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directions for use
Gluteal intramuscular injection of VIVITROL

Vivitrol—a once-monthly
injectable1
- VIVITROL is only available in one dose, 380 mg, and must be prepared and administered by a healthcare provider
- VIVITROL is given as a 4 mL gluteal intramuscular injection alternating buttocks for each subsequent injection
- VIVITROL is an extended-release microsphere formulation of naltrexone that delivers medication continuously over a one-month period (or 4 weeks)
-
VIVITROL must not be given intravenously, subcutaneously, or into adipose tissue
- Inadvertent subcutaneous injection of VIVITROL may increase the likelihood of severe injection site reactions
Injection site Reactions
- VIVITROL must be prepared and administered by a healthcare provider.
- VIVITROL injections may be followed by pain, tenderness, induration, swelling, erythema, bruising, or pruritus; however, in some cases injection site reactions may be very severe.
- Injection site reactions not improving may require prompt medical attention, including, in some cases, surgical intervention.
- Inadvertent subcutaneous/adipose layer injection of VIVITROL may increase the likelihood of severe injection site reactions.
- Select proper needle size for patient body habitus, and use only the needles provided in the carton.
- Patients should be informed that any concerning injection site reactions should be brought to the attention of their healthcare provider.
VIVITROL DELIVERY OVER THE APPROVED DOSING INTERVAL
Continuous delivery of medication over the approved dosing interval1
VIVITROL is an extended-release microsphere formulation of naltrexone that delivers medication continuously over a one-month period (or 4 weeks).1

The recommended dose of VIVITROL is 380 mg, delivered intramuscularly once a month (every 4 weeks).1

After intramuscular injection, the naltrexone plasma concentration time profile is characterized by a transient initial peak, which occurs approximately 2 hours after injection, followed by a second peak observed approximately 2-3 days later. Beginning approximately 14 days after dosing, concentrations slowly decline, with measurable levels for greater than 1 month.1
MEAN NALTREXONE CONCENTRATION1-3

Data for oral naltrexone beyond Day 5 have been extrapolated from a study of normal healthy volunteers (n=14) given oral naltrexone 50 mg daily for 5 days.
Plasma concentrations do not necessarily correlate with clinical efficacy.
Dosage and Administration1:
VIVITROL must be prepared and administered by a healthcare provider.
Prior to initiating VIVITROL, an opioid-free duration of a minimum of 7–10 days is recommended for patients, to avoid precipitation of withdrawal that may be severe enough to require hospitalization.
VIVITROL is available in one dose, 380 mg, delivered intramuscularly every 4 weeks or once a month by a healthcare provider.
- VIVITROL must not be administered intravenously or subcutaneously
- Inadvertent subcutaneous injection of VIVITROL may increase the likelihood of severe injection site reactions
- Alternate buttocks for each subsequent injection
- The needles provided in the carton are customized needles. VIVITROL must not be injected using any other needle. Proper needle from the carton should be selected based on body habitus
- Administer with caution in patients with moderate to severe renal impairment, thrombocytopenia, or any other coagulation disorder
- If a patient misses a dose, he/she should be instructed to receive the next dose as soon as possible
- Patients reinitiating treatment with VIVITROL should be opioid-free at the time of dose administration
- Patients should be alerted that they may be more sensitive to opioids, even at lower doses
- See additional dosage and administration information in the VIVITROL Full Prescribing Information
VIVITROL is not right for everyone. There are significant risks from VIVITROL treatment, including risk of opioid overdose, injection site reactions and sudden opioid withdrawal.
See Important Safety Information below. Discuss all benefits and risks with your patients. See Prescribing Information. Review Medication Guide with your patients.