Patient Counseling Information

Physicians should include the following issues in discussions with patients for whom they prescribe VIVITROL (for more information, see FDA-Approved Medication Guide):

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A reaction at the site of VIVITROL injection may occur
. Reactions include pain, tenderness, induration, swelling, erythema, bruising, or pruritus. Serious injection site reactions including necrosis may occur. Patients should receive their injection from a healthcare professional qualified to administer the injection. Patients should be advised to seek medical attention for worsening skin reactions.
Patients should be off all opioid-containing medicines
(including methadone or buprenorphine) for 7-10 days before starting VIVITROL in order to avoid precipitation of opioid withdrawal. Advise patients that they should not take VIVITROL if they have any symptoms of opioid withdrawal. Advise patients with alcohol dependence that it is imperative to notify healthcare professionals of any recent use of opioids or any history of opioid dependence before starting VIVITROL to avoid precipitation of opioid withdrawal.
If patients have previously used opioids, they may be more sensitive
to lower doses of opioids after VIVITROL treatment is discontinued. It is important that patients inform family members and the people closest to the patient of this increased sensitivity to opioids and the risk of overdose.
Administration of large doses of heroin or any other opioid while on VIVITROL
may lead to serious injury, coma, or death. In addition, administration of previously-tolerated doses of opioids at the end of the dosing interval or after missing a dose my lead to overdose.
Because VIVITROL can block the effects
of opiates and opiate-like drugs, patients will not perceive any effect if they attempt to self-administer heroin or any other opioid drug in small doses while on VIVITROL. Also, patients on VIVITROL may not experience the same effects from opioid-containing analgesic, antidiarrheal, or antitussive medications.
VIVITROL may cause liver injury in people
who develop liver disease from other causes. Patients should immediately notify their physician if they develop symptoms and/or signs of liver disease.
Patients may experience depression while taking VIVITROL
. It is important that patients inform family members and the people closest to the patient that they are taking VIVITROL and that they should call a doctor right away if they become depressed or experience symptoms of depression.
VIVITROL may cause an allergic pneumonia. Patient should immediately
notify their physician if they develop signs and symptoms of pneumonia, including dyspnea, coughing, or wheezing.
Patients should carry documentation to alert
medical personnel to the fact that they are taking VIVITROL (naltrexone for extended-release injectable suspension). This will help to ensure that patients obtain adequate medical treatment in an emergency.
Patients may experience nausea
following the initial injection of VIVITROL. These episodes of nausea tend to be mild and subside within a few days post-injection. Patients are less likely to experience nausea in subsequent injections. Patients should be advised that they may also experience tiredness, headache, vomiting, decreased appetite, painful joints and muscle cramps.
Because VIVITROL is an intramuscular
injection and not an implanted device, once VIVITROL is injected, it is not possible to remove it from the body.
VIVITROL has been shown to treat alcohol and opioid
dependence only when used as part of a treatment program that includes counseling and support.
Dizziness may occur with VIVITROL treatment
, and patients should avoid driving or operating heavy machinery until they have determined how VIVITROL affects them.
Patients should notify their physician if they
:
  • Become pregnant or intend to become pregnant during treatment with VIVITROL
  • Are breast feeding
  • Experience respiratory symptoms such as dyspnea, coughing or wheezing when taking VIVITROL
  • Experience any allergic reactions when taking VIVITROL
  • Experience other unusual or significant side effects while on VIVITROL therapy
Patients should be advised of any other risks and information based on the clinical judgment of their physician.
IMPORTANT SAFETY INFORMATION
FOR VIVITROL
WARNING: HEPATOTOXICITY

Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses.

Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects.

The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only five-fold or less. VIVITROL does not appear to be a hepatotoxin at the recommended doses.

Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis. Use of VIVITROL should be discontinued in the event of symptoms and/or signs of acute hepatitis.

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ADDITIONAL IMPORTANT SAFETY INFORMATION FOR VIVITROL®
(naltrexone for extended-release injectable suspension) 380mg/vial

INDICATIONS

Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support. Opioid-dependent patients, including those being treated for alcohol dependence, must be opioid-free at the time of initial VIVITROL administration. VIVITROL is indicated for the 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. VIVITROL is also indicated for the prevention of relapse to opioid dependence, following opioid detoxification.

CONTRAINDICATIONS

VIVITROL is contraindicated in patients with acute hepatitis or liver failure, patients receiving opioid analgesics, patients with current physiologic opioid dependence, patients in acute opioid withdrawal, any individual who has failed the naloxone challenge test or has a positive urine screen for opioids, and in patients who have previously exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose or any other components of the diluent.

WARNINGS/PRECAUTIONS

VIVITROL is administered as an intramuscular (IM) gluteal injection. Inadvertent subcutaneous injection of VIVITROL may increase the likelihood of severe injection site reactions. VIVITROL must be injected using one of the customized needles provided in the carton. Because needle length may not be adequate due to body habitus, each patient should be assessed prior to each injection to assure that needle length is adequate for IM administration. 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. Consider the diagnosis of eosinophilic pneumonia if patients develop progressive dyspnea and hypoxemia. Patients should be warned of the risk of hypersensitivity reactions, including anaphylaxis. Opioid-dependent patients including those being treated for alcohol dependence, must be opioid-free for a minimum of 7-10 days before VIVITROL treatment. Attempts to overcome opioid blockade due to VIVITROL may result in a fatal overdose. After opioid detoxification, patients are likely to have reduced tolerance to opioids. Use of lower doses of opioids after VIVITROL is discontinued, at the end of a dosing interval or after missing a dose could result in life threatening opioid intoxication. Alcohol- and opioid-dependent patients, including those taking VIVITROL, should be monitored for the development of depression or suicidal thoughts. As with any IM injection, VIVITROL should be administered with caution to patients with thrombocytopenia or any coagulation disorder. In an emergency situation in patients receiving VIVITROL, suggestions for pain management include regional analgesia or use of non-opioid analgesics. Patients requiring reversal of the VIVITROL blockade for pain management should be monitored by appropriately trained personnel in a setting equipped for cardiopulmonary resuscitation. Caution is recommended in administering VIVITROL to patients with moderate to severe renal impairment.

ADVERSE EVENTS

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 include hepatic enzyme abnormalities, injection site pain, nasopharyngitis, insomnia, and toothache.

VIVITROL [full prescribing information]. Waltham, MA: Alkermes, Inc; rev October 2010.

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