SUBLOCADE

What it is

SUBLOCADE is available as a buprenorphine modified release solution for injection in two strengths: 100 mg/0.5 mL and 300 mg/1.5 mL. It is a clear colourless to yellow to amber sterile solution for subcutaneous injection only that forms a depot upon administration designed to deliver buprenorphine at a controlled rate over a one-month period.

Approved indications

— Treatment of opioid dependence, within a framework of medical, social and psychological treatment.

Dosing overview

SUBLOCADE is for subcutaneous injection only and must not be administered intravenously, intramuscularly or intradermally. Patients appropriate for SUBLOCADE are adults, and only healthcare providers should prepare and administer it. Treatment with SUBLOCADE should be initiated only after establishing tolerability with at least one dose of a buprenorphine-containing product. The recommended dose of SUBLOCADE is 300 mg for the first two injections, with the second injection administered as early as 1 week and up to 1 month after the initial injection, based on patient need. After the first two injections, the recommended maintenance dosage of SUBLOCADE is 100 mg monthly. In clinical trials, the 300 mg per month maintenance dose did not provide additional efficacy compared to 100 mg per month and was associated with a higher incidence of adverse events; however, a monthly maintenance dosage of 300 mg may be considered in patients who tolerate SUBLOCADE but do not demonstrate a satisfactory clinical response. Maintenance doses should be administered with at least 26 days between injections.

Key safety warnings

Serious harm or death could result if SUBLOCADE is administered intravenously, as it forms a solid mass upon contact with body fluids and may cause occlusion, local tissue damage and thrombo-embolic events, including life threatening pulmonary emboli. Serious, life-threatening or fatal respiratory depression may occur with the use of SUBLOCADE. Be aware of situations which increase the risk of respiratory depression, and monitor patients closely, especially on initiation or following a dose increase. Concomitant use of opioids with benzodiazepines, gabapentinoids, antihistamines, tricyclic antidepressants, antipsychotics, cannabis or other central nervous system depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Although SUBLOCADE is indicated for the treatment of opioid dependence it still poses risks of hazardous and harmful use which can lead to overdose and death. The patient's ongoing risk of hazardous and harmful use should be monitored regularly during opioid substitution therapy with SUBLOCADE. Inadvertent intramuscular or intradermal administration may increase the likelihood of serious injection site reactions. In some post-marketing case reports injection site reactions have involved abscess, ulceration, and necrosis, with some cases resulting in surgical depot removal, debridement, antibiotic administration, and SUBLOCADE discontinuation.

Contraindications

Hypersensitivity to buprenorphine or any other component of the delivery system. Severe hepatic insufficiency (Child-Pugh C). Subjects less than 18 years of age. Severe respiratory insufficiency. Acute intoxication with alcohol or other CNS depressants.

PBS listing

SUBLOCADE 300 mg in 1.5 mL pre-filled syringe and 100 mg in 0.5 mL pre-filled syringe are each listed on the PBS with streamlined restriction at an ex-manufacturer price of A$351.12.

Regulatory history

SUBLOCADE was first registered on the ARTG on 18 July 2019, with both the 100 mg/0.5 mL and 300 mg/1.5 mL strengths registered as licence category RE (restricted entry) products. In November 2019, the PBAC recommended SUBLOCADE as a new listing for opiate use disorder under the Opiate Dependence Treatment Program with a Section 100 restricted benefit listing, cost-minimised against Buvidal on a cost per patient per day basis.