Vivitrol

Generic name: naltrexone (injection)
Drug class: Drugs used in alcohol dependence

Medically reviewed by A Ras MD.

What is Vivitrol?

Vivitrol is a prescription medicine that is used to help keep you alcohol-free. It is used to keep a drug-free state.

Description

VIVITROL® (naltrexone for extended-release injectable suspension) is supplied as a microsphere formulation of naltrexone for suspension, to be administered by intramuscular injection. VIVITROL contains naltrexone base anhydrous as the active pharmaceutical ingredient. Naltrexone is an opioid antagonist with little, if any, opioid agonist activity.

Naltrexone is morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-(5α) (CAS Registry # 16590-41-3). The molecular formula is C20H23NO4 and its molecular weight is 341.41 in the anhydrous form (ie, < 1% maximum water content). The structural formula is:

Naltrexone base anhydrous is an off-white to a light tan powder with a melting point of 168 °C to 170 °C (334 °F to 338 °F). It is insoluble in water and is soluble in ethanol.

VIVITROL is provided in a carton containing one vial of VIVITROL microspheres, one vial of diluent, one 5-mL syringe, one 1-inch 20-gauge preparation needle, two 1 1/2-inch 20-gauge, and two 2-inch 20-gauge administration needles with needle protection device.

VIVITROL microspheres consist of a sterile, off-white to light tan powder that is available in a dosage strength of 380 mg of naltrexone per vial. Naltrexone base anhydrous is incorporated in a biodegradable matrix of 75:25 polylactide-co-glycolide (PLG) at a concentration of 337 mg of naltrexone per gram of microspheres.

The diluent is a clear, colorless solution. Each mL of diluent contains 30.0 mg of carboxymethylcellulose sodium, 1.0 mg of polysorbate 20, 9.0 mg of sodium chloride, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. The pH of the diluent is in the range of 5.8 to 7.2.

Mechanism of Action

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

Before taking Vivitrol, tell your doctor:

If you are allergic to Vivitrol; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
If you are taking an opioid drug like morphine or oxycodone, are addicted to an opioid drug, or are having withdrawal signs.
If you have taken a pain drug within the past 7 to 14 days.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Vivitrol with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Vivitrol?

Tell all of your health care providers that you take Vivitrol. This includes your doctors, nurses, pharmacists, and dentists.
Avoid driving and doing other tasks or actions that call for you to be alert until you see how Vivitrol affects you.
Have blood work checked as you have been told by the doctor. Talk with the doctor.
This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take Vivitrol.
Avoid drinking alcohol while taking Vivitrol.
Do not take pain drugs while you are taking Vivitrol. Pain drugs will not work. Do not take more pain drugs to try to get them to work. Doing this may cause very bad injury, coma, or death. Talk with your doctor.
People taking Vivitrol to keep a drug-free state may get more effects from pain drugs when Vivitrol is stopped. Even low doses of pain drugs may cause very bad and sometimes deadly effects in these people. Talk with your doctor.
If you are addicted to pain drugs and are given Vivitrol, you may have signs of withdrawal. Talk with your doctor.
A type of lung infection caused by an allergic reaction has happened with Vivitrol. This may need to be treated in a hospital.
Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Vivitrol best taken?

Use Vivitrol as ordered by your doctor. Read all information given to you. Follow all instructions closely.

It is given as a shot into a muscle.

What do I do if I miss a dose?

Call your doctor to find out what to do.

What are the side effects of Vivitrol that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
New or worse behavior or mood changes like depression or thoughts of killing yourself.
Feeling confused.
Trouble breathing, slow breathing, or shallow breathing.
Sex problems in men.
Signs of lung or breathing problems like shortness of breath or other trouble breathing, cough, or fever.
Area that feels hard, blisters, dark scab, lumps, open wound, pain, swelling, or other very bad skin irritation where the shot was given.

What are some other side effects of Vivitrol?

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:

Feeling nervous and excitable.
Anxiety.
Headache.
Muscle cramps.
Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry.
More thirst.
Trouble sleeping.
Feeling dizzy, sleepy, tired, or weak.
Back, muscle, or joint pain.
Signs of a common cold.
Tooth pain.
Irritation where the shot is given.
Nose or throat irritation.
Dry mouth.

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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

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.

How do I store and/or throw out Vivitrol?

If you need to store Vivitrol at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PACKAGE LABEL- PRINCIPAL DISPLAY PANEL-VIVITROL®DILUENT VIAL LABEL

NDC: 65757-304-03
Rx Only
Diluent for use only with
VIVITROL®microspheres, 4 mL/Vial
Each mL of diluent contains 30.0 mg of carboxymethylcellulose sodium, 1.0 mg of polysorbate 20, 9.0 mg of sodium chloride, and sodium hydroxide and hydrochloric acid as pH adjusters, in water for injection. Single-dose Vial. Discard unused portion. Not for direct administration. See Package Insert for dose preparation. Storage: Refrigerate at 2°C to 8°C (36°F to 46°F). 4 mL (to withdraw 3.4 mL for reconstitution).
Manufactured for: Alkermes, Inc., Waltham, MA 02451