Brixadi is the brand name for a buprenorphine extended-release injection. It was first approved by the United States Food and Drug Administration in May 2023.
Like other drugs that contain buprenorphine, Brixadi is used in treating moderate to severe opioid use disorder (OUD). However, unlike oral forms of buprenorphine, Brixadi has to be administered by a healthcare professional through the Brixadi REMS Program.
Here’s a comprehensive look at Brixadi, its formulation, dose concentrations, uses, and potential side effects.
An Overview of Brixadi (Buprenorphine) Extended-Release Injection
Brixadi is a subcutaneous, extended-release buprenorphine injection released by Braeburn on May 23, 2023.
It’s a new method of administering buprenorphine by injecting it right beneath the skin. Once Brixadi comes into contact with the plasma surrounding the subcutaneous tissue, it becomes a gel with liquid crystal properties that slowly releases buprenorphine over a specific period.
This technology allows the administration of Brixadi once every week or month, depending on the concentration used.
Brixadi should be used as part of a complete treatment plan that includes counseling and therapy, to prevent potential abuse.
What Does Buprenorphine Do?
Buprenorphine is a drug approved in 2002 by the U.S. FDA to treat the withdrawal symptoms associated with opioid use disorder.
It’s a partial agonist of opioid receptors, which means it binds to the proteins on the surface of cells in the brain, spinal cord, gut, and other sites. It then activates them partially, similarly to how an illicit opioid drug would, but without providing the same euphoric feeling associated with the opioids.
When buprenorphine is administered, it prevents the intense withdrawal symptoms that usually start a few hours after a person stops taking opioids, which include:
- Craving opioids
- Hot and cold flashes
- Increased sweat, saliva, and tear production
- Irritability and anxiety
- Trouble sleeping and constant yawning
- Muscle tremors
This is meant to improve the person’s chances of staying off opioids while treating their OUD by making their physical condition less challenging during the withdrawal period.
Dosing and Administration of Brixadi
According to the official Braeburn Brixadi dosing guide, Brixadi is administered either weekly in 7-day intervals or monthly in 28-day intervals.
The weekly formulation is available in the following concentrations:
- 8 mg
- 16 mg
- 24 mg
- 32 mg
The monthly formulation is available in the following concentrations:
- 64 mg
- 96 mg
- 128 mg
People who have initiated treatment using oral buprenorphine (Suboxone, Subutex, or Zubsolv) can switch over to Brixadi injections based on their daily dose of buprenorphine as follows:
|
Daily Sublingual Buprenorphine Dose |
Weekly Brixadi Injection Dose |
Monthly Brixadi Injection Dose |
|
≤6 mg |
8 mg |
— |
|
8-10 mg |
16 mg |
64 mg |
|
12-16 mg |
24 mg |
96 mg |
|
18-24 mg |
32 mg |
128 mg |
If someone is going on buprenorphine therapy for the first time using Brixadi, their healthcare provider should follow these precautions:
- As soon as mild to moderate withdrawal symptoms appear, they should be given an initial dose of 4 mg oral buprenorphine. This is done to test the patient’s tolerance to the drug before injecting them with it.
- If the dose was enough to eliminate withdrawal symptoms successfully, then they should be injected with an 8 mg dose of Weekly Brixadi after 3 days of the oral buprenorphine dose.
- Brixadi can be injected in the buttock, thigh, abdomen, or upper arm, and the injection site should be alternated each time.
- For people starting buprenorphine therapy for the first time using Brixadi, the upper arm injection site should only be used after 4 consecutive injections or reaching a steady state. That’s because upper arm injections corresponded with 10% lower plasma availability than other injection sites.
Side Effects of Brixadi
Like any other medication, Brixadi use can come with some unwanted side effects. The most common adverse reactions associated with its use are:
- Injection site pain
- Headaches
- Digestive issues (nausea and constipation)
- Injection site pruritus (itching where the needle was stuck)
- Injection site erythema (redness and a hot sensation)
- Insomnia (trouble sleeping)
- Urinary tract infections
The adverse effects stem from the fact that buprenorphine is a Schedule III opioid, which means it carries a similar drug profile to other opioids, although at a lower risk. That’s why it comes with a long list of safety indications which we’ll explore in the following section.
Note: It’s important to avoid scratching the injection site to avoid dislodging the node, too, even if itchiness occurs. You can ask your healthcare provider for tips or topical products to relieve the pain or swelling.
Warnings and Precautions Before Using Brixadi
Brixadi is currently available through the Brixadi Risk Evaluation and Mitigation Strategy (REMS) program. This allows the patient to only receive Brixadi injections at the hands of a licensed clinician at a healthcare facility, preventing many of the potentially severe adverse reactions.
That said, it’s important to cover some info about the precautions needed to ensure the safest delivery and best therapeutic impact of Brixadi.
Intravenous Administration
Brixadi must never be injected intravenously and you should never self-administer Brixadi.
The drug forms a liquid crystalline gel “node” once injected under the skin as it makes contact with bodily fluids.
If injected into a blood vessel, there’s a high risk of the drug occluding their pathways (thrombus) or its particles becoming embedded in blood vessels supplying vital organs such as the heart, lungs, or brain (embolus).
This can lead to organ failure, stroke, or sudden death.
Addiction, Abuse, and Misuse
Buprenorphine is a Schedule III controlled substance, which means it has the potential for abuse, leading to addiction.
Healthcare providers must monitor all their patients receiving Brixadi injections to make sure they’re not exhibiting signs of drug misuse.
Respiratory and CNS Depression
Just like with other opioids, buprenorphine has the potential to cause respiratory and central nervous system (CNS) depression. If a patient has respiratory issues, like COPD, asthma, or other conditions, it’s best to monitor their condition, educate them and their caregivers about signs of respiratory failure, and instruct them to call for emergency services if any signs appear.
Interaction with Benzodiazepines
Psychoactive drugs containing benzodiazepines have CNS depressive properties. Using them concomitantly with Brixadi can increase the risk of overdose and death.
Interaction with Alcohol
Alcohol is also a CNS depressant, which can be highly risky if consumed when taking Brixadi. Clear instructions about using these substances alongside Brixadi should be given by the healthcare provider.
Neonatal Opioid Withdrawal Syndrome
Using opioids during pregnancy can cause neonatal opioid withdrawal syndrome (NOWS). It presents as muscle tremors in the newborn, excessive crying and irritability, and trouble sleeping, feeding, and breathing. Using buprenorphine during pregnancy can eliminate some of the associated risks.
Brixadi can also be expressed in breast milk, so lactating mothers should be educated about spotting signs of opioid exposure in their neonates, which might include drowsiness and breathing problems.
Use in Patients with Impaired Liver Function
Buprenorphine is metabolized by the liver, so it’s crucial to run hepatic function tests prior to and during Brixadi use. The presence of liver function issues can cause a dangerous elevation in Brixadi blood levels, leading to a high risk of toxicity and overdose.
If someone shows moderate to severe hepatic impairment before treatment, they’re not a good candidate for Brixadi therapy.
If someone develops hepatic impairment during Brixadi therapy, they should be monitored for signs of toxicity and transition to a less injurious substitute.
Hypersensitivity Reactions
Patients with a previous history of allergic reactions to drugs containing buprenorphine as an active ingredient don’t qualify as candidates for receiving Brixadi injections.
Severe cases of hypersensitivity reactions, like bronchospasm, angioneurotic edema, and anaphylactic shock, have been recorded in response to buprenorphine. This is why a tolerance test using 4 mg transmucosal buprenorphine is essential before initiating Brixadi therapy.
Latex Allergies
The cap on Brixadi pre-filled pens is made of natural rubber latex, so it can cause a hypersensitivity reaction in individuals with a latex allergy.
Access to Naloxone in Cases of Overdose
Since buprenorphine can be abused similarly to opioid drugs, it’s advised for physicians to prescribe naloxone as an accompaniment to the Brixadi prescription. That’s because Brixadi doesn’t have built-in naloxone like oral forms of buprenorphine do.
Naloxone is an opioid antagonist that prevents the binding of opioids to their receptors. This minimizes the chances of overdose and any long-term physical injury from abusing buprenorphine or other opioids.
Alongside the prescription, it’s also crucial to teach patients and their caregivers how to administer naloxone in cases of suspected overdose. Emphasis on calling 911 or other emergency services after administering naloxone cannot be overstated, since its effects are temporary and the person can go back to overdosing after it wears off.
Is Brixadi the Right Choice for You?
The factor that sets Brixadi apart from other buprenorphine medications is the flexibility it offers people in treatment for opioid use disorder. Instead of daily pills needed to control withdrawal, a single extended-release subcutaneous injection given in weekly or monthly doses is enough to prevent the unwanted symptoms.
If you’re currently in treatment for OUD and would like to inquire about whether you could benefit from a Brixadi prescription, book an appointment with one of our licensed clinicians today.
