Vivitrol for Opioid and Alcohol Addiction: Side Effects, Benefits & Risks

A long-acting injectable form of naltrexone, Vivitrol is used in the maintenance treatment of opioid or alcohol dependence

Vivitrol is the brand name of a medication known as naltrexone. Vivitrol is available as a long-acting injection. It is FDA-approved for the treatment of alcohol or opioid dependence.

What Is Vivitrol?

Vivitrol, the injectable form of naltrexone, is an opioid antagonist. As an antagonist, it binds opioid receptors without turning them on. In occupying the opioid receptors, Vivitrol prevents the potentially harmful side effects of opioids; side effects such as reduced breathing and circulatory collapse. The medication also works to reduce cravings and the desire to use.

Vivitrol FDA Approval

The Food and Drug Administration (FDA) approved Vivitrol for opioid dependence in October of 2010 and alcohol dependence in April of 2006.

Treating Opioid Dependence with Vivitrol

Used in the maintenance treatment of opioid dependence, Vivitrol reduces cravings and allows for longer treatment retention periods. Treating opioid dependence with Vivitrol is safe and effective.

Who Benefits Most?

Individuals who benefit most from Vivitrol include those diagnosed with alcohol or opioid addiction. As a month-long injection, Vivitrol also benefits those who encounter compliance issues or inadequate psychosocial support. The monthly medication schedule required for Vivitrol benefits those who wish to avoid a daily medication regimen. Those prescribed Vivitrol must first sustain a 7–14-day opioid-free period to prevent inducing uncomfortable opioid withdrawal symptoms.

Who Should Avoid Vivitrol?

Vivitrol is a long-acting medication that must not be used alongside other opioid products. Serious side effects can occur with the consumption of opioids while taking prescription Vivitrol. People who are currently using opioids should not receive Vivitrol.

Anyone who has experienced a previous allergic reaction in association with Vivitrol, or its active ingredient naltrexone, should not use Vivitrol. People with significant liver disease or hepatitis should not use Vivitrol.

How Does Vivitrol Work?

Vivitrol works in several ways to help you overcome alcohol or opioid dependence. On top of blocking opioid receptors and reducing cravings for one month, Vivitrol also acts to alter cues associated with triggers, such as a holiday event or an airport lounge. Without the daily battle of prompts and temptation, Vivitrol provides you with the opportunity to remain abstinent.

Monthly Injection

Vivitrol is given as a once-monthly 380 mg intramuscular (IM) injection. The monthly injection delivers a continuous and effective dose of medication while eliminating the need for daily medication. Vivitrol offers a convenient and effective option for long-term recovery.

Demonstrating increased efficacy and feasibility over the oral formulations, Vivitrol may provide additional benefit in the primary care setting.

Vivitrol vs. Suboxone

Suboxone is a form of a medication called buprenorphine. Suboxone acts as a partial agonist. This is in comparison with Vivitrol, which acts as an antagonist. Although they have different mechanisms of action, they are both options in treating opioid dependence.

Administering Vivitrol

Intramuscular injections of Vivitrol are delivered by a health care provider into the outer quadrant of the gluteal muscles (buttocks). Once injected, the medication lasts for a month and cannot be removed. The injection cannot be given elsewhere on the body.

The injection contains the active ingredient naltrexone, housed in a polylactide-co-glycolide shell. The name of the shell component is only important for those with a previous history of allergic reactions.

Precipitated Withdrawal Risk

The potential to precipitate (make worse) opioid withdrawal exists with all forms of opioid antagonists, such as naltrexone and Vivitrol. The long-term effect (one month) of the Vivitrol injection may further increase the risk.

It is imperative that anyone receiving the Vivitrol injection maintain an opioid-free period of a minimum of 7–14 days prior to receiving the injection. If an opioid-free period of 7–14 days is not completed prior to the use of Vivitrol, the risk of opioid withdrawal is significant. The opioid withdrawal experienced is not only overtly uncomfortable but also extremely dangerous. Sudden opioid withdrawal may also cause seizures.

Overdose Risk

People taking Vivitrol should be aware of the potential for accidental overdose. Once given an injection of Vivitrol, the medication blocks opioid receptors for one month. An attempt to overcome this blockade by taking large amounts of opioids is highly dangerous and can lead to serious injury, coma and death.

Another area of concern involves the risk once the Vivitrol regimen has been completed. Proceeding a month-long treatment of Vivitrol, an individual may be significantly more sensitive to opioids. This means that a previously tolerated dose may now prove instantly fatal. Speak with your health care provider about these risks to ensure the safe use of this medication.

Vivitrol Side Effects

Overall, Vivitrol is well tolerated. Little difference exists in the side effect profile between the injectable and oral formulations of naltrexone.

However, the medication does carry some risk of side effects. Some common side effects associated with Vivitrol use are:

• Nausea
• Vomiting
• Headache
• Dizziness
• Painful joints and/or muscle cramps
• Insomnia (difficulty sleeping)
• Pain at the injection site
• Tiredness or lethargy (do not operate heavy machinery or drive while taking this medication

There are also some rare, serious side effects of Vivitrol, including:

• Serious allergic reaction, also called hypersensitivity, may occur directly after injection. Tell your doctor if you experience severe rash, swelling of the face or mouth, trouble breathing, wheezing or chest pain.
• Eosinophilic (Allergic) pneumonia
• Depressed mood
• Injection-site reaction, such as infection or abscess

The active ingredient in Vivitrol, naltrexone, can cause liver damage (hepatotoxicity) in some users. Although this may not be the case for Vivitrol, if signs of liver toxicity do develop (stomach pain, dark urine, yellowing of the eyes), contact your health care provider immediately.

Vivitrol and Pregnancy

While it is not known if Vivitrol is specifically harmful to a pregnant mother or her unborn baby, the active ingredient within it, called naltrexone, is harmful. Naltrexone is classified as a Category C medication, meaning it was shown to produce damaging effects in animal studies. As of now, there are no equivalent studies in humans.

Naltrexone use during pregnancy is a delicate matter. While naltrexone has potential in the treatment of opioid-dependent pregnant women, its current uses are limited, as little data exists on its safety profile.

What is well known, however, is the direct adverse effects of opioids, such as heroin, on a developing infant. Opioid and alcohol use during pregnancy should be strictly avoided.

If someone becomes pregnant while prescribed naltrexone, they should discontinue taking the medication if the risk of opioid-relapse is low. If the risk of relapse is believed to be high, some people, teamed up with their physician, may decide to continue naltrexone. In this case, the good may outweigh the bad. Some studies have demonstrated favorable outcomes using naltrexone in heavy opioid users. Naltrexone may provide some heavy users the support needed to ensure an opioid-free pregnancy, and as a result, a healthy baby.

Additionally, naltrexone and its metabolites are found in breast milk, a consideration all breast-feeding mothers should discuss with their health care providers.

It is important to consult your health care provider if you become pregnant while taking naltrexone.

Vivitrol Cost

The standard cost for a 380 mg Vivitrol intramuscular injection is $1,570.80.

Vivitrol Cost

• Does Medicaid Cover Vivitrol?
  Florida Medicaid covers Vivitrol under FFS plans, eligible for patients aged 16 and older. While variations may occur depending on state regulations, you can see if your state covers it here.  
• What Is the Vivitrol Free Trial Program?
  A co-pay savings program may be offered for eligible patients with a Vivitrol prescription. The program covers up to $500 per month of co-pay or deductible expenses.  
• Does Insurance Cover Vivitrol?
  Vivitrol is listed on Florida’s preferred drug list under FFS plans through physician services. Individuals should speak with their insurance company or physician for additional information regarding eligibility.  

Vivitrol Effectiveness in Treating Opiate Addiction

A clinical review demonstrated an opioid-free rate of 82% with monthly Vivitrol injections, in comparison to a 54% rate in the group taking oral medications. The injection formula provides consistent blood medication levels and, as a result, optimal effectiveness.

Another review found that clients achieved a median 90% abstinence rates from 5–24 weeks, as well as a 50% reduction in cravings after using Vivitrol.