Generic Name
Naltrexone
Brand Names
Vivitrol, Contrave
FDA approval date: March 22, 2002
Classification: Aminoketone
Form: Tablet, Kit
What is Vivitrol (Naltrexone)?
Naltrexone hydrochloride tablets are indicated: In the treatment of alcohol dependence and for the blockade of the effects of exogenously administered opioids. Naltrexone hydrochloride tablets have not been shown to provide any therapeutic benefit except as part of an appropriate plan of management for the addictions.
Approved To Treat
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Brand Information
VIVITROL (naltrexone)
1INDICATIONS AND USAGE
Treatment with VIVITROL should be part of a comprehensive management program that includes psychosocial support.
1.1Alcohol Dependence
VIVITROL is indicated for the treatment of alcohol dependence in patients who are able to abstain from alcohol in an outpatient setting prior to initiation of treatment with VIVITROL. Patients should not be actively drinking at the time of initial VIVITROL administration.
1.2Opioid Dependence
VIVITROL is indicated for the prevention of relapse to opioid dependence, following opioid detoxification.
2DOSAGE FORMS AND STRENGTHS
VIVITROL is an off-white to light tan powder for injectable suspension in a 5 mL single-dose vial.
VIVITROL contains 380 mg of naltrexone in a microsphere formulation per vial (337 mg of naltrexone per gram of microspheres).
3CONTRAINDICATIONS
VIVITROL is contraindicated in:
- Patients receiving opioid analgesics
- Patients with current physiologic opioid dependence
- Patients in acute opioid withdrawal
- Any individual who has failed the naloxone challenge test or has a positive urine screen for opioids
- Patients who have previously exhibited hypersensitivity to naltrexone, PLG, carboxymethylcellulose, or any other components of the diluent
4ADVERSE REACTIONS
The following clinically significant adverse reactions are described elsewhere in the labeling:
- Accidental Opioid Overdose
- Injection Site Reactions
- Precipitated Opioid Withdrawal
- Hepatotoxicity
- Depression and Suicidality
- Eosinophilic Pneumonia
- Hypersensitivity Reactions
4.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In all controlled and uncontrolled trials during the premarketing development of VIVITROL, more than 1100 patients with alcohol and/or opioid dependence have been treated with VIVITROL. Approximately 700 patients have been treated for 6 months or more, and more than 400 for 1 year or longer.
5DRUG INTERACTIONS
Patients taking VIVITROL may not benefit from opioid-containing medicines. Naltrexone antagonizes the effects of opioid-containing medicines, such as cough and cold remedies, antidiarrheal preparations and opioid analgesics.
6OVERDOSAGE
There is limited experience with overdose of VIVITROL. Single doses up to 784 mg were administered to 5 healthy subjects. There were no serious or severe adverse events. The most common effects were injection site reactions, nausea, abdominal pain, somnolence, and dizziness. There were no significant increases in hepatic enzymes.
In the event of an overdose, appropriate supportive treatment should be initiated.
7DESCRIPTION
VIVITROL
Naltrexone is morphinan-6-one, 17-(cyclopropylmethyl)-4,5-epoxy-3,14-dihydroxy-(5α) (CAS Registry # 16590-41-3). The molecular formula is C
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.
8HOW SUPPLIED/STORAGE AND HANDLING
VIVITROL (naltrexone for extended-release injectable suspension) is supplied in cartons (NDC 65757-300-01). Each carton contains:
- one 380 mg vial of VIVITROL microspheres in a 5 mL single-dose vial,
- one vial containing 4 mL of diluent (to deliver 3.4 mL) for the suspension of VIVITROL,
- one 5-mL prepackaged syringe,
- one 20-gauge 1-inch needle,
- two 20-gauge 1 1/2-inch needles with needle protection devices, and;
- two 20-gauge 2-inch needles with needle protection devices
VIVITROL must be prepared and administered by a healthcare provider.
8.1Storage and Handling
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.
Keep out of Reach of Children.
9PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-Approved patient labeling (Medication Guide).
Physicians should include the following issues in discussions with patients for whom they prescribe VIVITROL.
VIVITROL for Opioid Use Disorder:
- Advise patients that if they previously used opioids, they may be more sensitive to lower doses of opioids and at risk of accidental overdose should they use opioids when their next dose is due, if they miss a dose, or after VIVITROL treatment is discontinued. It is important that patients inform family members and the people closest to the patient of this increased sensitivity to opioids and the risk of overdose. Educate patients and caregivers on how to recognize the signs and symptoms of an opioid overdose.
- Advise patients that because VIVITROL can block the effects of opioids, patients will not perceive any effect if they attempt to self-administer heroin or any other opioid drug in small doses while on VIVITROL. Further, emphasize that administration of large doses of heroin or any other opioid to try to bypass the blockade and get high while on VIVITROL may lead to serious injury, coma, or death.
- Patient Access to Naloxone for the Emergency Treatment of Opioid Overdose
Because of the vulnerability to opioid overdose described above, discuss with the patient and caregiver the importance of having access to naloxone, and inform them of options for obtaining it, as permitted by individual state naloxone dispensing and prescribing requirements or guidelines (e.g., by prescription, directly from a pharmacist, or as part of a community-based program) Educate patients and caregivers on how to recognize the signs and symptoms of an opioid overdose. Explain to patients and caregivers that naloxone's effects are temporary, and that they must call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if naloxone is administered. If naloxone is prescribed, also advise patients and caregivers: - How to treat with naloxone in the event of an opioid overdose
- To tell family and the people closest to the patient about their naloxone and to keep it in a place where family and the people closest to the patient can access it in an emergency
- To read the Patient Information (or other educational material) that will come with their naloxone. Emphasize the importance of doing this before an opioid emergency happens, so the patient and caregiver will know what to do.
VIVITROL for All Indications:
- Inform patients on VIVITROL that they may not experience the expected effects from opioid-containing analgesic, antidiarrheal, or antitussive medications.
- Instruct patients that VIVITROL must be prepared and administered by a healthcare provider.
- Advise patients that a reaction at the site of VIVITROL injection may occur. Reactions include pain, tenderness, induration, swelling, erythema, bruising, or pruritus. Serious injection site reactions including necrosis may occur. Some of these injection site reactions have required surgery. Patients should be advised to seek medical attention for worsening skin reactions.
- Advise patients that they should be off all opioids, including opioid-containing medicines, for a minimum of 7 – 10 days before starting VIVITROL in order to avoid precipitation of opioid withdrawal. Patients transitioning from buprenorphine or methadone may be vulnerable to precipitation of withdrawal symptoms for as long as two weeks. Ensure that patients understand that withdrawal precipitated by administration of an opioid antagonist may be severe enough to require hospitalization if they have not been opioid-free for an adequate period of time, and is different from the experience of spontaneous withdrawal that occurs with discontinuation of opioid in a dependent individual. Advise patients that they should not take VIVITROL if they have any symptoms of opioid withdrawal. Advise all patients, including those with alcohol dependence, that it is imperative to notify healthcare providers of any recent use of opioids or any history of opioid dependence before starting VIVITROL to avoid precipitation of opioid withdrawal.
- Advise patients that VIVITROL may cause liver injury. Patients should immediately notify their physician if they develop symptoms and/or signs of liver disease.
- Advise patients that they may experience depression while taking VIVITROL. It is important that patients inform family members and the people closest to the patient that they are taking VIVITROL and that they should call a doctor right away should they become depressed or experience symptoms of depression.
- Advise patients to carry documentation to alert medical personnel to the fact that they are taking VIVITROL (naltrexone for extended-release injectable suspension). This will help to ensure that patients obtain adequate medical treatment in an emergency.
- Advise patients that VIVITROL may cause an allergic pneumonia. Patients should immediately notify their physician if they develop signs and symptoms of pneumonia, including dyspnea, coughing, or wheezing.
- Advise patients that they should not take VIVITROL if they are allergic to VIVITROL or any of the microsphere or diluent components.
- Advise patients that they may experience nausea following the initial injection of VIVITROL. These episodes of nausea tend to be mild and subside within a few days post-injection. Patients are less likely to experience nausea in subsequent injections. Patients should be advised that they may also experience tiredness, headache, vomiting, decreased appetite, painful joints and muscle cramps.
- Advise patients that because VIVITROL is an intramuscular injection and not an implanted device, once VIVITROL is injected, it is not possible to remove it from the body.
- Advise patients that VIVITROL has been shown to treat alcohol and opioid dependence only when used as part of a treatment program that includes counseling and support.
- Advise patients that dizziness may occur with VIVITROL treatment, and they should avoid driving or operating heavy machinery until they have determined how VIVITROL affects them.
- Advise patients to notify their physician if they:
9.1Frequently Asked Questions About Administering VIVITROL:
- Can I prepare the suspension prior to my patient's arrival?No. You may remove the carton from the refrigerator prior to the patient's arrival, but once the diluent is added to the VIVITROL microspheres, the dose should be mixed and the suspension administered immediately. It is very important to use proper aseptic technique when preparing the suspension [see Dosage and Administration (
- How much time do I have between preparing and administering the dose?It is recommended that the suspension be administered immediately once the product has been suspended and transferred into the syringe. If a few minutes' delay occurs after suspension but before transfer into the syringe [see Dosage and Administration (, the vial can be inverted a few times to resuspend and then transferred into the syringe for immediate use [see Dosage and Administration (
- Can I use needles other than those provided in the carton?No. The needles in the carton are specially designed for administration of VIVITROL. Do not make any substitutions for components of the carton [see Dosage and Administration (.
- The suspension is milky white upon mixing with the diluent. Is this normal?Yes. VIVITROL microspheres will form a milky suspension when mixed with the provided diluent [see Dosage and Administration (
- What if a needle clog occurs during administration of the product?If a clog occurs during administration, the needle should be withdrawn from the patient, capped with the attached needle protection device, and replaced with the spare administration needle. Gently push on the plunger until a bead of the suspension appears at the tip of the needle. The remainder of the suspension should then be administered into an adjacent site in the same gluteal region [see Dosage and Administration (
For additional information, visit www.vivitrol.com or call 1-800-848-4876
Manufactured and marketed by:
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US Patent No. 7,919,499