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Brixadi
buprenorphine
Black Box Warnings .
Appropriate Use
restricted distribution program (Brixadi REMS) due to risk of serious harm or death from IV self-admin; healthcare settings and pharmacies must be certified and meet all requirements
Not for IV Use
serious harm or death could result from IV admin; buprenorphine extended-release injection forms a liquid crystalline gel upon contact w/ body fluids and may cause occlusion, local tissue damage, and thrombo-emoblic events, incl. life-threatening pulmonary emboli, if administered IV
Adult Dosing .
Dosage forms: INJ (pre-filled syringe, weekly): 8 mg per 0.16 mL, 16 mg per 0.32 mL, 24 mg per 0.48 mL, 32 mg per 0.64 mL; INJ (pre-filled syringe, monthly): 64 mg per 0.18 mL, 96 mg per 0.27 mL, 128 mg per 0.36 mL
Restricted Distribution in US
- [1-833-274-9234 or www.BRIXADIREMS.com]
- Info: healthcare settings and pharmacies that order and dispense buprenorphine extended-release injection must be certified and verify the drug is dispensed to a healthcare provider for admin. by a healthcare provider and not dispensed to the pt; certified healthcare settings and pharmacies must not distribute, transfer, loan, or sell buprenorphine extended-release injection
Special Note
- [prescribing info]
- Info: weekly form not interchangeable w/ monthly form due to pharmacokinetic profiles; do not combine doses of weekly form to yield monthly dose; do not divide doses; strongly consider prescribing naloxone if risk of opioid overdose or accidental ingestion
opioid dependence, moderate-severe
- [buprenorphine-naive pts, weekly form]
- Dose: 24 mg SC qwk; Start: after 4 mg transmucosal buprenorphine test dose; 16 mg SC x1 on day 1, then 8 mg SC x1 w/in 3 days of 1st dose; Max: 32 mg/wk; Info: may give additional 8 mg SC x1 at least 24h after last dose during 1st wk of tx based on clinical response
- [buprenorphine-experienced pts, conversion from SL buprenorphine <7 mg/day, weekly form]
- Dose: 8 mg SC qwk; Max: 32 mg/wk; Info: may give additional 8 mg SC x1 during dosing interval based on clinical response
- [buprenorphine-experienced pts, conversion from SL buprenorphine 8-10 mg/day, weekly form]
- Dose: 16 mg SC qwk; Max: 32 mg/wk; Info: may give additional 8 mg SC x1 during dosing interval based on clinical response
- [buprenorphine-experienced pts, conversion from SL buprenorphine 8-10 mg/day, monthly form]
- Dose: 64 mg SC qmo; Max: 128 mg/mo; Info: may give additional 8 mg SC (weekly form) x1 during dosing interval based on clinical response
- [buprenorphine-experienced pts, conversion from SL buprenorphine 12-16 mg/day, weekly form]
- Dose: 24 mg SC qwk; Max: 32 mg/wk; Info: may give additional 8 mg SC x1 during dosing interval based on clinical response
- [buprenorphine-experienced pts, conversion from SL buprenorphine 12-16 mg/day, monthly form]
- Dose: 96 mg SC qmo; Max: 128 mg/mo; Info: may give additional 8 mg SC (weekly form) x1 during dosing interval based on clinical response
- [buprenorphine-experienced pts, conversion from SL buprenorphine 18-24 mg/day, weekly form]
- Dose: 32 mg SC qwk; Max: 32 mg/wk; Info: may give additional 8 mg SC x1 during dosing interval based on clinical response
- [buprenorphine-experienced pts, conversion from SL buprenorphine 18-24 mg/day, monthly form]
- Dose: 128 mg SC qmo; Max: 128 mg/mo; Info: may give additional 8 mg SC (weekly form) x1 during dosing interval based on clinical response
renal dosing
- [not defined]
- renal impairment: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- moderate-severe impairment: avoid use, dose adjustment not possible w/ extended-release injection
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.