As of December 8, 2015, VIVITROL® (naltrexone for extended-release injectable suspension) has new Prescribing Information (12/2015). The Dosage and Administration, Section 2.4 Directions for Use has been updated. When administering VIVITROL, please refer to Section 2.4 Directions for Use in the VIVITROL Prescribing Information that is provided in the carton you are administering.
Your safety is important to us. READ THIS IMPORTANT SAFETY INFORMATION.
What is the most important information I should know about VIVITROL?
VIVITROL can cause serious side effects, including:
Risk of opioid overdose.You can accidentally overdose in two ways.
VIVITROL blocks the effects of opioids, such as heroin or opioid pain medicines. Do not try to overcome this blocking effect by taking
large amounts of opioids—this can lead to serious injury, coma, or death.
During treatment with VIVITROL and after you stop taking VIVITROL, you may be more sensitive to the effects of lower amounts of opioids than you used to take:
after you have gone through detoxification
if you miss a dose of VIVITROL
when your next VIVITROL dose is due
after you stop VIVITROL treatment
Get emergency medical help right away if you have trouble breathing; become very drowsy with slowed breathing; have slow, shallow breathing; feel faint, dizzy, confused; or have other unusual symptoms.
Tell your family and the people closest to you of this increased sensitivity to opioids and the risk of overdose.
Severe reactions at the site of injection.Some people on VIVITROL have had severe injection site reactions, including tissue death. Some of these reactions have required surgery. Call your healthcare provider right away if you notice any of the following at any of your injection sites:
the area feels hard
an open wound
large area of swelling
a dark scab
Tell your healthcare provider about any reaction at an injection site that concerns you, gets worse over time, or does not get better within two weeks.
Sudden opioid withdrawal.Anyone who receives a VIVITROL injection must not use any type of opioid (must be opioid-free) including street drugs, prescription pain medicines, cough, cold, or diarrhea medicines that contain opioids, or opioid dependence treatments, buprenorphine or methadone, for at least 7 to 14 days before starting VIVITROL. You must be opioid-free before receiving VIVITROL unless your healthcare provider decides that you don’t need to go through detox first. Instead, your doctor may decide to give your VIVITROL injection in a medical facility that can treat you for sudden opioid withdrawal. Sudden opioid withdrawal can be severe, and you may need to go to the hospital.
Liver damage or hepatitis.Naltrexone, the active ingredient in VIVITROL, can cause liver damage or hepatitis. Tell your healthcare provider if you have any of these symptoms during treatment with VIVITROL:
stomach area pain lasting more than a few days
yellowing of the whites of your eyes
Your healthcare provider may need to stop treating you with VIVITROL if you get signs or symptoms of a serious liver problem.
What is VIVITROL?
VIVITROL is a prescription injectable medicine used to:
treat alcohol dependence. You should stop drinking before starting VIVITROL.
prevent relapse to opioid dependence, after opioid detoxification. You must stop taking opioids before you start receiving VIVITROL.
To be effective, VIVITROL must be used with other alcohol or drug recovery programs such as counseling. VIVITROL may not work for everyone.
It is not known if VIVITROL is safe and effective in children.
Who should not receive VIVITROL?
Do not receive VIVITROL if you:
are using or have a physical dependence on opioid-containing medicines or opioid street drugs, such as heroin. To test for a physical dependence on opioid-containing medicines or street drugs, your healthcare provider 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 at that time. Your healthcare provider may repeat the test after you have stopped using opioids to see whether it is safe to start VIVITROL.
are having opioid withdrawal symptoms. Opioid withdrawal symptoms may happen when you have been taking opioid-containing medicines or opioid street drugs regularly and then stop. Symptoms of opioid withdrawal 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.
are allergic to naltrexone or any of the ingredients in VIVITROL or the liquid used to mix VIVITROL (diluent). See the medication guide for the full list of ingredients.
What should I tell my healthcare provider before receiving VIVITROL?
Before you receive VIVITROL, tell your healthcare provider if you:
have liver problems, use or abuse street (illegal) drugs, have hemophilia or other bleeding problems, have kidney problems, or have any other medical conditions.
are pregnant or plan to become pregnant. It is not known if VIVITROL will harm your unborn baby.
are breastfeeding. It is not known if VIVITROL passes into your milk, and if it can harm your baby. Naltrexone, the active ingredient in VIVITROL, is the same active ingredient in tablets taken by mouth that contain naltrexone. Naltrexone from tablets passes into breast milk. Talk to your healthcare provider about whether you will breastfeed or take VIVITROL. You should not do both.
Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you take any opioid-containing medicines for pain, cough or colds, or diarrhea.
If you are being treated for alcohol dependence but also use or are addicted to opioid-containing medicines or opioid street drugs, it is important that you tell your healthcare provider before starting VIVITROL to avoid having sudden opioid withdrawal symptoms when you start VIVITROL treatment.
What are other possible serious side effects of VIVITROL?
VIVITROL can cause serious side effects, including:
Depressed mood. Sometimes this leads to suicide, or suicidal thoughts, and suicidal behavior. Tell your family members and people closest to you that you are taking VIVITROL.
Pneumonia. Some people receiving VIVITROL treatment have had a type of pneumonia that is caused by an allergic reaction. If this happens to you, you may need to be treated in the hospital.
Serious allergic reactions. Serious allergic reactions can happen during or soon after an injection of VIVITROL. Tell your healthcare provider or get medical help right away if you have any of these symptoms:
trouble breathing or wheezing
feeling dizzy or faint
swelling of your face, eyes, mouth, or tongue
Common side effects of VIVITROL may include:
nausea. Nausea may happen after your first VIVITROL injection and usually improves within a few days. Nausea is less likely with future injections of VIVITROL.
These are not all the side effects of VIVITROL. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. You may report side effects to the FDA at 1-800-FDA-1088.
This is only a summary of the most important information about VIVITROL.
This information is based on the VIVITROL Medication Guide (Rev. July 2013).
*Eligibility for Alkermes-Sponsored Co-pay Assistance: Offer valid only for prescriptions for FDA-approved indications. You must be at least 18 years old. If you are purchasing your VIVITROL prescriptions with benefits from Medicare, including Medicare Part D or Medicare Advantage plans; Medicaid, including Medicaid Managed Care or Alternative Benefit Plans (“ABPs”) under the Affordable Care Act; Medigap; Veterans Administration (“VA”); Department of Defense (“DoD”); TriCare®; or any similar state funded programs such as medical or pharmaceutical assistance programs, you are not eligible for this offer. Void where prohibited by law, taxed or restricted. Alkermes, Inc. reserves the right to rescind, revoke, or amend these offers without notice.
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