Sublocade is the first once-monthly injectable form of buprenorphine approved for the treatment of moderate-to-severe opioid use disorder. The patient can be transitioned to Sublocade after receiving a stable dose of a transmucosal buprenorphine-naloxone product for at least a week. The drug must be administered subcutaneously by a health care professional. A depot is created from the injection that slowly releases the drug. Sublocade must be prescribed as part of a Risk Evaluation and Mitigation Strategy (REMS) to ensure that it is not distributed directly to patients. The drug should be used in conjunction with counseling and psychosocial supportive therapy.

Two clinical studies of Sublocade were conducted in 848 adults diagnosed with moderate-to-severe opioid use disorder who had been stabilized on buprenorphine-naloxone sublingual film. Patients treated with Sublocade remained opioid free longer than patients who did not receive the drug. No one younger than 18 or older than 65 was included in the clinical trials. Postmarketing trials will determine if Sublocade can be given without a dose stabilization period of sublingual buprenorphine.

The most common adverse effects of Sublocade include nausea, vomiting, headache, drowsiness, injection site pain, injection site pruritus, and abnormal liver function tests. Most of these are similar to the adverse effects of other forms of buprenorphine. Other warnings and precautions are also similar to those of other buprenorphine products.

Sublocade should not be started in patients with moderate-to-severe hepatic disease. These patients do not metabolize Sublocade normally; therefore, the half-life of the drug is longer in these patients, and circulating levels of the drug are higher.

Nurses or NPs who administer Sublocade should confirm they are injecting it into the subcutaneous tissue. Accidental administration into a vessel will cause the depot that forms to block blood flow. Serious harm, including occlusion, local tissue damage, thromboembolic events, or death could result from this blockade.

For complete prescribing information for Sublocade, see http://www.accessdata.fda.gov/drugsatfda_docs/label/2017/209819s000lbl.pdf.