Vivitrol

What is Vivitrol?

• Vivitrol (naltrexone) an opioid antagonist, used for the treatment of alcohol dependence, opioid dependence.

Naltrexone skeletal

Naltrexone-from-xtal-3D-bs-17

What are the uses of this medicine?

VIVITROL is a prescription injectable medicine used to:

• treat alcohol dependence. You should stop drinking before starting VIVITROL.
• prevent relapse to opioid dependence, after opioid detoxification. This means that if you take opioids or opioid-containing medicines, you must stop taking them before you start receiving VIVITROL.

• Treatment with VIVITROL must be used with other alcohol or drug recovery programs such as counseling.
• VIVITROL may not work for everyone.

How does this medicine work?

• Naltrexone is an opioid antagonist with highest affinity for the mu opioid receptor.
• Naltrexone has little or no opioid agonist activity.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• receiving opioid analgesics
• with current physiologic opioid dependence
• acute opioid withdrawal
• who has failed the naloxone challenge test or has a positive urine screen for opioids
• who have previously exhibited hypersensitivity to naltrexone, PLG, carboxymethylcellulose, or any other components of the diluent

What drug interactions can this medicine cause?

• Naltrexone antagonizes the effects of opioid-containing medicines, such as cough and cold remedies, antidiarrheal preparations and opioid analgesics.

Is this medicine FDA approved?

• Naltrexone was first made in 1965 and was approved for medical use in the United States in 1984.

How should this medicine be used?

• Prior to initiating VIVITROL, an opioid-free duration of a minimum of 7–10 days is recommended for patients, to avoid precipitation of opioid withdrawal that may be severe enough to require hospitalization.

Recommended dosage:

• The recommended dose of VIVITROL is 380 mg delivered intramuscularly (IM) as a gluteal injection, every 4 weeks or once a month, alternating buttocks for each subsequent injection, using the carton components provided.

Administration:

• VIVITROL is injected by a healthcare provider, about 1 time each month.
• VIVITROL must be injected by a healthcare provider. Do not attempt to inject yourself with VIVITROL. Serious reactions, some that may require hospitalization, might happen.
• VIVITROL is given as an injection into a muscle in your buttocks using a special needle that comes with VIVITROL.
• After VIVITROL is injected, it lasts for a month and it cannot be removed from the body.
• If you miss your appointment for your VIVITROL injection, schedule another appointment as soon as possible.
• 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.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As an injectable suspension containing 380 mg of naltrexone in a microsphere formulation in a single-dose vial

This medicine is available in fallowing brand namesː

• VIVITROL

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• sleepiness
• headache
• dizziness
• vomiting
• decreased appetite
• painful joints
• muscle cramps
• cold symptoms
• trouble sleeping
• toothache

VIVITROL can cause serious side effects, including:

• Risk of opioid overdose
• injection site reactions
• Sudden opioid withdrawal
• Liver damage or hepatitis
• Depressed mood
• Pneumonia
• Serious allergic reactions

What special precautions should I follow?

• Following VIVITROL treatment opioid tolerance is reduced from pretreatment baseline, and patients are vulnerable to potentially fatal overdose at the end of a dosing interval, after missing a dose, or after discontinuing VIVITROL treatment. Attempts to overcome blockade may also lead to fatal overdose. Strongly consider prescribing naloxone for the emergency treatment of opioid overdose.
• VIVITROL must be prepared and administered by a healthcare provider. In some cases, injection site reactions may be very severe. Some cases of injection site reactions required surgical intervention.
• Opioid-dependent and opioid-using patients, including those being treated for alcohol dependence, should be opioid-free before starting VIVITROL treatment, and should notify healthcare providers of any recent opioid use. An opioid-free duration of a minimum of 7-10 days is recommended for patients to avoid precipitation of opioid withdrawal that may be severe enough to require hospitalization.
• Cases of hepatitis and clinically significant liver dysfunction were observed in association with VIVITROL treatment during the clinical development program and in the postmarketing period. Discontinue use of VIVITROL in the event of symptoms or signs of acute hepatitis.
• Monitor patients for the development of depression or suicidal thinking.
• In an emergency situation in patients receiving VIVITROL, suggestions for pain management include regional analgesia or use of non-opioid analgesics. Irrespective of the drug chosen to reverse VIVITROL blockade, the patient should be monitored closely by appropriately trained personnel in a setting equipped and staffed for cardiopulmonary resuscitation.
• In clinical trials with VIVITROL, there was one diagnosed case and one suspected case of eosinophilic pneumonia. Patients should be warned of the risk of eosinophilic pneumonia, and advised to seek medical attention should they develop symptoms of pneumonia.
• Cases of urticaria, angioedema, and anaphylaxis have been observed with use of VIVITROL. In the event of a hypersensitivity reaction, patients should be advised to seek immediate medical attention in a healthcare setting prepared to treat anaphylaxis. The patient should not receive any further treatment with VIVITROL.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• injection site reactions
• nausea
• abdominal pain
• somnolence
• dizziness

Management of overdosage:

• In the event of an overdose, appropriate supportive treatment should be initiated.

Can this medicine be used in pregnancy?

• The available data from published case series with VIVITROL use in pregnant women are insufficient to identify a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• The safety and efficacy of VIVITROL have not been established in the pediatric population.
• The pharmacokinetics of VIVITROL have not been evaluated in a pediatric population.

What are the active and inactive ingredients in this medicine?

• Active ingredient: naltrexone
• Inactive ingredients: polylactide-co-glycolide (PLG)
• Diluent ingredients: carboxymethylcellulose sodium, polysorbate 20, sodium chloride, sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection.

Who manufactures and distributes this medicine?

• Manufactured and marketed by:

Alkermes, Inc. 852 Winter Street Waltham, MA

What should I know about storage and disposal of this medication?

• The entire dose pack should be stored in the refrigerator (2 °C to 8 °C, 36 °F to 46 °F).
• Unrefrigerated, VIVITROL can be stored at temperatures not exceeding 25 °C (77 °F) for no more than 7 days prior to administration.
• Do not expose the product to temperatures above 25 °C (77 °F).
• VIVITROL should not be frozen.

• Dailymed label info on Vivitrol
• FDA Vivitrol

Vivitrol Resources
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