Patient Information

Guidelines for storage and preparation

Storage of VIVITROL

VIVITROL® is shipped and should be stored under specific temperature-controlled conditions to ensure proper delivery and help secure patient safety. Follow these handling instructions for VIVITROL before administering to patients:

  • VIVITROL should always be refrigerated at 2° to 8°C (36° to 46°F) and not frozen
  • Store VIVITROL separately from food, in accordance with Occupational Safety and Health Administration Guidelines
  • Unrefrigerated, VIVITROL microspheres can be stored at temperatures not exceeding 25°C (77°F) for no more than 7 days prior to administration
  • The product expiration date is printed on the carton
  • Product received from a pharmacy (specialty or other) is patient-specific

Each carton of VIVITROL includes:

One - Package Insert/Directions for Use

One - Medication Guide

(A) One - Diluent for the Suspension of VIVITROL Microspheres

(B) One - Vial Containing VIVITROL Microspheres

(C) One - Prepackaged Syringe

(D) Two - TERUMO® 1 1/2 inch 20G Administration Needles with clear Needle Protection Device [one spare]

(E) Two - TERUMO® 2-inch 20G Administration Needles with clear Needle Protection Device [one spare]

(F) One - TERUMO® 1-inch 20G Preparation Needle [Not for Administration]

Preparation of VIVITROL

Please ensure that your patient is not physically dependent on opioid-containing medicines or opioid street drugs and has not taken opioid-containing medicines or opioid street drugs for 7-10 days prior to injecting VIVITROL.

  • VIVITROL is supplied in single-use cartons
    • ­Each carton contains one 380 mg vial of VIVITROL microspheres, diluent for suspension, one 5-mL prepackaged syringe, and customized 1 1/2- and 2-inch administration (thin-walled) needles with needle protection devices
  • Prior to preparation:
    • ­Remove carton from refrigeration and allow VIVITROL to reach room temperature (approximately 45 minutes)
    • Parenteral products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit
    • ­Carton components should not be substituted
  • VIVITROL must be suspended only in the diluent supplied and must be administered only with one of the needles supplied
  • Select needle length based on assessment of patient’s body habitus
    • ­Consider using the 2-inch needle with protection device for patients with a large amount of subcutaneous tissue overlying the gluteal muscle
    • ­Consider alternative treatment for patients whose body type precludes an intramuscular injection with one of the provided needles
  • After preparation, a properly mixed suspension will be milky white, will not contain clumps, and will move freely down the walls of the vial

See Prescribing Information for complete directions for use.

Important Safety Information


VIVITROL is indicated for:

  • Treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting. 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.


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


Vulnerability to Opioid Overdose: Because VIVITROL blocks the effects of exogenous opioids for approximately 28 days after administration, patients are likely to have a reduced tolerance to opioids after opioid detoxification. As the blockade dissipates, 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.

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 injections may be followed by pain, tenderness, induration, swelling, erythema, bruising, or pruritus; however, in some cases injection site reactions may be very severe. 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: Withdrawal precipitated by administration of VIVITROL may be severe. Some cases of withdrawal symptoms have been severe enough to require hospitalization and management in the ICU. To prevent precipitated withdrawal, patients, including those being treated for alcohol dependence:

  • Should be opioid-free (including tramadol) for a minimum of 7–10 days before starting VIVITROL.
  • Patients transitioning from buprenorphine or methadone may be vulnerable to precipitated withdrawal for as long as two weeks.

Patients should be made aware of the risk associated with precipitated withdrawal and be encouraged to give an accurate account of last opioid use.

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: Cases of eosinophilic pneumonia requiring hospitalization have been reported. Warn patients of the risk of eosinophilic pneumonia and to seek medical attention if they develop symptoms of pneumonia.

Hypersensitivity Reactions: Patients should be warned of the risk of hypersensitivity reactions, including anaphylaxis.

Intramuscular Injections: As with any IM injection, VIVITROL should be administered with caution to patients with thrombocytopenia or any coagulation disorder.


Serious adverse reactions that may be associated with VIVITROL therapy in clinical use include severe injection site reactions, eosinophilic pneumonia, serious allergic reactions, unintended precipitation of opioid withdrawal, accidental opioid overdose, and depression and suicidality. The adverse events seen most frequently in association with VIVITROL therapy for alcohol dependence include nausea, vomiting, injection site reactions (including induration, pruritus, nodules, and swelling), 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 also include hepatic enzyme abnormalities, injection site pain, nasopharyngitis, insomnia, and toothache.

You are encouraged to report negative side effects to the FDA. Visit or call 1-800-FDA-1088.

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.