What should clinicians know about Sublocade (Suboxone)?

Sublocade is a long-acting injectable (LAI) formulation of suboxone. It is administered subcutaneously in the abdomen. Sublocade is FDA-indicated to treat moderate to severe opioid use disorder in patients who have initiated treatment with buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days . It can be given monthly, a minimum of 26 days must be between doses.

Sublocade (Suboxone)
Indication(s)	Treatment of moderate to severe opioid use disorder in patients who have initiated treatment with buprenorphine-containing product, followed by dose adjustment for a minimum of 7 days.
Dosing available as prefilled syringes	100 mg/0.5 mL and 300 mg/1.5 mL
Needle Size and Gauge	19 gauge – 5/8 inches
Recommended starting and maintenance dose for ititiation fo treamtment following induction	300mg for the first 2 months and then 100mg monthly maintenance doses
Transition of patients established on long-term treatment with transmucosal buprenorphine	Patients established on long-term treatment with transmucosal burprenorphine (8-24 mg/day) and whose disease symptoms are controlled may be directly transitioned to Sublocade. See table below for dosing.
Dosing exclusions	N/A
Loading dose	300mg for first 2 months to load
Oral overlap	Not required
Storage	Refrigerated. Discard SUBLOCADE if left at room temperature for longer than 12 weeks.
Reconstitution or mixing	Remove Sublocade from the refrigerator prior to administration. Allow the product to come to room temperature (~15 minutes). Remove the foil pouch and safety needle from the carton. Open the pouch and remove the syringe. Remove the cap from the syringe and the safety needle supplied in the carton. Gently twist the needle clockwise until it is tight and firmly attached. Hold the syringe upright for several seconds to allow air bubbles to rise. Remove needle cover and slowly depress the plunger to push out the excess air from the syringe. If medication is seen at the needle tip, pull back slightly on the plunger to prevent medication spillage.
Injection site	Subcutaneous injection in the abdomen
Injection interval	Every 4 weeks, a minimum of 26 days between doses
Administration considerations	For abdominal subcutaneous injection only. Do not inject intravenously, intramuscularly, or intradermally
Timing variations	If needed an allowance for a 2-month interval possible - administer a single 300 mg dose to cover a two-month period then resume with 100 mg monthly
When a dose is missed	If a dose is missed, the next dose should be administered as soon as possible. Occasional delays in dosing up to 2 weeks are not expected to have a clinically significant impact on treatment effect.
REMS	Yes - www.SublocadeREMS.com

Transition of Patients Established on Long-Term Treatment with Transmucosal Buprenorphine to Sublocade in whose Disease Symptoms are Controlled
Oral Dose	LAI Dose
8 - 18 mg/day	1st dose: 300 mg 2nd dose: 100 mg* Maintenance dose 100 mg
20 - 24 mg/day	1st dose: 300 mg 2nd dose: 300 mg Maintenance dose: 100 mg
Reference: Reference: Sublocade package insert (Indivior Inc.) 2023. *For patients still experiencing craving or withdrawal symptoms after the initial 300 mg dose, consider giving 300 mg as the second dose

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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