Sublocade


In November 2017, the FDA approved Indivior’s Sublocade, an extended-release buprenorphine injection for the treatment of moderate-to-severe opioid use disorder in adult patients who have initiated treatment with a transmucosal buprenorphine-containing product. With its approval, Sublocade became the first once-monthly buprenorphine injection for the treatment of opiate use disorder. Sublocade is formulated in a biodegradable polymer and biocompatible solvent (Atrigel) designed to deliver the drug at a controlled rate over a one-month period after subcutaneous administration.


Sublocade is indicated for the treatment of moderate to severe opioid use disorder in those individuals who have initiated treatment with a transmucosal buprenorphine containing product (such as Suboxone), followed by dose adjustment for a minimum of 7 days. It should be used as part of a complete treatment plan that includes counseling and psychosocial support. Sublocade is only appropriate in adults who have initiated treatment on a transmucosal buprenorphine-containing product delivering the equivalent of 8 to 24 mg of buprenorphine daily. The patient may only be transitioned to this medication after a minimum of 7 days. Initiating treatment with Sublocade as the first buprenorphine product has not currently been studied.


Sublocade contains an extended-release formulation of buprenorphine, which is a partial agonist at the mu opioid receptor and an antagonist at the kappa opioid receptor. Buprenorphine displays high affinity at these receptions and therefore is not easily replaced by other opioids.


Only licensed health care providers should prepare and administer Sublocade. Additionally, Sublocade is subject to a risk evaluation and mitigation strategy (REMS) program that includes a restricted distribution system to ensure that Sublocade is only administered by a licensed healthcare provider. Therefore, this is not a medication that would typically be dispensed through a retail pharmacy; it is shipped directly to our office for administration.


The recommended dose of Sublocade following induction and dose adjustment with transmuscosal buprenorphine is 300 mg monthly by subcutaneous injection in the abdominal region for the first 2 months followed by a maintenance dose of 100 mg monthly. The maintenance dose may be increased to 300 mg monthly for patients who tolerate the 100 mg dose, but do not demonstrate a satisfactory clinical response, as evidenced by self-reported illicit opioid use or urine drug screens positive for illicit opioid use.


A patient who misses a dose should receive the next dose as soon as possible, with the following dose given no less than 26 days later. Occasional delays in dosing up to 2 weeks are not expected to have a clinically significant impact on treatment effect.


As with all medications used in medication assisted treatment (MAT), buprenorphine is prescribed as part of a comprehensive treatment plan that includes counseling and participation in social support programs; this is a absolute requirement for participation in the MAT program at Pathways Addiction Recovery, with no exceptions given. Use of buprenorphine alone, without counseling and participation in social support systems is not considered an appropriate form of treatment.


Understanding that patients often have challenges accessing treatment, Indivior, the manufacturer of Sublocade, has also launched INSUPPORT™, an interactive service to help streamline the access processes on behalf of patients seeking treatment with all Indivior products. INSUPPORT provides online and telephone resources for both patients and healthcare providers, including a copay assistance program, provider locator tool and information for providers' office staff.


Sublocade is not right for everyone. There are significant risks from undergoing Sublocade treatment, including risk of opioid overdose, severe reaction at the injection site and sudden opioid withdrawal. Sublocade should not be used in conjunction with certain other medications. Contact us today to find out if Sublocade may be right for you. For more information on Sublocade and how it works in the brain, a comprehensive educational brochure can be downloaded HERE.



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