Generic Name and Formulations:
Brodalumab 210mg/1.5mL; soln for SC inj; preservative-free.
Valeant Pharmaceuticals, Inc
Indications for SILIQ:
Moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy and unresponsive to other systemic therapies.
Give by SC inj into thigh, abdomen (except for area around navel), outer area of upper arm; rotate inj sites. 210mg at Weeks 0, 1, and 2 followed by 210mg every 2 weeks. If adequate response not achieved after 12–16 weeks, consider discontinuing.
Must enroll patients in the Siliq REMS program; advise patients of the risk of suicidal ideation and behavior. History of depression or suicidality. May increase risk of infections. Chronic or history of recurrent infection: consider the risks and benefits. If a serious infection develops or is not responding to standard therapy, monitor closely and discontinue until resolves. Evaluate for TB infection prior to initiating; monitor for active TB during and after therapy. Patients with active TB infection: do not initiate. History of latent or active TB; consider anti-TB therapy prior to initiation. Discontinue if Crohn’s disease develops. Pregnancy. Nursing mothers.
Avoid concomitant live vaccines. Concomitant CYP450 substrates with a narrow therapeutic index (eg, warfarin, cyclosporine); monitor and consider adjusting dose.
Arthralgia, headache, fatigue, diarrhea, oropharyngeal pain, nausea, myalgia, inj site reactions, influenza, neutropenia, tinea infections.
Single-dose prefilled syringes—2