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(naltrexone)
*Retrieved from MedicalNewsToday.com
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. 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 becoming dependent on opioids again after you’ve used them 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 normally without the opioids or
alcohol. Opioid dependence is now referred to as “opioid use disorder.”
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 provider 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 men had five or more alcoholic drinks or women
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.
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. 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 becoming dependent on opioids again after you’ve used them 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.
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 men had five or more
alcoholic drinks or women 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.
Opioid dependence is now referred to as “opioid use disorder.” 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 normally 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.
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.
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.
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:
o nausea, vomiting, and diarrhea
o fast heartbeat
o high blood pressure
o trouble sleeping
o anxiety
o muscle aches
o sweating
Liver disease such as hepatitis (swelling in your liver) or changes in your liver function tests. Symptoms
can include:
o pain in your stomach that lasts more than a few days
o yellow tint to the white part of your eyes
o feeling tired
o dark urine
Serious injection site reactions. Symptoms can include:
o hard lump at the injection site
o swelling that gets worse
o severe pain
o an open wound
o dark scabbing
Pneumonia (a type of lung infection). Symptoms can include:
o fever
o chest pain
o trouble breathing
Other serious side effects, explained in more detail below in “Side effect details,” include:
allergic reaction
depression and suicidal thoughts or actions
Suicide prevention
If you know someone at immediate risk of self-harm, suicide, or hurting another person:
Ask the tough question: “Are you considering suicide?”
Listen to the person without judgment.
Call 911 or the local emergency number, or text TALK to 741741 to communicate with a trained crisis
counselor.
Stay with the person until professional help arrives.
Try to remove any weapons, medications, or other potentially harmful objects.
If you or someone you know is having thoughts of suicide, a prevention hotline can help. The National Suicide
Prevention Lifeline is available 24 hours per day at 800-273-8255. During a crisis, people who are hard of
hearing can use their preferred relay service or dial 711 then 800-273-8255.
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 (warmth and redness in your skin)
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 reportedTrusted Source 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.
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.
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 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
provider 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.
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 used to treat a different condition.
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.
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.
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.
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.
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.
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.
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.
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 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 death
of the baby. Alcohol use during pregnancy can cause decreased growth of the baby, birth defects such as heart
problems, slower development, or even death of the baby.
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 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.
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 loss.
If you’re looking to lose weight, talk with your doctor. They can suggest a treatment plan that’s right for you.
It’s possible that the weight gain that did occur was 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.
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. To find current prices for Vivitrol in your area, check
out GoodRx.com:
Alkermes PLC, the manufacturer of Vivitrol, offers a copay program 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.
Vivitrol reaches steady state in the body at the end of the first month of using the medication. Naltrexone
exposure is three to four times greater when using Vivitrol as opposed to using oral naltrexone 50 mg tablets
once daily. There is less than 15% accumulation of naltrexone with repeated use.
Vivitrol plasma protein binding is about 21%. The half-life of Vivitrol is about 5 to 10 days. The half-life of the
main metabolite, 6-beta-naltrexol, is also 5 to 10 days.
The metabolism of Vivitrol does not involve the cytochrome P450 system. Instead, the drug is extensively
metabolized by dihydrodiol dehydrogenase to the primary metabolite, 6-beta-naltrexol. Vivitrol is eliminated in
the urine.
Contraindications
Vivitrol is contraindicated in patients who:
are taking opioid medications
have current physiologic opioid dependence
are in acute opioid withdrawal
have failed a naloxone challenge test or have a positive opioid urine screen
have hypersensitivity to naltrexone or any components of Vivitrol (including polylactide-co-glycolide
and carboxymethylcellulose)