Brixadi (buprenorphine) is a prescription medication indicated for treating opioid use disorder in adults. The drug can produce a range of side effects from mild to severe. Common examples include headache, constipation, and nausea.
More specifically, Brixadi is used for opioid use disorder in adults who have previously received another buprenorphine therapy. Treatment with Brixadi is intended to be combined with counseling and psychosocial support.
The active component in Brixadi is buprenorphine. (An active ingredient is the substance that produces the therapeutic effect.) Brixadi is supplied as a liquid in a prefilled syringe and is administered as a subcutaneous injection. A healthcare professional gives the injection in a clinic or physician’s office.
Continue reading to find details about the common, mild, and serious adverse effects linked to Brixadi. For a general summary of the medication, including its uses, see the referenced article.
What are the more common side effects of Brixadi?
People receiving Brixadi may encounter side effects that vary from mild to serious. Some of the more frequently reported adverse reactions include:
- pain, itching, redness, or darkening of skin at the injection site
- headache
- constipation
- nausea
- insomnia
What are the mild side effects of Brixadi?
Mild adverse effects have been reported with Brixadi. They include:
- pain, itching, redness, or darkening of skin at the injection site
- headache
- joint discomfort
- constipation
- diarrhea
- nausea and vomiting
- anxiety
- insomnia
- urinary tract infection (UTI)
- upper respiratory infection, like the common cold
- rapid heart rate
- mild allergic reaction*
What are the serious side effects of Brixadi?
Serious adverse events have been reported with Brixadi. These include:
- opioid withdrawal symptoms if Brixadi is given while you are still taking opioids
- physical dependence, which can result in withdrawal symptoms* if Brixadi is stopped abruptly
- excessive drowsiness and slowed responses that can impair driving
- orthostatic hypotension (a drop in blood pressure on standing that can cause dizziness)
- liver injury
- gallbladder issues
- adrenal insufficiency (reduced steroid hormone production by the adrenal glands)
- increased pressure in the cerebrospinal fluid
- central nervous system (CNS) depression and respiratory depression†
- boxed warning: risk of severe harm or death if injected into a vein†
- severe allergic reaction†
If you experience serious side effects while on Brixadi, contact your healthcare provider immediately. If you believe you are having a life-threatening reaction or a medical emergency, call 911 or your local emergency number right away.
* Dependence occurs when the body becomes accustomed to a drug and requires it to function normally. Withdrawal symptoms result from abrupt cessation. † See the “Side effects explained” section below for more information on these effects.
Note: After the Food and Drug Administration (FDA) approves a drug, it monitors and reviews reports of adverse effects. To report a side effect you’ve experienced with Brixadi, visit MedWatch.
FAQ about Brixadi’s side effects
Answers to common questions about Brixadi’s adverse effects are below.
How do side effects of Brixadi compare with those of Sublocade?
Brixadi and Sublocade are both long-acting injectable therapies for opioid use disorder and both contain buprenorphine. Because they share the same active ingredient, they can produce similar side effects.
Talk with your doctor to learn more about how Brixadi and Sublocade compare for your situation.
Does Brixadi cause long-term side effects?
Long-term adverse effects are possible. These include effects that may start at any point during treatment, even after prolonged use, and those that may persist after stopping the drug.
Examples of long-term effects reported in Brixadi’s clinical data include:
- adrenal insufficiency
- liver injury
- physical dependence, potentially leading to withdrawal if Brixadi is abruptly discontinued
Consult your physician to discuss possible long-term effects of Brixadi and their likely duration.
Side effects explained
More detail about specific side effects associated with Brixadi is provided below.
Risk of severe harm or death if injected into a vein
Brixadi is intended for subcutaneous injection. The formulation creates a crystalline gel under the skin that gradually releases medication into the body.
If Brixadi is injected into a vein, it can form crystalline material within the blood vessel. This may cause serious injury—for example, by blocking the vein or damaging surrounding tissue. The crystalline material can also travel through the bloodstream and obstruct blood flow to vital organs such as the lungs, potentially causing death.
What might help
Because of the danger of severe injury or death from intravenous injection, Brixadi must be administered only by a specially certified healthcare professional.
Brixadi is distributed solely through a risk evaluation and mitigation strategy (REMS). Only healthcare providers certified in the REMS program can obtain, prescribe, and give Brixadi.
For information about the Brixadi REMS, visit the website, call 833-274-9234, or speak with your provider.
CNS depression and respiratory depression
As an opioid, Brixadi can cause CNS and respiratory depression. CNS depression reduces activity in the brain and nervous system and, in severe cases, can lead to coma. Respiratory depression causes slow, shallow breathing and can, in severe instances, stop breathing entirely. These effects can be life threatening.
Symptoms of CNS or respiratory depression may include:
- severe drowsiness
- confusion
- loss of coordination
- slurred speech
- slow, shallow, or weak breathing
- loss of consciousness
How often these effects occurred in Brixadi studies is not well defined. Because Brixadi injections are administered by clinicians, the risk when given this way is low.
Factors that increase the risk of CNS and respiratory depression include misusing the medication by self-injecting it, combining it with alcohol, or taking other CNS depressant drugs. Examples of other CNS depressants are:
- other opioids
- benzodiazepines
- sleeping aids
- muscle relaxants
- certain antihistamines
What might help
Avoid alcohol during Brixadi therapy. Also avoid other opioids and CNS depressants unless prescribed by your physician.
Your doctor will likely suggest keeping Narcan (naloxone) available during Brixadi treatment. Narcan is a nasal spray used in emergencies to reverse opioid overdose and relieve CNS and respiratory depression.
Narcan can be prescribed by your doctor or purchased over the counter in many pharmacies. Inform people you live with or who are close to you where Narcan is stored, since they may need to administer it and call 911 after use. Multiple doses may be necessary.
If you have concerns about the risk of CNS or respiratory depression with Brixadi, speak with your doctor or pharmacist. They can also discuss Narcan with you.
Allergic reaction
As with most medications, Brixadi can trigger allergic reactions in some individuals, though these were rare in the drug’s clinical trials. Reactions can range from mild to severe and may include:
- skin rash
- itching
- flushing (temporary warmth, redness, or darkening of the skin)
- swelling under the skin (often of eyelids, lips, hands, or feet)
- swelling of the mouth, tongue, or throat that can make breathing difficult
What might help
If you develop mild allergic signs, such as a minor rash, contact your physician. They may recommend treatments to ease symptoms, such as:
- an oral antihistamine like Benadryl (diphenhydramine)
- a topical product, such as hydrocortisone cream
If your physician confirms a mild allergic reaction to Brixadi, they will determine whether you should continue therapy.
If you experience severe allergic symptoms—such as significant swelling or breathing difficulty—call 911 or your local emergency number immediately. These signs can be life threatening and require urgent treatment.
If a serious allergy to Brixadi is confirmed, your doctor may recommend switching to a different treatment.
Keeping track of side effectsDuring Brixadi therapy, consider recording any adverse effects you notice so you can discuss them with your clinician. This is especially useful when starting a new medication or combination.Your notes might include:what dose you were taking when the effect occurred how soon the effect appeared after that dose what symptoms you experienced how the symptoms affected your daily life what other medicines you were taking any additional relevant detailsSharing these notes with your clinician helps them understand how Brixadi affects you and lets them adjust your care plan if needed.
Warnings for Brixadi
Important considerations to review before beginning Brixadi therapy are listed below.
Boxed warning: Risk of severe harm or death if injected into a vein
Brixadi carries a boxed warning about the risk of serious injury or death if the product is injected intravenously. A boxed warning is the FDA’s most serious safety alert. See the “Side effects explained” section above for more information.
Other warnings
Brixadi can cause harmful effects in individuals with certain medical conditions. These drug-condition interactions and other factors may influence whether Brixadi is suitable for you. Discuss your medical history with your provider before starting Brixadi. Be sure to tell them if any of the following apply:
- liver disease
- lung or breathing disorders
- heart conditions, such as slow or irregular heartbeat, heart failure, or long QT syndrome
- low potassium or magnesium levels
- gallbladder disease
- adrenal gland disorders, like Addison’s disease
- thyroid disorders
- enlarged prostate or difficulty urinating
- recent head injury or neurologic condition
- mental health disorders
- planned surgery
- latex allergy
- previous allergic reaction to Brixadi
- pregnancy
- breastfeeding
Alcohol and Brixadi
You should avoid consuming alcohol during Brixadi therapy. Alcohol can raise the risk of CNS and respiratory depression—serious side effects of Brixadi. See the “Side effects explained” section above for more details.
If you have questions about alcohol use while on Brixadi, speak with your doctor or pharmacist.
Pregnancy and breastfeeding with Brixadi
If you are pregnant, planning to become pregnant, or breastfeeding, discuss Brixadi with your physician before starting treatment.
Pregnancy
There are risks associated with Brixadi during pregnancy. For instance, newborns may experience neonatal opioid withdrawal, which can be fatal if untreated. However, untreated opioid use disorder during pregnancy also carries serious risks. If you are pregnant or planning pregnancy, consult your doctor before beginning Brixadi.
Breastfeeding
Brixadi is generally regarded as acceptable during breastfeeding, but you should still review risks and monitoring with your doctor. If you breastfeed while on Brixadi, they may advise watching your infant for drowsiness and feeding or breathing problems.
Brixadi and misuse
Brixadi contains buprenorphine, an opioid that carries a risk of misuse. “Misuse” means using the medication in a way not prescribed by a healthcare provider.
Injecting Brixadi into a vein can cause severe injury or death; this risk is highlighted in the boxed warning. See the “Side effects explained” section above for more information.
Mistakenly using other opioids while on Brixadi can increase the chance of serious adverse effects, particularly CNS and respiratory depression. See the “Side effects explained” section above for details.
What to ask your doctor
Like many medications, Brixadi can cause side effects ranging from mild to severe. Most are temporary and resolve in days to weeks. If you have concerns about Brixadi’s adverse effects, discuss them with your physician. Useful questions to start with include:
- Which pain relievers are safe to use during Brixadi treatment?
- Will I need monitoring tests for Brixadi side effects?
- Do other treatment options for opioid use disorder have comparable side effects?
To learn more about Brixadi, see these resources:
- All About Brixadi
- Dosage Details for Brixadi
For information on various conditions and tips to support your health, consider subscribing to HealthEH’s newsletters. You might also explore online communities like Bezzy, where people with health conditions can connect and find support.
Disclaimer: HealthEH has worked to ensure that the information provided is accurate, thorough, and current. This article is not a replacement for the advice of a licensed healthcare professional. Always consult your doctor or another qualified healthcare provider before starting any medication. Drug information changes over time and may not include every possible use, instruction, precaution, warning, interaction, allergic reaction, or adverse event. The lack of specific warnings or other information for a given drug does not imply that the drug or combination is safe, effective, or appropriate for all patients or uses.
Leave a Reply
You must be logged in to post a comment.