Vivitrol
Vivitrol
Purpose
Vivitrol (naltrexone for extended-release injectable suspension) is a once-monthly injection used in the treatment of alcohol dependence in patients who are able to abstain from alcohol at least seven to ten days prior to treatment.
Description
Naltrexone, the active ingredient in Vivitrol, is an opioid antagonist that blocks the effects of alcohol; it is not an aversive therapy that pairs a strong feeling of dislike or disgust with alcohol. Naltrexone has few, if any, intrinsic actions other than as an opioid antagonist. It produces withdrawal symptoms in patients physically dependent on opioids . Vivitrol should be used as only one component of a comprehensive alcoholism management program that includes counseling, self-help support groups , or other psychosocial support.
Recommended Dosage
The recommended dosage of Vivitrol is 380 mg once a month. Vivitrol is delivered by intramuscular gluteal injection and should not be administered intravenously. Patients missing a dose should be given the next dose as soon as possible. Vivitrol must be administered by a healthcare professional.
Before starting treatment with Vivitrol, the patient should abstain from alcohol in an outpatient setting, not be actively drinking, not be in acute opiate withdrawal, and be opioid-free for at least seven to ten days.
Precautions
In excessive doses, naltrexone has been found to cause liver damage. Therefore, Vivitrol is not recommended for use in cases of acute hepatitis or liver failure. Careful consideration should be given before administering Vivitrol to patients with liver disease. Vivitrol should be discontinued in the event of signs of acute hepatitis.
Vivitrol should not be given to patients with a physiological dependence on opioids or who are in opioid withdrawal. To prevent withdrawal, Vivitrol should not be administered to patients receiving opioid analgesics. In cases where Vivitrol blockade needs to be reversed for pain management, patients should be monitored in a setting enabled for cardio-pulmonary resuscitation.
Side Effects
Vivitrol counteracts the effects of opioid-containing medications, including analgesics, cough and cold medications, and antidiarrheal preparations.
Vivitrol is generally well tolerated. In clinical trials , serious adverse reactions occurred in patients receiving Vivitrol at a similar rate to patients receiving a placebo. Mild to moderate adverse events were seen in most patients. The most common of these were nausea, vomiting, headache, dizziness, insomnia , fatigue , and injection site reaction.
In clinical trials, suicidal tendencies (including thoughts of suicide , suicide attempts, and completed suicides), although infrequent, occurred more often in
patients treated with Vivitrol (1 percent) than in patients receiving a placebo (0). Similarly, depression-related events were higher for patients taking Vivitrol (1 percent) than for those taking a placebo (0). Patients taking Vivitrol should be monitored for depression or suicidal thinking.
Side effects and other reactions reported include:
- blood and lymphatic system disorders (e.g., swollen, firm, or possibly tender lymph nodes; increased white blood cell count)
- cardiac disorders (e.g., palpitations, atrial fibrillation, myocardial infarction, angina pectoris, angina unstable, congestive heart failure, atherosclerosis)
- eye disorders (e.g., conjunctivitis)
- gastrointestinal disorders (e.g., constipation, toothache, flatulence, gastroesophageal reflux disease, hemorrhoids, colitis, gastrointestinal hemorrhage, paralysis/obstruction of the intestine, perirectal abscess)
- general disorders (e.g., fever, lethargy, rigors, chest pain or tightness, weight loss)
- liver disorders (e.g., gallstones)
- infections and infestations (e.g., influenza, bronchitis, urinary tract infection, gastroenteritis, tooth abscess, pneumonia)
- immune system disorders (e.g., seasonal allergy, hypersensitivity reaction)
- injection site reactions (e.g., pain, tenderness, skin reactions)
- metabolism and nutrition disorders (e.g., anorexia, appetite disorders, increased appetite, heat exhaustion, dehydration, elevated blood cholesterol)
- musculoskeletal and connective tissue disorders (e.g., pain in limbs, muscle spasms, joint stiffness)
- nausea, particularly after initial injection
- nervous system disorders (e.g., headache and migraine, dizziness, fainting, sleepiness, abnormality of the sense of taste, disturbance in attention, mental impairment, convulsions, ischemic stroke, cerebral arterial aneurysm)
- psychiatric disorders (e.g., irritability, decreased libido, abnormal dreams, alcohol withdrawal syndrome, agitation, euphoric mood, delirium)
- respiratory, thoracic, and mediastinal disorders (e.g., shortness of breath, sinus congestion, chronic obstructive airways disease)
- skin and subcutaneous tissue disorders (e.g., increased sweating, night sweats)
- vascular disorders (e.g., elevated blood pressure, hot flushes, deep venous thrombosis, pulmonary embolism)
KEY TERMS
Alcohol dependence —A chronic disease with both neurological and genetic factors. Diagnostic criteria include increased tolerance for alcohol, withdrawal symptoms, and manifestations of behavior, loss of control over the use of alcohol, and/or impaired function. Alcohol dependence is distinguished from alcohol abuse, alcohol withdrawal syndrome, and other alcohol-induced syndromes.
Analgesic —A medication to reduce or eliminate pain.
Opioid —A synthetic narcotic that resembles natural opiates.
Placebo —A preparation without pharmacological effect that is given in place of a drug in clinical trials to determine the effectiveness of the drug under study; a “sugar pill.”
Interactions
Although Vivitrol is a powerful drug with prolonged effects for blocking the action of opiods, the blockade can be overcome. However, such action is extremely dangerous. Any attempt by the patient to overcome the blockage by taking higher amounts of opioids or large dose of heroin while on Vivitrol could lead to serious injury, coma, or death.
At the time of this writing, no clinical drug interaction studies had been performed with Vivitrol. Pre-scribers, therefore, should carefully weigh the risks and benefits of use. Patients treated simultaneously with Vivitrol and antidepressant medications (e.g., sertraline , citalopram , paroxetine , fluoxetine , trazadone, bupropion hydrochloride) had similar safety profiles to patients taking Vivitrol without antidepressants .
Resources
BOOKS
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 4th edition, Text Revision, Washington D.C.: American Psychiatric Association, 2000.
OTHER INFORMATION
Cephalon, Inc. “Generation information regarding use of VIVITROL (Naltrexone for Extended Release Injectable Suspension) for the Treatment of Alcohol Dependence.” Enclosure to letter dated 1 December 2006.
Cephalon, Inc. “Vivitrol Prescribing Information.” Enclosure to letter dated 1 December 2006.
Ruth A. Wienclaw, Ph.D.