Answers to questions you may have about BRIXADI
Other questions you may have about BRIXADI:
BRIXADI is an FDA-approved medicine that can help treat moderate to severe OUD. BRIXADI and counseling can help reduce your drug use.
BRIXADI is injected as a liquid just under the skin (subcutaneously) by your healthcare provider. After the injection, BRIXADI changes to a gel form called a depot. The depot is not always felt under the skin. The depot slowly releases buprenorphine into your body throughout the entire week or month at a steady rate. This means that the medicine is released all week or month without daily ups and downs.
BRIXADI is an injection given just under the skin (subcutaneously) by your healthcare provider at their office.
BRIXADI is available as a once-a-week or once-a-month injection. You and your healthcare provider will decide which dose is right for you.
Deciding which dose is right for you should be a partnership between you and your healthcare provider. The right dose for you could depend on:
- What point you are at in your recovery journey
- Whether you have taken buprenorphine before
- Your ability to come to the office on a weekly or monthly basis
Talk openly with your healthcare provider if you have any concerns about BRIXADI.
The safety profile of BRIXADI was consistent with the known safety profile of oral buprenorphine with the exception of mild-to-moderate injection-site reactions. The most common side effects of BRIXADI include:
- Injection site pain
- Headache
- Constipation
- Nausea
- Injection site redness
- Injection site itching
- Trouble sleeping (insomnia)
- Urinary tract infection
These are not all the possible side effects of BRIXADI. Tell your healthcare provider if you experience any side effects from BRIXADI.
Upon injection, the depot slowly releases buprenorphine into your body and continues to release medicine throughout the entire week or month at a steady rate. This means that the medicine is released all week or month without daily ups and downs.
There are 2 forms of buprenorphine to treat opioid addiction: a daily oral tablet or film and a long-acting injection. BRIXADI is the only long-acting injection that has both weekly and monthly doses.
Withdrawal is not required to switch from oral buprenorphine to BRIXADI. Speak to your healthcare provider if you have concerns about withdrawal when switching from oral buprenorphine to BRIXADI.
BRIXADI may affect the way other medicines work. Other medicines may also affect how BRIXADI works. Some medicines may cause serious or life-threatening medical problems when taken with BRIXADI. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Your healthcare provider will help decide if BRIXADI is the right choice for you.
Call your healthcare provider immediately to reschedule if you know you are going to miss an appointment to ensure they get their medicine as soon as possible.
BRIXADI must be given by a healthcare provider in their office. This means they will never give you a dose of BRIXADI to take home, and you won’t be able to give yourself the injection.
OUD is a chronic, relapsing disease, which means that long-term treatment (including medicine and counseling) may be needed. Your healthcare provider will decide how long you should stay on medicine. Talk to your healthcare provider about your treatment goals.
Questions about starting BRIXADI:
Click here to find a healthcare provider in your area who can prescribe BRIXADI.
In most cases, your healthcare provider will order BRIXADI for you through a specialty pharmacy. This is different from a retail pharmacy. The pharmacy may need to contact you to complete the request. Remember to return their call or text to ensure there is no delay in the shipment. BRIXADI will be shipped directly to your healthcare provider’s office, and it will be ready for you when you arrive for your appointment to receive BRIXADI.
If you have private insurance (not state or government funded), you may be able to receive BRIXADI at no cost through the BRIXADI Copay Savings Program. See if you’re eligible.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about BRIXADI?
- Because of the serious risk of potential harm or death from self-injecting BRIXADI into a vein (intravenously), it is only available through a restricted program called the BRIXADI Risk Evaluation and Mitigation Strategy (REMS) Program.
- BRIXADI is not available in retail pharmacies.
- Your BRIXADI injection will only be given to you by a healthcare provider.
- BRIXADI (buprenorphine) extended-release injection for subcutaneous use 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 an overdose or accidental use of an opioid.
- BRIXADI can cause serious and life-threatening breathing problems. Get emergency help right away if you:
- feel faint
- feel dizzy
- are confused
- feel sleepy or uncoordinated
- have blurred vision
- have slurred speech
- are breathing slower than normal
- cannot think well or clearly
- Do not take BRIXADI with certain medicines. Taking BRIXADI with other opioid medicines, benzodiazepines, alcohol, other central nervous system depressants (including street drugs) can cause severe drowsiness, decreased awareness, breathing problems, coma, and death.
- In an emergency, have family members tell the emergency department staff that you are physically dependent on an opioid and are being treated with BRIXADI.
- You may have detectable levels of BRIXADI in your body for several months after stopping treatment with BRIXADI.
Do not receive BRIXADI if you are allergic to buprenorphine or any ingredients in BRIXADI:
- BRIXADI weekly: anhydrous ethanol, soybean phosphatidylcholine, glycerol dioleate
- BRIXADI monthly: N-methylpyrrolidone, soybean phosphatidylcholine, glycerol dioleate
Before receiving BRIXADI, tell your healthcare provider about all of 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 history of alcoholism
- A head injury or brain problem
- Mental health problems
- Adrenal gland or thyroid gland problems
- A latex allergy. The BRIXADI needle cap contains latex.
Tell your healthcare provider if you are:
- pregnant or plan to become pregnant. If you receive BRIXADI 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 become pregnant.
- breastfeeding. BRIXADI can pass into your breast milk and may harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment with BRIXADI. Monitor your baby for increased drowsiness and breathing problems if you breastfeed during treatment with BRIXADI.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Talk with your healthcare provider before starting any new medicines during or after stopping treatment with BRIXADI.
What should I avoid while receiving BRIXADI?
- Do not drive, operate heavy machinery or perform any other dangerous activities until you know how BRIXADI affects you. BRIXADI can cause drowsiness and slow reaction times. BRIXADI can make you sleepy, dizzy, or lightheaded. This may happen more often in the first few days after your injection and when your dose is being changed.
- You should not drink alcohol or use prescription or over-the-counter medicines that contain alcohol during treatment with BRIXADI, because this can lead to loss of consciousness or even death.
What are the possible side effects of BRIXADI?
BRIXADI can cause serious side effects, including:
- Trouble breathing. Taking BRIXADI with other opioid medicines, benzodiazepines, alcohol, or other central nervous system depressants can cause breathing problems that can lead to coma and death.
- Sleepiness, dizziness, and problems with coordination.
- Physical dependence or abuse.
- Liver problems. Call your healthcare provider right away if you notice any of these symptoms:
- your skin or the white part of your 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
- nausea
- Allergic reaction. You may have a rash, hives, swelling of your face, wheezing, light-headedness when changing positions, feeling faint, or loss of consciousness. Call your healthcare provider or get emergency help right away.
- Opioid withdrawal. Call your healthcare provider right away if you get any of these symptoms:
- shaking
- sweating more than normal
- feeling hot or cold more than normal
- runny nose
- watery eyes
- goose bumps
- diarrhea
- vomiting
- muscle aches
- Decrease in blood pressure. You may feel dizzy if you get up too fast from sitting or lying down.
- The most common side effects of BRIXADI include: injection site pain, headache, constipation, nausea, injection site redness, injection site itching, trouble sleeping (insomnia), and urinary tract infection.
Your healthcare provider should do tests to check your liver before and during treatment with BRIXADI.
These symptoms may start weeks to months after your last dose of BRIXADI. Tell your healthcare provider if you develop any of these symptoms.
BRIXADI 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 BRIXADI. Call your healthcare provider for medical advice about side effects.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
For more information about BRIXADI, ask your healthcare provider or go to www.BRIXADI.com or call 1-833-274-9234.
This information does not take the place of talking with your healthcare provider for medical advice about your condition or treatment.
Please see BRIXADI Medication Guide and Full Prescribing Information, including BOXED WARNING.
What is BRIXADI?
BRIXADI is a prescription medicine used to treat moderate to severe opioid addiction (dependence) to opioid drugs (prescription or illegal) in people:
- who have started treatment with a single dose of a buprenorphine medicine in the form of a sublingual tablet or buccal film (transmucosal), OR
- who are already being treated with buprenorphine
BRIXADI should be used as part of a complete treatment plan that also includes counseling and behavioral therapy.