WHAT IS VIVITROL?

Opioid addiction is a chronic, relapsing brain disease that affects people psychologically and physically. Effective treatment programs often focus on both aspects of addiction through counseling and medication.1,2 VIVITROL is the first and only non-addictive, once-monthly medication that, when combined with counseling, is proven to help prevent relapse to opioid dependence, after detox. VIVITROL blocks opioid receptors in the brain while you work with the psychological aspects of counseling.2,3

TREATING OPIOID DEPENDENCE
WITH VIVITROL AND COUNSELING3

When used as part of a treatment plan that includes counseling, VIVITROL can help prevent relapse to opioid dependence after detox.

During a 6-month, double-blind, placebo-controlled, randomized clinical study, compared to opioid-dependent patients being treated with a placebo and counseling (n=124), opioid-dependent patients being treated with VIVITROL and counseling (n=126):

PRIMARY ENDPOINT

Had 90% opioid-free weeks (compared to 35% receiving the placebo)* P=0.0002

SECONDARY ENDPOINT

Had a 55% decrease in self-reported opioid craving from baseline. (Placebo increased 3% from baseline.)** P<0.0001 (adjusted)

SECONDARY ENDPOINT

Were 17x less likely to relapse to physical dependence (compared to placebo) P<0.0001

SECONDARY ENDPOINT

Stayed in treatment longer: >168 days (compared to 96 days for those receiving the placebo) P=0.0042 (adjusted)


*Confirmed abstinence was defined as a negative urine drug test for opioids and no self-reported opioid use for all weekly visits. **Craving was measured by self-reported “need for opioids” using a visual analog scale.

See how VIVITROL works in the brain

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 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.

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. Treatment Approaches for Drug Addiction.
    https://www.drugabuse.gov/publications/drugfacts/treatment-approaches-drug-addiction. Accessed on September 21, 2016.
  2. VIVITROL [prescribing information]. Waltham, MA: Alkermes, Inc; rev December 2015.
  3. Krupitsky E, Nunes EV, Ling W, Illeperuma A, Gastfriend DR, Silverman BL. Injectable extended-release naltrexone for opioid dependence: a double-blind, placebo-controlled, multicentre randomised trial. Lancet. 2011;377(9776):1506-1513.
*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.