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Sublocade
buprenorphine
Black Box Warnings .
Appropriate Use
restricted distribution program (Sublocade 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 solid mass 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): 100 mg per 0.5 mL, 300 mg per 1.5 mL
Restricted Distribution in US
- [1-866-258-3905 or www.SublocadeREMS.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: strongly consider prescribing naloxone if risk of opioid overdose or accidental ingestion
opioid dependence, moderate-severe
- [buprenorphine-naive pts]
- Dose: 100-300 mg SC qmo; Start: 4 mg transmucosal buprenorphine test dose x1, then 300 mg SC x1 after 1h, then 300 mg SC x1 1wk-1mo after 1st dose, then 100 mg SC qmo, then may incr. to 300 mg SC qmo; Info: on day 1, may give up to 8 mg additional SL buprenorphine for withdrawal sx; space maint. injections at least 26 days apart
- [buprenorphine-experienced pts, conversion from SL buprenorphine 8-18 mg/day]
- Dose: 100-300 mg SC qmo; Start: 300 mg SC x2 doses 1wk-1mo apart, then 100 mg SC qmo, then may incr. to 300 mg SC qmo; Info: may give 100 mg SC x1 for 2nd dose if sx controlled after 1st dose of 300 mg SC x1; space maint. injections at least 26 days apart
- [buprenorphine-experienced pts, conversion from SL buprenorphine 20-24 mg/day]
- Dose: 100-300 mg SC qmo; Start: 300 mg SC x2 doses 1wk-1mo apart, then 100 mg SC qmo, then may incr. to 300 mg SC qmo; Info: space maint. injections at least 26 days apart
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 with extended-release injection
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.