Addiction is a chronic, relapsing brain disease that can happen to anyone.1 VIVITROL and counseling may help you treat your patients’ alcohol dependence and prevent relapse to opioid dependence after detox when used with counseling.2 Before your patients start treatment with VIVITROL, there are some things you should discuss with them.
Advise patients that if they previously used opioids, they may be more sensitive to lower doses of opioids and at risk of accidental overdose should they use opioids when their next dose is due, if they miss a dose, or 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.
Advise patients that because VIVITROL can block the effects of opioids, patients will not perceive any effect if they attempt to self-administer heroin or any other opioid drug in small doses while on VIVITROL. Further, emphasize that administration of large doses of heroin or any other opioid to try to bypass the blockade and get high while on VIVITROL may lead to serious injury, coma, or death.
Patients on VIVITROL may not experience the expected effects from opioid-containing analgesic, antidiarrheal, or antitussive medications.
Advise patients 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. Some of these injection site reactions have required surgery. 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.
Advise patients that they should be off all opioids, including opioid-containing medicines, for a minimum of 7–10 days before starting VIVITROL in order to avoid precipitation of opioid withdrawal. Patients transitioning from buprenorphine or methadone may be vulnerable to precipitation of withdrawal symptoms for as long as two weeks. Ensure that patients understand that withdrawal precipitated by administration of an opioid antagonist may be severe enough to require hospitalization if they have not been opioid-free for an adequate period of time, and is different from the experience of spontaneous withdrawal that occurs with discontinuation of opioid in a dependent individual. Advise patients that they should not take VIVITROL if they have any symptoms of opioid withdrawal. Advise all patients, including those with alcohol dependence, that it is imperative to notify healthcare providers of any recent use of opioids or any history of opioid dependence before starting VIVITROL to avoid precipitation of opioid withdrawal.
Advise patients that VIVITROL may cause liver injury. Patients should immediately notify their physician if they develop symptoms and/or signs of liver disease.
Advise patients that they 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 healthcare provider right away should they become depressed or experience symptoms of depression.
Advise patients to 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.
Advise patients that VIVITROL may cause an allergic pneumonia. Patients should immediately notify their physician if they develop signs and symptoms of pneumonia, including dyspnea, coughing, or wheezing.
Advise patients that they should not take VIVITROL if they are allergic to VIVITROL or any of the microsphere or diluent components.
Advise patients that they 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.
Advise patients that 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.
Advise patients that VIVITROL has been shown to treat alcohol and opioid dependence only when used as part of a treatment program that includes counseling and support.
Advise patients that dizziness may occur with VIVITROL treatment, and they should avoid driving or operating heavy machinery until they have determined how VIVITROL affects them.
Advise patients to 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.
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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.
See Important Safety Information below. Discuss all benefits and risks with your patients. See Prescribing Information. Review Medication Guide with your patients.