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VIVITROL® (naltrexone for extended-release injectable suspension) logo
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WHAT COULD YOUR
NEXT
PATIENT ACHIEVE
WITH
VIVITROL and
counseling?

Opioid dependence data

Prior to initiating VIVITROL, 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

OPIOID DEPENDENCE PIVOTAL STUDY

VIVITROL and counseling may help prevent relapse to opioid dependence in your appropriate opioid-detoxed patients1


The efficacy of VIVITROL in the treatment of opioid dependence was evaluated in a 24-week, placebo-controlled, multicenter, double-blind, randomized trial of opioid-dependent (DSM-IV) outpatients, who were completing or had recently completed detoxification2

Prior to treatment initiation, patients were voluntarily seeking treatment, completing ≤30 days of inpatient opioid detoxification, and not taking opioids for at least 7 days.

Participants were randomized to receive VIVITROL (n=126) or placebo (n=124), with a urine drug test (UDT) every week, psychosocial support every 2 weeks, and treatment injection every 4 weeks.

The age range for study participants was between 21 and 52 years, with an average age of 29.4 years. The duration of opioid dependence ranged from 1 to 26 years, with more patients in the VIVITROL group reporting shorter duration. For example, duration of use of <10 years was 47% vs 36% for the VIVITROL group vs the placebo group, respectively.

Opioid study design Opioid study design

After randomization, there was a 4-week period for treatment engagement during which opioid use, if it occurred, was allowed. This period was not included in the analysis. Subjects provided additional self-report of opioid use.

ENDPOINTS2

The primary endpoint was the confirmed opioid abstinence in the VIVITROL group in comparison to the placebo group.

  • Confirmed abstinence was defined as a negative UDT for opioids and no self-reported drug use
  • Weeks 1-4 were omitted from the endpoint to allow for stabilization of abstinence

Secondary endpoints were self-reported opioid-free days, opioid craving scores, treatment retention days, and relapses to physiological opioid dependence.

Please see below for full study limitations.

Study participants

Demographics and clinical baseline characteristic2

VIVITROL (n=126) Placebo (n=124)
Age in years 29.4 (±4.8) 29.7 (±3.6)
Men 113 (90%) 107 (86%)
White 124 (98%) 124 (100%)
Duration of opioid dependence in years 9.1 (±4.5) 10.0 (±3.9)
Days of pre-study inpatient detoxification 18 (±9) 18 (±7)
Opioid craving scale 18 (±23) 22 (±24)
HIV serology positive 51 (40%) 52 (42%)
Hepatitis C positive 111 (88%) 117 (94%)
Data are mean (SD) or number (%).

Study Limitations2

  • Retention in the placebo group might have been reduced by recognition, upon opioid use, that one was on placebo
    • Or, among patients in the placebo group who had relapsed to regular opioid use, by reluctance to return to the clinic and face a withdrawal reaction from a naloxone challenge test
  • The placebo group showed a substantial retention and response profile, and a markedly higher rate of positive naloxone challenge tests
  • The high retention rate might have been influenced by:
    • Inclusion criterion that patients have someone available to supervise attendance
    • Provision of individual counseling
    • Absence of alternative treatments in Russia
    • Promise of active VIVITROL treatment for all patients after 6 months, in the subsequent open-label extension safety study
  • Analyses of group central tendencies (median, mean) do not reflect the experience of individual patients

VIVITROL and counseling may help
your opioid-dependent patients
achieve more opioid-free weeks
following opioid detox1,2

With VIVITROL and counseling, 36% of patients in the pivotal trial maintained complete abstinence for Weeks 5-24 vs 23% with placebo and counseling


The primary endpoint was the confirmed abstinence in the VIVITROL group in comparison to the placebo group. Secondary endpoints include self-reported opioid-free days, opioid craving scores, number of days of retention, and relapse to physiological opioid dependence.

Subjects sustaining varying percentages of opioid-free weeks*

Percentage of opioid-free patients chart Percentage of opioid-free patients chart

Data were not collected during Weeks 1-4 of the trial to allow for stabilization of abstinence.

The median of the VIVITROL group had confirmed abstinence* for 90% of the weeks in the evaluation period vs 35% for the median of the placebo group.

Number of patients with a positive naloxone challenge (1 VIVITROL patient vs 17 placebo patients) at the end of 24 weeks.

*Confirmed abstinence or “opioid-free” was defined as a negative UDT for opioids and no self-reported opioid use. †Psychosocial support consisted of bi-weekly counseling sessions of individual drug counseling, adapted for opioid dependence.
Data represented as the median.

Secondary Endpoint:
Mean change in opioid craving2

Mean change in self-reported opioid craving‡ in patients receiving VIVITROL and counseling vs placebo


Patients given VIVITROL had a -10.1 mean change in craving visual analog scale (VAS) score, while patients given placebo had a +0.7 change in craving VAS score

Mean change in self-reported craving score2,3

Mean change in self-reported craving chart Mean change in self-reported craving chart
  • Patients in the VIVITROL group had a 55% lower mean craving score at 24 weeks than the mean score at baseline. Patients in the placebo group had a 3% higher mean craving score at 24 weeks than the mean score at baseline.3
‡Craving (described as a “need for opioids”) was reported weekly according to a VAS of 0 to 100, with 0 being “not at all” and 100 “very much so.”2 §Psychosocial support consisted of bi-weekly sessions of individual drug counseling, adapted for opioid dependence.2

Secondary Endpoint:
Median time in treatment2

A greater percentage of subjects in the VIVITROL group (53%, n=67) remained in the study compared to the placebo group (38%, n=47; P=0.0171)


  • At the end of the study period (168 days), the median VIVITROL patient had not dropped out
∥Psychosocial support consisted of bi-weekly counseling sessions of individual drug counseling, adapted for opioid dependence.

Adverse reactions in opioid dependence pivotal trial1

Treatment-emergent adverse reactions (occurring in ≥2% of patients and more frequently in the VIVITROL group than the placebo group) in the pivotal trial for opioid dependence

Events VIVITROL 380 mg with
psychosocial support (n=126)
Placebo with
psychosocial support (n=124)
Alanine aminotransferase increased 13% 6%
Aspartate aminotransferase increased 10% 2%
Gamma-glutamyltransferase increased 7% 3%
Nasopharyngitis 7% 2%
Insomnia 6% 1%
Influenza 5% 4%
Hypertension 5% 3%
Injection site pain 5% 1%
Toothache 4% 2%
Headache 3% 2%

Please see the complete list of adverse reactions in the VIVITROL Prescribing Information.

Discontinuation rates due to adverse events1

Opioid dependence pivotal trial

Discontinuation rate bar chart

VIVITROL is not right for everyone. There are significant risks from VIVITROL treatment, including risk of opioid overdose, injection site reactions, and sudden opioid withdrawal. Strongly consider prescribing naloxone for the emergency treatment of opioid overdose. See Important Safety Information below. See Prescribing Information. Review Medication Guide with your patients.

  • What is vivitrol?
  • How does vivitrol work?
  • Alcohol Dependence Data
    • Pivotal Study
    • Post hoc analyses
  • Opioid Dependence Data
    • Pivotal Study
    • Extension study
    • Investigational
      head-to-head study: x:bot
    • Investigational
      head-to-head study: tanum
Clinical trial results for VIVITROL® used in the treatment of alcohol dependence

Review an investigational open-label, head-to-head study in the treatment of opioid dependence.

Read the study >

VIVITROL1:
  • Once-monthly extended-release injectable naltrexone (380 mg)
  • HCP prepared and administered
  • Requires opioid detox for a minimum of 7-10 days prior to initiation
  • Part of a comprehensive management program that includes psychosocial support

It is recommended patients stop taking opioids or opioid-containing medications for a minimum of 7-10 days before starting VIVITROL to avoid precipitation of opioid withdrawal that may be severe.


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VIVITROL must be prepared and administered by an HCP by intramuscular injection

Get more information on dosing and administration of VIVITROL >

VIVITROL® packaging and vials Vials not actual size.
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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.

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Important safety information MORE

Important safety information

Important safety information

Contraindications

VIVITROL is contraindicated in patients:

  • Receiving opioid analgesics
  • With current physiologic opioid dependence
  • In acute opioid withdrawal
  • Who have failed the naloxone challenge test or have a positive urine screen for opioids
  • Who have exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose, or any other components of the diluent

Indications

VIVITROL is indicated for:

  • Treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. Patients should not be actively drinking at the time of initial VIVITROL administration.
  • Prevention of relapse to opioid dependence, following opioid detoxification.
  • VIVITROL should be part of a comprehensive management program that includes psychosocial support.

Warnings and precautions

Vulnerability to Opioid Overdose:

  • After opioid detoxification, patients are likely to have a reduced tolerance to opioids. VIVITROL blocks the effects of exogenous opioids for approximately 28 days after administration. As the blockade wanes and eventually dissipates completely, use of previously tolerated doses of opioids could result in potentially life-threatening opioid intoxication (respiratory compromise or arrest, circulatory collapse, etc.).
  • Cases of opioid overdose with fatal outcomes have been reported in patients who used opioids at the end of a dosing interval, after missing a scheduled dose, or after discontinuing treatment. Patients and caregivers should be told of this increased sensitivity to opioids and the risk of overdose. Discuss the availability of naloxone for the emergency treatment of opioid overdose with the patient and caregiver, at the initial VIVITROL injection and with each subsequent injection. Strongly consider prescribing naloxone for the emergency treatment of opioid overdose.
  • Although VIVITROL is a potent antagonist with a prolonged pharmacological effect, the blockade produced by VIVITROL is surmountable. The plasma concentration of exogenous opioids attained immediately following their acute administration may be sufficient to overcome the competitive receptor blockade. This poses a potential risk to individuals who attempt, on their own, to overcome the blockade by administering large amounts of exogenous opioids.
  • Any attempt by a patient to overcome the VIVITROL blockade by taking opioids may lead to fatal overdose. Patients should be told of the serious consequences of trying to overcome the opioid blockade.

Injection Site Reactions:

  • VIVITROL must be prepared and administered by a healthcare provider.
  • VIVITROL injections may be followed by pain, tenderness, induration, swelling, erythema, bruising, or pruritus; however, in some cases injection site reactions may be very severe.
  • In the clinical trials, one patient developed an area of induration that continued to enlarge after 4 weeks, with subsequent development of necrotic tissue that required surgical excision.
  • Injection site reactions not improving may require prompt medical attention, including, in some cases, surgical intervention.
  • Inadvertent subcutaneous/adipose layer injection of VIVITROL may increase the likelihood of severe injection site reactions.
  • Select proper needle size for patient body habitus, and use only the needles provided in the carton.
  • Patients should be informed that any concerning injection site reactions should be brought to the attention of their healthcare provider.

Precipitation of Opioid Withdrawal:

  • When withdrawal is precipitated abruptly by administration of an opioid antagonist to an opioid-dependent patient, the resulting withdrawal syndrome can be severe. Some cases of withdrawal symptoms have been severe enough to require hospitalization, and in some cases, management in the ICU.
  • To prevent occurrence of precipitated withdrawal, opioid-dependent patients, including those being treated for alcohol dependence, should be opioid-free (including tramadol) before starting VIVITROL treatment:
    • An opioid-free interval of a minimum of 7–10 days is recommended for patients previously dependent on short-acting opioids.
    • Patients transitioning from buprenorphine or methadone may be vulnerable to precipitated withdrawal for as long as two weeks.
  • If a more rapid transition from agonist to antagonist therapy is deemed necessary and appropriate by the healthcare provider, monitor the patient closely in an appropriate medical setting where precipitated withdrawal can be managed.
  • Patients should be made aware of the risk associated with precipitated withdrawal and be encouraged to give an accurate account of last opioid use.
  • Precipitated opioid withdrawal has been observed in alcohol-dependent patients in circumstances where the prescriber had been unaware of the additional use of opioids or co-dependence on opioids.

Hepatotoxicity:

  • Cases of hepatitis and clinically significant liver dysfunction have been observed in association with VIVITROL. Warn patients of the risk of hepatic injury; advise them to seek help if experiencing symptoms of acute hepatitis. Discontinue use of VIVITROL in patients who exhibit acute hepatitis symptoms.

Depression and Suicidality:

  • Alcohol- and opioid-dependent patients taking VIVITROL should be monitored for depression or suicidal thoughts. Alert families and caregivers to monitor and report the emergence of symptoms of depression or suicidality.

When Reversal of VIVITROL Blockade Is Required for Pain Management:

  • For VIVITROL patients in emergency situations, suggestions for pain management include regional analgesia or use of non-opioid analgesics. If opioid therapy is required to reverse the VIVITROL blockade, patients should be closely monitored by trained personnel in a setting staffed and equipped for CPR.

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.
  • Patients should be warned of the risk of hypersensitivity reactions, including anaphylaxis.
  • In the event of a hypersensitivity reaction, patients should be advised to seek immediate medical attention in a healthcare setting prepared to treat anaphylaxis. The patient should not receive any further treatment with VIVITROL.

Intramuscular Injections:

  • As with any intramuscular injection, VIVITROL should be administered with caution to patients with thrombocytopenia or any coagulation disorder.

Alcohol Withdrawal:

  • Use of VIVITROL does not eliminate nor diminish alcohol withdrawal symptoms.

Interference with Laboratory Tests:

  • VIVITROL may be cross-reactive with certain immunoassay methods for the detection of drugs of abuse (specifically opioids) in urine.
  • For further information, reference to the specific immunoassay instructions is recommended.

Adverse reactions

  • The adverse events seen most frequently in association with VIVITROL therapy for alcohol dependence (ie, 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), arthralgia, arthritis, or joint stiffness, muscle cramps, dizziness or syncope, somnolence or sedation, anorexia, decreased appetite or other appetite disorders.
  • The adverse events seen most frequently in association with VIVITROL in opioid-dependent patients (ie, those occurring in ≥2% and at least twice as frequently with VIVITROL than placebo) were hepatic enzyme abnormalities, injection site pain, nasopharyngitis, insomnia, and toothache.

You are encouraged to report side effects to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

References: 1. VIVITROL [prescribing information]. Waltham, MA: Alkermes, Inc; rev March 2021. 2. 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 randomized trial. Lancet. 2011;377(9776):1506-1513. 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.

As of December 8, 2015, VIVITROL® (naltrexone for extended-release injectable suspension) has new Prescribing Information (12/2015). The Dosage and Administration, Section 2.4 Directions for Use has been updated. When administering VIVITROL, please refer to Section 2.4 Directions for Use in the VIVITROL Prescribing Information that is provided in the carton you are administering.

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As of December 8, 2015, VIVITROL® (naltrexone for extended-release injectable suspension) has new Prescribing Information (12/2015). The Dosage and Administration, Section 2.4 Directions for Use has been updated. When administering VIVITROL, please refer to Section 2.4 Directions for Use in the VIVITROL Prescribing Information that is provided in the carton you are administering.

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During the evolving COVID-19 situation, we want to help patients with access to receiving their injection of VIVITROL® (naltrexone for extended-release injectable suspension). If your patients need access to alternate injection providers, please contact Vivitrol2gether℠ Patient Support Services at 1-800-VIVITROL (1-800-848-4876) for assistance in locating a healthcare provider who is providing injections or click on 'Find A Vivitrol Provider' on Vivitrol.com to get a listing of injection providers in your area. Vivitrol2gether can contact injection sites to confirm treatment availability.

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