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VIVITROL

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Generic Name for VIVITROL

Naltrexone 380mg/vial; ext-rel susp for IM inj.

Legal Classification:

Pharmacological Class for VIVITROL

Opioid antagonist.

Manufacturer of VIVITROL

Alkermes

Indications for VIVITROL

Alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting, in conjunction with psychosocial support (eg, counseling or group therapy).

Adult dose for VIVITROL

Give by IM inj into alternating buttocks. 380mg once every 4 weeks.

Children's dosing for VIVITROL

Not recommended.

Contraindications for VIVITROL

Concomitant opioids. Current physiologic opioid dependence. Acute opiate withdrawal. Failed naloxone challenge test. Positive urine test for opioids. Acute hepatitis. Liver failure.

Warnings/Precautions for VIVITROL

Active liver disease (monitor closely). Discontinue if hepatitis develops. Consider naloxone challenge test before treating to exclude recent (7–10 days) opioid use. Moderate to severe renal dysfunction. Coagulation disorders. Risk of eosinophilic pneumonia; follow-up if respiratory symptoms occur. Monitor for depression and/or suicidality. Advise patient of reduced post-treatment opioid tolerance and of danger of attempting to overcome opioid blockade; advise use of medication alert documentation. Elderly. Pregnancy (Cat.C). Nursing mothers: not recommended.

Interactions for VIVITROL

See Contraindications. Antagonizes opioids (eg, antitussives, antidiarrheals, analgesics); use non-opioids, and/or anesthesia if pain management is necessary. May interfere with urine opioid tests.

Adverse Reactions for VIVITROL

GI upset, fatigue, headache, dizziness, decreased appetite, inj site reactions (may be serious; eg, induration, cellulitis, hematoma, abscess, sterile abscess, necrosis), hepatotoxicity (overdosage); rare: allergic (eosinophilic) pneumonia.

How is VIVITROL supplied?

Vial—1 (w. supplies)

Related Disease:

Alcoholism

Suboxone sublingual film approved to treat opioid dependence

August 31, 2010

Reckitt Benckiser announced that the FDA has approved Suboxone (buprenorphine and naloxone) sublingual film for maintenance treatment of opioid dependence in conjunction with counseling and psychosocial support.

FDA grants priority review to Vivitrol for opioid dependence

May 25, 2010

Alkermes announced that the supplemental New Drug Application (sNDA) for Vivitrol (naltrexone for extended-release injectable suspension) for opioid dependence has been granted priority review by the FDA.

FDA launches "Bad Ad Program" to detect misleading drug ads

May 11, 2010

The FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) has launched the Bad Ad Program, designed to educate healthcare providers about their role in ensuring that prescription drug advertising and promotion is truthful, and not misleading.

Medication guide required by FDA for Vivitrol

May 04, 2010

The FDA and Alkermes have notified healthcare professionals and patients of an update to the Warnings, Information for Patients, and Dosage and Administration sections of the Vivitrol (naltrexone injection) Prescribing Information to strengthen language regarding the risk of injection site reactions based on postmarketing reports that had been received prior to June 2009.

Phase 3 study of extended-release injectable naltrexone for treatment of opioid dependence

November 16, 2009

Alkermes Inc. announced positive preliminary results from a Phase 3 clinical trial of naltrexone for extended-release injectable suspension (XR-NTX) for the treatment of opioid dependence.