Brixadi Generic Name & Formulations
Single-dose prefilled syringe (Weekly or Monthly)—1
Mechanism of Action
Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor.
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.
Brixadi Boxed Warnings
Risk of serious harm or death with IV administration. Brixadi REMS program.
Plasma protein bound: ~96%.
Fecal (69%), renal (30%). Half-life: 3–5 days (weekly); 19–26 days (monthly).
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
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
Brixadi Patient Counseling