Vivitrol

Generic name: Naltrexone
Dosage form: extended-release intramuscular injection (powder for suspension)
Drug class: Drugs used in alcohol dependence

Usage of Vivitrol

Vivitrol is a long-acting injectable form of naltrexone, which is a medication used to treat two substance use disorders - opioid use disorder and alcohol use disorder (alcoholism). Vivitrol is used as part of a treatment program. It helps prevent people with alcohol or opioid dependence from feeling like they need to use these substances.

Vivitrol is an opioid antagonist, which works by blocking mu opioid receptors. It also suppresses the amount of alcohol you feel like drinking by changing how your hypothalamus, pituitary gland and adrenal gland work together. Vivitrol blocks the intoxication and euphoria or 'high' that alcohol and opioids cause. It also blocks the pain relief that opioids provide.

Vivitrol is an extended-release suspension that is injected into your gluteal muscle. Once injected, it slowly releases naltrexone (the active ingredient) for about a month.

Vivitrol was first approved by the US Food and Drug Administration in 2006.

Vivitrol side effects

Serious side effects of Vivitrol include:

See 'Important information' above

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. You, a family member, or the people closest to you should call your healthcare provider 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.

Pneumonia. Some people receiving Vivitrol treatment have had a certain type of pneumonia that is caused by an allergic reaction. If this happens to you, you may need to be treated in the hospital. Tell your healthcare provider right away if you have any of these symptoms during treatment with Vivitrol:

shortness of breath or wheezing

coughing that does not go away

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 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

Common side effects of Vivitrol 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.

sleepiness

headache

dizziness

vomiting

decreased appetite

painful joints

muscle cramps

cold symptoms

trouble sleeping

toothache

Tell your healthcare provider if you have 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 provider or pharmacist.

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

Before taking Vivitrol

Tell your healthcare provider if you are pregnant or plan to become pregnant. It is not known if Vivitrol will harm your unborn baby.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if naltrexone, the active ingredient in Vivitrol, passes into your milk when administered by IM injection, and if it can harm your baby. 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.

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How to use Vivitrol

The recommended dose of Vivitrol is 380 mg delivered intramuscularly (IM) as a gluteal injection, every 4 weeks or once a month, alternating buttocks for each subsequent injection.

See Full Prescribing Information for further information about dosing.

Warnings

Vivitrol can cause serious side effects, including:

1. 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 take large amounts of opioids, including opioid-containing medicines, such as heroin or prescription pain pills, to try to overcome the opioid-blocking effects of this medication. This can lead to serious injury, coma, or death.

After you receive a dose of Vivitrol, its blocking effect slowly decreases and completely goes away over time. If you have used opioid street drugs or opioid-containing medicines in the past, using opioids in amounts that you used before treatment with Vivitrol can lead to overdose and death. You may also be more sensitive to the effects of lower amounts of opioids:

after you have gone through detoxification

when your next Vivitrol dose is due

if you miss a dose of this medication

after you stop treatment with this medication 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 call 911 or 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 Talk to your healthcare provider about naloxone, a medicine that is available to patients for the emergency treatment of an opioid overdose. Call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if naloxone is administered.

2. Severe reactions at the site of the injection (injection site reactions). Some people on Vivitrol have had severe injection site reactions, including tissue death (necrosis). Some of these injection site reactions have required surgery. This medication must be injected by a healthcare provider. Call your healthcare provider right away if you notice any of the following 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 healthcare provider 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.

3. 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 treatment with this medication. Using opioids in the 7 to 14 days before you start receiving Vivitrol may cause you to suddenly have symptoms of opioid withdrawal when you get your injection. Sudden opioid withdrawal can be severe, and you may need to go to the hospital.

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 injection in a medical facility that can treat you for sudden opioid withdrawal.

4. 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 the following symptoms of liver problems during treatment with Vivitrol:

stomach area pain lasting more than a few days

dark urine

yellowing of the whites of your eyes

tiredness Your healthcare provider may need to stop treating you with this medication if you get signs or symptoms of a serious liver problem.

What other drugs will affect Vivitrol

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. See 'Important information' above.

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.

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

Disclaimer

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