VIVITROL® (Naltrexone)

VIVITROL®

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Important Safety Information

VIVITROL® (naltrexone) is a monthly injection used to prevent an opioid dependence relapse after the patient has undergone detoxification. It’s also used to treat alcohol dependence — as long as the patient has stopped drinking prior to starting treatment.

Before starting infusion therapy with VIVITROL®, it’s crucial to be opioid-free for a minimum of 14 days to avoid withdrawal symptoms. Do not start treatment while undergoing withdrawal symptoms. These include fast heart rate, restlessness, anxiety, excessive sweating, sleeping difficulties, muscle aches, high blood pressure, dilated pupils, goosebumps on the skin, nausea, vomiting, and/or diarrhea. How long these symptoms last depends on the type of opioid you’re withdrawing from.

Only use VIVITROL® while participating in a drug or alcohol recovery program that includes counseling. Taking this medication may increase the risk of an opioid overdose — since it blocks the effects of opioids, a patient without adequate support may attempt to overcome this effect by taking additional opioids. This could be life-threatening, as it could result in coma or death.

It is also possible to experience severe reactions at the site of injection. Tell your doctor immediately if you notice swelling or intense pain at the site of injection, blisters, lumps, scabs, or if the area feels hard.

What is the most important information I should know about VIVITROL®?

The active ingredient in VIVITROL® is naltrexone, which can cause liver damage or hepatitis. Tell your doctor if you have a history of liver problems, or if you experience yellowing of the skin and whites of your eyes, dark urine, tiredness, and/or abdominal pain.

You may experience adverse reactions if VIVITROL® is mixed with other medications. Let your healthcare professional know if you are taking other medications — including prescription, over-the-counter, herbal supplements, and/or vitamins.

It is not known if VIVITROL® could harm an unborn baby. Tell your doctor if you’re pregnant, there’s a possibility you are pregnant, or you’re planning on becoming pregnant. It is also unknown if VIVITROL® can be passed on to a baby through breast milk. Talk with your doctor about feeding alternatives for your baby.

Side Effects of VIVITROL®

As with any prescription medication, VIVITROL® carries the risk of side effects. The most common ones include:

  • Headache
  • Dizziness
  • Toothache
  • Decreased appetite
  • Sleepiness
  • Muscle cramps
  • Nausea
  • Vomiting
  • Joint pain
  • Sleeping difficulties
  • Cold symptoms

In rare cases, you may experience more serious side effects. These include:

  • Chest pain
  • Breathing difficulties
  • Serious allergic reactions — including itching, hives, breathing difficulties, skin rash, and/or swelling of the face, tongue, and lips

Tell a trusted person if you’re thinking about suicide, as these thoughts may be a side effect of taking VIVITROL®. Also mention if you’re experiencing symptoms of severe depression — including hopelessness, losing interest in activities you once enjoyed, not caring about eating, personal hygiene, or work obligations, and/or recurring thoughts about harming yourself or something bad happening.

Tell your doctor if you experience any negative side effects. You are also encouraged to report such side effects to the Food and Drug Administration (FDA) by visiting www.fda.gov/medwatch, or by calling 1-800-FDA-1088.

Indications

VIVITROL® infusion treatments are administered once a month, at a dosage of 380 mg. Prior to starting treatment, your healthcare provider should conduct a urine analysis to detect the presence of opioids. You should also undergo a naloxone challenge test and only proceed with treatment if results are negative.

Please refer to the full prescribing information.