Label Changes for:

Vivitrol (naltrexone for extended-release injectable suspension)

July 2013

Changes have been made to the WARNINGS and PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) 

 

July 2013

WARNINGS AND PRECAUTIONS

Vulnerability to Opioid Overdose
  • Patients should be alerted that they may be more sensitive to opioids, even at lower doses, after VIVITROL treatment is discontinued, especially at the end of a dosing interval (i.e., near the end of the month that VIVITROL was administered), or after a dose of VIVITROL is missed. 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
Injection Site Reactions
  • For patients with a larger amount of subcutaneous tissue overlying the gluteal muscle, the administering healthcare provider may utilize the supplied 2-inch needle with needle protection device to help ensure that the injectate reaches the intramuscular mass. For very lean patients, the 1.5-inch needle may be appropriate to prevent the needle contacting the periosteum. Either needle may be used for patients with average body habitus.
Precipitation of Opioid Withdrawal
  • The symptoms of spontaneous opioid withdrawal (which are associated with the discontinuation of opioid in a dependent individual) are uncomfortable, but they are not generally believed to be severe or necessitate hospitalization. However, when withdrawal is precipitated abruptly by the administration of an opioid antagonist to an opioid-dependent patient, the resulting withdrawal syndrome can be severe enough to require hospitalization. Review of postmarketing cases of precipitated opioid withdrawal in association with naltrexone treatment has identified cases with symptoms of withdrawal severe enough to require hospital admission, and in some cases, management in the intensive care unit.
Hepatotoxicity
  • Cases of hepatitis and clinically significant liver dysfunction were observed in association with VIVITROL exposure during the clinical development program and in the postmarketing period. Transient, asymptomatic hepatic transaminase elevations were also observed in the clinical trials and postmarketing period. Although patients with clinically significant liver disease were not systematically studied, clinical trials did include patients with asymptomatic viral hepatitis infections. When patients presented with elevated transaminases, there were often other potential causative or contributory etiologies identified, including pre-existing alcoholic liver disease, hepatitis B and/or C infection, and concomitant usage of other potentially hepatotoxic drugs. Although clinically significant liver dysfunction is not typically recognized as a manifestation of opioid withdrawal, opioid withdrawal that is precipitated abruptly may lead to systemic sequelae including acute liver injury.  

 

March 2010

 

WARNINGS

Injection Site Reactions
  • Vivitrol injections may be followed by pain, tenderness, induration, swelling, erythema, bruising, or pruritus; atoma, abscess, sterile abscess, and necrosis, have been reported. Some cases required surgical intervention,including debridement of necrotic tissue. Some cases resulted in significant scarring. The reported cases occurred primarily in female patients.
  • Vivitrol is administered as a gluteal intramuscular injection, and inadvertent subcutaneous injection of
  • Vivitrol may increase the likelihood of severe injection site reactions. The needle provided in the carton is a customized needle. Vivitrol must not be injected using any other needle. The needle length may not be adequate in every patient because of body habitus. Body habitus should be assessed prior to each injection for each patient to assure that needle length is adequate for intramuscular administration. Healthcare providers should ensure that the Vivitrol injection is given correctly, and should consider alternate treatment for those patients whose body habitus precludes a gluteal intramuscular injection with the provided needle.
  • Patients should be informed that any concerning injection site reactions should be brought to the attention of the healthcare provider. Patients exhibiting signs of abscess, cellulitis, necrosis, or extensive swelling should be evaluated by a physician to determine if referral to a surgeon is warranted.

PRECAUTIONS

General

When Reversal of Vivitrol Blockade Is Required for Pain Management

  • If opioid therapy is required as part of anesthesia or analgesia, such patients should be continuously monitored, in an anesthesia care setting, by persons not involved in the conduct of the surgical or diagnostic procedure. The opioid therapy must be provided by individuals specifically trained in the use of anesthetic drugs and the management of the respiratory effects of potent opioids, specifically the establishment and maintenance of a patent airway and assisted ventilation.
Information for Patients
  • Patients should be advised that 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 provider qualified to administer the injection. Patients should be advised to seek medical attention for worsening skin reactions.
  • Patients should be advised that dizziness may occur with Vivitrol treatment, and they should avoid driving or operating heavy machinery until they have determined how Vivitrol affects them.

 

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