vivitrol
Pharmaranks rates Vivitrol 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Vivitrol (Naltrexone) is an opioid antagonist used to treat Alcoholism, Opioid-Related Disorders, Drug Overdose.
Naltrexone · by Alkermes Inc
Available as a generic: Naltrexone
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Naltrexone
- Drug class
- Opioid Antagonist
- Form
- Kit
- Strength
- Naltrexone 380MG/VIAL
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- alcoholism, opioid-related disorders, drug overdose
- Manufacturer
- Alkermes Inc
- What the pharmacy pays
- ~$36.35 for 30 — not your price
- FDA application
- NDA021897
What is Vivitrol?
From the FDA label:Naltrexone for extended-release injectable suspension is supplied as a microsphere formulation of naltrexone for suspension, to be administered by deep intramuscular injection by a healthcare practitioner. Naltrexone for extended-release injectable suspension 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 C 20 H 23 NO 4 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. Naltrexone for extended-release injectable suspension is provided in a carton containing one vial of naltrexone for extended-release injectable suspension 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. Naltrexone for extended-release injectable suspension microspheres consist of a sterile, off-white to light tan powder that is available in a dosage strength of 380 mg of naltrexone…
How to use
Naltrexone for extended-release injectable suspension must be prepared and administered by a healthcare provider (2.1 , 2.6) . Prior to initiating naltrexone for extended-release injectable suspension, 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 (2.1) . The recommended dose of naltrexone for extended-release injectable suspension is 380 mg delivered intramuscularly (deep) as a gluteal injection, every 4 weeks or once a month, alternating buttocks for each subsequent injection, using the carton components provided (2.1) . Naltrexone for extended-release injectable suspension must ONLY be administered as a deep intramuscular gluteal injection ( 2.1 ) . See Full Prescribing Information for complete Directions for Use (2.6) . 2.1 Important Dosage and Administration Information Naltrexone for extended-release injectable suspension must be prepared and administered by a healthcare provider. Naltrexone for extended-release injectable suspension must ONLY be administered as a deep intramuscular gluteal injection. Parenteral products should be visually inspected for particulate matter and discoloration prior to administration whenever solution and container permit. A properly mixed suspension will be milky white, will not contain clumps, and will move…
Side effects
The following clinically significant adverse reactions are described elsewhere in the labeling: Accidental Opioid Overdose [see Warnings and Precautions ( 5.1 ) ] Injection Site Reactions [see Warnings and Precautions ( 5.2 ) ] Precipitated Opioid Withdrawal [see Warnings and Precautions ( 5.3 ) ] Hepatotoxicity [see Warnings and Precautions ( 5.4 ) ] Depression and Suicidality [see Warnings and Precautions ( 5.5 ) ] Eosinophilic Pneumonia [see Warnings and Precautions ( 5.7 ) ] Hypersensitivity Reactions [see Warnings and Precautions ( 5.8 ) ] The adverse events seen most frequently in association with naltrexone for extended-release injectable suspension therapy for alcohol dependence (i.e., those occurring in ≥5% and at least twice as frequently with naltrexone for extended-release injectable suspension than placebo) include nausea, vomiting, injection site reactions (including induration, pruritus, nodules and swelling), muscle cramps, dizziness or syncope, somnolence or sedation, anorexia, decreased appetite or other appetite disorders (6) . The adverse events seen most frequently in association with naltrexone for extended-release injectable suspension therapy in opioid-dependent patients (i.e., those occurring in ≥2% of patients treated with naltrexone for extended-release injectable suspension and at least twice as frequently with naltrexone for extended-release…
Warnings
Important safety information
Vulnerability to Opioid Overdose : Following naltrexone for extended-release injectable suspension 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 naltrexone for extended-release injectable suspension treatment. Attempts to overcome blockade may also lead to fatal overdose. Strongly consider recommending or prescribing an opioid reversal agent (e.g., naloxone, nalmefene) for the emergency treatment of opioid overdose (5.1) . Injection Site Reactions : Naltrexone for extended-release injectable suspension 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 (5.2) . Precipitation of Opioid Withdrawal : Opioid-dependent and opioid-using patients, including those being treated for alcohol dependence, should be opioid-free before starting naltrexone for extended-release injectable suspension 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 (5.3) . Hepatotoxicity : Cases of hepatitis and clinically significant liver dysfunction were observed in association with naltrexone for extended-release injectable suspension treatment during the clinical development program and in the postmarketing period. Discontinue use of naltrexone for extended-release injectable suspension in the event of symptoms or signs of acute hepatitis (5.4) . Depression and Suicidality : Monitor patients for the development of depression or suicidal thinking (5.5) . When Reversal of Naltrexone for Extended-Release Injectable Suspension B lockade Is Required for Pain Management : In an emergency situation in patients receiving naltrexone for extended-release injectable suspension, suggestions for pain management include regional analgesia or use of non-opioid analgesics (5.6) . Eosinophilic Pneumonia : Patients who develop dyspnea and hypoxemia should seek medical attention immediately. Consider the possibility of eosinophilic pneumonia in patients who do not respond to antibiotics (5.7) . Hypersensitivity Reactions Including Anaphylaxis : Cases of urticaria, angioedema, and anaphylaxis have been observed with the use of naltrexone for extended-release injectable suspension (5.8) . 5.1 Vulnerability to Opioid Overdose After opioid detoxification, patients are likely to have reduced tolerance to opioids. Naltrexone for extended-release injectable suspension blocks the effects of exogenous opioids for approximately 28 days after administration. However, as the blockade wanes and eventually dissipates completely, patients who have been treated with naltrexone for extended-release injectable suspension may respond to lower doses of opioids than previously used, just as they would have shortly after completing detoxification. This could result in potentially life-threatening opioid intoxication (respiratory compromise or arrest, circulatory collapse, etc.) if the patient uses previously tolerated doses of opioids. Cases of opioid overdose with fatal outcomes have been reported in patients who used opioids at the end of a dosing interval, after missing a scheduled dose, or after discontinuing treatment. Patients should be alerted that they may be more sensitive to opioids, even at lower doses, after naltrexone for extended-release injectable suspension treatment is discontinued, especially at the end of a dosing interval (i.e., near the end of the month that naltrexone for extended-release injectable suspension was administered), or after a dose of naltrexone for extended-release injectable suspension is missed. 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 [see Patient Counseling Information ( 17 ) ]. There is also the possibility that a patient who is treated with naltrexone for extended-release injectable suspension could overcome the opioid blockade effect of naltrexone for extended-release injectable suspension. Although naltrexone for extended-release injectable suspension is a potent antagonist with a prolonged pharmacological effect, the blockade produced by naltrexone for extended-release injectable suspension is surmountable. The plasma concentration of exogenous opioids attained immediately following their acute administration may be sufficient to overcome the competitive receptor blockade. This poses a potential risk to individuals who attempt, on their own, to overcome the blockade by administering large amounts of exogenous opioids. Any attempt by a patient to overcome the antagonism by taking opioids is especially dangerous and may lead to life-threatening opioid intoxication or fatal overdose. Patients should be told of the serious consequences of trying to overcome the opioid blockade [see Patient Counseling Information ( 17 ) ] . Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose At the initial naltrexone for extended-release injectable suspension injection and with each subsequent injection, inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene) and discuss the importance of having access to an opioid overdose reversal agent. Because of the risks for opioid overdose described above, both at the initial naltrexone for extended-release injectable suspension injection and with each subsequent injection, strongly consider recommending or prescribing an opioid overdose reversal agent for the emergency treatment of an opioid overdose. Discuss the options for obtaining an opioid overdose reversal agent (e.g., prescription, over-the-counter, or as part of a community-based program). There are important differences among the opioid overdose reversal agents, such as route of administration, product strength, approved patient age range, and pharmacokinetics. Be familiar with these differences, as outlined in the approved labeling for those products, prior to recommending or prescribing such an agent. Educate patients and caregivers on how to recognize the signs and symptoms of an opioid overdose and how to use an opioid overdose reversal agent for the emergency treatment of opioid overdose. Emphasize the importance of calling 911 or getting emergency medical help in all cases of known or suspected opioid overdose, even if an opioid overdose reversal agent is administered. 5.2 Injection Site Reactions Naltrexone for extended-release injectable suspension must be prepared and administered by a healthcare provider. Naltrexone for extended-release injectable suspension must ONLY be administered as a deep intramuscular gluteal injection. Naltrexone for extended-release injectable suspension injections may be followed by pain, tenderness, induration, swelling, erythema, bruising, or pruritus; however, in some cases injection site reactions may be very severe. In the clinical trials, one patient developed an area of induration that continued to enlarge after 4 weeks, with subsequent development of necrotic tissue that required surgical excision. In the postmarketing period, additional cases of injection site reaction with features including induration, cellulitis, hematoma, abscess, sterile abscess, and necrosis, have been reported. Some cases required surgical intervention, including debridement of necrotic tissue. Some cases resulted in significant scarring. The reported cases occurred primarily in female patients. Naltrexone for extended-release injectable suspension is administered as a deep intramuscular gluteal injection, and inadvertent subcutaneous injection of naltrexone for extended-release injectable…
Who should not take Vivitrol
Naltrexone for extended-release injectable suspension is contraindicated in: Patients receiving opioid analgesics [see Warnings and Precautions ( 5.3 ) ] . Patients with current physiologic opioid dependence [see Warnings and Precautions ( 5.3 ) ] . Patients in acute opioid withdrawal [see Warnings and Precautions ( 5.3 ) ] . Any individual who has failed the naloxone challenge test or has a positive urine screen for opioids [see Warnings and Precautions ( 5.3 ) ] . Patients who have previously exhibited hypersensitivity to naltrexone, PLG, carboxymethylcellulose, or any other components of the diluent [see Warnings and Precautions ( 5.8 ) ]. Naltrexone for extended-release injectable suspension is contraindicated in: Patients receiving opioid analgesics (4) . Patients with current physiologic opioid dependence (4) . Patients in acute opioid withdrawal (4) . Any individual who has failed the naloxone challenge test or has a positive urine screen for opioids (4) . Patients who have previously exhibited hypersensitivity to naltrexone, polylactide-co-glycolide (PLG), carboxymethylcellulose, or any other components of the diluent (4) .
Overdose — what happens if you take too much
There is limited experience with overdose of naltrexone for extended-release injectable suspension. 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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Patients taking naltrexone for extended-release injectable suspension 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. Naltrexone antagonizes the effects of opioid-containing medicines, such as cough and cold remedies, antidiarrheal preparations, and opioid analgesics (7) .
Drug class
How this class works, per Opioid Antagonists - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Vivitrol ranks — best-rated opioid antagonist for:
Dosage forms
Kit
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Vivitrol treat?
- Vivitrol (Naltrexone) may be used to treat alcoholism, opioid-related disorders, drug overdose, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Vivitrol work?
- Vivitrol is a opioid antagonist. Opioid antagonists attach to the same brain and body receptors that opioids use, but without switching them on. By occupying those receptors, they block opioids from binding and can rapidly reverse an overdose or curb opioid cravings.
- How is Vivitrol rated?
- pharmaranks gives Vivitrol a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Vivitrol cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $36.35 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Vivitrol?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Vivitrol. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Vivitrol?
- Vivitrol is marketed by Alkermes Inc. You can see Alkermes Inc's full profile, rating, and other products on pharmaranks.
- Is Vivitrol a brand-name or generic drug?
- Vivitrol is a brand-name product with the active ingredient Naltrexone. Lower-cost generic equivalents containing Naltrexone are available — ask your pharmacist.
- Is Vivitrol available over the counter?
- No. Vivitrol is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Vivitrol come in?
- Vivitrol is currently marketed as kit, per the FDA's National Drug Code Directory.
- What class of drug is Vivitrol?
- Vivitrol is classified as opioid antagonist, per the FDA's Established Pharmacologic Class.
- Is Vivitrol FDA-registered?
- Vivitrol is on record with the U.S. FDA under application number NDA021897. You can verify this on its official FDA label.
- Has Vivitrol been recalled by the FDA?
- Yes. Vivitrol has 2 recorded FDA recall events in the openFDA enforcement database. A recall removes specific lots from the market — usually for manufacturing, contamination, potency, or labeling issues — and does not mean the drug is unsafe to take; your specific lot was almost certainly never affected. This recall history is factored into its safety score above. Always check the FDA recall database or your pharmacist for current alerts.
- Is Vivitrol safe?
- There's no single safe-or-not verdict. pharmaranks gives Vivitrol a recall-safety score of 70/100, based on its FDA recall history (2 recorded recall events) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Vivitrol?
- Vivitrol's side effects are taken directly from its FDA label. From the label: The following clinically significant adverse reactions are described elsewhere in the labeling: Accidental Opioid Overdose [see Warnings and Precautions ( 5.1 ) ] Injection Site Reactions [see Warnings and Precautions ( 5.2 ) ] Precipitated Opioid Withdrawal [see Warnings and Precautions ( 5.3 ) ] H… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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vivitrol
70/100