Brixadi is a long-acting injectable (LAI) formulation of Subutex. It is administered subcutaneously in the gluteal, thigh, abdomen or upper arm. Brixadi is FDA-indicated to treat 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 (Subutex) | |
Indication(s) | 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 buprenophine |
Dosing available as prefilled syringes | Weekly prefilled syringe: 8 mg/0.16 mL, 16 mg/ 0.32 mL, 24 mg/0.48 mL, 32 mg /0.64 mL Monthly prefilled syringe: 64 mg/0.18 mL, 96 mg/0.27 mL, 128 mg/0.36 mL |
Needle Size and Gauge | 23 gauge - ½ inch |
Recommended starting and maintenance dose for patients not currently receiving Buprenorphine treatment | For patients not currently receiving buprenorphine treatment, being with a test dose of 4 mg transmucosal buprenorphine to establish buprenorphine is tolerated without precipitated withdrawal. Initial dose of 16mg sq Brixadi weekly (after tolerability established) Administer an additional dose of 8 mg BRIXADI (weekly) within 3 days of the first dose to achieve the recommended 24 mg BRIXADI (weekly) dose. If needed, during this first week of treatment, administer an additional 8 mg dose of BRIXADI (weekly), waiting at least 24 hours after the previous injection, for a total weekly dose of 32 mg BRIXADI (weekly). Continue at established dose not to exceed 32mg weekly. Administer subsequent Brixadi (weekly) injections based on the total weekly dose that was established during Week One. Dosage adjustments can be made at weekly appointments with the maximum Brixadi (weekly) dose being 32 mg. |
Patients switching from transmucosal buprenorphine-containing products to brixadi | See table below on daily dose of sublingual buprenorpine to Brixadi (weekly) or Brixadi (monthly) |
Patients transitioning between brixadi (weekly) and brixadi (monthly) | Patients may be transitioned from weekly to monthly or from monthly to weekly dosing of Brixadi based on clinical judgement. (See table below) |
Dosing exclusions | N/A |
Loading dose | See starting/maintenance dose |
Oral overlap | Not required |
Establishing tolerability | A single test dose of 4mg transmucosal buprenorphine or has already been treated with buprenorphine |
Storage | Store at room temperature at 20°C to 25°C (68°F to 77° F); with excursions permitted at 15°C to 30° C (59°F to 86°F) |
Reconstitution or mixing | N/A |
Injection site | Subcutaneous injection in the buttock, thigh, abdomen, or upper arm |
Injection interval | Every 1 week or every 4 weeks |
Preparation | |
Administration considerations | The upper arm site should only be used after steady state has been achieved (4 consecutive doses). Brixadi should not be administered to the same site of injection for at least 8 weeks for Brixadi (weekly). No injection site rotation is required for Brixadi (monthly). Should be injected slowly, Discard if the liquid contains visible particles or is cloudy. |
Timing variations | Patients currently being treated with a transmucosal buprenorphine-containing product may be switched directly to either BRIXADI (weekly) or BRIXADI (monthly). |
When a dose is missed | If a dose is missed, the next dose should be administered as soon as possible. Next dose should be given as soon as possible; Brixadi (weekly) should be administered in 7-day intervals. Weekly dose may be administered up to 2 days before or after the weekly time point. |
REMS | Yes - www.BRIXADIREMS.com |
Dose Conversion of Oral Subutex, Subocone, or generic product equivelants to Brixadi | ||
Daily Sublingual Dose | Brixadi Weekly Dose | Brixadi Monthly Dose |
≤ 6mg | 8 mg | N/A |
8 - 10 mg | 16 mg | 64 mg |
12 - 16 mg | 24 mg | 96 mg |
18 - 24 mg | 32 mg | 128 mg |
Reference: BRIXADI. Prescribing information. Braeburn Inc; 2023. | ||
FDA medication label
If you would like more information on this topic, or would like to provide any feedback, please send us a message using our consultation system. Be sure to let us know about which tip you are writing. We would love to hear from you, and the consultation system is free to use and confidential. Thank you!