Sublocade and Brixadi

Buprenorphine Extended-Release (XR) Injection

Brixadi®

Sublocade®

• Approved for the treatment of moderate to severe OUD for either:​
• Patients who have initiated treatment with a single dose of a transmucosal buprenorphine product.​
• Patients who are already being treated with buprenorphine.
• There is no naloxone contained in this medication.

• Before initiating, patient should be stabilized on transmucosal buprenorphine (8 mg-24 mg daily) for at least seven days.​
• There is insufficient data on its use in pregnancy.
• There is no naloxone contained in this medication.​

Inform patient:​

• Medication only available in specific pharmacies as IV self-administration can be fatal.​

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SOURCE: SAMHSA TIP 63; Sublocade® Package Insert​; Brixadi® Package Insert

BUP-XR

Serum Buprenorphine Levels

300/100 mg BUP/XR

300/300 mg BUP/XR

Buprenorphine concentration ((ng/mL)

Buprenorphine concentration ((ng/mL)

Time (weeks)

Time (weeks)

300/100mg Sublocade® or 64mg Brixadi®

300/300mg Sublocade® or 128mg Brixadi®

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SOURCE: DOI: 10.1007/s40262-020-00957-0​

BUP-XR Comparisons

Sublocade®

Brixadi®

Formulation & Administration

• Monthly injection subQ with a pre-filled syringe 19 gauge ⅝ inch needle

• Weekly or monthly injection subQ with a pre-filled syringe 23 gauge ½ inch needle ​

Warnings & Precautions

• Risk of serious injection site reactions increased with IM or ID administration

• Needle cap derived from rubber latex ​

REMS

• Required

• Required

Storage

• Refrigerate at 2 - 8oC ​(35 6 - 46 4oF)​
• Can be at Room Temperature for up to 7 days prior to admin

• Room Temperature 20 - 25oC ​(68 - 77oF)​

• Excursions permitted 15 - 30oC​ (59 - 86oF)

Injection Sites

• Buttock, thigh, abdomen, upper arm ​

• Abdomen ONLY

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SOURCE: Brixadi (buprenorphine)[package insert] Pharmaceutics International, Inc; Cockeyville (MD): 05/2023 Sublocade (buprenorphine)[package insert] Curia Global, Inc; Albany (NY): 08/2022

BUP-XR Comparisons

Brixadi® (monthly)

Sublocade®

Brixadi® (weekly)

Bridging Period

Patients Not Currently Receiving Buprenorphine Treatment

• 7 days of 8-24 mg/day transmucosal buprenorphine
• If tolerated without withdrawal administer 300 mg monthly subQ around umbilicus ONLY
• After 2 months administer maintenance dose of 100 mg monthly

• 7 days of 8-24 mg/day transmucosal buprenorphine
• No dosing recommendations

• 1 test dose of 4 mg transmucosal buprenorphine
• If tolerated without withdrawal administer weekly 16 mg subQ*
• Administer an additional 8 mg SubQ within 3 days of first dose for recommended dose

*Only able to switch to the weekly formulation while naive to treatment NOT approved for monthly.

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SOURCE: Brixadi (buprenorphine)[package insert] Pharmaceutics International, Inc; Cockeyville (MD): 05/2023 Sublocade (buprenorphine)[package insert] Curia Global, Inc; Albany (NY): 08/2022

Transitioning Periods for Brixadi®

Daily Dose of Sublingual Buprenorphine

Brixadi® (Weekly)​ (Q7 days +/-2 days)

Brixadi® (Monthly)​ (Q28 days +/- 7 days)

≤ 6 mg​

8 mg

8 - 10 mg​

16mg

64 mg

12 - 16 mg​

96 mg

24 mg

18 - 24 mg​

32 mg

128 mg

*If patients have precipitated withdrawal symptoms from the test dose, they do not qualify for weekly Brixadi

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SOURCE: Brixadi (buprenorphine)[package insert] Pharmaceutics International, Inc; Cockeyville (MD): 05/2023 Sublocade (buprenorphine)[package insert] Curia Global, Inc; Albany (NY): 08/2022

Administration Tips

Tips

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For first-timers who are very nervous:

• Consider offering an ice pack or topical spray on the injection site for 5 minutes or even a subcutaneous lidocaine injection.
• Trying to make the experience less painful for patients is very important, as it is their first experience with this intervention.

Remind patients:

• A subcutaneous bump will be palpable but usually not visible. Counsel patients that it will dissolve/shrink but can last for 6 weeks after administration and that there is no need to be alarmed.

Sublocade®

Brixadi®

Guide

Guide

Video

Video

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BUP-XR Limitations

Cost

Insurance Coverage

• Currently unknown at this time​
• Pricing of Sublocade® is about $243 USD for out-of-pocket spending with commercial insurance and Medicare insurance plans​

• Buvidal (Brixadi®) ≈ $800 USD ​
• Sublocade® ≈ $1,920 50 USD monthly