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Vivitrol Warnings and Precautions

People who have bleeding problems, depression, or other medical issues should review the risks that may apply to them if they receive Vivitrol. Other warnings and precautions apply to people using certain medications and women who are pregnant or breastfeeding. You should not take Vivitrol if you have acute hepatitis, liver failure, or a physical dependence on opioids.

What Should I Tell My Healthcare Provider?

Talk with your healthcare provider prior to using Vivitrol® (naltrexone injection) if you have:
  • Used a narcotic (opioid), alcohol, or an illegal drug in the last 7 to 10 days
  • Liver disease, such as cirrhosis, liver failure, or hepatitis
  • Kidney disease, such as kidney failure (renal failure)
  • Hemophilia, low platelet count (thrombocytopenia), or other bleeding problems
  • Depression or have had depression in the past
  • Had thoughts of suicide or harming yourself
  • Symptoms of drug or alcohol withdrawal
  • Any allergies, including to foods, dyes, or preservatives.
Also, let your healthcare provider know if you are:
  • Breastfeeding
  • Pregnant or thinking of becoming pregnant.
You should also tell your healthcare provider about all other medications you are taking, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Specific Precautions and Warnings With Vivitrol

Some warnings and precautions to be aware of prior to using this drug include the following:
  • Vivitrol may cause liver damage, especially when used in doses that are higher than the usual recommended dose. Let your healthcare provider know if you develop symptoms of liver problems during treatment, which may include:
    • Abdominal (stomach) pain
    • Pale-colored stool
    • Dark urine
    • Yellowing of the skin or whites of the eyes (jaundice).
  • Some people have developed reactions at the site of their Vivitrol injection. In some cases, the reactions were so severe that they caused scarring and tissue death that required surgery. Contact your healthcare provider right away if you develop any severe side effects at the site of your injection, or reactions that do not go away, including:
    • Pain or tenderness that is severe or does not go away
    • Hardening of the skin
    • Extensive swelling
    • Lumps
    • Blisters
    • An open wound
    • A dark scab. 
  • There have been reports of severe allergic pneumonia occurring in people given this medication. Let your healthcare provider know right away if you develop shortness of breath, wheezing, or a persistent cough during treatment.
  • Some people given Vivitrol have developed serious allergic reactions to the medication. If you have an allergic reaction to Vivitrol, you should not receive the medication again. Seek immediate medical attention if you have signs of an allergic reaction, such as:
    • A rash
    • Swelling of the face, mouth, or tongue
    • Difficulty breathing
    • Wheezing
    • Chest pain
    • Dizziness or fainting.
  • You may be more sensitive to the effects of opioids (including opioid narcotics and opioid street drugs) after treatment with Vivitrol ends, when it is time for your next Vivitrol dose, or if you miss a Vivitrol dose. It is important that you tell family members and people closest to you about this increased sensitivity to opioids, as it could cause overdose and death.
  • Vivitrol blocks the effects of opioids, including the "high" feelings and the pain-relieving effects. Do not try to overcome this by taking large amounts of opioids or heroin. Doing so is quite dangerous and may cause coma and death.
  • Because Vivitrol blocks the effects of opioids, if you need medication for pain, cough, or diarrhea during Vivitrol treatment, you will need to take a medicine that does not contain an opioid.
  • You should carry identification, such as a medical card or medical bracelet, to alert medical personnel that you are being treated with Vivitrol. This will help ensure you receive appropriate care in the case of an emergency.
  • Vivitrol can cause withdrawal symptoms when taken with opioids. Therefore, you should not receive Vivitrol if you have taken an opioid in the last 7 to 10 days. Your healthcare provider may want to do certain tests, such as a urine test or a test called a naloxone challenge test, to make sure you are opioid-free before starting treatment. Let your healthcare provider know if you are having symptoms of opioid withdrawal, such as:
    • Anxiety or restlessness
    • Insomnia
    • Yawning
    • Sweating
    • Excessive watering of the eyes
    • Runny nose
    • Goosebumps
    • Fever, shaking, and chills
    • Muscle aches
    • Nausea and vomiting
    • Abdominal (stomach) cramps.
  • You should know that this drug will not lessen or prevent alcohol withdrawal symptoms. You should be alcohol-free when you start Vivitrol treatment.
  • This medication should be used cautiously in people with severe liver disease or moderate-to-severe kidney disease. Make sure your healthcare provider knows if you have liver or kidney problems.
  • Substance abuse puts people at an increased risk for depression and suicide. Vivitrol does not reduce this risk. Seek immediate medical care if you feel depressed or have thoughts of suicide or of harming yourself.
  • Like all injections given into a muscle (intramuscular, or IM, injections), Vivitrol should be used with caution in people with disorders that could cause excessive bleeding, such as thrombocytopenia (low blood platelet levels) or hemophilia.
  • Vivitrol is just one part of a comprehensive treatment program for drug or alcohol dependence. Your healthcare provider may recommend other types of treatment, such as counseling or support groups. 
  • It is not entirely known if Vivitrol passes through breast milk. Therefore, if you are breastfeeding or plan to start, you should discuss this with your healthcare provider prior to using the drug (see Vivitrol and Breastfeeding).
  • Vivitrol is a pregnancy Category C medication, which means it may not be safe for use during pregnancy, although the full risks are currently unknown (see Vivitrol and Pregnancy).
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