Vivitrol (naltrexone)

What is Vivitrol?

Vivitrol is a brand-name prescription medication used to:

• Treat alcohol dependence. Vivitrol is used for people who aren’t in the hospital for their alcohol dependence (also called alcohol use disorder). You must stop drinking alcohol before and while using Vivitrol.
• Prevent opioid dependence after opioid detoxification. An opioid is a powerful type of drug often prescribed to treat pain. Opioid detoxification involves clearing the drug from your body. Vivitrol is meant to help you avoid opioid dependence (also called opioid use disorder) after you’ve used opioids in the past. You must stop using opioids for at least 7 to 10 days before taking Vivitrol.

Vivitrol should be used along with counseling, education, and support groups.

Dependence can occur when you take opioids or drink alcohol repeatedly. Your brain can get used to the substance being in your body. When you’re dependent, your brain can’t work like usual without the opioids or alcohol.

Vivitrol contains the drug naltrexone, which is in a class of drugs called opioid antagonists. (A class of drugs is a group of medications that work in a similar way.) Vivitrol isn’t approved to be used in children.

Vivitrol is given as an injection into the muscle (intramuscular) of your buttock. A healthcare professional will give you an injection at your doctor’s office once every 4 weeks.

Effectiveness

Clinical trials showed that Vivitrol was effective in treating people with alcohol or opioid dependence.

Vivitrol helps treat alcohol dependence by decreasing cravings for alcohol. In one clinical trial, people who used the approved dose of Vivitrol had 25% fewer heavy drinking days than people who took a placebo (no treatment). Heavy drinking days were defined as days when males* had five or more alcoholic drinks or females* had four or more alcoholic drinks.

For the treatment of opioid dependence, researchers found that 36% of people who took Vivitrol didn’t use any opioids throughout the 24-week study. In comparison, only 23% of people who took a placebo didn’t use any opioids for this time frame.

* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

Vivitrol uses

The Food and Drug Administration (FDA) approves prescription drugs such as Vivitrol to treat certain conditions. Vivitrol is FDA approved to:

• Treat alcohol dependence. Vivitrol is for people who aren’t in the hospital for their alcohol dependence (also called alcohol use disorder). You must stop drinking alcohol before and while using Vivitrol.
• Prevent opioid dependence after opioid detoxification. An opioid is a powerful type of drug often prescribed to treat pain. Opioid detoxification involves clearing the drug from your body. So Vivitrol is meant to help you avoid opioid dependence (also called opioid use disorder) after you’ve used opioids. You must stop using opioids for at least 7 to 10 days before taking Vivitrol.

Vivitrol should be used along with counseling, education, and support groups.

Vivitrol for alcohol dependence

Alcohol use disorder is when you have a drinking problem that may become serious. Alcohol use disorder can lead to alcohol dependence. Alcohol dependence can start after the continual use of alcohol, usually in large quantities.

Alcohol use disorder is defined by the Diagnostic Statistical Manual of Mental Disorders (DSM-5) as meeting at least two or more of the following conditions:

• having to drink more alcohol than you used to for the same effect
• having withdrawal symptoms (such as nausea or increased heartbeat) after the alcohol effects fade
• drinking more or longer than you wanted to
• wanting or trying to drink less or stop drinking but can’t
• spending a lot of time drinking or being sick from drinking too much
• not doing things you used to enjoy in order to drink
• continuing to drink even if it makes you depressed, causes other health problems, or causes you to black out

Vivitrol works for alcohol dependence by decreasing cravings for alcohol. In a clinical trial, people who received a 380-mg injection of Vivitrol every 4 weeks had 25% fewer heavy drinking days than people who received a placebo (no treatment). Heavy drinking days were defined as days when males* had five or more alcoholic drinks or females* had four or more alcoholic drinks.

Clinical trials also showed that people who stopped drinking alcohol for 1 week before starting to take Vivitrol were more likely to not drink at all during treatment. This was compared to people who took a placebo. The studies also showed that people who took Vivitrol drank on fewer days and had fewer heavy drinking days than people who took a placebo.

* Sex and gender exist on spectrums. Use of the terms “male” and “female” in this article refers to sex assigned at birth.

Vivitrol for opioid dependence

In the United States, about 2 million people misuse opioid medications as well as heroin, which acts on your brain in the same way as opioid drugs. Examples of opioids include:

• codeine/acetaminophen (Tylenol #3)
• butalbital/acetaminophen/caffeine/codeine (Fioricet with codeine)
• diphenoxylate/atropine (Lomotil)
• fentanyl (Duragesic)
• heroin
• hydrocodone (Zohydro ER)
• acetaminophen/hydrocodone (Norco)
• hydromorphone (Dilaudid)
• methadone (Dolophine)
• oxycodone (OxyContin, Roxicodone)
• oxycodone/acetaminophen (Percocet)
• promethazine with codeine
• tramadol (Ultram)
• tramadol/acetaminophen (Ultracet)

Opioid use disorder is defined by the DSM-5 as meeting at least two of the following conditions:

• taking opioids in larger amounts or over a longer time than intended
• wanting to but not being able to decrease opioid use
• spending a lot of time to access opioids
• craving the drugs
• not being able to meet responsibilities at work, home, or school due to drug use
• not doing things you used to enjoy
• having recurring social or personal problems because of drug use
• using opioids in situations where it’s physically dangerous
• using opioids even knowing you have a physical or psychological problem caused or worsened by them
• having tolerance symptoms (needing more drugs for the same effects)
• having withdrawal symptoms

Dependence can occur when you use opioids repeatedly. Your brain can get used to the drugs being in your body. Once you’re dependent on opioids, your brain can’t work like usual without the opioids. When you stop using opioids, you may have withdrawal symptoms such as nausea and vomiting.

Sometimes people start using opioids again so that the withdrawal effects will go away. Over time, they may need to take more of the opioid to feel the original effects of the drug. This is called tolerance. Opioid dependence can lead to addiction and put you at risk for overdose.

Vivitrol is a medication that’s used to prevent relapse (going back to taking opioid medications). If you’re taking an opioid, don’t start using Vivitrol. You should stop taking opioids at least 7 to 10 days before starting Vivitrol treatment. This decreases the risk of sudden opioid withdrawal, which can be dangerous.

Before starting Vivitrol, you should go through opioid detoxification. This means that you stop taking any opioid medications.

Researchers found that 36% of people who used Vivitrol didn’t use any opioids throughout a 24-week study. In comparison, 23% of people who took a placebo (no treatment) didn’t use any opioids throughout this time frame.

Vivitrol generic

Vivitrol is available only as a brand-name medication. It’s not currently available in generic form.

Vivitrol contains the active drug naltrexone.

Vivitrol side effects

Vivitrol can cause mild or serious side effects. The following lists contain some of the key side effects that may occur while taking Vivitrol. These lists don’t include all possible side effects.

For more information on the possible side effects of Vivitrol, talk with your doctor or pharmacist. They can give you tips on how to deal with any side effects that may be bothersome.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to report to the FDA a side effect you’ve had with Vivitrol, you can do so through MedWatch.

More common side effects

The more common side effects of Vivitrol for alcohol dependence can include:

• nausea or vomiting
• diarrhea
• belly pain
• injection site reactions (redness or deepening of skin color, swelling, or pain in the injection area)
• muscle cramps
• dizziness or fainting
• feeling sleepy
• decreased appetite
• anxiety
• joint pain or stiffness
• headache

The more common side effects of Vivitrol for opioid dependence can include:

• injection site pain
• toothache
• trouble sleeping
• nasopharyngitis (common cold) or the flu
• headache
• increased blood pressure

Most of these side effects may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk with your doctor or pharmacist.

Serious side effects

Serious side effects from Vivitrol aren’t common, but they can occur. Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency.

Most of the serious side effects that can occur while you’re taking Vivitrol can happen whether you’re taking the medication for alcohol or opioid dependence. The only exception is opioid withdrawal. To have opioid withdrawal, you must’ve been taking an opioid medication.

Serious side effects and their symptoms can include the following:

• Opioid withdrawal, which can occur after you stop taking an opioid drug. Opioid withdrawal would occur only if you’ve recently used opioid medications. Symptoms can include:
  • nausea, vomiting, and diarrhea
  • fast heartbeat
  • high blood pressure
  • trouble sleeping
  • anxiety
  • muscle aches
  • sweating
• Liver disease such as hepatitis (swelling in your liver) or changes in your liver function tests. Symptoms can include:
  • pain in your stomach that lasts more than a few days
  • yellow tint to the white part of your eyes
  • feeling tired
  • dark urine
• Serious injection site reactions. Symptoms can include:
  • hard lump at the injection site
  • swelling that gets worse
  • severe pain
  • an open wound
  • dark scabbing
• Pneumonia (a type of lung infection). Symptoms can include:
  • fever
  • chest pain
  • trouble breathing

Other serious side effects, explained in more detail below in “Side effect details,” include:

• allergic reaction
• depression and suicidal thoughts or actions

Side effect details

You may wonder how often certain side effects occur with this drug. Here’s some detail on some of the side effects this drug may cause.

Allergic reaction

As with most drugs, some people can have an allergic reaction after taking Vivitrol. It’s not known how often allergic reactions occur with Vivitrol. Symptoms of a mild allergic reaction can include:

• skin rash
• itchiness
• hives (itchy welts on your skin)
• flushing

A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include:

• swelling under your skin, typically in your eyelids, lips, face, hands, or feet
• swelling of your tongue, mouth, or throat
• trouble breathing
• chest pain
• feeling dizzy

Call your doctor right away if you have a severe allergic reaction to Vivitrol. Call 911 if your symptoms feel life threatening or if you think you’re having a medical emergency. In clinical trials of Vivitrol, there was no data on how many people had an allergic reaction.

Withdrawal symptoms

While you’re taking Vivitrol, it’s important that you don’t take any opioid medications. And you shouldn’t take any opioids within 7 to 10 days before starting Vivitrol treatment. This is because if you use opioid medications during these times, you may have symptoms of opioid withdrawal.

Symptoms of opioid withdrawal can be mild or severe, but usually withdrawal symptoms aren’t severe. However, if you’ve recently taken an opioid medication and then start Vivitrol treatment, you can have sudden opioid withdrawal symptoms. In such cases, you may need to stay in a hospital or be monitored for symptoms such as a fast heart rate and high blood pressure.

In some situations, your doctor may give you a Vivitrol injection if you’ve taken an opioid within 7 to 10 days. The injection would be given in a medical facility where doctors and nurses can monitor your symptoms. If you develop any serious withdrawal symptoms, they can help treat you.

In clinical trials of Vivitrol, people couldn’t be part of or remain in a study if they used opioid medications. Therefore, there are no statistics on the number of people who may have had withdrawal symptoms.

However, after the Food and Drug Administration (FDA) approved Vivitrol, some people who used opioid medications while taking Vivitrol reported having withdrawal symptoms. (It’s important to note that using opioids while taking Vivitrol isn’t recommended.)

Before you start taking Vivitrol, check any medications that you take including cough and cold medicines, pain medicines, and diarrhea medicines. Sometimes these drugs can have opioids in them. And if you’re concerned about withdrawal symptoms and Vivitrol, talk with your doctor.

Depression and suicidal actions

Mood changes can occur with Vivitrol. In clinical trials for the treatment of alcohol dependence, about 10% of people who took Vivitrol had a depressed mood. In comparison, 5% of people who took a placebo (no treatment) also had a depressed mood. Suicide or thoughts of suicide affected 1% of people who took Vivitrol and didn’t occur at all in people who took a placebo.

In a 24-week clinical trial for the treatment of opioid dependence, no one reported a depressed mood or suicidal thinking. This includes people who took Vivitrol or a placebo.

A safety study was also performed to compare Vivitrol with the drug naltrexone in tablet form. (Naltrexone is the active drug in Vivitrol.) This was a long-term study that compared side effects in people who received Vivitrol injections with those in people who took naltrexone tablets.

In this study, 5% of people who took Vivitrol had a depressed mood or suicidal thoughts or actions. In comparison, 10% of people who took naltrexone tablets had these symptoms.

Symptoms of a depressed mood or suicidal thoughts can include:

• feeling hopeless
• feeling sad or crying a lot
• not feeling interested in doing things you usually enjoy
• sleeping a lot more or a lot less than usual
• feeling more angry or aggressive than usual
• having thoughts of hurting yourself

It’s important to talk with your doctor if you notice any changes in your mood. If you have any thoughts about hurting yourself or ending your life, tell your doctor, a family member, or a close friend right away. They can help you get treatment.

Long-term side effects

Long-term side effects such as liver disease, including hepatitis (swelling in your liver), can occur during the use of Vivitrol.

Sometimes the first sign of a liver problem is a higher level of liver enzymes (a type of protein). In clinical studies, these levels were often increased for only a short period of time, and they didn’t cause any side effects. However, some people did develop hepatitis or liver disease after taking Vivitrol. There isn’t any data from clinical trials on how many people taking Vivitrol developed hepatitis or liver disease.

There are many enzymes that doctors can monitor to check the function of your liver. Some of these enzymes are called alanine aminotransferase (ALT) and aspartate aminotransferase (AST).

In clinical trials of people who took Vivitrol for opioid dependence, ALT increased in about 13% of the people. In comparison, ALT only increased in about 6% of people who took a placebo. AST also increased in about 10% of people who took Vivitrol. In comparison, only 2% of people who took a placebo had an increase in AST.

It’s possible that using Vivitrol can cause liver injury. If you have belly pain, yellowing of the skin or eyes, or dark urine, tell your doctor right away. Sometimes liver injury can be treated, and other times it may cause long-term problems.

Other long-term side effects may occur from using Vivitrol, but more long-term studies are needed. If you have questions about any long-term side effects of taking Vivitrol, including liver problems, talk with your doctor.

Nausea

Nausea is a possible side effect of taking Vivitrol. In clinical studies, about 33% of people who took the approved dose of Vivitrol (380 mg) for alcohol dependence had nausea. In comparison, 11% of people who took a placebo also had nausea.

In a long-term clinical trial that looked at opioid dependence, more than 5% of people who took Vivitrol had nausea. It’s not known how many people who took a placebo had this side effect.

Some people may become nauseous after their first Vivitrol injection. Usually, the feeling will be mild and will go away within a few days. After your first injection, it’s less likely that you’ll feel nauseous with the following doses. But if you have nausea that’s bothersome to you, talk with your doctor about ways to feel more comfortable.

Diarrhea

Diarrhea can occur while taking Vivitrol. In clinical trials, about 13% of people who received the approved dose of Vivitrol (380 mg) for alcohol dependence had diarrhea. In comparison, about 10% of people who took a placebo had diarrhea as side effect.

In a long-term clinical trial that looked at opioid dependence, more than 5% of people who took Vivitrol had diarrhea. It’s not known how many people who took a placebo had this side effect.

If you have diarrhea while you’re taking Vivitrol, talk with your doctor about possible remedies.

Headache

Headaches can occur when taking Vivitrol. In clinical studies, about 25% of people who took Vivitrol for alcohol dependence had headaches. In comparison, about 18% of people who took a placebo also had headaches.

Headaches were also reported in people who took Vivitrol for opioid dependence. About 3% of people who took Vivitrol for opioid dependence had headaches. In comparison, 2% of people who took a placebo also had headaches.

If you have headaches that are bothersome while taking Vivitrol, talk with your doctor about ways to find relief.

Injection site reactions

Reactions at the site of injection were a common side effect that occurred in people who received injections of Vivitrol. After a Vivitrol injection, you may have pain, swelling, bruising, or redness where the medication was injected.

In clinical trials of people who took Vivitrol for alcohol dependence, 69% of people who received the approved dose (380 mg) had an injection site reaction. In comparison, 50% of people who received a placebo injection had an injection site reaction.

Injection site pain occurred in about 5% of people who took Vivitrol for opioid dependence. In comparison, injection site pain occurred in only 1% of people who received a placebo injection.

Most people who had injection site reactions had only mild symptoms. However, in some cases, these reactions became severe.

In clinical trials, one person who received Vivitrol had a severe injection site reaction. The swelling at the site continued to get worse over a 4-week period. Surgery was needed to remove some of the necrotic (dead) skin.

Since the Food and Drug Administration (FDA) approved Vivitrol, there have been a few other cases of skin infections or severe swelling. And some of these cases also needed surgical treatment.

Proper injection

There’s an increased risk of injection site reactions occurring if Vivitrol is injected under your skin (subcutaneous) instead of into your muscle (intramuscular). For this reason, it’s important that a healthcare professional gives you Vivitrol. They can inject the drug properly into your muscle. Don’t try to give yourself this medication. (Although you’ll receive Vivitrol injections at your doctor’s office, you may be able to get the drug at a pharmacy to bring to the office.)

If you have any swelling or lumps under your skin after a Vivitrol injection, tell your doctor. They can look at the area and treat it if needed.

Vivitrol and alcohol

Liver problems are a possible side effect of Vivitrol. Because drinking alcohol can also affect your liver, you should avoid alcohol before and while taking Vivitrol. If you’re using Vivitrol and have any of these symptoms, tell your doctor right away:

• nausea
• vomiting
• yellow tint to your skin or the whites of your eyes
• belly pain

They could be possible signs of liver damage.

There’s no interaction between Vivitrol and alcohol. People who drink alcohol while taking Vivitrol tend to have the same side effects as other people who drink alcohol. This includes loss of coordination and a slower response time.

Keep in mind that people taking Vivitrol for alcohol dependence shouldn’t drink alcohol even though they may have a lower desire to drink. This is because of the way the medication works. Vivitrol reduces cravings for alcohol, so you may drink less alcohol while taking Vivitrol.

If you drink alcohol and have questions about how to stop drinking before taking Vivitrol, talk with your doctor.

Alternatives to Vivitrol

Other drugs are available that can treat alcohol or opioid dependence. Some may be better suited for you than others. If you’re interested in finding an alternative to Vivitrol, talk with your doctor. They can tell you about other medications that may work well for you.

Note: Some of the drugs listed here are used off-label to treat these specific conditions. Off-label use is when a drug that’s approved to treat one condition is prescribed to treat a different condition.

Alternatives for alcohol dependence

Examples of other drugs that may be used to treat alcohol dependence include:

• naltrexone tablets
• acamprosate
• disulfiram
• topiramate (Topamax)
• gabapentin (Neurontin)

Alternatives for opioid dependence

Examples of other drugs that may be used to treat opioid dependence include:

• naloxone/buprenorphine (Suboxone, Zubsolv)
• buprenorphine (Sublocade, Probuphine)
• methadone (Dolophine)
• naltrexone tablets

Vivitrol vs. Sublocade

You may wonder how Vivitrol compares with Sublocade. These drugs are both used to treat opioid dependence (also called opioid use disorder).

Check out this article to learn how these drugs compare. Also, be sure to talk with your doctor about which drug is right for you.

Vivitrol vs. Suboxone

You may wonder how Vivitrol compares to other medications that are prescribed for similar uses. Here we look at how Vivitrol and Suboxone are alike and different.

Uses

The Food and Drug Administration has approved Vivitrol to treat opioid dependence and alcohol dependence.

Suboxone is FDA-approved to treat only opioid dependence. Suboxone isn’t approved to treat alcohol dependence.

Drug forms and administration

Vivitrol contains the drug naltrexone. Suboxone contains buprenorphine and naloxone.

Vivitrol comes in a vial that contains 380 mg of Vivitrol and 4 mL of a solution that helps dilute (thin) the drug. A healthcare professional will give you Vivitrol as an injection into the muscle (intramuscular) of your buttock. You’ll receive an injection once every 4 weeks at your doctor’s office.

Suboxone comes as a film that dissolves under your tongue (sublingual) or between your gums and cheek (buccal). Depending on what type of opioid medications you were taking, you may use Suboxone once a day. The film comes in these strengths:

• 2 mg buprenorphine/0.5 mg naloxone
• 4 mg buprenorphine /1 mg naloxone
• 8 mg buprenorphine /2 mg naloxone
• 12 mg buprenorphine /3 mg naloxone

Side effects and risks

Vivitrol and Suboxone both contain medications in a drug class called opioid antagonists. (A class of drugs is a group of medications that work in a similar way.) Therefore, both Vivitrol and Suboxone can cause very similar side effects. Below are examples of these side effects.

More common side effects

These lists contain examples of more common side effects that can occur with Vivitrol, with Suboxone, or with both drugs (when taken individually).

• Can occur with Vivitrol when taken for opioid dependence:
  • injection site pain
  • toothache
  • nasopharyngitis (common cold) or the flu
  • increased blood pressure
• Can occur with Suboxone:
  • sweating
  • constipation
  • pain in your tongue
  • decreased sensitivity in your mouth
  • redness in your mouth
  • pain in the belly or back
• Can occur with Vivitrol when taken for opioid dependence and Suboxone:
  • nausea or vomiting
  • trouble sleeping
  • headache

Serious side effects

These lists contain examples of serious side effects that can occur with Vivitrol, with Suboxone, or with both drugs (when taken individually).

• Can occur with Vivitrol:
  • serious injection site reactions
  • pneumonia, a type of lung infection
  • depression and suicidal thoughts or actions
• Can occur with Suboxone:
  • peripheral edema, which is swelling of your arms or legs
  • addiction or misuse
  • overdose
  • respiratory depression (slowed breathing)
  • adrenal insufficiency, a condition that occurs when your adrenal gland makes a decreased amount of hormones
• Can occur with both Vivitrol and Suboxone:
  • allergic reaction
  • opioid withdrawal symptoms
  • liver disease such as hepatitis (swelling in your liver) or changes in liver function tests

Effectiveness

Vivitrol and Suboxone have different FDA-approved uses, but they’re both used to treat opioid dependence.

The use of Vivitrol and Suboxone in treating opioid dependence has been directly compared in a clinical study. The results showed that opioid relapses (taking opioid medications again) occurred in 65% of people who took Vivitrol and in 57% of people who took Suboxone.

However, it was much more difficult to start having people take Vivitrol than Suboxone. Before starting to use Vivitrol, you can’t take any opioid medications for 7 to 10 days. On the other hand, you can start to take Suboxone even if you’ve taken an opioid drug in the last 7 to 10 days.

In the study, 28% of people in the Vivitrol group dropped out before opioid detoxification. This was compared to only 6% of people in the Suboxone group. Opioid detoxification involves clearing the drug from your body. The numbers of fatal or nonfatal overdoses or other serious side effects such as infections and psychiatric conditions were similar between the two groups.

In another study that compared Vivitrol to Suboxone, there was no significant difference between the effectiveness of the two drugs. People who received Vivitrol remained in the study for about 69 days, compared to people who received Suboxone, who remained in the study for about 64 days. Remaining in the study meant that people continued to take the medication for 12 weeks, as opposed to dropping out of the study.

Costs

Vivitrol and Suboxone are both brand-name drugs. There’s no generic form of Vivitrol. But there is currently a generic form of Suboxone called buprenorphine/naloxone. Brand-name medications usually cost more than generics.

Suboxone and its generic form generally cost less than Vivitrol. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Vivitrol vs. naltrexone

Like Suboxone (above), the drug naltrexone has uses similar to those of Vivitrol. Here’s a comparison of how Vivitrol and naltrexone are alike and different.

Uses

The Food and Drug Administration has approved Vivitrol to treat opioid dependence and alcohol dependence.

Naltrexone tablets are also FDA-approved to treat opioid dependence and alcohol dependence.

Drug forms and administration

Vivitrol contains the drug naltrexone. Naltrexone contains naltrexone. Both medications contain the same active drug. However, naltrexone is a tablet that must be taken every day to be effective. Vivitrol is an injectable form of naltrexone that’s given only once a month. This one injection should help decrease your cravings over the course of the month.

Vivitrol comes in a vial that contains 380 mg of Vivitrol and 4 mL of a solution that helps dilute (thin) the drug. A healthcare professional will give you Vivitrol as an injection into your muscle (intramuscular) of your buttock. You’ll receive an injection once every 4 weeks at your doctor’s office.

Naltrexone is available as a tablet that contains 50 mg of the drug. The recommended dose is one tablet, taken once a day by swallowing it.

Side effects and risks

Vivitrol and naltrexone both contain the active medication naltrexone. Therefore, both drugs can cause very similar side effects. Below are examples of these side effects.

More common side effects

These side effects differ based on the condition the drugs are used to treat.

When the drugs are used to treat alcohol dependence

Side effects can occur with Vivitrol, with naltrexone, or with both drugs (when taken individually) when the drugs are used to treat alcohol dependence. These lists contain examples of more common side effects that may occur with Vivitrol, with naltrexone, or with both drugs (when taken individually).

• Can occur with Vivitrol:
  • injection site reactions (redness or deepening of skin color, swelling, or pain in the injection area)
  • muscle cramps
  • decreased appetite
  • joint pain or stiffness
• Can occur with naltrexone:
  • fatigue (lack of energy)
  • trouble sleeping
• Can occur with both Vivitrol and naltrexone:
  • nausea or vomiting
  • diarrhea
  • belly pain
  • headache
  • dizziness or fainting
  • feeling sleepy
  • anxiety

When the drugs are used to treat opioid dependence

When Vivitrol and naltrexone are used to treat opioid dependence, side effects can occur. These lists contain examples of more common side effects that may happen with Vivitrol, with naltrexone, or with both drugs (when taken individually).

• Can occur with Vivitrol:
  • injection site pain
  • toothache
  • nasopharyngitis (common cold) or the flu
• Can occur with naltrexone:
  • anxiety
  • feeling nervous
  • belly pain or cramps
  • low energy
  • joint or muscle pain
• Can occur with both Vivitrol and naltrexone:
  • nausea or vomiting
  • trouble sleeping
  • headache
  • Increased blood pressure

Serious side effects

These lists contain examples of serious side effects that can occur with Vivitrol, with naltrexone, or with both drugs (when taken individually) when used to treat alcohol or opioid dependence.

• Can occur with Vivitrol:
  • serious injection site reactions
  • pneumonia (a type of lung infection)
• Can occur with naltrexone:
  • few unique serious side effects
• Can occur with both Vivitrol and naltrexone:
  • allergic reaction
  • opioid withdrawal symptoms
  • liver disease such as hepatitis (swelling in your liver) or changes in liver function tests
  • depression and suicidal thoughts or actions

Effectiveness

The only conditions both Vivitrol and naltrexone are used to treat are opioid dependence and alcohol dependence.

The use of Vivitrol and naltrexone in treating opioid dependence has been directly compared in a clinical study. About 60% of people who took Vivitrol stayed in treatment for 24 weeks. In comparison, about 28% of people who took naltrexone tablets stayed in the study treatment for 24 weeks.

The 24-week time frame was the average time that people in the trial continued taking the medication being studied. Usually, dropping out of an opioid-treatment study indicates that the person has relapsed.

There is currently an ongoing study comparing how effective Vivitrol and naltrexone tablets are in treating alcohol dependence.

Costs

Vivitrol is a brand name medication. However, naltrexone is a generic medication. Brand-name medications usually cost more than generics.

Naltrexone generally costs less than Vivitrol. The actual price you’ll pay for either drug depends on your insurance plan, your location, and the pharmacy you use.

Vivitrol dosage

Your doctor will prescribe Vivitrol based on several factors. These include:

• the type and severity of the condition you’re using Vivitrol to treat
• other medical conditions you may have

The following information describes dosages that are commonly used or recommended. However, be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to suit your needs.

Drug forms and strengths

Vivitrol comes in a vial that contains 380 mg of Vivitrol and 4 mL of a solution that helps dilute (thin) the drug. A healthcare professional will give you Vivitrol as an injection into the muscle (intramuscular) of your buttock.

Dosage for alcohol dependence

The dose for alcohol dependence is one 380-mg injection every 4 weeks.

Each month, your doctor or healthcare professional will alternate which buttock you receive the Vivitrol injection in. For example, if you receive an injection in your left buttock, your next injection will be in your right buttock. This is called rotating injection sites. The purpose of this is to decrease scarring and reactions that can occur when you have a medication injected into the same place. (For more about injection site reactions, see the “Vivitrol side effects” section above.)

Dosage for opioid dependence

The dose for opioid dependence is one 380-mg injection every 4 weeks.

Each month, your doctor or healthcare professional will alternate which buttock you receive the Vivitrol injection in. For example, if you receive an injection in your left buttock, your next injection will be in your right buttock. This is called rotating injection sites. The purpose of this is to decrease scarring and reactions that can occur when you have a medication injected into the same place. (For more about injection site reactions, see the “Vivitrol side effects” section above.)

What if I miss a dose?

If you miss a dose of Vivitrol, you should schedule an appointment to receive the next dose as soon as possible.

To help make sure that you don’t miss a dose, try setting a reminder on your phone. You can also put your appointments in a calendar.

Will I need to use this drug long term?

Vivitrol is meant to be used as a long-term treatment for alcohol or opioid dependence. If you and your doctor determine that Vivitrol is safe and effective for you, you’ll likely take it long term.

Vivitrol use with other treatments

Vivitrol is recommended to be used along with psychosocial support. This means that you should be going to support groups or counseling sessions while you’re taking Vivitrol to treat alcohol or opioid dependence.

Dependence affects both your physical and mental state. Although Vivitrol can help with the physical changes in your brain due to dependence, the drug doesn’t help as much with your mental condition. Going to counseling or support groups can help you to deal with the anxiety and emotional changes from not taking a drug or alcohol that you’ve become used to.

Vivitrol interactions

Vivitrol can interact with several other medications. It’s not known to interact with supplements or foods.

Different interactions can cause different effects. For instance, some interactions can interfere with how well a drug works. Other interactions can increase the number of side effects or make them more severe.

Vivitrol and other medications

Below is a list of medications that can interact with Vivitrol. This list doesn’t contain all drugs that may interact with Vivitrol.

Before taking Vivitrol, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, and supplements you use. Sharing this information can help you avoid potential interactions.

If you have questions about drug interactions that may affect you, ask your doctor or pharmacist.

Vivitrol and tramadol

You should avoid using the pain reliever tramadol while taking Vivitrol. You also shouldn’t use tramadol within 7 to 10 days before starting to take Vivitrol. Tramadol is an opioid, and Vivitrol blocks the effects of opioids. This can make the opioid not work. Never try to overcome this by taking more tramadol. This may lead to serious injury including overdose or death.

Examples of medications that contain tramadol include:

• tramadol (Ultram)
• tramadol/acetaminophen (Ultracet)

If you need pain management medication while taking Vivitrol, talk with your doctor. They may recommend local treatment for just the part of your body that’s hurting you or a non-opioid medication.

Vivitrol and opioid-containing medicines

You shouldn’t use any medications that contain opioids while you’re taking Vivitrol because Vivitrol blocks the effects of opioid medications. So taking an opioid drug with Vivitrol would cause the opioid to not work properly. Never try to overcome this by taking a larger amount of opioids. That can cause serious injury or death.

Keep in mind that the effects of Vivitrol decrease over the course of 1 month. So you may be more sensitive to opioid medications right before your next dose of Vivitrol, if you miss a dose, or if you stop treatment. Because of this, taking the same amount of opioids that you took before using Vivitrol may cause overdose or death.

If you need pain treatment while you’re taking Vivitrol, talk with your doctor. They may recommend non-opioid pain medications such as ibuprofen (Advil) or acetaminophen (Tylenol). Your doctor may also suggest local pain treatments that can numb the area of your body that’s hurting.

Vivitrol and Xanax (not an interaction)

There are no known interactions between Vivitrol and Xanax (alprazolam). Vivitrol doesn’t work on the same part of your brain that Xanax affects. So the effects of Xanax won’t be changed by using Vivitrol.

However, Xanax, much like alcohol and opioids, is an addicting medication. If you’re prone to dependence, your doctor may want you to take a different medication so that you don’t risk becoming dependent on Xanax.

It’s also important that you don’t take Xanax with either alcohol or opioids. All of these are depressant medications, which slow down your brain activity and heart rate. This can lead to serious problems such as:

• loss of consciousness
• changes in blood pressure and heart rhythm
• coma
• overdose
• death

If you’re using Xanax, tell you doctor before you start taking Vivitrol. They may suggest a different medication for you.

Vivitrol and Adderall (not an interaction)

There are no known interactions between Vivitrol and Adderall (amphetamine/dextroamphetamine). Adderall is a stimulant medication that works in a different way than Vivitrol. Stimulant drugs excite your central nervous system, which includes your brain, and may help you focus or wake up. Taking the two drugs together won’t affect the way that Adderall works.

However, your body can become dependent on Adderall, just as it can be dependent on alcohol or opioid medications. Because of this, your doctor may switch you to a non-habit-forming medication so that you don’t risk becoming dependent on Adderall.

It’s also important that you don’t take Adderall with opioid medications or alcohol. Because Adderall is a stimulant medication, it increases your brain activity and heart rate. Alcohol and opioids, on the other hand, are depressant medications, which slow down your brain activity and heart rate. Taking Adderall with opioids or alcohol can cause serious effects such as heart attack, overdose, loss of consciousness, or death.

If you’re using Adderall, tell you doctor before you start taking Vivitrol. They may suggest a different medication for you.

Vivitrol and herbs and supplements

There aren’t any herbs or supplements that have been specifically reported to interact with Vivitrol. However, you should still check with your doctor or pharmacist before using any of these products while taking Vivitrol.

Vivitrol and pregnancy

It’s not known if Vivitrol, which is given as an injection, is safe to take during pregnancy. No human or animal studies have been done on the effects of Vivitrol during pregnancy.

However, the tablet form of the active drug in Vivitrol (naltrexone) has been studied in animals. Researchers found that pregnant animals that were given naltrexone tablets every day had an increased risk of miscarriage. There was no increased risk of congenital anomalies (commonly known as birth defects) in these studies. Animal studies don’t always predict what happens in humans though.

It’s important to note that untreated opioid or alcohol dependence during pregnancy can also cause harm. Opioid use during pregnancy has been shown to cause early (preterm) birth, low birth weights, and even pregnancy loss. Alcohol use during pregnancy can cause decreased growth of the fetus, congenital anomalies such as heart problems, slower development, and pregnancy loss.

If you’re pregnant or planning to become pregnant, talk with your doctor before using Vivitrol. They can review the pros and cons of the medication with you.

Vivitrol and birth control

It’s not known if Vivitrol is safe to take during pregnancy. If you or your sexual partner can become pregnant, talk with your doctor about your birth control needs while you’re using Vivitrol.

Vivitrol and breastfeeding

It’s not known if it’s safe to breastfeed while taking Vivitrol. The drug is present in breast milk, so a breastfeeding child may consume the medication. However, it’s not known what effects Vivitrol may have on breast milk or on a breastfed child.

If you’re breastfeeding, talk with your doctor before using Vivitrol. They can advise you on the best way to feed your child.

Common questions about Vivitrol

Here are answers to some frequently asked questions about Vivitrol.

Is Vivitrol a controlled substance?

No. Vivitrol isn’t a controlled substance. A controlled substance is typically a drug that you can become dependent on and misuse.

Vivitrol is the only medication that the Food and Drug Administration (FDA) has approved for opioid dependence that isn’t a controlled substance. This is because Vivitrol isn’t addictive and can’t be misused.

Can Vivitrol be taken to help me lose weight?

No, the FDA hasn’t approved Vivitrol to treat weight loss. And the medication hasn’t been studied in relation to weight loss.

However, the active drug in Vivitrol (naltrexone) is sometimes used along with another medication called bupropion for weight loss. This combined drug (naltrexone/bupropion) is called Contrave, which helps decrease cravings for food and reduces hunger.

In clinical trials, 14% of people who took Vivitrol at the approved dose for alcohol dependence experienced decreased appetite. In comparison, only 3% of people who took a placebo (no treatment) had these side effects.

More testing needs to be done to determine if Vivitrol is a safe and effective medication for weight management.

If you’re looking to lose weight, talk with your doctor. They can suggest a treatment plan that’s right for you.

Will I gain weight while I’m taking Vivitrol?

It’s possible, but not likely.

In clinical trials, weight gain rarely occurred in people who took Vivitrol. It’s possible that this weight gain occurred due to better nutrition. People who are dependent on opioids or alcohol may not eat properly or may vomit their food. So it’s possible that by stopping the use of alcohol or opioids and returning to a healthy lifestyle, you may gain weight.

However, naltrexone (the active drug in Vivitrol) can be used with another medication called bupropion for weight loss. Therefore, naltrexone may control other cravings for food as well. Weight gain is probably not a side effect of Vivitrol use because naltrexone is also used for weight loss.

If you’re concerned about weight gain while taking Vivitrol, talk with your doctor. They can review your diet and exercise habits.

Can I take Vivitrol to treat an opioid overdose?

No, you shouldn’t take Vivitrol to treat an opioid overdose. Vivitrol works to help stop opioid cravings and the feeling that you need opioids in your body. The drug acts slowly but lasts for a long time in your body. An opioid overdose requires a medication that acts quickly, so Vivitrol isn’t a good choice to treat overdoses. Vivitrol doesn’t work fast enough to stop an overdose.

Naloxone (Narcan), on the other hand, is a medication that’s used to treat opioid overdoses. This medication stops the “high” feeling you may get from opioids. Naloxone works for only a short period of time to reverse an overdose that already occurred. Naloxone acts very quickly (within minutes) to help reverse an overdose.

To sum up, Vivitrol can be used to help stop opioid cravings, but it won’t work quickly enough in the case of an opioid overdose. Narcan can be used in the case of an opioid overdose, but it won’t help in the treatment of alcohol or opioid dependence.

If you have any questions about Vivitrol or naloxone, or how to treat an opioid overdose, talk with your doctor.

Vivitrol cost

As with all medications, the cost of Vivitrol can vary. The actual price you’ll pay depends on your insurance plan, your location, and the pharmacy you use.

Your insurance company may require you to get prior authorization before they approve coverage for Vivitrol. This means that your doctor will need to send a request to your insurance company asking them to cover the drug. The insurance company will review the request and let you and your doctor know if your plan will cover Vivitrol.

If you’re not sure if you’ll need to get prior authorization for Vivitrol, contact your insurance company.

Financial and insurance assistance

If you need financial support to pay for Vivitrol, or if you need help understanding your insurance coverage, help is available.

A copay program is available that may help lower the cost of Vivitrol. For more information and to find out if you’re eligible for support, visit the program website.

If you need help understanding your insurance coverage, you can fill out this form or call 800-848-4876 (800-VIVITROL) to speak with a customer support specialist.

How Vivitrol is given

You should take Vivitrol according to your doctor or healthcare professional’s instructions.

Vivitrol is given as an injection into the muscle (intramuscular) of your buttock. Ahealthcare professional will give you the injections at your doctor’s office.

Each month, your doctor will alternate which buttock you receive the Vivitrol injection in. For example, if you receive an injection in your left buttock, your next injection will be in your right buttock. This is called rotating injection sites. The purpose of this is to decrease scarring and reactions that can occur when you have a medication injected into the same place. (For more about injection site reactions, see the “Vivitrol side effects” section above.)

Once Vivitrol is injected, it lasts in your body for about 1 month. It can’t be removed from your body.

It’s important to never give yourself a Vivitrol injection. (Although you’ll receive Vivitrol injections at your doctor’s office, you may be able to get the drug at a pharmacy to bring to the office.) The drug needs to be injected into a muscle, as opposed to in a vein or under your skin (subcutaneous). Incorrect injections can cause serious injury and may require you to go to a hospital.

When to take

You should have your Vivitrol injections one time each month, or about every 4 weeks. You should have your injections at about the same time every month so that you don’t go too long without the medication. If you forget or miss a dose, schedule your appointment as soon as you remember.

To help make sure that you don’t miss a dose, try setting a reminder on your phone. You can also put your appointments in a calendar.

How Vivitrol works

Vivitrol is approved to treat alcohol dependence and prevent opioid dependence after opioid detoxification. (An opioid is a powerful type of drug often prescribed to treat pain. And opioid detoxification involves clearing the drug from your body.) Vivitrol should be used along with counseling, education, and support groups.

Dependence can occur when you take opioids or drink alcohol repeatedly. Your brain can get used to the substance being in your body. Once you’re dependent, your brain can’t work like usual without the opioids or alcohol. When you stop using opioids or alcohol, you may have withdrawal symptoms such as nausea and vomiting. Sometimes you may have symptoms so severe that you need to go to a hospital.

Taking opioid medications or drinking alcohol causes the release of dopamine (a chemical) in your brain. The release of dopamine makes you want to take the drug or drink alcohol again.

Vivitrol is a type of medication called an opioid antagonist. Antagonists are medications that block certain receptors (proteins on the outside of cells that act like docking stations). Vivitrol blocks molecules from attaching to opioid receptors so dopamine can’t be released. Vivitrol works for both opioid and alcohol dependence by blocking these receptors in the brain for 1 month. This helps you have fewer cravings and helps prevent relapse (going back to taking opioids or drinking alcohol again).

How long does it take to work?

Vivitrol can start working within 2 hours after your first injection. The drug works over the course of 4 weeks. However, after the first 2 weeks, the level of medication in your body slowly decreases.

Vivitrol precautions

Before taking Vivitrol, talk with your doctor about your health history. Vivitrol may not be right for you if you have certain medical conditions or other factors affecting your health. These include:

Allergic reactions

If you’ve had an allergic reaction to Vivitrol or any of the ingredients in the drug, you shouldn’t take Vivitrol. Ask your doctor what other treatments may a better choice for you.

Opioid overdose

After using Vivitrol, opioid medications may affect you more than they used to. You have a higher risk for overdose if you:

• take any opioids right before your next dose of Vivitrol
• missed a dose of Vivitrol and take any opioids
• just stopped Vivitrol treatment and take any opioids

The overdose risk is higher at these times because Vivitrol isn’t working as well or at all to stop your cravings. Your tolerance for opioids may be decreased due to Vivitrol. So taking the same doses of opioid medications that you took before starting to use Vivitrol may cause serious overdose or even death.

In some cases, your doctor may prescribe naloxone (Narcan) for you while you’re using Vivitrol. Naloxone is used to help reverse an opioid overdose. This treatment can be lifesaving if opioid overdose has occurred.

If you’re concerned about opioid overdose while or after taking Vivitrol, talk with your doctor.

Opioid withdrawal

You should stop using any opioid medications 7 to 14 days before starting treatment with Vivitrol. This is because if you start taking Vivitrol while you have opioids in your body, you can have severe opioid withdrawal. The withdrawal may be so severe that you need to go to the hospital for treatment. If you have questions about stopping opioid use, ask your doctor.

Pregnancy

It’s not known if Vivitrol is safe to take during pregnancy. For more information, please see the “Vivitrol and pregnancy” section above.

Breastfeeding

It’s not known if Vivitrol is safe to use while breastfeeding. For more information, please see the “Vivitrol and breastfeeding” section above.

Note: For more information about the potential negative effects of Vivitrol, see the “Vivitrol side effects” section above.

Liver problems

It’s possible for Vivitrol to cause liver problems. Your risk for these problems may be higher if you already have liver problems or if you drink a lot of alcohol. Talk with your doctor about any liver problems you have before starting Vivitrol treatment.

Kidney problems

It’s not known if it’s safe to take Vivitrol if you have kidney problems that are moderate or severe. Your doctor will recommend whether Vivitrol treatment is safe for you if you have problems with your kidneys.

Bleeding problems

If you have a blood disorder or bleeding problems, such as hemophilia, you may have a high risk of bleeding after Vivitrol injections. Be sure to talk with your doctor if you have any conditions that affect your blood. They might recommend a drug other than Vivitrol.