the right upon reasonable prior written notice, during normal business hours, and subject to applicable law, to audit compliance with this program.