SUBOXONE® (buprenorphine and naloxone) Sublingual Film (CIII) is a prescription medicine used to treat adults who are addicted to (dependent on) opioid drugs (either prescription or illegal) as part of a complete treatment program that also includes counseling and behavioral therapy.
Keep SUBOXONE Film in a secure place out of sight and reach of children, and in a location not accessible by others, including visitors to the home. Accidental use by a child is a medical emergency and can result in death. If a child accidently uses SUBOXONE Film, get emergency help right away.
SUBOXONE Film can cause serious and life‐threatening breathing problems. Call your healthcare provider right away or get emergency help if:
These can be signs of an overdose or other serious problems.
Do not switch from SUBOXONE Film to other medicines that contain buprenorphine without talking with your healthcare provider. The amount of buprenorphine in a dose of SUBOXONE Film is not the same as the amount of buprenorphine in other medicines that contain buprenorphine. Your healthcare provider will prescribe a starting dose of SUBOXONE Film that may be different than other buprenorphine containing medicines you may have been taking.
SUBOXONE sublingual film contains an opioid that can cause physical dependence with chronic use.
Life-threatening breathing problems, an overdose and even death can happen if you take benzodiazepines, sedatives, tranquilizers, antidepressants, or alcohol while using SUBOXONE Film. Ask your healthcare provider what you should do if you are taking one of these.
Call your healthcare provider or get emergency help right away if you:
Do not inject (“shoot‐up”) SUBOXONE Film.
In an emergency, have family members tell emergency department staff that you are physically dependent on an opioid and are being treated with SUBOXONE Film.
SUBOXONE film is a controlled substance (CIII) because it contains buprenorphine, which can be a target for people who abuse prescription medicines or street drugs. Keep your SUBOXONE sublingual film in a safe place to protect it from theft. Never give your SUBOXONE sublingual film to anyone else; it can cause death or harm them. Selling or giving away this medicine is against the law.
Death has been reported in those who are not opioid dependent.
Do not take SUBOXONE Film if you are allergic to buprenorphine or naloxone, as serious negative effects, including anaphylactic shock, have been reported.
Do not take SUBOXONE Film before the effects of other opioids (e.g., heroin, hydrocodone, methadone, morphine, oxycodone) have started to wear off as you may experience withdrawal symptoms.
SUBOXONE Film may not be right for you. Before taking SUBOXONE Film, tell your healthcare provider about all of your medical conditions, including:
Tell your healthcare provider about all the medicines you take, including prescription and over- the-counter medicines, vitamins and herbal supplements. SUBOXONE Film may affect the way other medicines work and other medicines may affect how SUBOXONE Film works. Some medicines may cause serious or life-threatening medical problems when taken with SUBOXONE Film.
Sometimes the doses of certain medicines may need to be changed if used together. Do not take any medicine while using SUBOXONE Film until you have talked with your healthcare provider. Your healthcare provider will tell you if it is safe to take other medicines while you are taking SUBOXONE Film.
Be especially careful about taking other medicines that may make you sleepy, such as pain medicines, tranquilizers, antidepressant medicines, sleeping pills, anxiety medicines or antihistamines while using SUBOXONE Film until you have talked with your healthcare provider.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist each time you get a new medicine.
SUBOXONE Film can cause serious side effects, including:
These are not all the possible side effects. Call your healthcare provider for medical advice about side effects.
To report pregnancy or side effects associated with taking SUBOXONE Film, please call 1-877-782-6966. You are encouraged to report negative side effects of drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information about SUBOXONE Film, see the full Prescribing Information, and Medication Guide or talk to your healthcare provider. For REMS information visit www.suboxoneREMS.com.
SUBOXONE® and SUBUTEX® are registered trademarks of Indivior UK Limited.
SUBOXONE Film is manufactured for Indivior Inc., North Chesterfield, VA 23235 by Aquestive Therapeutics, Warren, NJ 07059.
This site is sponsored by Indivior Inc. and intended solely for residents of the United States only.
© Indivior PLC | INDIVIOR is a registered trademark of Indivior UK Limited | All rights reserved
P-SBF-US-00199
Naloxone is a medication approved by the Food and Drug Administration (FDA) to prevent overdose by opioids such as heroin, morphine, and oxycodone. It blocks opioid receptor sites, reversing the toxic effects of the overdose. Naloxone is administered when a patient is showing signs of opioid overdose. The medication can be given by intranasal spray, intramuscular (into the muscle), subcutaneous (under the skin), or intravenous injection.
A doctor can prescribe naloxone to patients who are in medication-assisted treatment (MAT), especially if the patient is taking medications used in MATor considered a risk for opioid overdose. Candidates for naloxone are those who:
Pregnant women can be safely given naloxone in limited doses under the supervision of a doctor.
A doctor or pharmacist can show patients, their family members, or caregivers how to administer naloxone. Intravenous injection every two to three minutes is recommended in emergencies.
Patients given an automatic injection device or nasal spray should keep the item available at all times. Medication should be replaced when the expiration date passes.
Naloxone is effective if opioids are misused in combination with other sedatives or stimulants. It is not effective in treating overdoses of benzodiazepines or stimulant overdoses involving cocaine and amphetamines.
Patients who experience an allergic reaction from naloxone, such as hives or swelling in the face, lips, or throat, should seek medical help immediately. They should not drive or perform other potentially unsafe tasks.
Use of naloxone may cause symptoms of opioid withdrawal, including:
Opioid overdose can happen:
Opioid overdose is life-threatening and requires immediate emergency attention. Recognizing the signs of opioid overdose is essential to saving lives. Learn more about opioid overdose.
In an effort to save more lives from opioid overdose, SAMHSA published the Opioid Overdose Prevention Toolkit – 2018. The Toolkit equips communities and local governments with material to develop policies and practices to help prevent opioid-related overdoses and deaths. It also serves as a foundation for educating and training:
SAMHSA is also working with its federal partners and state and local law enforcement to expand the safe administration of naloxone by first responders.
SAMHSA is working with emergency medical service professionals to:
The SAMHSA publication Expansion of Naloxone in the Prevention of Opioid Overdose – 2014 (PDF | 479 KB) explains this effort further.
Naloxone is a regulated medication and must be administered properly. SAMHSA’s Division of Pharmacologic Therapies (DPT) provides opioid prescribing courses for physicians, webinars, workshops, and summits.
If you or your loved one is considering treatment options for an opioid-free recovery journey, it may be time to discuss VIVITROL with a healthcare provider.
Before starting VIVITROL, you must be opioid-free for a minimum of 7 to 14 days to avoid sudden opioid withdrawal.
Patient stories reflect personal experiences. Individual experiences may vary.
"I think that along with counseling and along with the injection, we'd finally found a treatment that was right for her."
LISA
Click here to download the video. 200.3MB
When used as part of a treatment plan that includes counseling, VIVITROL prevents relapse to opioid dependence after opioid detox.
Patients were less likely to relapse to dependence2,3
Patients had a significant reduction in opioid cravings2
This data is from a 6-month, double-blind, placebo-controlled, randomized clinical study of 124 opioid-dependent patients treated with placebo and counseling who were compared to 126 opioid-dependent patients treated with VIVITROL and counseling, following opioid detoxification.1,2
*Complete abstinence was defined as a negative urine drug test for opioids and no self-reported opioid use for all weekly visits.†During Weeks 5-24 of the study. Data were not collected during Weeks 1-4 of the trial to allow for stabilization of abstinence.‡Craving described as a "need for opioids" and measured on a scale from 0-100 (with 0 being "none" and 100 being "very much so") was reported every week.
WHAT DOES VIVITROL DO? SEE HOW IT WORKS.
Yes. One serious side effect of VIVITROL is the risk of opioid overdose. Using opioids, even in amounts that you used before VIVITROL treatment, can lead to accidental overdose, serious injury, coma, or death.
Get emergency medical help right away if you:
It is important that you tell your family and the people closest to you of this increased sensitivity to opioids and the risk of overdose.
Yes. One serious side effect of VIVITROL is severe reactions at the site of the injection, including tissue death. Some injection site reactions have required surgery. VIVITROL must be injected by a healthcare provider. Call your healthcare provider right away if you notice any of the following at your injection site:
Tell your healthcare provider about any injection site reaction that concerns you, gets worse over time, or does not get better by two weeks after the injection.
Yes. One serious side effect of VIVITROL is sudden opioid withdrawal. You must stop taking any opioids or opioid-containing medications, including buprenorphine or methadone, for at least 7 to 14 days before starting VIVITROL. If your healthcare provider decides that you don’t need to complete detox first, he or she may give you VIVITROL in a medical facility that can treat sudden opioid withdrawal. Sudden opioid withdrawal can be severe and may require hospitalization.
VIVITROL is not right for everyone. There are significant risks from VIVITROL treatment, including risk of opioid overdose, severe reaction at the injection site and sudden opioid withdrawal.
See Important Safety Information below. Discuss all benefits and risks with a healthcare provider. See Prescribing Information and Medication Guide.
This tool can help you find a healthcare provider in your area who can answer your questions about VIVITROL.
Learn how the VIVITROL® Co-pay Savings Program may assist eligible* patients with out-of-pocket expenses for their VIVITROL prescriptions.
SEARCHLEARN MORE
WARNING: RISK OF SERIOUS HARM OR DEATH WITH INTRAVENOUS ADMINISTRATION;
SUBLOCADE RISK EVALUATION AND MITIGATION STRATEGY
CONTRAINDICATIONS: SUBLOCADE should not be administered to patients who are hypersensitive to buprenorphine or any component of the ATRIGEL® delivery system.
Addiction, Abuse, and Misuse: SUBLOCADE contains buprenorphine, a Schedule III controlled substance that can be abused in a manner similar to other opioids. Buprenorphine is sought by people with opioid use disorder and is subject to criminal diversion. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors.
Risk of Respiratory Depression and Concomitant Use of Benzodiazepines or Other CNS Depressants with Buprenorphine: Buprenorphine has been associated with life-threatening respiratory depression, overdose, and death, particularly when misused by self-injection or with concomitant use of benzodiazepines or other CNS depressants, including alcohol. Warn patients of the potential danger of self-administration of benzodiazepines, other CNS depressants, opioid analgesics, and alcohol while under treatment with SUBLOCADE. Counsel patients that such medications should not be used concomitantly unless supervised by a healthcare provider.
Use with caution in patients with compromised respiratory function (e.g., chronic obstructive pulmonary disease, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, or pre-existing respiratory depression).
Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome (NOWS) is an expected and treatable outcome of prolonged use of opioids during pregnancy. NOWS may be life-threatening if not recognized and treated in the neonate. Newborns should be observed for signs of NOWS and managed accordingly. Advise pregnant women receiving opioid addiction treatment with SUBLOCADE of the risk of neonatal opioid withdrawal syndrome.
Adrenal Insufficiency: Adrenal insufficiency has been reported with opioid use. If adrenal insufficiency is diagnosed, treat with physiologic replacement doses of corticosteroids. Wean the patient off the opioid.
Discontinuation of SUBLOCADE Treatment: Due to the long-acting nature of SUBLOCADE, if treatment is discontinued, monitor patients for several months for withdrawal and treat appropriately.
Inform patients that they may have detectable levels of buprenorphine for a prolonged period of time after treatment with SUBLOCADE. Considerations of drug-drug interactions, buprenorphine effects, and analgesia may continue to be relevant for several months after the last injection.
Risk of Hepatitis, Hepatic Events: Because cases of cytolytic hepatitis and hepatitis with jaundice have been observed in individuals receiving buprenorphine, monitor liver function tests prior to treatment and monthly during treatment.
Hypersensitivity Reactions: Hypersensitivity to buprenorphine-containing products have been reported most commonly as rashes, hives, and pruritus. Some cases of bronchospasm, angioneurotic edema, and anaphylactic shock have also been reported.
Precipitation of Opioid Withdrawal in Patients Dependent on Full Agonist Opioids: Buprenorphine may precipitate opioid withdrawal signs and symptoms in persons who are currently physically dependent on full opioid agonists such as heroin, morphine, or methadone before the effects of the full opioid agonist have subsided. Verify that patients have tolerated and are dose adjusted on transmucosal buprenorphine before subcutaneously injecting SUBLOCADE.
Risks Associated With Treatment of Emergent Acute Pain: When patients need acute pain management, or may require anesthesia, treat patients receiving SUBLOCADE currently or within the last 6 months with a non-opioid analgesic whenever possible. If opioid therapy is required, patients may be treated with a high-affinity full opioid analgesic under the supervision of a physician, with particular attention to respiratory function, as higher doses may be required for analgesic effect and therefore, a higher potential for toxicity exists with opioid administration.
Advise patients of the importance of instructing their family members, in the event of emergency, to inform the treating healthcare provider or emergency room staff that the patient is physically dependent on an opioid and that the patient is being treated with SUBLOCADE.
Use in Opioid Naïve Patients: Because death has been reported for opioid naïve individuals who received buprenorphine sublingual tablet, SUBLOCADE is not appropriate for use in opioid naïve patients.
Use in Patients With Impaired Hepatic Function: Because buprenorphine levels cannot be rapidly decreased, SUBLOCADE is not recommended for patients with pre-existing moderate to severe hepatic impairment. Patients who develop moderate to severe hepatic impairment while being treated with SUBLOCADE should be monitored for several months for signs and symptoms of toxicity or overdose caused by increased levels of buprenorphine.
Use in Patients at Risk for Arrhythmia: Buprenorphine has been observed to prolong the QTc interval in some patients participating in clinical trials. Avoid use of buprenorphine in patients with a history of Long QT Syndrome or an immediate family member with this condition or those taking Class IA antiarrhythmic medications (e.g., quinidine, procainamide, disopyramide) or Class III antiarrhythmic medications (e.g., sotalol, amiodarone, dofetilide), or other medications that prolong the QT interval.
Impairment of Ability to Drive or Operate Machinery: SUBLOCADE may impair the mental or physical abilities required for the performance of potentially dangerous tasks such as driving a car or operating machinery. Caution patients about driving or operating hazardous machinery until they are reasonably certain that SUBLOCADE does not adversely affect their ability to engage in such activities.
Orthostatic Hypotension: Buprenorphine may produce orthostatic hypotension.
Elevation of Cerebrospinal Fluid Pressure: Buprenorphine may elevate cerebrospinal fluid pressure and should be used with caution in patients with head injury, intracranial lesions, and other circumstances when cerebrospinal pressure may be increased. Buprenorphine can produce miosis and changes in the level of consciousness that may interfere with patient evaluation.
Elevation of Intracholedochal Pressure: Buprenorphine has been shown to increase intracholedochal pressure, as do other opioids, and thus should be administered with caution to patients with dysfunction of the biliary tract.
Effects in Acute Abdominal Conditions: Buprenorphine may obscure the diagnosis or clinical course of patients with acute abdominal conditions.
Unintentional Pediatric Exposure: Buprenorphine can cause severe, possibly fatal, respiratory depression in children who are accidentally exposed to it.
ADVERSE REACTIONS: Adverse reactions commonly associated with SUBLOCADE (≥5% of subjects) during clinical trials were constipation, headache, nausea, vomiting, increased hepatic enzymes, fatigue, and injection site pain and pruritus. This is not a complete list of potential adverse events. Please see the full Prescribing Information for a complete list.
CYP3A4 Inhibitors and Inducers: Monitor patients starting or ending CYP3A4 inhibitors or inducers for potential over- or under-dosing.
Serotonergic Drugs: If concomitant use with serotonergic drugs is warranted, monitor for serotonin syndrome, particularly during treatment initiation, and during dose adjustment of the serotonergic drug.
Consult the full Prescribing Information for SUBLOCADE for more information on potentially significant drug interactions.
Pregnancy: Opioid-dependent women on buprenorphine maintenance therapy may require additional analgesia during labor.
Lactation: Buprenorphine passes into the mother's milk. Advise breastfeeding women to monitor the infant for increased drowsiness and breathing difficulties.
Fertility: Chronic use of opioids may cause reduced fertility. It is not known whether these effects on fertility are reversible.
Geriatric Patients: Monitor geriatric patients receiving SUBLOCADE for sedation or respiratory depression.
To report pregnancy or side effects associated with taking SUBLOCADE, please call 1-877-782-6966.
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