BRIXADI BUPRENORPHINE 8 mg/.16mL Injection, 1 syringe

1 INDICATIONS AND USAGE BRIXADI is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. BRIXADI should be used as part of a complete treatment plan that includes counseling and psychosocial support. BRIXADI contains buprenorphine, a partial opioid agonist.

BRIXADI is indicated for the treatment of moderate to severe opioid use disorder in patients who have initiated treatment with a single dose of a transmucosal buprenorphine product or who are already being treated with buprenorphine. ( 1 ) BRIXADI should be used as part of a complete treatment plan that includes counseling and psychosocial support. ( 1 )

2 DOSAGE AND ADMINISTRATION Only healthcare providers should prepare and administer BRIXADI. ( 2.1 ) BRIXADI (weekly) and BRIXADI (monthly) are different formulations. Doses of BRIXADI (weekly) cannot be combined to yield an equivalent BRIXADI (monthly) dose.

( 2.1 ) BRIXADI should be injected slowly, into the subcutaneous tissue of the buttock, thigh, abdomen, or upper arm ( 2.1 ) Strongly consider recommending or prescribing an opioid overdose reversal agent (e.g., naloxone, nalmefene) at the time BRIXADI is initiated or renewed because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose. ( 2.2 ) Injection sites for BRIXADI (weekly) should be alternated/rotated for each injection. ( 2.7 ) See Full Prescribing Information for administration instructions.

( 2.7 )

2.1Important Dosage and Administration Instructions FOR SUBCUTANEOUS INJECTION ONLY. DO NOT ADMINISTER BRIXADI INTRAVENOUSLY, INTRAMUSCULARLY, OR INTRADERMALLY [see Warnings and Precautions (5.1) , Instructions for Use (2.6) ]. BRIXADI exists in two formulations.

Doses of BRIXADI (weekly) cannot be combined to yield a monthly dose. Only healthcare providers should prepare and administer BRIXADI. Administer BRIXADI as a single injection.

Do not divide. BRIXADI should be injected slowly, into the subcutaneous tissue of the buttock, thigh, abdomen, or upper arm. In patients who are not currently receiving buprenorphine treatment, for BRIXADI (weekly), the upper arm site should only be used after steady-state has been achieved (4 consecutive doses) [see Instructions for Use (2.6) ].

Injection in the arm site was associated with approximately 10% lower plasma levels than other sites. Injection sites should be alternated/rotated between injections for BRIXADI (weekly) [see Instructions for Use (2.6) ]. For all patients, the dose of BRIXADI must be individualized based on patient tolerability and/or efficacy.

BRIXADI (weekly) should be administered in 7-day intervals. BRIXADI (monthly) should be administered in 28-day intervals. For patients not currently receiving buprenorphine treatment, begin with a test dose of 4 mg transmucosal buprenorphine to establish that buprenorphine is tolerated without precipitated withdrawal, and then transition to BRIXADI (weekly).

Initiating treatment with BRIXADI as the first buprenorphine product has not been studied. Initiating treatment with BRIXADI (monthly) in new entrants to treatment has not been studied [see Dosage and Administration (2.3) ] . Patients who are currently being treated with other buprenorphine-containing products can start treatment with either BRIXADI (weekly) or BRIXADI (monthly) [see Dosage and Administration (2.3) ] .

Administer each injection using only the syringe and safety needle included with the product [see Instructions for Use (2.6) ] . Caution: The BRIXADI needle cap is synthetically derived from natural rubber latex which may cause allergic reactions in latex-sensitive individuals [see Warnings and Precautions (5.10) ] . To avoid missed doses, the weekly dose may be administered up to 2 days before or after the weekly time point, and the monthly dose may be administered up to 1 week before or after the monthly time point.

If a dose is missed, the next dose should be administered as soon as practically possible.

2.2Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene) and discuss the importance of having access to an opioid overdose reversal agent. Because patients being treated for opioid use disorder have the potential for relapse, putting them at risk for opioid overdose, strongly consider prescribing or recommending an overdose reversal agent for the emergency treatment of opioid overdose, both when initiating and renewing treatment with BRIXADI.

Also consider prescribing or recommending such a…

3 DOSAGE FORMS AND STRENGTHS BRIXADI is a sterile, yellowish to yellow-clear liquid solution and is provided as two different formulations, one for weekly and one for monthly administration in pre-filled, single-dose, syringes, with 23 gauge ½ inch needles, available in the following dosage strengths. Table 3: BRIXADI (weekly) Strengths BRIXADI (weekly) 50 mg/mL buprenorphine Dosage Strength Dosage Volume 8 mg 0.16 mL 16 mg 0.32 mL 24 mg 0.48 mL 32 mg 0.64 mL Table 4: BRIXADI (monthly) Strengths BRIXADI (monthly) 356 mg/mL buprenorphine Dosage Strength Dosage Volume 64 mg 0.18 mL 96 mg 0.27 mL 128 mg 0.36 mL BRIXADI is a weekly and monthly injection provided in a pre-filled single-dose syringe with a 23 gauge ½ inch needle.

( 3 ) BRIXADI (weekly) is available in 8 mg/0.16 mL, 16 mg/0.32 mL, 24 mg/0.48 mL, and 32 mg/0.64 mL; BRIXADI (monthly) is available in 64 mg/0.18 mL, 96 mg/0.27 mL, and 128 mg/0.36 mL.

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Medication Guide). Instruct patients to read the Medication Guide each time BRIXADI is administered because new information may be available. Safe Use Before initiating treatment with BRIXADI, explain the points listed below to patients and caregivers.

BRIXADI Risk Evaluation and Mitigation Strategy (REMS) Advise patients that because of the risk of serious harm or death due to intravenous self-administration, BRIXADI is available only through a restricted distribution program called the BRIXADI REMS. Healthcare settings and pharmacies are certified and only dispense BRIXADI directly to a healthcare provider for administration by a healthcare provider [see Warnings and Precautions (5.2) ] . Life Threatening Respiratory Depression Educate patients and caregivers on how to recognize respiratory depression and emphasize the importance of calling 911 or getting emergency medical help right away in the event of a known or suspected overdose [see Warnings and Precautions 5.4) ] .

Patient Access to an Opioid Overdose Reversal Agent for the Emergency Treatment of Opioid Overdose Inform patients and caregivers about opioid overdose reversal agents (e.g., naloxone, nalmefene) and discuss the importance of having access to an opioid overdose reversal agent. Because patients being treated for opioid use disorder are at risk for relapse, discuss the importance of having access to an opioid overdose reversal agent. Also discuss the importance of having access to an opioid overdose reversal agent if there are householdmembers (including children) or other close contacts at risk for accidental ingestion or opioid overdose.

Discuss with the patient the options for obtaining an opioid overdose reversal agent (e.g., prescription, over-the-counter (some products), or as part of a community-based program) [see Dosage and Administration (2.2) , Warnings and Precautions (5.4) ]. There are important differences among the opioid overdose reversal agents, such as route of administration, product strength, approved patient age range, and pharmacokinetics. Be familiar with these differences, as outlined in the approved labeling for those products, prior to recommending or prescribing such an agent.

Educate patients and caregivers on how to recognize the signs and symptoms of an opioid overdose. Explain to patients and caregivers that effects of opioid overdose reversal agents like naloxone and nalmefene are temporary, and that they must call 911 or get emergency medical help right away in all cases of known or suspected opioid overdose, even if an opioid overdose reversal agent is administered. Repeat administration may be necessary, particularly for overdose involving buprenorphine. [see Dosage and Administration (2.2) , Warnings and Precautions (5.4) , Overdosage (10) ].

Advise patients and caregivers: how to treat with an opioid overdose reversal agent in the event of an opioid overdose to tell family and friends about their opioid overdose reversal agent and to keep it in a place where family and friends can easily access it in an emergency to read the Patient Information (or other educational material) that will come with their opioid overdose reversal agent. Emphasize the importance of doing this before an opioid emergency happens, so the patient and caregiver will know what to do.

Interaction with Benzodiazepines and other CNS Depressants Inform patients and caregivers that potentially fatal additive effects may occur if BRIXADI is used with benzodiazepines or other CNS depressants, including alcohol, and not to use these concomitantly unless supervised by a healthcare provider [see Warnings and Precautions (5.5) and Drug Interactions (7) ]. Serotonin Syndrome Inform patients that BRIXADI could cause a rare but potentially life-threatening condition resulting from concomitant administration of serotonergic drugs.

Warn patients of the symptoms of seroton…

Medication Guide BRIXADI ® (brix-a-dee) (buprenorphine) extended-release injection, for subcutaneous use (CIII) This Medication Guide has been approved by the U. S. Food and Drug Administration.

BRX-MG-002 Issued: 12/2025 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 REMS Program. BRIXADI is not available in retail pharmacies.

Your BRIXADI injection will only be given to you by a healthcare provider. BRIXADI 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.

Ask your healthcare provider about medicines like naloxone or nalmefene that can be used in an emergency to reverse opioid overdose. If a medication is given to reverse opioid overdose, 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, gabapentinoids (gabapentin or pregabalin), 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. 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.

It is not known if BRIXADI is safe and effective in children. Who should not receive BRIXADI? Do not receive BRIXADI if you are allergic to buprenorphine or any ingredients in BRIXADI.

See the end of this Medication Guide for a list of ingredients in BRIXADI . 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…