Brixadi is an extended release subcutaneous injection that is used as part of the treatment plan of moderate to severe opioid use disorder (OUD) alongside counseling and behavioral therapy.
The active ingredient is buprenorphine, which acts to prevent opioid withdrawal symptoms and mitigate craving.
That said, Brixadi, like any medication on the market, comes with a set of side effects.
They range from common, mild reactions, like nausea, constipation, and injection site pain, to severe, life-threatening effects, like blood vessel occlusion and dependence.
Healthcare providers conduct a Brixadi risk evaluation before starting the treatment to ensure the benefits outweigh the side effects.
Let’s explore the potential adverse events associated with using Brixadi or any other buprenorphine drug and look into ways to minimize the unwanted drug effects.
Brixadi Side Effects
Side effects that show up after using Brixadi can be precipitated by young age, low body weight, various drug interactions, and other concomitant medical conditions. Allergic reactions and injection site pain were also reported.
The goal of the Brixadi REMS program or “Risk Evaluation and Mitigation Strategy” is to ensure the benefits of starting the treatment outweighs the risks.
You should report suspected adverse reactions immediately to your doctor and seek care in cases of emergency, like anaphylaxis.
Common Side Effects of Brixadi
The most common adverse reactions of Brixadi include headache, constipation, and nausea. For the most part, those side effects don’t require medical attention and they’ll spontaneously resolve on their own during the course of the treatment.
Injection site pruritus (itching) and injection site erythema (redness) are also commonly seen with Brixadi subcutaneous injections. A mild allergic reaction can occur with a single dose of Brixadi, and these symptoms can gradually disappear with subsequent injections.
Mild Side Effects of Brixadi
Brixadi is used to prevent the withdrawal symptoms associated with opioid use. However, the medication itself can sometimes cause opioid withdrawal signs. Those include diarrhea, trouble sleeping or insomnia, and muscle stiffness.
Mood changes like irritability and anxiety can also be seen. Those symptoms are more common when first starting the treatment and with long-acting opioid agonists under which Brixadi is classified.
Other mild side effects of Brixadi include:
- Drowsiness and dizziness
- Vomiting
- Changes of the skin color at the injection site
- Increased heart rate and palpitations
- Urinary tract infection presenting as burning sensation, frequent urination, and the feeling of the need to urinate although the bladder is empty
- Upper respiratory tract infection like common cold and middle ear inflammation
Those symptoms are transient and can be easily controlled. Nevertheless, they can persist in some cases and become bothersome. You shouldn’t stop Brixadi treatment on your own as this can cause more severe withdrawal symptoms that might be difficult to deal with on your own.
Reach out to a healthcare professional and follow their instructions to mitigate side effects and ensure better odds of completing your treatment plan.
Serious Side Effects of Brixadi
The following Brixadi side effects are very rare, however, they can be life-threatening and require timely intervention to avoid serious harm.
If you notice any symptoms that signal one of the following side effects, seek help from a healthcare professional immediately.
Risks Associated with Intravenous Administration
Brixadi formulations received FDA approval for subcutaneous injections only. That means the needle should only be placed under the dermis layer of the skin, no deeper.
In case of accidental administration into a vein, Brixadi turns into a gel-like substance when coming in contact with body fluids. This leads to the occlusion of blood vessels, tissue damage, and serious consequences like stroke.
If you notice pain, bruising, or numbness after the injection, let your healthcare provider know at once.
Risks of Dependence and Abuse
Buprenorphine is a member of the opioid family and receives the same schedule III controlled substance classification. This poses the same risks of abuse, misuse, and increased risk of opioid addiction.
In order to minimize the risk of addiction, Brixadi is administered by a healthcare professional in a supervised clinic or hospital setting. Also, it’s recommended to monitor the progression of opioid use disorder in people receiving Brixadi.
Central Nervous System (CNS) Depression
Brixadi has sedative effects as it acts directly on the nervous system. This can lead to slurred speech, lack of coordination, and drowsiness. If CNS depression worsens, people on Brixadi can suffer from slowed heart rate, poor judgment, and confusion.
Known or suspected overdose can lead to coma, which necessitates prescribing naloxone to reverse the effects of Brixadi and prevent life-threatening consequences.
Respiratory Depression
Brixadi administration is associated with respiratory center depression, which leads to difficulty breathing. This explains why drugs acting on opioid receptors must be used with caution in people with chronic respiratory conditions like asthma.
The leading cause of Brixadi-associated death is respiratory failure. The drug can precipitate sleep-related respiratory depression and lead to poor oxygenation during sleep. This leads to day-time sleepiness, poor concentration, and increased risk of developing hypertension.
Serious Drug Interactions
The effects of central nervous system and respiratory depression becomes far worse in people using other CNS depressant drugs, including alcohol.
Healthcare providers prescribing benzodiazepines for the treatment of psychiatric disorders find a replacement as Brixadi isn’t a safe option in those particular cases. This creates more barriers for the treatment of OUD and compounds the risks of morbidity and mortality associated with opioid misuse.
Risk of Causing Neonatal Opioid Withdrawal Syndrome
Prolonged use of opioids during pregnancy leads to a spectrum of signs and symptoms seen in the newborn known as neonatal opioid withdrawal syndrome. After birth, the infant abruptly loses its opioid source and develops a range of symptoms that include runny nose, increased sweating, tearing of the eyes, yawning, and diarrhea.
Brixadi treatment is meant to mitigate withdrawal symptoms in the mother, but in the process the neonate is exposed to forms of opioid at an early age.
That said, pregnant patients requiring opioid therapy show higher rates of adverse pregnancy outcomes if left untreated, which means Brixadi can be useful if the case necessitates a prescription.
Adrenal Insufficiency
Upon receiving Brixadi treatment for over a month, people might be at increased risk of developing adrenal insufficiency. This occurs as Brixadi suppresses the function of the adrenal glands and decreases the natural body production of a hormone called cortisol.
In the absence of cortisol, people present with low blood pressure, low blood sugar levels, and weight loss. Women might also have irregular menstrual cycles or missed periods. If unaddressed, extreme weakness, kidney failure, and shock can be the consequences of adrenal insufficiency.
Severe Liver Damage
In rare cases, people receiving Brixadi can suffer from severe hepatic impairment. The liver damage associated with Brixadi can range from mild elevation of liver markers with no symptoms to severe liver damage that could lead to death.
This side effect mainly affects people with pre-existing liver conditions like hepatitis and those receiving other drugs that cause hepatotoxicity. It’s worth noting that upon stopping Brixadi, the liver adverse events can be reversed. In other cases, the liver damage resolves on its own without the need to change Brixadi dosage.
Before starting Brixadi, your doctor can order some blood tests, including liver function tests. Periodic evaluation of liver functions continues throughout treatment to ensure potential liver damage is discovered early and addressed before liver failure ensues.
Life-Threatening Hypersensitivity Reactions
A severe allergic reaction like bronchospasm or trouble breathing can be a serious consequence of Brixadi treatment. Hypersensitivity reactions also include swelling in the face, airways, and neck (anaphylaxis). Hives and rash can also be seen in addition to other injection site reactions.
If you’ve experienced any drug allergic reactions before, you should disclose this information to your doctor to assess whether Brixadi hypersensitivity might be an issue.
Brixadi formulations come in prefilled syringes with a needle cap made of synthetic rubber latex. People with latex sensitivity can present with serious allergic reactions that require emergency interventions.
What Is Brixadi Used for?
Brixadi contains the active drug buprenorphine, which is a partial agonist for opioid receptors. It’s used for the treatment of opioid use disorder in adults with moderate to severe symptoms, and the dosage is adjusted on a case by case basis.
Daily sublingual buprenorphine works for highly motivated patients who don’t mind taking medications everyday.
However, since Brixadi is an extended release formulation, it can be taken less frequently as weekly or monthly doses. The convenience and ease of use increase compliance with OUD medication-assisted treatment, having better outcomes for patients.
In terms of route of administration, Brixadi is used as an extended release subcutaneous injection that goes under the skin. It’s administered by a healthcare provider in a clinic or hospital setting.
In case of an accidental overdose, you’ll receive an antidote that reverses the acute effects associated with the exaggerated activation of the opioid receptors.
Special Cases for Brixadi Use
Females who use opioids during pregnancy can give birth to a child with neonatal opioid withdrawal syndrome. The child has been exposed to opioids in the womb and upon birth the connection between the child and the mother comes to an end by cutting the umbilical cord.
So, the child experiences symptoms of opioid withdrawal and might need medical treatment to control severe presentations. Special care may be needed when using Brixadi in children, and you should consult your medical professionals to settle on the best treatment plan.
Should You Use Brixadi Despite the Side Effects?
A complete treatment plan for opioid use disorder includes psychosocial support, medical treatment, and counseling. Brixadi is a buprenorphine medication that can be administered as weekly or monthly injections making it way more convenient than the daily transmucosal buprenorphine product it’s set to replace.
Brixadi presents with a number of adverse events. Some are mild and self-limited like nausea, headaches, and constipation. Others are more serious like confusion, breathing difficulties, and liver damage.
Reach out to your medical provider if you experience any of the Brixadi side effects. You shouldn’t stop treatment on your own as this might put you at risk of opioid withdrawal. Your doctor can tailor your treatment plan to minimize the risk of adverse events while sustaining the benefits of Brixadi.
Furthermore, Brixadi overdose is a potential concern and prescribing naloxone in a timely manner is needed to reverse the overactivation of the opioid receptors.
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