Vivitrol (Naltrexone) - Intramuscular

What Is Vivitrol?

Vivitrol (naltrexone) is a medication option used to treat alcohol dependence. It can also be used as a maintenance treatment for opioid use disorder (OUD).

Vivitrol should be used along with a complete recovery treatment program. These programs may include counseling, adherence monitoring, and other treatment or support methods.

As an opioid antagonist, Vivitrol works by attaching to mu-opioid receptors (binding sites) in the brain and blocking their effects. So, you're less likely to have feelings of euphoria (pleasure) from opioids or alcohol.

Vivitrol is available as a prescription injection given by your healthcare provider. You may also see naltrexone available as an oral (by mouth) tablet. The Food and Drug Administration (FDA) hasn't assigned any black box warnings for naltrexone.

What Is Vivitrol Used For?

Vivitrol is a medication option used to treat alcohol dependence. This prescription is also used for the maintenance treatment of opioid use disorder (OUD).

The 2019 National Survey of Drug Use and Health (NSDUH) says that roughly 15 million people 12 years and older have alcohol use disorder (AUD). Every year in the United States (U.S.), alcohol is responsible for 140,000 deaths. Among these individuals who passed away, their lives were shortened by 26 years.

In 2020, approximately 2.7 million people at least 12 years old had OUD within the previous 12 months. In 2019, about 50,000 deaths in the U.S. were opioid-related.

In general, substance use disorder (SUD) includes AUD or OUD. Typical symptoms of SUD may include poor hygiene and mood or behavior changes. There might also be a decline in performance at school, work, or at home.

How to Take Vivitrol

To receive Vivitrol, you'll need to see your healthcare provider. The following is additional information on what to expect during your visits with your healthcare provider.

• Before starting Vivitrol treatment, your healthcare provider will ensure that you've been opioid-free for at least seven to 10 days.
• The typical Vivitrol dose is 380 milligrams (mg).
• You'll receive this dose as an injection into your gluteal (butt) muscle every month.
• Your healthcare provider will switch buttcheeks for every monthly injection. In other words, you'll not receive a Vivitrol injection in the same buttcheek for two months.
  

Storage

You can only receive Vivitrol from a healthcare provider. Therefore, you do not need to worry about how to store the medication or how to travel with it.

Off-Label Uses

Vivitrol doesn't have any off-label uses. The naltrexone tablet, on the other hand, does have an off-label use for pruritis (itchiness) due to different reasons, such as liver-related conditions.

What Are the Side Effects of Vivitrol?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the Food and Drug Administration (FDA) at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

Some common side effects of Vivitrol for alcohol dependence include:

• Appetite-related effects—like appetite loss
• Dizziness
• Fainting
• Hardening of skin at the injection site
• Injection site itchiness
• Injection site swelling
• Nodule (lump) at the injection site
• Muscle cramps
• Sleepiness or drowsiness
• Nausea
• Vomiting

Common side effects of Vivitrol for opioid use disorder include:

• Abnormal liver-related labs
• Common cold-like symptoms
• Injection site pain
• Sleeping difficulties
• Toothache
  

Severe Side Effects

Serious side effects with Vivitrol may include:

• Severe allergic reaction: If you have a severe allergic reaction to Vivitrol, symptoms may include breathing difficulties, rash, and swelling.
• Eosinophilic pneumonia: Eosinophilic pneumonia is a type of pneumonia. It happens when white blood cells gather in the lungs because of an allergic reaction. Symptoms include breathing troubles and wheezing. You may also have a cough that doesn't go away.
• Injection site reactions: Side effects at the injection site are common but can become excessive and severe.
• Liver problems: Vivitrol is linked to liver impairment and hepatitis (liver inflammation or swelling). Symptoms of liver damage may include dark-colored urine, yellowing of the eyes, and stomach pain that doesn't go away.
• Mood or behavioral changes: Vivitrol might be linked to depression and suicidal thoughts. Keep an eye out for changes in mood or behavior, such as sudden crying spells and feelings of hopelessness. You may also lose interest in things you used to enjoy.
• Opioid overdose risk: Your risk of an opioid overdose increases in certain situations, such as missing a Vivitrol dose or stopping Vivitrol treatment. Some people with OUD are more likely to use opioids during these situations. Since Vivitrol lowers your opioid tolerance level, there is a higher risk of overdose. If you're experiencing an opioid overdose, symptoms may include slow breathing rate, confusion, and drowsiness.
• Pain management concerns: Let your healthcare provider know you're receiving Vivitrol in an emergency that requires pain management. Your healthcare provider will likely try topical and non-opioid medications first. If necessary, they may need to reverse the effects of Vivitrol and closely monitor you for side effects while they manage your pain.
• Severe opioid withdrawal: You'll need to be opioid-free for a minimum of seven to 10 days before starting Vivitrol treatment. If not, you may experience severe opioid withdrawal that warrants a hospital visit. If you're having withdrawal, you may experience sleeping difficulties, mood changes, excessive sweating, and diarrhea.

Contact your healthcare provider if you're experiencing severe side effects. If you suspect that your symptoms are life-threatening, call 911.

Long-Term Side Effects

Long-term use of Vivitrol may include some of the following side effects:

• Depression
• Suicidal thoughts
• Nausea
• Diarrhea
• Side effects at the injection site
• Sore throat

Some people may also experience a high creatinine phosphokinase (CPK) level. High CPK levels might mean an injury to the muscles, heart, or brain. Again, this isn't a complete list of side effects. If you have any questions or concerns, talk with your pharmacist or healthcare provider.

Dosage: How Much Vivitrol Should I Take?

Since you'll only receive Vivitrol from your healthcare provider, they will determine and administer the proper dosage of Vivitrol for you. For your reference, however, the dosage is typically 380 milligrams (mg) every month.

Modifications

The following modifications (changes) should be kept in mind when using Vivitrol:

Severe allergic reaction: If you have a severe allergic reaction to Vivitrol, your healthcare provider wouldn't recommend this medication.

Pregnancy: There's not enough information about the effects and safety of Vivitrol on the unborn fetus. However, in animal studies, oral naltrexone was linked to adverse effects on the unborn fetus. Untreated AUD and opioid use disorder may also lead to adverse effects on the unborn fetus. These effects may include preterm birth, low birth weight, and abnormal central nervous system (brain and spinal cord) development.

Discuss with your healthcare provider if you are or plan to become pregnant. They will help you weigh the benefits and risks of using Vivitrol during your pregnancy.

Breastfeeding: When your body uses Vivitrol, it breaks it down to an active substance (metabolite). Vivitrol and its active metabolite are present in human breastmilk. The effects and safety of Vivitrol on the nursing baby are unclear.

However, there is a report about a breastfeeding parent who took a daily oral dose of naltrexone 50 mg. Roughly nine and a half hours after a dose (30 minutes after breastfeeding the baby), the nursing baby had minimal amounts of naltrexone and its active metabolite in the bloodstream. The nursing infant also didn't experience any adverse effects.

Talk with your healthcare provider if you plan to breastfeed. Your healthcare provider may help you weigh the benefits and harms of using Vivitrol while nursing. They can also discuss the different ways available to feed your baby.

Adults over 65: Clinical studies haven't included a large enough number of people in this age group to see whether they respond differently from younger adults. Some older adults may have a higher likelihood of kidney impairment and should use caution with Vivitrol.

Children: There is limited effectiveness and safety information about Vivitrol for children.

Kidney problems: Vivitrol hasn't been studied in people with moderate to severe kidney impairment. Since the kidneys are involved in clearing out Vivitrol and its active metabolite from the body, use caution with Vivitrol in people with moderate to severe kidney impairment.

Liver problems: Vivitrol hasn't been studied in people with severe liver impairment. Vivitrol, however, is linked to liver problems—like severe liver impairment. If you develop severe liver impairment from Vivitrol, your healthcare provider will likely stop Vivitrol treatment.

Missed Dose

You can only receive Vivitrol from your healthcare provider. If you miss a Vivitrol treatment appointment, reach out to your healthcare provider and reschedule as soon as possible.

Vivitrol might be less effective in treating alcohol dependence and OUD if you miss your Vivitrol treatment appointments. Missing your appointments may also raise the risk of an opioid overdose.

Overdose: What Happens If I Take Too Much Vivitrol?

There is limited information available about Vivitrol overdose, but a high one-time dose of 784 milligrams (mg), wasn't linked to serious side effects. Common side effects, however, did include:

• Dizziness
• Nausea
• Sleepiness or drowsiness
• Stomach pain

If you think you're experiencing an overdose or life-threatening symptoms, seek immediate medical attention.

Precautions

What Are Reasons I Shouldn’t Take Vivitrol?

Before receiving Vivitrol treatment, talk with your healthcare provider if any of the following applies to you:

• Severe allergic reaction: Vivitrol isn't ideal for you if you have a severe allergic reaction to it or its diluent (mixing liquid). If you're severely allergic to the components (ingredients) of Vivitrol or its diluent, this medication is also not a viable option for you.
• Opioid use within the previous seven to 10 days: Before starting Vivitrol treatment, you must be opioid-free for at least seven to 10 days. If not, you might experience severe opioid withdrawal symptoms that may require a hospital visit.
• Active opioid withdrawal: If you currently have opioid withdrawal symptoms, you shouldn't start on Vivitrol yet.
• Pregnancy: There isn't enough information to assess Vivitrol's effects and safety on the unborn fetus. Animal studies, however, suggest that Vivitrol might be linked to adverse effects, but untreated alcohol dependence and OUD are also linked to adverse effects. Discuss with your healthcare provider the benefits and risks of receiving Vivitrol treatment during pregnancy.
• Breastfeeding: Vivitrol and its active metabolite can be present in human breastmilk. Some reports on oral naltrexone suggest no negative effects on nursing babies. However, the impact and safety of Vivitrol on nursing infants aren't clear. Talk with your healthcare provider if you have questions or concerns about using Vivitrol while nursing.
• Children: There is minimal effectiveness and safety data on Vivitrol in children.
• Adults over 65: There isn't enough available data to compare the differences in responses between older and younger adults for Vivitrol. Some older adults may have a higher likelihood of kidney impairment and should use Vivitrol cautiously.
• Liver problems: If you develop severe liver impairment from Vivitrol, your healthcare provider will likely discontinue this treatment.

What Other Medications Interact With Vivitrol?

Use caution when taking Vivitrol with the following opioid-containing medications:

• Opioid pain relievers: Morphine is typically used to relieve severe pain.
• Antidiarrhea medications: Lomotil (diphenoxylate and atropine) is used for diarrhea. The diphenoxylate component is very similar to meperidine, which is an opioid.
• Cough and cold medications: Tussionex (hydrocodone and chlorpheniramine) is a strong cough medication that contains hydrocodone, which is an opioid.
  

Vivitrol blocks the effects of opioids. Opioid-containing medications will be less effective at relieving pain, diarrhea, or cough symptoms.

This isn't a complete list of possible interactions with Vivitrol. Talk with your pharmacist or healthcare provider for more detailed information about medication interactions with Vivitrol.

And be sure to talk with your healthcare provider about any other medicines you take or plan to take, including over-the-counter (OTC), nonprescription products, vitamins, herbs, or plant-based medicines.

What Medications Are Similar?

Vivitrol is an opioid antagonist. Vivitrol is unique in its ability to treat alcohol dependence—in addition to opioid use disorder. However, the FDA didn't approve Vivitrol to treat opioid overdoses. Opioid antagonists that are used for opioid overdoses include naloxone and nalmefene.

Most of the other opioid antagonists are used for digestive system problems. These include:

• Entereg (alvimopan): Alvimopan helps you regain regular bowel movements after bowel surgery.
• Movantik (naloxegol): Naloxegol is typically used to treat opioid-induced constipation (OIC).
• Relistor (methylnaltrexone): In general, methylnaltrexone may also be used for OIC.
• Symproic (naldemedine): Similar to naloxegol and methylnaltrexone, naldemedine is also used for OIC.

Samidorphan is another opioid antagonist. It's combined with olanzapine (an antipsychotic) called Lybalvi—to possibly lessen some of olanzapine's side effects. Lybalvi is a prescription used for mental health conditions like schizophrenia.

With all of these medications being opioid antagonists, they're not typically used together. Since Vivitrol has an opioid overdose risk, however, it's typically recommended for you to carry naloxone with you.

How Can I Stay Healthy While Taking Vivitrol?

If you're taking Vivitrol, chances are alcohol use disorder (AUD) or opioid use disorder (OUD) has negatively affected your quality of life. You may have tried different approaches or treatments. While living with AUD or OUD does have its challenges, there are ways to help improve your quality of life. Refer below for some general tips to support your health as you address AUD or OUD:

• Take AUD or OUD-related medications as recommended by your healthcare provider.
• Participate in a complete recovery program.
• Participate in therapy and self-help groups.
• Consider support groups or working with a mental health professional to help you find coping strategies to change the way you think, feel, react, or respond to living with AUD or OUD.
• Know your triggers for alcohol or opioid use.
• Work with your healthcare provider and keep up with your appointments.
• Make sure you and your loved ones know how to use your naloxone prescription in case of an opioid overdose.
• Take care of yourself through regular exercise, a healthy sleep routine, and balanced meals.