What is the recommended dosing protocol for Sublocade (buprenorphine) in a patient with moderate to severe opioid use disorder?

Sublocade Dosing Protocol for Opioid Use Disorder

Sublocade (buprenorphine extended-release) should be initiated with two consecutive monthly 300 mg subcutaneous injections, followed by monthly maintenance doses of either 100 mg or 300 mg based on patient response, with higher 300 mg maintenance doses specifically indicated for patients who inject opioids. 1

Critical Pre-Treatment Requirements

Patients must be stabilized on sublingual buprenorphine (typically 8-24 mg daily) for at least 7 days before receiving the first Sublocade injection to prevent precipitated withdrawal. 2, 3 The American College of Physicians explicitly advises against administering Sublocade to patients not already receiving sublingual buprenorphine, as buprenorphine's high mu-receptor affinity will displace other opioids and trigger severe withdrawal. 2

Standard Dosing Algorithm

Induction Phase (Months 1-2)

• Month 1: 300 mg subcutaneous injection 1, 4
• Month 2: 300 mg subcutaneous injection 1, 4

Maintenance Phase (Month 3 onwards)

For non-injecting opioid users:

• 100 mg monthly is equally effective as 300 mg 1
• Either dose maintains therapeutic buprenorphine plasma concentrations ≥2 ng/mL 3

For patients who inject opioids:

• 300 mg monthly maintenance dose is strongly recommended 1
• This population requires higher buprenorphine plasma concentrations to achieve comparable abstinence rates 1
• The 300 mg dose provides clinically meaningful improvements in treatment retention and opioid abstinence compared to 100 mg in this high-risk population 1

Injection Site Options

Sublocade can be administered subcutaneously in four locations, offering flexibility for chronic treatment: 3

• Abdomen (FDA-approved primary site)
• Upper arm (39% higher Cmax versus abdomen, but no increased adverse events)
• Thigh (52% higher Cmax versus abdomen, but no increased adverse events)
• Buttocks (comparable Cmax to abdomen)

All sites maintain therapeutic plasma concentrations and have comparable safety profiles. 3

Safety and Tolerability Profile

Injection-site reactions are the most common adverse events (81% of patients), but are typically mild-to-moderate and rapidly resolving. 5, 4 Pain at the injection site occurs in approximately 27% of adverse events. 5

The incidence of treatment-emergent adverse events decreases substantially in the second 6 months of treatment compared to the first 6 months, indicating improved tolerability with continued use. 4

Clinical Outcomes

After 12 months of treatment, 62-76% of patients achieve opioid abstinence, with 12-month retention rates of approximately 50%. 4 In head-to-head comparison with daily methadone or sublingual buprenorphine, Sublocade delivers superior abstinence from non-medical opioids (adjusted mean 123 days versus 104 days over 24 weeks). 5

Critical Management Considerations

Patients on Sublocade require higher doses of full agonist opioids (morphine, fentanyl, oxycodone, hydromorphone) for acute pain management due to competitive receptor binding. 2 Careful monitoring for respiratory depression is essential when combining full agonists with buprenorphine. 2

Avoid mixed agonist-antagonist opioids (pentazocine, nalbuphine, butorphanol) during Sublocade treatment, as they will precipitate withdrawal by displacing buprenorphine from mu-receptors. 2

Cost-Effectiveness Considerations

Sublocade demonstrates cost-effectiveness (dominance over standard-of-care) specifically in two populations: 5

• Patients with more severe opioid use disorder at baseline
• Patients whose current treatment episode exceeds 28 days

In these subgroups, Sublocade is both more effective and less costly from a societal perspective. 5