Vivitrol Naltrexone injectable Suspension Extended-Release 380 mg (RX)

Vivitrol® 380 mg by Alkermes is an FDA-approved, once-monthly extended-release injectable suspension of naltrexone designed to help prevent relapse in patients with opioid dependence and to support abstinence in alcohol-dependent patients. Offering powerful, non-addictive, and convenient support, Vivitrol® helps those in recovery by blocking the euphoric and sedative effects of opioids and reducing alcohol cravings. Manufactured to the highest pharmaceutical standards, Vivitrol® ensures reliable dosing, consistent results, and increased patient compliance. Choose Alkermes’ innovative solution for superior, clinically-proven recovery support.

Vivitrol Naltrexone 380mg is a medication used to help prevent relapse in those who have recently stopped using opioids or alcohol. It is a once-monthly injection that contains naltrexone, which works by blocking the effects of opioids and alcohol in the brain. This can help reduce cravings and prevent a relapse from occurring. Vivitrol is intended to be used in combination with counseling or other support programs as part of a comprehensive treatment plan for substance use disorders.

Uses

• Opioid Dependence: For the prevention of relapse in opioid-dependent patients who have successfully completed detoxification.
• Alcohol Dependence: Helps maintain abstinence by reducing cravings and the urge to drink in alcohol-dependent individuals.

Benefits

• Once-Monthly Dosing: No daily pills, supporting improved adherence and reducing the risk of missed doses.
• Non-Addictive: Vivitrol® is not a narcotic or a controlled substance and does not cause physical dependence.
• Blocks Opioid High: Naltrexone binds to opioid receptors, preventing users from experiencing euphoric effects if opioids are used.
• Reduces Alcohol Craving: Helps maintain abstinence and decreases the frequency of heavy drinking days.
• Improves Outcomes: Shown in clinical trials to help patients stay in treatment and avoid relapse.
• Easy Administration: Pre-filled vial for intramuscular gluteal injection by a qualified healthcare professional.

Specifications

• Active Ingredient: Naltrexone 380 mg per vial (as extended-release injectable suspension)
• Dosage Form: Intramuscular injectable suspension (extended-release)
• Packaging: 1 single-use vial (kit contains vial, diluent, mixing needle, and administration needle)
• Manufacturer: Alkermes, Inc.
• NDC: 65757-0300-01
• Administration Site: Intramuscular injection into the gluteal muscle only
• Storage: Store refrigerated at 2°C–8°C (36°F–46°F); do not freeze. Bring to room temperature before mixing and administering.

Directions for Use

1. Preparation:
   • Only a healthcare provider should prepare and administer this medication.
   • Use kit contents and follow directions in the full prescribing information for proper reconstitution and administration.
2. Dosing:
   • Administer one 380 mg injection intramuscularly into the buttock (gluteal muscle) every 4 weeks or once a month.
3. Patient Requirements:
   • Patients must be opioid-free for at least 7–14 days before first injection to avoid sudden opioid withdrawal.
   • Complete a thorough medical assessment prior to therapy initiation.
4. Follow-Up:
   • Patients should continue counseling and additional recovery supports while on Vivitrol®.

Side Effects

Common:

• Injection site reactions (pain, swelling, redness, lumps)
• Nausea, vomiting
• Headache or dizziness
• Fatigue or weakness
• Increased liver enzymes

Serious (Seek immediate medical attention):

• Severe allergic reactions (rash, swelling, trouble breathing)
• Liver dysfunction (yellowing of skin/eyes, dark urine)
• Pneumonia (especially eosinophilic pneumonia)
• Depression, suicidal thoughts or behavior

Warnings & Precautions

• Opioid Use Warning: Do not use opioids while on Vivitrol®. Using opioids after sudden discontinuation may increase overdose risk due to lowered opioid tolerance.
• Liver Warning: Risk of liver injury—monitor liver function tests regularly.
• Injection Site Complications: May cause injection site abscess, cellulitis, necrosis—seek medical help if severe pain, swelling, or hardening occurs.
• Pregnancy & Breastfeeding: Use with caution and only if potential benefit justifies risk.
• Not for use in patients currently physically dependent on opioids.
• Medical ID: Patients should carry medical identification stating they are receiving naltrexone.
• Only for administration by a qualified healthcare provider.

Why Choose Vivitrol® by Alkermes?

• Once-monthly extended-release therapy supports long-term recovery
• Highly effective for opioid and alcohol dependence
• Backed by extensive clinical research
• Trusted by addiction medicine professionals nationwide
• Non-addictive and non-habit forming

Order Vivitrol® (Naltrexone Injectable Suspension, Extended-Release) 380 mg by Alkermes (NDC: 65757-0300-01) today for proven, once-monthly support in opioid and alcohol dependence recovery!