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VIVITROL (naltrexone for extended-release injectable suspension) VIVITROL: A Treatment Option For The Daily Struggle Against Alcohol Dependence. One dose all month long.
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Common Questions


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Common questions about VIVITROL

What are the most important things I should know about VIVITROL?
Who should not take VIVITROL?
What should I tell my healthcare professional before starting VIVITROL?
How do I know if I should be treated with VIVITROL?
How do I take VIVITROL?
What should I avoid while taking VIVITROL?
What are the possible side effects of VIVITROL?
What are the ingredients in VIVITROL?
 

Q: What are the most important things I should know about VIVITROL?
 
A:  VIVITROL may be associated with liver damage or hepatitis. Call your healthcare professional if you develop stomach area pain lasting more than a few days, light-colored bowel movements, dark urine, or yellowing of your eyes.8

VIVITROL blocks the effects of opioid-containing medicines and illegal (street) drugs that contain opioids such as heroin. You may not feel the same effects of opioid-containing medicines including medicines for pain, cough, and diarrhea.8

You may not feel the same effects if you use or abuse heroin and other illegal (street) opioids.8

Do not take large amounts of opioid medicines to overcome the VIVITROL block. This can lead to serious injury, coma, or death.8

VIVITROL has been associated with severe allergic pneumonia. Call your healthcare professional if you develop shortness of breath, coughing, or wheezing.8
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Q: Who should not take VIVITROL?
 
A:  Do not take VIVITROL if you:
  • Are taking or have a physical dependence on opioid-containing medicines.
  • Use or have a physical dependence on opioid street drugs.
  • Are allergic to VIVITROL or any of its components. The active ingredient is naltrexone. (See "What are the ingredients in VIVITROL?")8
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Q: What should I tell my healthcare professional before starting VIVITROL?
 
A:  Tell your healthcare professional about all of your medical conditions, including if you:
  • Have liver problems
  • Use opioid-containing medicines
  • Use or abuse street (illegal) drugs
  • Have hemophilia or other bleeding problems
  • Have kidney problems
  • Are pregnant or plan to become pregnant. It is not known if VIVITROL can harm your unborn baby
  • Are breastfeeding. It is not known if VIVITROL passes into your milk, and if it can harm your baby8

Tell your healthcare professional about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. Especially tell your healthcare professional if you take any opioid-containing medicines for pain, cough, or diarrhea.

Carry written information to alert medical personnel that you are taking VIVITROL, so that they can treat you properly in an emergency.
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Q: How do I know if I should be treated with VIVITROL?
 
A:  You should see a healthcare professional who can make an assessment of your condition and determine whether VIVITROL is right for you.
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Q: How do I take VIVITROL?
 
A:  VIVITROL is given as a shot (injection) in your buttocks. It is injected by your healthcare professional about once a month. Because VIVITROL is an injection, once it is given you cannot remove it from the body.

If you miss your appointment for your VIVITROL injection, schedule another appointment as soon as possible.

Whenever you need medical treatment, be sure to tell the treating healthcare professional that you are receiving VIVITROL injections.8
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Q: What should I avoid while taking VIVITROL?
 
A:  VIVITROL may make you feel dizzy. Do not drive a car, work with machines, or do other dangerous activities until you know how VIVITROL affects you.8

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Q: What are the possible side effects of VIVITROL?
 
A:  VIVITROL may cause side effects including:
  • A reaction at the injection site. The reaction could be pain, tenderness, swelling, redness, and/or itching. Tell your healthcare professional if the reaction gets worse over time
  • Nausea
The other common side effects of VIVITROL are:
  • Headache
  • Fatigue
  • Dizziness
  • Vomiting
  • Decreased appetite
  • Painful joints
  • Muscle cramps

Tell your healthcare professional about any side effect that bothers you or that does not go away.

These are not all the side effects of VIVITROL. For more information, ask your healthcare professional.8
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Q: What are the ingredients in VIVITROL?
 
A:  Active ingredient: naltrexone

Inactive ingredients: polylactide-co-glycolide (PLG)

Diluent: carboxymethylcellulose sodium salt, polysorbate 20, sodium chloride, and water8
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Important Safety Information
Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses. Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects. The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only five-fold or less. VIVITROL does not appear to be a hepatotoxin at the recommended doses. Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis. Use of VIVITROL should be discontinued in the event of symptoms and/or signs of acute hepatitis.
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.

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