FREQUENTLY ASKED QUESTIONS ABOUT SUBOXONE (BUPRENORPHINE NALOXONE)
- Suboxone/Buprenorphine is a Medication used to help people quit or reduce their use of opioids or other opioids (pain relievers like morphine).
- It comes as a dissolvable film strip or a pill. The Medication contains Buprenorphine (an opioid Medication) and Naloxone (Narcan). If you take it under the tongue, the Buprenorphine works in your body but the Naloxone is not absorbed (not active). But if you crush it up and inject it or snort it, the Naloxone is active and will make you withdraw if you have other opioids in your body . This helps to make sure people only take it under the tongue and not inject the medicine.
- Maintenance treatment is taking Buprenorphine every day in order to:
- Cut Cravings.
- Stop withdrawal symptoms for at least 24 hours.
- Act as a chemical shield - Suboxone/Buprenorphine acts at the same place in the brain as opioids, while taking Suboxone/Buprenorphine, it prevents from getting high from other opioids.
- Suboxone/Buprenorphine is a medicine that helps to treat addiction to opioids. It does not treat other kinds of addictions, such as Alcohol, Methamphetamine, Marijuana, etc.
- Medication treatment is very effective in keeping patients off opioids. It treats withdrawal, cravings and decreases the risk of overdose.
- Suboxone/Buprenorphine is very safe with a low risk of overdose. But, when mixed with Benzodiazepines (Xanax, Ativan, Valium, Lorazepam, Clonazepam) in large doses, or with large amounts of Alcohol, there is a risk of overdose (a chance of stopping breathing and dying).
- Just like taking pain pills or opioids regularly, your body becomes used to (physically dependent) on the Suboxone/Buprenorphine so if you stop it suddenly, you will withdraw (”kick”). If you want to stop taking it every day, talk with your Provider first and it can be slowly stopped.
- Side effects are rare, but they can include constipation, headache, trouble sleeping, ankle swelling, trouble urinating; and rarely, liver irritation.
- Pregnant women should not take Suboxone/Buprenorphine. Instead they should use Methadone or a different form of Buprenorphine called Subutex. Small children and babies should never take Suboxone/Buprenorphine, since it can cause them to stop breathing and die. It is very important to keep all Suboxone/Buprenorphine away from babies and small children, and call 911 if they accidentally taste or swallow any.
- No! When people are addicted to a drug, they crave it, want larger and larger quantities, can't stop, and often do risky things to obtain it. They also feel high when they take it. None of these are true with Suboxone/Buprenorphine. Suboxone/Buprenorphine does not make you addicted. Many patients say that Suboxone/Buprenorphine makes them feel “normal” rather than “high”.
- Suboxone/Buprenorphine can only be prescribed by a Provider with a special license.
- There is no copay with Medicaid.
- Without insurance, costs are approximately $500 a month.
- There is no limit to how long someone can take Suboxone/Buprenorphine.
- Both are good Medications that help patients cut their use of opioids.
- Methadone is administered via a Methadone clinic. One can obtain Suboxone/Buprenorphine via prescription from a Provider.
- Compared to Methadone, many patients say Subuxone/Buprenorphine makes them feel "less sleepy" and "less high".
BUPRENORPHINE/NALOXONE MAINTENANCE TREATMENT FOR OPIOID DEPENDENCE
INFORMATION for FAMILY MEMBERS
Family members of patients who have been prescribed Buprenorphine/Naloxone for treatment of opioid addiction often have questions about this treatment.
Opioids are narcotics (medicines that are used to treat pain, cough or opioid addiction and which produce drowsiness, fuzzy thinking, and euphoria in some). Opioids are in the same family as Opium, Morphine, and Opioids. This includes many prescription pain Medications, such as Codeine, Vicodin, Lortab or Lorcet, Demerol, Dilaudid, Morphine, MSContin, Oxycontin, and Percodan or Percocet. Methadone and Buprenorphine are also opioids. Buprenorphine is the opioid medicine in Buprenorphine/Naloxone that treats opioid addiction.
Many family members wonder why Providers use Buprenorphine to treat opiate addiction, since it is in the same family as opioids. Some of them ask “Isn't this substituting one addiction for another?” But the Medications used to treat addiction to opioids and prescription pain Medications — Methadone and Buprenorphine are longer-acting than other opioids like opioids and so are not just substitution. Many medical studies since 1965 show that maintenance treatment with these long-acting opioids helps keep patients healthier, and helps to prevent them from getting other diseases such as Hepatitis and/or HIV/AIDS.
Buprenorphine/Naloxone is a tablet or strip that combines the opioid Medication, Buprenorphine, and Naloxone, a Medication called an opioid antagonist, for treatment of opioid dependence. Buprenorphine/Naloxone is a medicine that is taken once daily by dissolving under the tongue. Naloxone is inactive (poorly absorbed) when taken this way. However, Naloxone when injected by someone whose body is physically dependent on opioids will produce opiate withdrawal. In this way, the Naloxone helps to prevent abuse of Buprenorphine/Naloxone by injection.
Family members of patients who have been addicted to opioids or prescription opioids have watched as their loved ones use a drug that makes them intoxicated or ‘high’ or have watched the painful withdrawal that occurs when the drug is not available. Sometimes the family has not seen the normal person for years. They may have seen the patient misuse Providers’ prescriptions for opiate narcotics to get ’high’. They are rightly concerned that the patient might misuse or take too much of the Buprenorphine/Naloxone prescribed by the Provider. They may watch the patient and notice that the patient seems drowsy, or stimulated, or restless, and think that the Buprenorphine/Naloxone will be just as bad as opioids or other prescription opioids that the patient is abusing.
Every opioid can have stimulating or sedating effects, especially in the first weeks of treatment. Once a patient is stabilized on the correct dose of Buprenorphine, the patient should not feel 'high', and there should be no excessive sleepiness or intoxication. The ‘right' dose of Buprenorphine/Naloxone is the one that allows the patient to feel and act normally. Most patients will need 8/2mg (Buprenorphine/Naloxone) to 16/4mg of Buprenorphine/Naloxona daily to achieve relief of opiate withdrawal symptoms and cravings. Most patients can be inducted onto the Buprenorphine/Naloxone and stabilized within a few days. Occasionally it may take a little longer to find the right dose (up to a few weeks). During the period of dose adjustment, the Buprenorphine level in the Buprenorphine/Naloxone may be too high, or too low, which can lead to withdrawal, Daytime sleepiness, or trouble sleeping at night. The patient may ask that family members help keep track of the timing of these symptoms, and write them down. Then the Provider can use all these clues to adjust the amount and time of day for the Buprenorphine/Naloxone dose.
Once the right dose is found, it is important to take It on time in a regular basis (once daily), so the patient's body and brain can adjust.
Even though maintenance treatment for opioid addiction works very well, it is NOT a cure. This means that the patient will continue to need the stable dose of Buprenorphine/Naloxone, with regular monitoring by the Provider. This is similar to other chronic diseases, such as diabetes or asthma. These illnesses can be treated, but there is no permanent cure, so patients often stay on the same Medication for a extended period of time. The best way to help and support the patient is to encourage regular medical care, and encourage the patient not to skip or forget to take the Medication.
- Regular medical care
Patients will be required to see the physician for ongoing Buprenorphine/Naloxone treatment at least every two to four weeks, once they are stable. If they miss an appointment, they may not be able to refill the Medication on time, and may even go into withdrawal, which could be uncomfortable. The patient will be asked to bring the Medication container to each visit, and may be asked to give urine, blood or breath samples at the time of the visit. Sometimes the patient may be called in randomly to have their pills counted and/or to give a urine analysis to test for the presence of other drugs or Alcohol. This is a regular part of drug abuse treatment and is done for the patient's safety and to make sure that they are getting the treatment needed.
Patients who are recovering from addiction need counseling and other psychosocial treatments. The patient may have regular appointments with an individual counselor or be involved in group therapy. These appointments are key parts of treatment, and work together with the Buprenorphine/Naloxone to improve i.e success in treatment for addiction. Sometimes family members may be asked to join in family therapy sessions which also are geared to improve addiction care.
Most patients use some kind of recovery group to maintain their sobriety. It sometimes takes several visits to different groups to find the right ‘home’ meeting. In the first year of recovery some patients go to meetings every day, or several times per week. These meetings work to improve success in treatment, in addition to taking Buprenorphine/Naloxone. Family members may have their own meetings, such as Al-Anon, or ACA, to support them in adjusting to life with a patient who has addiction.
- Taking the Medication
Buprenorphine/Naloxone Medication is unusual because it must be dissolved under the tongue, rather than swallowed. Please be aware that this can take up to a few minutes. While the Medication is dissolving, the patient will not be able to answer the phone, or the doorbell, or speak very easily. This means that the family will need to get used to the patient being ‘out of commission’ for a few minutes whenever the regular dose is scheduled.
- Storing the Medication
If Buprenorphine/Naloxone is lost or misplaced, the patient may skip doses or go into withdrawal, so it is very important to find a good place to keep the Medication safely at home preferably in a locked cabinet or lock box - away from children or pets who can become seriously ill or even die if they accidentally take this Medication. Always keep the medicine in the same location, so it can be easily found. The Provider may give the patient a few ‘backup’ pills, in a separate bottle, in case an appointment has to be rescheduled, or there is an emergency of some kind. DO NOT put the Buprenorphine/Naloxone next to the vitamins, or the aspirin, or other over-the-counter Medications, to avoid confusion. If a family member or visitor takes Buprenorphine/Naloxone by mistake, he or she should be checked by a physician or taken to an emergency department immediately as serious adverse reactions can occur if someone who does not usually take this medicine were to take it by mistake.
It is hard for any family when a member finds out he or she has a disease that is not curable. This is true for addiction as well. When chronic diseases go untreated, they have severe complications which can lead to disability and death. Fortunately, Buprenorphine/Naloxone maintenance can be a successful treatment, especially if it is integrated with counseling and support for life changes that the patient has to make to remain sober.
Chronic disease means the disease is there every day, and must be treated every day. This takes time and attention away from other things, and family members may resent the effort and time and money that it takes for Buprenorphine/Naloxone treatment and counseling. It might help to compare addiction to other chronic diseases, like diabetes or high blood pressure.
Another very important issue for family members to know about is that addiction can be partly inherited. Research is showing that some people have more risk for becoming addicted than others and that some of this risk is genetic. So when one member develops opioid addiction, it means that other blood relatives should learn themselves ‘at risk’ of developing addiction.
It is common for people to think of addiction as a weakness in character, instead of as a disease. Perhaps the first few times the person used drugs it was poor judgment. However, by the time the patient is addicted, using every day, and needing medical treatment, it should be considered to be a ‘brain disease’ rather than a problem with willpower.
Sometimes when the patient improves and starts feeling "normal", the family has to get used to the new “normal" person. The family interactions might have been all about trying to help this person in trouble, and now he or she is no longer in so much trouble. Some families can use some help themselves during this change and might ask for family therapy for a while.
SUBLOCADE (SUB‐lo‐kade) (Buprenorphine extended‐release) injection, for Subcutaneous use, (CIII)
- Because of the serious risk of potential harm or death from self‐injecting Sublocade into a vein (intravenously), it is only available through a restricted program called the Sublocade REMS Program.
- Sublocade is not available in retail pharmacies.
- Your Sublocade injection will only be given to you by a certified healthcare Provider.
- Sublocade contains a medicine called Buprenorphine. Buprenorphine is an opioid that can cause serious and life-threatening breathing problems, especially if you take or use certain other medicines or drugs.
- Talk to your healthcare Provider about Naloxone. Naloxone is a medicine that is available to patients for the emergency treatment of an opioid overdose. If Naloxone is given, you must call 911 or get emergency medical help right away to treat overdose or accidental use of an opioid.
- Sublocade may cause serious and life‐threatening breathing problems. Get emergency help right away for these symptoms:
- Feel faint.
- Feel dizzy.
- Are confused.
- Feel sleepy or uncoordinated.
- Have blurred vision.
- Have slurred speech.
- Breathing Slower than normal.
- Cannot think well or clearly.
Do not take certain medicines during treatment with Sublocade. Taking other opioid medicines, Benzodiazepines, Alcohol, or other central nervous system depressants (including street drugs) while on Sublocade can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
- In an emergency, have family members tell emergency department staff that you are physically dependent on an opioid and are being treated with Sublocade.
- Detectable levels of Sublocade for extended periods of time after stopping treatment is likely.
Sublocade is a prescription medicine used to treat adults with moderate to severe addiction (dependence) to opioid drugs (prescription or illegal) who:
- Have received treatment with an oral transmucosal (used under the tongue or inside the cheek) Buprenorphine‐containing medicine for 7 days and
- Are taking a dose that controls withdrawal symptoms for at least 7 days.
- Sublocade is part of a complete treatment plan that could include counseling.
Do not use Sublocade if you are allergic to Buprenorphine or any ingredient in the prefilled syringe (ATRIGEL® delivery system). See the end of this Medication Guide for a list of ingredients in Sublocade.
Before starting Sublocade, tell your healthcare Provider about all your medical conditions, including if you have:
- Trouble breathing or lung problems.
- A curve in your spine that affects your breathing.
- Addison’s disease.
- An enlarged prostate (men).
- Problems urinating.
- Liver, kidney, or gallbladder problems.
- A head injury or brain problem.
- Mental health problems.
- Adrenal gland or thyroid gland problems.
Tell your healthcare Provider if you are:
- pregnant or plan to become pregnant. If you receive Sublocade while pregnant, your baby may have symptoms of opioid withdrawal at birth that could be life‐threatening if not recognized and treated. Talk to your healthcare Provider if you are pregnant or plan to become pregnant.
- breastfeeding or plan to breastfeed. Sublocade can pass into your breast milk and harm your baby. Talk to your healthcare Provider about the best way to feed your baby during treatment with Sublocade. Monitor your baby for increased drowsiness and breathing problems if you breastfeed during treatment with Sublocade.
Tell your healthcare Provider about all the medicine you take, including prescription and over‐the‐counter medicine, vitamins and herbal supplements.
- You will receive Sublocade by your healthcare Provider as an injection just under the skin (Subcutaneous) of your stomach (abdomen). You will receive Sublocade monthly (with at least 26 days between doses).
- Sublocade is injected as a liquid. After the injection, Sublocade changes to a solid form called a depot. The depot may be seen or felt as a small bump under your skin at the injection site on your abdomen for several weeks. The depot will get smaller over time.
- Do not try to remove the depot.
- Do not rub or massage the injection site.
- Try not to let belts or clothing waistbands rub against the injection site.
- If you miss a dose of Sublocade, see your healthcare Provider to get your Sublocade injection as soon as possible.
- Do not drive, operate heavy machinery, or perform any other dangerous activities until you know how Sublocade affects you. Buprenorphine can cause drowsiness and slow reaction times. Sublocade can make the patient feel sleepy, dizzy, or lightheaded. This may happen more often in the first few days after the injections and when the dosage is changed.
- You should not drink Alcohol or take prescription or over‐the‐counter medicine that contain Alcohol during treatment with Sublocade, because this can lead to loss of consciousness or even death.
Sublocade can cause serious side effects, including:
- Trouble breathing. Taking other opioid medicine, Benzodiazepines, Alcohol, or other central nervous system depressants during treatment with Sublocade can cause breathing problems that can lead to coma and death.
- Sleepiness, dizziness, and problems with coordination.
- Physical dependence.
- Liver problems. Call your healthcare Provider right away if you notice any of these symptoms:
- Skin or the white part of eyes turns yellow (jaundice).
- Dark or 'tea-colored' urine.
- Light colored stools (bowel movements).
- Loss of appetite.
- Pain, aching, or tenderness on the right side of your stomach area.
- Your healthcare Provider should do blood tests to check your liver before you start and during treatment with Sublocade.
- Allergic reaction. You may have a rash, hives, swelling of your face, wheezing, low blood pressure, or loss of consciousness. Call a healthcare Provider or get emergency help right away.
- Opioid withdrawal. Call your healthcare Provider right away if you get any of these symptoms:
- Sweating more than normal.
- Feeling hot or cold more than normal.
- Runny nose.
- Watery eyes.
- Goose bumps.
- Muscle aches.
- Decrease in blood pressure. Dizziness may occur upon getting up from a seated or laying down position.
- The most common side effects of Sublocade include:
- Injection site itching.
- Increase in liver enzymes.
- Injection site pain.
- Sublocade may affect fertility in males and females. Talk to your healthcare Provider if this is a concern for you.
These are not all the possible side effects of Sublocade.
Call your Provider for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
General information about Sublocade
medicine are sometimes prescribed for purposes other than those listed in a Medication Guide. Ask a Provider or Pharmacist for information on Sublocade that is written for healthcare professionals.
Active ingredient: Buprenorphine
ATRIGEL ® delivery system: biodegradable 50:50 poly(DL‐lactide‐co‐glycolide) polymer and a biocompatible solvent, N‐
Manufactured for Indivior Inc., North Chesterfield, VA 23235 by AMRI, Burlington, MA 01803
SUBLOCADE® is a registered trademark of Indivior UK Limited.
For more information, go to www.SUBLOCADE.com or call 1-877-782-6966.
This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 03/2021