• Addiction/dependence

Brixadi Generic Name & Formulations

General Description

Buprenorphine Weekly (8mg/0.16mL, 16mg/0.32mL, 24mg/0.48mL, 32mg/0.64mL); Monthly (64mg/0.18mL, 96mg/0.27mL, 128mg/0.36mL); ext-rel; soln for SC inj.

Pharmacological Class

Opioid (partial agonist-antagonist).

How Supplied

Single-dose prefilled syringe (Weekly or Monthly)—1

Generic Availability


Mechanism of Action

Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor.

Brixadi Indications


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, as part of a complete treatment plan that includes counseling and psychosocial support. 

Brixadi Dosage and Administration


See full labeling. For slow SC inj only into buttock, thigh, abdomen, or upper arm (should use upper arm site only after steady-state has been achieved). Rotate inj sites for Brixadi (weekly) inj. Individualize. Give Brixadi (weekly) in 7-day intervals, and Brixadi (monthly) in 28-day intervals. Currently not receiving buprenorphine: initiate with 4mg transmucosal buprenorphine test dose to establish tolerance. If tolerated without withdrawal, give 16mg weekly inj (as 1st dose); then give 8mg weekly inj (as additional dose) within 3 days of the 1st dose to achieve a total of 24mg/week. Switching from transmucosal buprenorphine-containing products: may start either Brixadi (weekly) or (monthly) inj based on sublingual buprenorphine dose equivalents. Transitioning between Brixadi (weekly) and (monthly): based on clinical judgment. Dose adjustments: may give additional 8mg weekly inj during dosing interval as clinically needed; max 32mg/week or 128mg/month.


Not established.

Brixadi Contraindications

Not Applicable

Brixadi Boxed Warnings

Boxed Warning

Risk of serious harm or death with IV administration. Brixadi REMS program.

Brixadi Warnings/Precautions


Potential risk for opioid overdose; strongly consider prescribing naloxone when initiating and renewing therapy. Consider prescribing naloxone if the patient has household members (eg, children) or other close contacts at risk of accidental ingestion or overdose. Not for IV, IM, or intradermal inj; risk of serious harm or death. Evaluate and treat if serious inj site reactions develop. Abuse potential (monitor). Risk of life-threatening respiratory and CNS depression; monitor. Compromised respiratory function (eg, COPD, cor pulmonale, decreased respiratory reserve, hypoxia, hypercapnia, pre-existing respiratory depression). Sleep-related breathing disorders (including central sleep apnea (CSA), sleep-related hypoxemia); consider dose reduction if CSA develops. Adrenal insufficiency. Risk of QT prolongation (esp. in those with hypokalemia, bradycardia, recent conversion from atrial fibrillation, CHF, digitalis therapy, baseline QT prolongation, subclinical long-QT syndrome, severe hypomagnesemia). Obtain LFTs prior to initiation and during treatment; evaluate if hepatic event is suspected. Prescribe a non-opioid analgesic for managing acute pain; may use opioid therapy under physician supervision. Avoid in opioid-naïve. Elevated CSF pressure (eg, head injury, intracranial lesions). Biliary tract dysfunction. Acute abdomen. Unintentional pediatric exposure. Acute alcoholism. Drug abusers. Latex allergy. Reevaluate periodically. Avoid abrupt cessation. Moderate to severe hepatic impairment: not recommended. Elderly. Pregnancy; potential neonatal opioid withdrawal syndrome during prolonged use. Labor & delivery, nursing mothers: monitor infants.



Brixadi Pharmacokinetics


Plasma protein bound: ~96%.


Hepatic (CYP3A4). 


Fecal (69%), renal (30%). Half-life: 3–5 days (weekly); 19–26 days (monthly). 

Brixadi Interactions


Increased risk of respiratory depression, sedation, coma, and death with benzodiazepines or other CNS depressants (eg, non-benzodiazepine sedatives/hypnotics, anxiolytics, general anesthetics, tranquilizers, muscle relaxants, antipsychotics, alcohol, other opioids); discontinue these agents are preferred; or in some patients, gradually taper off or reduce to lowest effective dose may be appropriate; strongly consider prescribing naloxone if concomitant use is warranted. During or within 14 days of MAOIs (eg, phenelzine, tranylcypromine, linezolid): not recommended. Risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, 5-HT3 antagonists, mirtazapine, trazodone, tramadol, cyclobenzaprine, metaxalone, MAOIs, linezolid, IV methylene blue); monitor and discontinue if suspected. Concomitant NNRTIs (eg, efavirenz, nevirapine, etravirine, delavirdine) or PIs (eg, atazanavir with/without ritonavir); monitor and use SL buprenorphine, if needed. Potentiated by CYP3A4 inhibitors (eg, macrolides, azole antifungals, protease inhibitors). Antagonized by CYP3A4 inducers (eg, rifampin, carbamazepine, phenytoin, phenobarbital). May antagonize diuretics; monitor. Paralytic ileus may occur with anticholinergics.

Brixadi Adverse Reactions

Adverse Reactions

Inj site pain/erythema/pruritus, headache, constipation, nausea, insomnia, urinary tract infection; respiratory depression, withdrawal signs/symptoms, orthostatic hypotension, hepatitis, hypersensitivity reactions.

Brixadi Clinical Trials

See Literature

Brixadi Note

Not Applicable

Brixadi Patient Counseling

See Literature