Description

Generic name: naltrexone
Dosage form: injection
Drug class: Drugs used in alcohol dependence

Indications and Usage for Vivitrol

Treatment with Vivitrol should be part of a comprehensive management program that includes psychosocial support.

Alcohol Dependence

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.

Opioid Dependence

Vivitrol is indicated for the prevention of relapse to opioid dependence, following opioid detoxification.

Vivitrol Dosage and Administration

Important Dosage and Administration Information

Vivitrol must be prepared and administered by a healthcare provider.

Parenteral products should be visually inspected for particulate matter and discolouration prior to administration whenever solution and container permit. A properly mixed suspension will be milky white, will not contain clumps, and will move freely down the wall of the vial.

Prior to initiating Vivitrol, an opioid-free duration of a minimum of 7–10 days is recommended for patients, to avoid precipitation of opioid withdrawal that may be severe enough to require hospitalization [see Warnings and Precautions.

The recommended dose of Vivitrol is 380 mg delivered intramuscularly every 4 weeks or once a month. The injection should be administered by a healthcare provider as an intramuscular (IM) gluteal injection, alternating buttocks for each subsequent injection, using the carton components provided [see How Supplied/Storage and Handling]. The needles provided in the carton are customized needles. Vivitrol must not be injected using any other needle. The needle lengths (either 1 1/2 or 2 inches) may not be adequate for 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. 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 a needle protection device to help ensure that the injectate reaches the intramuscular mass. The 1 1/2-inch needle may be appropriate for very lean patients to prevent the needle from contacting the periosteum. Either needle may be used for patients with average body habitus. Healthcare providers should ensure that the Vivitrol injection is given correctly, and should consider alternate treatment for those patients whose body habitus precludes an intramuscular gluteal injection with one of the provided needles.

General information about VIVITROL

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. This Medication Guide summarizes the most important information about VIVITROL. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about VIVITROL that is written for health professionals.

For more information about VIVITROL call 1-800-848-4876, Option #1 or go to www.vivitrol.com.

What are the ingredients in VIVITROL?

Active ingredient: naltrexone

Inactive ingredients: polylactide-co-glycolide (PLG)

Diluent ingredients: carboxymethylcellulose sodium, polysorbate 20, sodium chloride, sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection.

This Medication Guide has been approved by the U.S. Food and Drug Administration.