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Vivitrol

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Vivitrol

PATIENT INFORMATION

MEDICATION GUIDE

VIVITROL®
[viv'-T-trol]
(naltrexone for extended-release injectable suspension)

Read this Medication Guide before you start getting VIVITROL (naltrexone xr inj) injections and each time you get an injection. There may be new information. This information does not take the place of talking to your doctor about your medical condition or your treatment.

What is the most important information I should know about VIVITROL (naltrexone xr inj) ?

VIVITROL (naltrexone xr inj) can cause serious side effects, including:

  1. Severe reactions at the site of injection
  2. Liver damage or hepatitis
  3. Risk of opioid overdose
  4. Severe allergic pneumonia
  5. Serious allergic reactions

1. Severe reactions at the site of the injection. Some people on VIVITROL (naltrexone xr inj) treatment have had severe reactions at the site of the injection (injection site reactions), including tissue death (necrosis). Some of these injection site reactions have required surgery. Call your doctor right away if you have any of the following things happen at any of your injection sites:

  • intense pain
  • the area feels hard
  • large area of swelling
  • lumps
  • blisters
  • an open wound
  • a dark scab

Tell your doctor about any reaction at an injection site that concerns you, gets worse over time, or does not get better by two weeks after the injection.

2. Liver damage or hepatitis. Naltrexone, the active ingredient in Vivitrol (naltrexone xr inj) , can cause liver damage (including liver failure) or hepatitis, if you take more than the recommended dose.

Tell your doctor if you have any of the following symptoms of liver problems during treatment with VIVITROL (naltrexone xr inj) :

  • stomach area pain lasting more than a few days
  • dark urine
  • yellowing of the whites of your eyes
  • tiredness

Your doctor may need to stop treating you with VIVITROL (naltrexone xr inj) if you get signs or symptoms of a serious liver problem.

3. Risk of Opioid Overdose. If you have used opioid-containing medicines or opioid street drugs in the past, you may be more sensitive to lower doses of opioids:

  • after VIVITROL (naltrexone xr inj) treatment stops
  • when your next VIVITROL (naltrexone xr inj) dose is due
  • if you miss a dose of VIVITROL (naltrexone xr inj)

Using opioids in amounts that you used before treatment with VIVITROL (naltrexone xr inj) can lead to overdose and death.

  • You may not feel the usual effects if you use or abuse heroin and other illegal (street) opioids while on VIVITROL (naltrexone xr inj) . Do not take large amounts of opioids, including opioid-containing medicines, such as prescription pain pills, or heroin, to overcome effects of VIVITROL (naltrexone xr inj) . This can lead to overdose including serious injury, coma, or death.
  • You may not feel the usual effects of opioid-containing medicines including medicines for pain, cough and diarrhea while on VIVITROL (naltrexone xr inj) .
  • It is important that you tell your family and the people closest to you of this increased sensitivity to opioids and the risk of overdose.

You or someone close to you should get emergency medical help right away if you:

  • have trouble breathing
  • become very drowsy with slowed breathing
  • have slow, shallow breathing (little chest movement with breathing)
  • feel faint, very dizzy, confused, or have unusual symptoms

4. Severe allergic pneumonia. Some people on VIVITROL (naltrexone xr inj) treatment have had severe allergic pneumonia. Call your doctor if you have any of these symptoms:

You may need to go to the hospital for treatment with antibiotic and steroid medicines.

5. Serious allergic reactions. Serious allergic reactions can happen during or soon after an injection of VIVITROL (naltrexone xr inj) . Tell your doctor or get medical help right away if you have any of these symptoms of a serious allergic reaction.

  • skin rash
  • swelling of your face, eyes, mouth, or tongue
  • trouble breathing or wheezing
  • chest pain
  • feeling dizzy or faint

6. Carry written information with you at all times to alert medical personnel that you are taking VIVITROL (naltrexone xr inj) , so that they can treat you properly in an emergency.

What is VIVITROL (naltrexone xr inj) ?

VIVITROL (naltrexone xr inj) is a prescription injectable medicine used:

  • to treat alcohol dependence
  • to prevent relapse to opioid dependence, after opioid detoxification
  • You should stop drinking before starting VIVITROL (naltrexone xr inj) .
  • If you take opioids or opioid-containing medicine, such as prescription pain medicines, you must stop these opioids or medicines before starting VIVITROL (naltrexone xr inj) .
  • To be effective, treatment with VIVITROL (naltrexone xr inj) must be used with other alcoholism or drug recovery programs such as counseling.

VIVITROL (naltrexone xr inj) may not work for everyone.

VIVITROL (naltrexone xr inj) has not been studied in children under the age of 18 years.

Who should not take VIVITROL (naltrexone xr inj) ?

Do not take VIVITROL (naltrexone xr inj) if you:

  • are using or have a physical dependence on opioid-containing medicines or opioid street drugs.
  • You must not take opioid-containing medicines or opioid street drugs for 7 to 10 days before you start taking VIVITROL (naltrexone xr inj) . See "What is the most important information I should know about VIVITROL (naltrexone xr inj) ?"
  • To see whether you have a physical dependence on opioid-containing medicines or opioid street drugs, your doctor may give you a small injection of a medicine called naloxone. This is called a naloxone challenge test. If you get symptoms of opioid withdrawal after the naloxone challenge test, do not start treatment with VIVITROL (naltrexone xr inj) at that time. Your doctor may repeat the test after you have stopped using opioids to see whether it is safe to start VIVITROL (naltrexone xr inj) .
  • have opioid withdrawal symptoms.
    • Opioid withdrawal symptoms may happen when you have been taking opioid-containing medicines or opioid street drugs regularly and then stop. These symptoms may include anxiety, sleeplessness, yawning, fever, sweating, teary eyes, runny nose, goose bumps, shakiness, hot or cold flushes, muscle aches, muscle twitches, restlessness, nausea and vomiting, diarrhea, or stomach cramps. (See "What is the most important information I should know about VIVITROL (naltrexone xr inj) ?") Tell your doctor if you have any of these symptoms before taking VIVITROL (naltrexone xr inj) .
  • are allergic to VIVITROL (naltrexone xr inj) or any of the ingredients in the liquid used to mix VIVITROL (naltrexone xr inj) (diluent). See the end of this Medication Guide for a complete list of ingredients in VIVITROL (naltrexone xr inj) and the diluent.

What should I tell my doctor before starting VIVITROL (naltrexone xr inj) ?

Tell your doctor about all of your medical conditions, including if you:

  • have liver problems
  • use opioid-containing medicines. If you are being treated for alcoholism but also use or are addicted to opioid-containing medicines or opioid street drugs, it is important that you tell your doctor before starting VIVITROL (naltrexone xr inj) to avoid having withdrawal symptoms when you start treatment.
  • 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 (naltrexone xr inj) will harm your unborn baby.
  • are breastfeeding. It is not known if VIVITROL (naltrexone xr inj) passes into your milk, and if it can harm your baby. Naltrexone, the active ingredient in VIVITROL (naltrexone xr inj) , is the same active ingredient in tablets taken by mouth that contain naltrexone. Naltrexone from tablets passes into breast milk. Talk to your doctor about whether you will breast feed or take VIVITROL (naltrexone xr inj) . You should not do both.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Especially tell your doctor if you take any opioid-containing medicines for pain, cough or colds, or diarrhea. (See "What is the most important information I should know about VIVITROL (naltrexone xr inj) ?")

How should I take VIVITROL (naltrexone xr inj) ?

  • VIVITROL (naltrexone xr inj) is injected by a healthcare provider, about 1 time each month.
  • VIVITROL (naltrexone xr inj) is given as an injection into a muscle in your buttocks using a special needle that comes with VIVITROL (naltrexone xr inj) .
  • Once VIVITROL (naltrexone xr inj) is injected, it lasts for a month and it cannot be removed from the body.
  • If you miss your appointment for VIVITROL (naltrexone xr inj) injection, schedule another appointment as soon as possible. See "What's the most important information I should know about VIVITROL (naltrexone xr inj) ?"
  • Whenever you need medical treatment, be sure to tell the treating doctor or nurse that you are receiving VIVITROL (naltrexone xr inj) injections.

What should I avoid while taking VIVITROL (naltrexone xr inj) ?

VIVITROL (naltrexone xr inj) may make you feel dizzy. Do not drive a car, operate machinery, or do other dangerous activities until you know how VIVITROL (naltrexone xr inj) affects you. (See "What are the possible side effects of VIVITROL (naltrexone xr inj) ?")

What are the possible side effects of VIVITROL (naltrexone xr inj) ?

VIVITROL (naltrexone xr inj) can cause serious side effects.

  • See "What is the most important information I should know about VIVITROL (naltrexone xr inj) ?"
  • Depressed mood. Sometimes this leads to suicide, suicidal thoughts, and suicidal behavior. Tell your family members that you are taking VIVITROL (naltrexone xr inj) .

You or a family member should call your doctor right away if you become depressed or have any of the following symptoms of depression, especially if they are new, worse, or worry you:

  • You feel sad or have crying spells.
  • You are no longer interested in seeing your friends or doing things you used to enjoy.
  • You are sleeping a lot more or a lot less than usual.
  • You feel hopeless or helpless.
  • You are more irritable, angry or aggressive than usual.
  • You are more or less hungry than usual or notice a big change in your body weight.
  • You have trouble paying attention.
  • You feel tired or sleepy all the time.
  • You have thoughts about hurting yourself or ending your life.

Common side effects of VIVITROL (naltrexone xr inj) include:

  • nausea. Nausea usually improves within a few days after the first VIVITROL (naltrexone xr inj) injection. Nausea is less likely with future injections of VIVITROL (naltrexone xr inj) .
  • tiredness
  • headache
  • dizziness
  • vomiting
  • decreased appetite
  • painful joints
  • muscle cramps

Common side effects in people taking VIVITROL (naltrexone xr inj) for opioid dependence also include:

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

These are not all the side effects of VIVITROL (naltrexone xr inj) . For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about VIVITROL (naltrexone xr inj)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. VIVITROL (naltrexone xr inj) was prescribed for your medical condition.

This leaflet summarizes the most important information about VIVITROL (naltrexone xr inj) . If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about VIVITROL (naltrexone xr inj) that is written for health professionals.

For additional information about VIVITROL (naltrexone xr inj) call 1-800-848-4876 or visit www.vivitrol (naltrexone xr inj) .com.

What are the ingredients in VIVITROL?

Active ingredient: naltrexone

Inactive ingredients: polylactide-co-glycolide (PLG)

Diluent ingredients: carboxymethylcellulose sodium salt, polysorbate 20, sodium chloride, and water for injection

This Medication Guide has been approved by the U.S. Food and Drug Administration

Last reviewed on RxList: 11/8/2010
This monograph has been modified to include the generic and brand name in many instances.

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Vivitrol - User Reviews

Vivitrol User Reviews

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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