BRIXADI 32 mg/.64mL

BUPRENORPHINE · INJECTION · Braeburn Inc.

No Recall History

Plain English

BRIXADI is a injection containing buprenorphine at 32 mg/.64mL, taken subcutaneous. Manufactured by Braeburn Inc..

Key Facts

Brand Name: BRIXADI
Generic Name: BUPRENORPHINE
NDC Code (Product): 58284-232
Manufacturer: Braeburn Inc.
Strength: 32 mg/.64mL
Dosage Form: INJECTION
Route: SUBCUTANEOUS
Marketing Status
DEA Schedule: Schedule III (Controlled)
Application #: NDA210136
Drug Class: Partial Opioid Agonist [EPC]
Marketing Start: 06/06/2023

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug dependence4,114 reports

overdose2,119 reports

pain2,002 reports

drug abuse1,980 reports

drug ineffective1,606 reports

toxicity to various agents1,553 reports

death1,527 reports

drug withdrawal syndrome1,454 reports

nausea1,267 reports

emotional distress1,249 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 )

Dosage & Administration

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 ) 2.1 Important 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 provide…

Contraindications

4 CONTRAINDICATIONS BRIXADI is contraindicated in patients with hypersensitivity (e.g., anaphylactic shock) to buprenorphine, or any other ingredients in the solution for injection [see Warnings and Precautions (5.10) ]. Hypersensitivity to buprenorphine or any other ingredients in BRIXADI. ( 4 )

Drug Interactions

7 DRUG INTERACTIONS Table 7: Clinically Significant Drug Interactions Benzodiazepines and other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effects, the concomitant use of benzodiazepines or other CNS depressants, including alcohol, increases the risk of respiratory depression, profound sedation, coma, and death. Intervention: Cessation of benzodiazepines or other CNS depressants is preferred in most cases of concomitant use. In some cases, monitoring in a higher level of care for taper may be appropriate. In others, gradually tapering a patient off a prescribed benzodiazepine or CNS depressant or decreasing to the lowest effective dose may be appropriate. Similarly, cessation of other CNS depressants is preferred when possible. Before co-prescribing benzodiazepines for anxiety or insomnia, ensure that patients are appropriately diagnosed and consider alternative medications and non-pharmacologic treatment [see Warnings and Precautions (5.5) ] . If concomitant use is warranted, strongly consider recommending or prescribing an opioid overdose reversal agent, as is recommended for all patients on buprenorphine treatment for opioid use disor…

Adverse Reactions

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.3) ] Respiratory and CNS Depression [see Warnings and Precautions (5.4) ] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.6) ] Adrenal Insufficiency [see Warnings and Precautions (5.7) ] Opioid Withdrawal [see Warnings and Precautions (5.8 , 5.11) ] Hepatitis, Hepatic Events [see Warnings and Precautions (5.9) ] Hypersensitivity Reactions [see Warnings and Precautions (5.10) ] Orthostatic Hypotension [see Warnings and Precautions (5.17) ] Elevation of Cerebrospinal Fluid Pressure [see Warnings and Precautions (5.18) ] Elevation of Intracholedochal Pressure [see Warnings and Precautions (5.19) ] Adverse reactions commonly associated with BRIXADI administration (in ≥5% of patients) were injection site pain, headache, constipation, nausea, injection site erythema, injection site pruritus, insomnia, and urinary tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Braeburn at 1-833-274-9234 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience B…

Frequently Asked Questions

What is BRIXADI used for?

BRIXADI contains BUPRENORPHINE. It is a injection taken subcutaneous. Consult your doctor for specific uses.

Is BRIXADI a controlled substance?

Yes, BRIXADI is classified as CIII under the DEA Controlled Substances Act.

What is the generic name for BRIXADI?

The generic name for BRIXADI is BUPRENORPHINE. There are 12 other brand versions of BUPRENORPHINE.

What is the NDC code for BRIXADI 32 mg/.64mL?

The NDC (National Drug Code) for BRIXADI 32 mg/.64mL is 58284-232, listed by Braeburn Inc..

Product NDC

58284-232

Package NDC

58284-232-01

Other Buprenorphine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)