What should clinicians know about Vivitrol (Naltrexone)?

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

  • Information on this topic is found in the FDA medication label. Not all information in the FDA medication label is included here, and clinicians should read the entire FDA medication label before making treatment decisions.
  • Medication labels can be found by searching Drugs@FDA at the FDA website. Labels are also available using the Drugs@FDA app for Apple or Android devices. Labels change over time, and the current label should always be consulted.

If you would like more information on this topic, or would like to provide any feedback, please send us a message using our consultation system. Be sure to let us know about which tip you are writing. We would love to hear from you, and the consultation system is free to use and confidential. Thank you!

  • Was this Helpful ?
  • YesNo

Join our #MissionForBetter now

Sign up for our newsletter. We’ll let you know about new resources, education, and more.

non-image