Vivitrol

Naltrexone injection comes as a solution (liquid) to be given by injection into the muscle of the buttocks by a healthcare provider once every 4 weeks.

Naltrexone injection will not prevent withdrawal symptoms that may occur when you stop drinking alcohol after drinking large amounts for a long time or when you stop using opiate medications or street drugs.

Unless your doctor tells you otherwise, continue your normal diet.

Serious side effects have been reported with Vivitrol including the following:

1. Risk of opioid overdose. 
   You can accidentally overdose in two ways.
   • Vivitrol blocks the effects of opioids, such as heroin or opioid pain medicines. Do nottake large amounts of opioids, including opioid-containing medicines, such as heroin or prescription pain pills, to try to overcome the opioid-blocking effects of Vivitrol. This can lead to serious injury, coma, or death.
   • After you receive a dose of Vivitrol, its blocking effect slowly decreases and completely goes away over time. If you have used opioid street drugs or opioid-containing medicines in the past, using opioids in amounts that you used before treatment with Vivitrol can lead to overdose and death. You may also be more sensitive to the effects of lower amounts of opioids:
     • after you have gone through detoxification
     • when your next Vivitrol dose is due
     • if you miss a dose of Vivitrol
     • after you stop Vivitrol treatment

   It is important that you tell your family and the people closest to you of this increased sensitivity to opioids and the risk of overdose.

   You or someone close to you should get emergency medical help right away if you:

   • have trouble breathing
   • become very drowsy with slowed breathing
   • have slow, shallow breathing (little chest movement with breathing)
   • feel faint, very dizzy, confused, or have unusual symptoms
2. Severe reactions at the site of the injection (injection site reactions). Some people on Vivitrol have had severe injection site reactions, including tissue death (necrosis). Some of these injection site reactions have required surgery. Call your healthcare provider right away if you notice any of the following at any of your injection sites:
   • Intense pain
   • The area feels hard
   • Large area of swelling
   • Lumps
   • Blisters
   • An open wound
   • A dark scab

   Tell your healthcare provider about any reaction at an injection site that concerns you, gets worse over time, or does not get better by two weeks after the injection.

3. Sudden opioid withdrawal. 
   Anyone who receives a Vivitrol injection must not use any type of opioid (must be opioid-free) including street drugs, prescription pain medicines, cough,cold, or diarrhea medicines that contain opioids, or opioid dependence treatments, buprenorphine or methadone, for at least 7 to 14 days before starting Vivitrol. Using opioids in the 7 to 14 days before you start receiving Vivitrol may cause you to suddenly have symptoms of opioid withdrawal when you get the Vivitrol injection. Sudden opioid withdrawal can be severe and you may need to go to the hospital. 
   You must be opioid-free before receiving Vivitrol unless your healthcare provider decides that you don't need to go through detox first. Instead, your doctor may decide to give your Vivitrol injection in a medical facility that can treat you for sudden opioid withdrawal.
4. Liver damage or hepatitis. Naltrexone, the active ingredient in Vivitrol, can cause liver damage or hepatitis. 
   Tell your healthcare provider if you have any of the following symptoms of liver problems during treatment with Vivitrol:
   • Stomach area pain lasting more than a few days
   • Dark urine
   • Yellowing of the whites of your eyes
   • Tiredness

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

  5. Depressed mood. Sometimes this leads to suicide, or suicidal thoughts, and suicidal behavior. Tell your family members and     people closest to you that you are taking Vivitrol.

You, a family member, or the people closest to you should call your healthcare provider right away if you become depressed or have any of the following symptoms of depression, especially if they are new, worse, or worry you:

• You feel sad or have crying spells.
• You are no longer interested in seeing your friends or doing things you used to enjoy.
• You are sleeping a lot more or a lot less than usual.
• You feel hopeless or helpless.
• You are more irritable, angry, or aggressive than usual.
• You are more or less hungry than usual or notice a big change in your body weight.
• You have trouble paying attention.
• You feel tired or sleepy all the time.
• You have thoughts about hurting yourself or ending your life.

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

• Shortness of breath or wheezing
• Coughing that does not go away

​  7. Serious allergic reactions. Serious allergic reactions can happen during or soon after an injection of Vivitrol. Tell your healthcare provider or get medical help right away if you have any of these symptoms of a serious allergic reaction.

• Skin rash
• Swelling of your face, eyes, mouth, or tongue
• Trouble breathing or wheezing'
• Chest pain
• Feeling dizzy or faint

Vivitrol may make you feel dizzy and sleepy. Do not drive a car, operate machinery, or do other dangerous activities until you know how Vivitrol affects you.

Do not receive Vivitrol if you:

• are using or have a physical dependence on opioid-containing medicines or opioid street drugs. 
• are having opioid withdrawal symptoms. Opioid withdrawal symptoms may happen when you have been taking opioid-containing medicines or opioid street drugs regularly and then stop. Symptoms of opioid withdrawal may include: anxiety, sleeplessness, yawning, fever, sweating, teary eyes, runny nose, goose bumps, shakiness, hot or cold flushes, muscle aches, muscle twitches, restlessness, nausea and vomiting, diarrhea, or stomach cramps. Tell your healthcare provider if you have any of these symptoms before taking Vivitrol.
• are allergic to Vivitrol or any of the ingredients in Vivitrol or the liquid used to mix Vivitrol (diluent). 

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Vivitrol, there are no specific foods that you must exclude from your diet when receiving this medication. 

Vivitrol is injected by a healthcare provider, about 1 time each month. After Vivitrol is injected, it lasts for a month and it cannot be removed from the body.

• If you are taking Vivitrol to treat alcohol dependence, you should stop drinking before starting Vivitrol.
• If you are taking Vivitrol to prevent relapse to opioid dependence, after opioid detoxification, you must stop taking opioids or opioid-containing medicines before you start receiving Vivitrol. 

Vivitrol is given as an injection into a muscle in your buttocks using a special needle that comes with Vivitrol.

To be effective, treatment with Vivitrol must be used with other alcohol or drug recovery programs such as counseling. Vivitrol may not work for everyone.

Whenever you need medical treatment, be sure to tell the treating healthcare provider that you are receiving Vivitrol injections and mention when you got your last dose. This is important because Vivitrol can also block the effects of opioid-containing medicines that might be prescribed for you for pain, cough or colds, or diarrhea.

Carry written information with you at all times to alert healthcare providers that you are taking Vivitrol, so that they can treat you properly in an emergency. Ask your healthcare provider how you can get a wallet card to carry with you.

If you miss your appointment for your Vivitrol injection, schedule another appointment as soon as possible.

Vivitrol has the capacity to cause hepatocellular injury when given in excessive doses.

Vivitrol is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects.

The margin of separation between the apparently safe dose of Vivitrol and the dose causing hepatic injury appears to be only five-fold or less. Vivitrol does not appear to be a hepatotoxin at the recommended doses.

Patients should be warned of the risk of hepatic injury and advised to stop the use of Vivitrol and seek medical attention if they experience symptoms of acute hepatitis.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of naltrexone injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of naltrexone injection in the elderly.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Alfentanil
• Alphaprodine
• Anileridine
• Buprenorphine
• Butorphanol
• Codeine
• Diacetylmorphine
• Difenoxin
• Dihydrocodeine
• Diphenoxylate
• Ethylmorphine
• Fentanyl
• Hydrocodone
• Hydromorphone
• Ketobemidone
• Levorphanol
• Meperidine
• Methadone
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nicomorphine
• Opium
• Opium Alkaloids
• Oxycodone
• Oxymorphone
• Papaveretum
• Paregoric
• Piritramide
• Propoxyphene
• Remifentanil
• Sufentanil
• Tapentadol
• Tilidine
• Tramadol

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Naldemedine
• Naloxegol

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Yohimbine

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems (eg, hemophilia) or
• Kidney disease, moderate to severe or
• Liver disease, mild to moderate or
• Lung or breathing problems or
• Thrombocytopenia (low platelets in the blood)—Use with caution. May make these conditions worse.

• Drug dependence, especially narcotic abuse or dependence, history of or
• Failed the naloxone challenge test (medical test to check your dependence to opioid medicine) or
• Liver disease (including acute hepatitis), severe or
• Opioid withdrawal, acute or
• Positive urine test for opioids or
• Receiving opioid analgesics (eg, morphine)—Should not be used in patients with these conditions.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Nervous and excitable.
• Anxiety.
• Headache.
• Belly pain.
• Cramps.
• Not able to sleep.
• Upset stomach or throwing up.
• Dizziness.
• Feeling sleepy.
• Muscle or joint pain.
• Not hungry.
• Feeling tired or weak.
• Irritation where the shot is given.
• Dry mouth.
• Loose stools (diarrhea).

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine is refilled. If you have any questions about Vivitrol, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Vivitrol. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Vivitrol.

Review Date: October 4, 2017

Hepatotoxicity

Naltrexone has the capacity to cause hepatocellular injury when given in excessive doses.

Naltrexone is contraindicated in acute hepatitis or liver failure, and its use in patients with active liver disease must be carefully considered in light of its hepatotoxic effects.

The margin of separation between the apparently safe dose of naltrexone and the dose causing hepatic injury appears to be only five-fold or less. Vivitrol does not appear to be a hepatotoxin at the recommended doses.

Patients should be warned of the risk of hepatic injury and advised to seek medical attention if they experience symptoms of acute hepatitis. Use of Vivitrol should be discontinued in the event of symptoms and/or signs of acute hepatitis.

Eosinophilic pneumonia

In clinical trials with Vivitrol, there was one diagnosed case and one suspected case of eosinophilic pneumonia. Both cases required hospitalization, and resolved after treatment with antibiotics and corticosteroids. Should a person receiving Vivitrol develop progressive dyspnea and hypoxemia, the diagnosis of eosinophilic pneumonia should be considered (see ADVERSE REACTIONS). Patients should be warned of the risk of eosinophilic pneumonia, and advised to seek medical attention should they develop symptoms of pneumonia. Clinicians should consider the possibility of eosinophilic pneumonia in patients who do not respond to antibiotics.

Unintended Precipitation of Opioid Withdrawal

To prevent occurrence of an acute abstinence syndrome (withdrawal) in patients dependent on opioids, or exacerbation of a pre-existing subclinical abstinence syndrome, patients must be opioid-free for a minimum of 7-10 days before starting Vivitrol treatment. Since the absence of an opioid drug in the urine is often not sufficient proof that a patient is opioid-free, a naloxone challenge test should be employed if the prescribing physician feels there is a risk of precipitating a withdrawal reaction following administration of Vivitrol.

Opioid Overdose Following an Attempt to Overcome Opiate Blockade

Vivitrol is not indicated for the purpose of opioid blockade or the treatment of opiate dependence. Although Vivitrol is a potent antagonist with a prolonged pharmacological effect, the blockade produced by Vivitrol is surmountable. This poses a potential risk to individuals who attempt, on their own, to overcome the blockade by administering large amounts of exogenous opioids. Indeed, any attempt by a patient to overcome the antagonism by taking opioids is very dangerous and may lead to fatal overdose. Injury may arise because the plasma concentration of exogenous opioids attained immediately following their acute administration may be sufficient to overcome the competitive receptor blockade. As a consequence, the patient may be in immediate danger of suffering life-endangering opioid intoxication (e.g., respiratory arrest, circulatory collapse). Patients should be told of the serious consequences of trying to overcome the opioid blockade (see INFORMATION FOR PATIENTS).

There is also the possibility that a patient who had been treated with Vivitrol will respond to lower doses of opioids than previously used. This could result in potentially life-threatening opioid intoxication (respiratory compromise or arrest, circulatory collapse, etc.). Patients should be aware that they may be more sensitive to lower doses of opioids after Vivitrol treatment is discontinued (see INFORMATION FOR PATIENTS).