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VIVITROL® (naltrexone for extended-release injectable suspension) logo
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  • What is
    VIVITROL?
    • What is VIVITROL?
    • How does vivitrol work?
    • Alcohol dependence data
      • Pivotal Study
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POST HOC
ANALYSES

POST HOC ANALYSES

EARLY TREATMENT RESPONSE IN ALCOHOL DEPENDENCE WITH EXTENDED-RELEASE NALTREXONE1


Evaluating the time to onset of VIVITROL treatment response in alcohol-dependent patients1

Post hoc study design

A post hoc analysis of the alcohol dependence pivotal trial was performed on data from 624 alcohol-dependent patients who were randomly assigned to receive VIVITROL 380 mg, XR-NTX 190 mg, or placebo every 4 weeks for 24 weeks. In addition, patients received 12 counseling sessions. The subanalysis focused on the 30-day period following the first treatment dose and included the subset of the intent-to-treat (ITT) population that received all 6 doses of study treatment and provided sufficient timeline follow-back information without any major protocol violations.1

A total of 208 patients were randomized to the VIVITROL 380 mg group. Three patients did not receive any treatment due to enrollment failures based on investigator decision, leaving 205 patients included in the primary analysis and safety evaluation for the VIVITROL 380 mg group.1,2

Only data for VIVITROL 380 mg and placebo are presented here.

Number of drinks per day through Month 11

The Ciraulo et al post hoc analysis

*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.1
  • Analyses of group tendencies (median, mean) do not reflect the experience of individual patients

STUDY LIMITATIONS1,2

These analyses were based on a post hoc analysis of the clinical trial by Garbutt et al (2005).
This study was not specifically designed to assess the onset of effect of XR-NTX and may have been insufficiently powered for this purpose.

  • The study was not designed to answer whether naltrexone may or may not work for women
    • The women who participated may not be representative of women with alcohol dependence in the general population, and the number of women studied was small
    • Men and women in this study differed on a number of important variables, including the prevalence of smoking and antidepressant use, weight, and commitment to abstinence
    • The men and women in this sample may have differed on other variables that may positively influence naltrexone response but were not assessed in this study, such as family history of alcoholism
  • Clinical trials may enroll patients with a greater degree of motivation for change than is seen among patients who are treated in traditional outpatient settings
  • Although treatment attendance was relatively high in this study, dropouts reduce the extent to which the findings generalize to all of those with alcohol dependence. Drinking data for dropouts were not obtained once they left the study, so it is not known how these drinking outcomes would have affected the results
  • Patient motivation for change may have affected the response to treatment
    • Patients who enroll in clinical studies may be more motivated to change behavior than those who are treated in outpatient settings
    • A strong response to counseling, such as occurred in this trial, may be expected to obscure the detection of additional benefit from pharmacotherapy

A post hoc analysis of a subset of patients in the pivotal trial who abstained from drinking alcohol for ≥4 days prior to initiation of treatment3

Post hoc study design

This post hoc analysis was not prespecified and included a small sample size; thus, the results could represent chance findings and should be interpreted with caution. A post hoc analysis of the alcohol dependence pivotal trial was performed on data from 624 alcohol-dependent outpatients who were randomly assigned to receive VIVITROL 380 mg, XR-NTX 190 mg, or placebo every 4 weeks for 24 weeks, along with psychosocial support every other week. In the subanalysis, 82 patients were voluntarily abstinent for ≥4 days prior to treatment initiation. Evaluations occurred weekly for the first 4 weeks and then every 2 weeks for the next 20 weeks until the final visit.

Median heavy drinking† days per month: ≥4-day abstinent subset (n=82)3

  • VIVITROL 380 mg with psychosocial support‡ (n=28): 0.2 heavy drinking days
  • Placebo with psychosocial support† (n=28): 2.9 heavy drinking days

Median number of days to first heavy drinking event: ≥4-day abstinent subset population (n=82)3,4

Median number of days to first heavy drinking event graphic Median number of days to first heavy drinking event graphic †Heavy drinking was defined as a self-report of ≥5 standard drinks consumed on a given day for male patients and ≥4 drinks for female patients. ‡Psychosocial support was defined as biweekly counseling.5

STUDY LIMITATIONS2,3

  • Clinical trials may enroll patients with a greater degree of motivation for change than is seen among patients who are treated in traditional outpatient settings
  • Although treatment attendance was relatively high in this study, dropouts reduce the extent to which the findings generalize to all of those with alcohol dependence. Drinking data for dropouts were not obtained once they left the study, so it is not known how these drinking outcomes would have affected the results
  • Analyses of group central tendencies (median, mean) do not reflect the experience of individual patients

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
VIVITROL5:
  • 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

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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. Ciraulo DA, Dong Q, Silverman BL, Gastfriend DR, Pettinati HM. Early treatment response in alcohol dependence with extended-release naltrexone. J Clin Psychiatry. 2008;69(2):190-195. 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. O’Malley SS, Garbutt JC, Gastfriend DR, Dong Q, Kranzler HR. Efficacy of extended-release naltrexone in alcohol-dependent patients who are abstinent before treatment. J Clin Psychopharmacol. 2007;27:507-512. 4. Data on file. Alkermes, Inc. Waltham, MA. 5. VIVITROL [prescribing information]. Waltham, MA: Alkermes, Inc; rev March 2021.

§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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