VIVITROL AND
ALCOHOL DEPENDENCE

Alcohol addiction is a chronic, relapsing brain disease that affects people psychologically and physically. Effective treatment programs can address both aspects of addiction through counseling and medication.1,2 If you are seeking medication as part of your treatment plan, consider VIVITROL. VIVITROL is the first and only non-addictive, once-monthly medication that, when combined with counseling, is proven to help reduce heavy-drinking days. VIVITROL and counseling help reinforce recovery for one month at a time while you work on the psychological aspects of addiction through counseling.3

TREATING ALCOHOL DEPENDENCE
WITH VIVITROL AND COUNSELING4,5

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

PRIMARY ENDPOINT

P=0.03

In the overall treatment population of a 6-month, double-blind, placebo-controlled, randomized clinical study, patients treated with VIVITROL and counseling (n=205) demonstrated a 25% greater reduction in days of heavy drinking* than those treated with a placebo and counseling (n=209).

SUBSET POPULATION

P=0.005

A pre-specified subset of patients (n=53, or 8% of total study population) who abstained from alcohol completely during the week prior to their first dose of VIVITROL and counseling compared to placebo and counseling experienced:

  • 92% fewer heavy-drinking days*
  • Significantly fewer drinking days
  • More abstinent days per month
  • More success maintaining continuous abstinence**

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.


*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. **Continuous abstinence was defined as no self-reported alcohol use for all weekly visits.

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

Yes. If you are being treated for alcohol dependence but also use or are addicted to opioid-containing medicines or opioid street drugs, 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 doctor. See Prescribing Information and Medication Guide.

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LEARN ABOUT THE VIVITROL CO-PAY SAVINGS PROGRAM

Learn how the VIVITROL® Co-pay Savings Program may assist eligible* patients with out-of-pocket expenses for their VIVITROL prescriptions.

LEARN MORE

References:

  1. National Institute on Drug Abuse (NIDA). Drugs, brains, and behavior: the science of addiction. NIH publication 14-5605. https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/soa_2014.pdf. Revised July 2014. Accessed September 21, 2016.
  2. National Institute on Drug Abuse (NIDA). Treatment approaches for drug addiction. https://d14rmgtrwzf5a.cloudfront.net/sites/default/files/df_treatment_approaches_final_7_2016.pdf. Updated July 2016. Accessed September 21, 2016.
  3. VIVITROL [prescribing information]. Waltham, MA: Alkermes, Inc; rev December 2015.
  4. 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.
  5. Data on file. Alkermes, Inc.

*Eligibility for Alkermes-Sponsored Co-pay Assistance: Offer valid only for prescriptions for FDA-approved indications. You must be at least 18 years old. If you are purchasing your  VIVITROL prescriptions with benefits from Medicare, including Medicare Part D or Medicare Advantage plans; Medicaid, including Medicaid Managed Care or Alternative Benefit  Plans (“ABPs”) under the Affordable Care Act; Medigap; Veterans Administration (“VA”); Department of Defense (“DoD”); TriCare®; or any similar state funded programs such as  medical or pharmaceutical assistance programs, you are not eligible for this offer. Void where prohibited by law, taxed or restricted. Alkermes, Inc. reserves the right to rescind, revoke, or amend these offers without notice.