Vivitrol is a long-acting injectable formulation of naltrexone. It is administered intramuscularly in the gluteal site every 4 weeks. Vivitrol is FDA-indicated to treat patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with Vivitrol and for the prevention of relapse of opioid dependence.
Vivitrol (Naltrexone) | |
Indication(s) | Treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with Vivitrol. Prevention of relapse to opioid dependence, following opioid dependence. |
Dosing available as prefilled syringes | 380 mg (4mL) every four weeks |
Needle Size and Gauge | 20 gauge – 1.5 inch and 2 inch |
Recommended starting and maintenance dose | 380mg monthly for starting and maintenance dose |
Dosing exclusions | N/A |
Loading dose | Not required |
Oral overlap | Not required |
Storage | Dose pack to be refrigerated (36 °F to 46 °F), can be kept at room temperature (not exceeding 77 °F) for up to 7 days, ~45 minutes to reach room temperature |
Reconstitution or mixing | Remove the carton from the refrigerator. Allow medication to reach room temperature (~45 minutes). Firmly tap Vivitrol microspheres vial on a hard surfrace, ensuring the powder moves freely. Remove flip-off caps from both vials. Wipe the vial tops with an alcohol swap. Place 1-inch preparation needle on the syringe and withdraw 3.4 mL of the diulent from the diluent vial. Inject the 3.4 mL of diluent into the Vivitrol microsphere vial. Mix the powder and diluent by vigorously shaking the vial for approximately 1 minute. Immediately after suspension, withdraw 4.2 mL of the suspension into the syringe using the same preparation needle. Select the appropriate needle for a deep intramuscular injection based on patient's body habitus. Remove the preparation needle and replace with approximately selected administration needle for immediate use. Prior to injecting, tap the syringe to release any air bubbles, then push gently on the plunger until 4 mL of the suspension remains in the syringe. |
Injection site | Intramuscular injection into a gluteal muscle, alternating buttocks per monthly injection. Aspirate for blood before injection. Inject the suspension in a smooth and continuous motion. |
Injection interval | Every 4 weeks |
Administration considerations | Gluteal only. No opioid use for 7-10 days before administration. Alternate buttocks for each injection |
When a dose is missed | If a dose is missed, the next dose should be administered as soon as possible. |
REMS | No |
Dose Conversion of Oral Naltrexone to Vivitrol | |
Oral Dose | LAI Dose |
50 mg daily or bid | 380 mg |
8 - 10 mg | 16 mg |
12 - 16 mg | 24 mg |
18 - 24 mg | 32 mg |
Reference: VIVITROL® (naltrexone for extended-release injectable suspension) prescribing information. Waltham, MA: Alkermes, Inc; 2022. | |
FDA medication label
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