What should clinicians know about Brixadi (Subutex)?

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)


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


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


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


Injection site

Subcutaneous injection in the buttock, thigh, abdomen, or upper arm

Injection interval

Every 1 week or every 4 weeks


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.
A patient who misses a dose of Brixadi should receive the next dose as soon as possible. Brixadi (monthly) should be administered in 28-day intervals. Monthly dose may be administered up to 1 week before or after the monthly time point.


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


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.
**One Suboxone (buprenorphine/naloxone) 8 mg/2 mg sublingual tablet provides equivalent buprenorphine exposure to one Subutex (buprenorphine) 8 mg sublingual tablet or one Zubsolv (buprenorphine and naloxone) 5.7 mg/1.4 mg sublingual tablet 

FDA medication label

  • Information on this topic is found in the FDA medication label. Not all information in the FDA medication label is included here, and clinicians should read the entire FDA medication label before making treatment decisions.
  • Medication labels can be found by searching Drugs@FDA at the FDA website. Labels are also available using the Drugs@FDA app for Apple or Android devices. Labels change over time, and the current label should always be consulted.

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